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FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT
(Senate - May 24, 2012)

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[Pages S3536-S3608]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

  The ACTING PRESIDENT pro tempore. Under the previous order, the 
Senate will resume consideration of S. 3187, which the clerk will 
report.
  The assistant legislative clerk read as follows:

       A bill (S. 3187) to amend the Federal Food, Drug, and 
     Cosmetic Act to revise and extend the user-fee programs for 
     prescription drugs and medical devices, to establish user-fee 
     programs for generic drugs and biosimilars, and for other 
     purposes.

  Pending:

       Durbin/Blumenthal amendment No. 2127, to require 
     manufacturers of dietary supplements to register dietary 
     supplement products with the Food and Drug Administration.
       Sanders amendment No. 2109, to revoke the exclusivity of 
     certain entities that are responsible for violations of the 
     Federal Food, Drug, and Cosmetic Act, the False Claims Act, 
     and other certain laws.
       Coburn/Burr amendment No. 2131, to require an independent 
     assessment of the Food and Drug Administration's review of 
     drug applications.
       Coburn/Burr amendment No. 2132, to provide that a portion 
     of the performance awards of each employee of the Center for 
     Drug Evaluation and Research, the Center for Devices and 
     Radiological Health, and the Center for Biologics Evaluation 
     and Research be connected to an evaluation of the employee's 
     contribution to goals under the user fee agreements.
       Burr/Coburn amendment No. 2130, to ensure transparency in 
     Food and Drug Administration user fee agreement negotiations.
       Murkowski amendment No. 2108, to prohibit approval by the 
     Food and Drug Administration of genetically engineered fish 
     unless the National Oceanic and Atmospheric Administration 
     concurs with such approval.
       Paul amendment No. 2143, to amend the Federal Food, Drug, 
     and Cosmetic Act concerning claims about the effects of foods 
     and dietary supplements on health-related conditions and 
     disease, to prohibit employees of the Food and Drug 
     Administration from carrying firearms and making arrests 
     without warrants, and to adjust the mens rea of certain 
     prohibited acts under the Federal Food, Drug, and Cosmetic 
     Act to knowing and willful.

  Mr. REID. Mr. President, I suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. McCAIN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.


                           Amendment No. 2107

  Mr. McCAIN. I ask unanimous consent to call up amendment No. 2107 and 
make it pending.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Arizona [Mr. McCain] proposes an amendment 
     numbered 2107.

  Mr. McCAIN. Mr. President, I ask unanimous consent that the reading 
of the amendment be dispensed with.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  The amendment is as follows:

     (Purpose: To allow the importation by individuals of safe and 
                     affordable drugs from Canada)

       At the end of title XI, add the following:

     SEC. 11__. SAFE AND AFFORDABLE DRUGS FROM CANADA.

       Chapter VIII of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 381 et seq.), as amended by this Act, is further 
     amended by adding at the end the following:

     ``SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIPTION DRUGS 
                   FROM CANADA.

       ``(a) In General.--Notwithstanding any other provision of 
     this Act, not later than 180 days after the date of enactment 
     of this section, the Secretary shall promulgate regulations 
     permitting individuals to safely import into the United 
     States a prescription drug (other than a controlled 
     substance, as defined in section 102 of the Controlled 
     Substances Act) that--
       ``(1) is purchased from an approved Canadian pharmacy;
       ``(2) is dispensed by a pharmacist licensed to practice 
     pharmacy and dispense prescription drugs in Canada;
       ``(3) is purchased for personal use by the individual, not 
     for resale, in quantities that do not exceed a 90-day supply;
       ``(4) is filled using a valid prescription issued by a 
     physician licensed to practice in the United States; and
       ``(5) has the same active ingredient or ingredients, route 
     of administration, dosage form, and strength as a 
     prescription drug approved by the Secretary under chapter V.
       ``(b) Approved Canadian Pharmacy.--
       ``(1) In general.--In this section, an approved Canadian 
     pharmacy is a pharmacy that--
       ``(A) is located in Canada; and
       ``(B) that the Secretary certifies--
       ``(i) is licensed to operate and dispense prescription 
     drugs to individuals in Canada; and
       ``(ii) meets the criteria under subsection (c).
       ``(2) Publication of approved canadian pharmacies.--The 
     Secretary shall publish on

[[Page S3537]]

     the Internet Web site of the Food and Drug Administration a 
     list of approved Canadian pharmacies, including the Internet 
     Web site address of each such approved Canadian pharmacy, 
     from which individuals may purchase prescription drugs in 
     accordance with subsection (a).
       ``(c) Additional Criteria.--To be an approved Canadian 
     pharmacy, the Secretary shall certify that the pharmacy--
       ``(1) has been in existence for a period of at least 5 
     years preceding the date of enactment of this section and has 
     a purpose other than to participate in the program 
     established under this section;
       ``(2) operates in accordance with pharmacy standards set 
     forth by the provincial pharmacy rules and regulations 
     enacted in Canada;
       ``(3) has processes established by the pharmacy, or 
     participates in another established process, to certify that 
     the physical premises and data reporting procedures and 
     licenses are in compliance with all applicable laws and 
     regulations, and has implemented policies designed to monitor 
     ongoing compliance with such laws and regulations;
       ``(4) conducts or commits to participate in ongoing and 
     comprehensive quality assurance programs and implements such 
     quality assurance measures, including blind testing, to 
     ensure the veracity and reliability of the findings of the 
     quality assurance program;
       ``(5) agrees that laboratories approved by the Secretary 
     shall be used to conduct product testing to determine the 
     safety and efficacy of sample pharmaceutical products;
       ``(6) has established, or will establish or participate in, 
     a process for resolving grievances and will be held 
     accountable for violations of established guidelines and 
     rules;
       ``(7) does not resell products from online pharmacies 
     located outside Canada to customers in the United States; and
       ``(8) meets any other criteria established by the 
     Secretary.''.

  Mr. McCAIN. Mr. President, this is not a new issue. This has been 
before this body on several occasions. I want to assure my colleagues 
that if the lobbyists for the pharmaceutical companies in this town are 
able to block this, we will be revisiting this issue. This is an issue 
of fundamental fairness and decency and giving Americans the 
opportunity to have access to very important medication that in many 
cases is lifesaving. It has been blocked by one of the most powerful 
lobbies in Washington, that of the pharmaceutical companies.
  For years, along with many other Senators and the current occupant of 
the White House--the President of the United States, when he was a U.S. 
Senator, supported this amendment. I would love to see the 
administration weigh in and take the same position that then-Senator 
Obama took on this issue of basic and fundamental decency and fairness 
to people who are badly in need of medicine to, in many cases, 
literally save their lives.
  Industry opponents of the comprehensive importation proposals have 
found various ways to confuse the issue, raise red herrings about 
safety, or cut secret deals to block passage of reasonable and widely 
supported prescription drug importation programs.
  Let me give an example--this recently came up--of the activities of 
the pharmaceutical companies in the formulation of ObamaCare. ``GOP 
probe uncovers deal between Obama and drug companies,'' by Philip 
Klein, the senior editorial writer of the Washington Examiner.

       Three years ago, President Obama cut a secret deal with 
     pharmaceutical company lobbyists to secure the industry's 
     support for his national health care law. Despite Obama's 
     promises during his campaign to run a transparent 
     administration, the deal has been shrouded in mystery ever 
     since. But internal emails obtained by House Republicans now 
     provide evidence that a deal was struck and GOP investigators 
     are promising to release more details in the coming weeks.
       What the hell?'' White House Deputy Chief of Staff Jim 
     Messina, who is now Obama's campaign manager, complained to a 
     lobbyist for the Pharmaceutical Research and Manufacturers of 
     America (PhRMA) in January 15, 2010 email. ``This wasn't part 
     of our deal.''
       This reference to ``our deal'' came two months before the 
     final passage of Obamacare in an email with the subject line, 
     ``FW: TAUZIN EMAIL.''
       At the time Billy Tauzin was president and CEO of PhRMA--

  And I might add, one of the highest paid lobbyists in history, 
millions of dollars--

     the e-mail was uncovered as a part of Obama's closed-door 
     health care negotiations that was launched by the House 
     Energy and Commerce Committee oversight panel:
       ``In the coming weeks the Committee intends to show what 
     the White House agreed to do as part of its deal with the 
     pharmaceutical industry and how the full details of this 
     agreement were kept from both the public and the House of 
     Representatives,'' the committee's Republican members wrote 
     in a memo today.
       On June 20, 2009, Obama released a terse 296-word statement 
     announcing a deal between pharmaceutical companies and the 
     Senate that didn't mention any involvement by the White 
     House.
       ``The investigation has determined that the White House, 
     primarily through Office of Health Reform Director Nancy Ann 
     DeParle and Messina, with involvement from Chief of Staff 
     Rahm Emmanuel, was actively engaged in these negotiations 
     while the role of Congress was limited,'' the committee 
     members wrote. For example, three days before the June 20th 
     statement, the head of PhRMA--

  That is Mr. Tauzin--

     promised Messina, ``we will deliver a final yes to you by 
     morning.''
       Meanwhile, Ms. DeParle all but confirmed that half of the 
     Legislative Branch was shut out in an e-mail to a PhRMA 
     representative: ``I think we should have included the House 
     in the discussions, but maybe we never would have gotten 
     anywhere if we had.''

  What went on in the formulation of ObamaCare is still one of the 
worst, sleaziest exercises I have seen in my many years here, and this 
involvement by the pharmaceutical companies was probably the most 
egregious. All this amendment does is allow U.S. consumers who need 
more affordable prescription drug options to either go without their 
medications or pay higher prices than they could get from legitimate 
Canadian pharmacies. But that is not a reason. It is not a reason for 
us to stop fighting for those in the United States who need more 
affordable prescription medications.
  There are Americans in this country today who cannot afford their 
medications. They have a choice between eating or taking their 
prescription drugs. Meanwhile, there is a way for them to get much 
cheaper drugs, and this amendment does that.
  We will hear from the pharmaceutical company supporters in the Senate 
who will talk about safety and how Canadians don't have the same 
standards we do. Really? Do we really believe the Canadian regulations 
and oversight are any better or worse than the United States? To ensure 
that U.S. patients have at least one option, this amendment takes a 
very narrow approach to safe importation by focusing on legitimate 
Canadian pharmacies.
  Under this amendment the Secretary of Health and Human Services will 
certify ``approved Canadian pharmacies'' based on certain safety and 
quality criteria. To ensure that patients are not exposed to unsafe 
medications ``approved Canadian pharmacies'' can only sell drugs to 
U.S. customers that are the same as U.S. approved drugs. To protect 
U.S. patients against rouge distributors, a list of approved Canadian 
pharmacies must be published by the Secretary of Health and Human 
Services so Americans know which Canadian pharmacies are legitimate.
  The cost of health care, including prescription drugs, continues to 
increase. However, there is nothing in the underlying FDA bill that 
will bring down the cost of prescription drugs. I wonder if the bill 
should be enacted when it doesn't do anything to address costs. The 
quality of pharmaceuticals in this country is outstanding, and I 
recognize that. But don't we all know how expensive it is?
  For example, don't we know that in the United States of America, 
Nexium, 20-milligram, 30 tabs, is $195.99. The Canadian brand is 
$108.55, and Canadian generic is $69. For Plavix, the U.S. brand is 
$195; the Canadian brand, $132.
  I am sure many Americans whose health coverage does not include these 
very expensive pharmaceuticals would be eager to take advantage of the 
same quality brand of prescription drugs that are available at these 
pharmacies in Canada.
  As we all know, unemployment remains over 8 percent, and millions of 
families have mothers and fathers who remain unemployed or 
underemployed and have no health insurance coverage. But the unemployed 
and uninsured still have health conditions, and they need medications. 
Millions continue to search for more affordable ways to get their 
needed prescription drugs.
  Unfortunately, in my State many of my fellow citizens who cannot 
afford it go to Mexico to get drugs, and I cannot guarantee what they 
purchase there will always be what it is purported to be. That is not a 
criticism of my friends south of the border. But the fact is in Canada 
they have the same kind of process we do. Despite there being no 
official program to import medications from Canada, approximately 1 
million U.S. consumers use

[[Page S3538]]

their own money to safely get their medications from legitimate 
Canadian pharmacies.
  In Arizona, over 20,000 patients purchase their medications safely 
from Canadian pharmacies. In Florida over 85,000 patients purchase 
their medications safely from Canadian pharmacies. A recent study from 
Roger Bate, an AEI scholar, confirms that in drugs dispensed from 
legitimate Canadian pharmacies there was no failure of authenticity 
between drug samples obtained online from U.S. pharmacies compared to 
the same drug from Canadian pharmacies. Within the verified pharmacies 
U.S. prices on average were 52.5 percent higher than Canadian pharmacy 
prices. In other words, the drugs from Canadian pharmacy sites are the 
same dosage, form, and potency as drugs in the United States, only much 
less expensive.
  The drugs are the same as I mentioned. This amendment doesn't 
authorize insurance companies, huge pharmacy chains, or drug 
wholesalers to import massive quantities into the U.S. system. This is 
about safely allowing uninsured, unemployed, and the underemployed to 
individually import these drugs they need.
  So, please, somebody explain to me how we tell the struggling family 
who needs their medications that they cannot use their own money to get 
the same drug from legitimate Canadian pharmacies where the costs can 
be more than 50 percent lower than U.S. prices. It is not about the 
alarms of safety because this amendment requires the Secretary of 
Health and Human Services to promulgate regulations permitting 
individuals to safely import medications from Canada, and the following 
safety criteria must be met for a patient to import drugs from FDA-
approved Canadian pharmacies: The prescribed drug must be dispensed by 
a licensed Canadian pharmacist; the prescribed drug must be for 
personal use in quantities that don't exceed a 90-day supply; the 
prescribed drug must be dispensed in accordance with a valid 
prescription issued by a physician licensed to practice in the United 
States; the imported drug must have ``the same active ingredient or 
ingredients, route of administration, dosage form, and strength as a 
prescription drug approved by the Secretary.''

  The amendment recognizes that approved Canadian pharmacies meeting 
safety criteria can and should provide needed alternatives to U.S. 
patients using their own money to affordably obtain their medications. 
The Secretary is required to publish on the FDA Web site a list of 
``approved Canadian pharmacies'' that meet the following stringent 
criteria: The pharmacy has been in existence for 5 years prior to 
enactment of the program and has a purpose other than to participate in 
the U.S.-Canadian safe drug importation program; the pharmacy operates 
in accordance with provincial pharmacy rules and regulations; the 
pharmacy complies with all inspection and data reporting procedures; 
the pharmacy agrees that labs approved by the Secretary shall be used 
to conduct product testing to determine the safety and efficacy of 
sample pharmaceutical products; the pharmacy does not resell products 
from online pharmacies located outside Canada to consumers in the 
United States.
  Safe drug importation is a bipartisan issue. People in all of our 
States are still struggling with family budgets, and the Senate cannot 
do anything to give patients more choices about where they can get 
their needed drugs because the drug industry opposes allowing 
individual Americans to use their own money to safely get the same 
drugs from Canada, and it doesn't make sense.
  Just a word about the types of medications that are eligible. I have 
been asked by colleagues whether biologic medicines can be part of the 
program. The answer is not unless they can be safely imported under the 
provisions of the amendment and regulations issued by the Secretary.
  The amendment doesn't discriminate against the type of conditions or 
medicines that patients should be able to safely import under this 
program. Not all biologics are the same. Some biologic medicines are 
available in capsules; others are injectable medications that require 
refrigeration. Some injectables don't require refrigeration and are 
shipped to patients throughout the United States every day.
  I don't believe U.S. patients should be necessarily prevented from 
saving money on biologics. If a biologic medicine cannot meet the 
various safety provisions in the amendment, it should not be eligible. 
If it can meet the requirements of the amendment, then a biologic can 
be available to U.S. patients.
  If the past is a prologue, then obviously this amendment will go 
down. Then after this amendment is rejected, I hope none of my 
colleagues have any curiosity about the way the American people feel 
about us; about the incredible, inordinate, illegitimate, outrageous 
influence of the pharmaceutical companies in America over the average 
American citizen. American citizens should be able to purchase 
pharmaceuticals from an approved pharmacy in Canada that many times is 
saving them half the money.
  I am sure the distinguished chairman, my friend from Iowa, knows how 
many families do not have prescription drug coverage who are making a 
choice today between eating and medicine. What are we going to do? We 
are going to turn down this commonsense amendment.
  Congratulations ahead of time to the corrupt pharmaceutical companies 
and their influence in the United States Senate and Capitol.
  Mr. President, I ask for the yeas and nays on the amendment.
  The ACTING PRESIDENT pro tempore. Is there a sufficient second?
  There appears to be a sufficient second.
  The yeas and nays were ordered.
  Mr. McCAIN. Mr. President, I suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. HARKIN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. HARKIN. Mr. President, I understand the Republican leader is 
about to come to the floor to give his leader remarks.
  I just wish to let Senators know we are moving ahead on the bill. 
Senator McCain just brought up his amendment and spoke about it. I know 
there are some who want to speak in opposition to the McCain amendment. 
We still have amendment No. 2111 by Senator Bingaman to be called up. 
We have two amendments, No. 2146 and No. 2145, by Senator Portman that 
need to be called up. I ask Senators to please come over and call up 
their amendments so we can debate them and move ahead to expeditiously 
voting on those amendments and final passage of the bill.
  I see the Republican leader is on the floor, and I yield the floor.


                   Recognition of the Minority Leader

  The ACTING PRESIDENT pro tempore. The Republican leader is 
recognized.
  Mr. McCONNELL. Mr. President, I think we are under a time agreement 
on the bill; is that correct?
  The ACTING PRESIDENT pro tempore. The leader is correct.
  Mr. McCONNELL. I wish to proceed under my leader time.
  The ACTING PRESIDENT pro tempore. The Senator has that right.


                      Student Loan Interest Rates

  Mr. McCONNELL. Mr. President, today we will once again attempt to 
prevent student loan interest rates from going up. This problem could 
have been solved literally weeks ago, but our friends on the other side 
were not interested in solving the problem; they wanted a scapegoat 
more than a solution.
  So this afternoon we will vote on two different ways of addressing 
the issue. The Democratic plan is designed to fail. In order to cover 
the cost of a temporary rate freeze that both parties actually want, 
they propose to divert $6 billion from Medicare and to raise taxes on 
small businesses, hurting the very companies we are counting on to hire 
today's college graduates. They have known for months that we would not 
support this tax hike and that it couldn't pass this Chamber or the 
House of Representatives. It has already failed, but they are proposing 
it anyway, for a second time.
  If our Democratic friends would allow it, the chairman and ranking

[[Page S3539]]

member could write a bill that could actually pass. But since passage 
isn't their goal, our friends on the other side huddled behind closed 
doors, out of sight of the public and the press, and produced the tax 
hike instead of letting the committee actually do its work.
  We already know how this story is going to end. We know exactly, 
already, how the story will end. So why are the Democrats forcing us to 
vote on their failed proposal yet again? Because, as I have said, they 
are more interested in drawing our opposition--of trying to create a 
bad guy--than in actually solving the problem.
  When it comes to college graduates today, the bigger issue is the 
President's economic agenda which has created an environment in which 
most of them can't find a decent job. So I can understand why our 
Democratic friends want to change the subject, but if we are actually 
going to do something to solve the problem, we are going to need to get 
past the political theatrics.
  If Senate Democrats reject the bipartisan fix the House already 
passed--one that doesn't raise taxes or divert a single dollar away 
from Medicare and is an offset they have used themselves before--then I 
hope they will turn around and work with us on a bipartisan fix that 
doesn't tax small businesses--a proposal that is actually designed to 
pass and become law.
  But let's be clear about something. The real issue isn't the fact 
that certain students are going to see an interest rate hike because we 
will address that concern; it is that so many young people today can't 
find a job that will enable them to pay off their loans in the first 
place. That is the much larger problem. The solution is a progrowth 
agenda that would make it easier for U.S. businesses to hire, not a tax 
hike that will actually make it harder for them to hire.
  In the short term, Republicans are ready to work to offer this 
temporary relief, but we are still waiting on the Democratic leadership 
to propose a solution of their own that can actually pass either one or 
two Chambers of Congress.
  I would, once again, urge the President to get involved. If the 
President has time to run around to late-night comedy shows and college 
campuses talking about this issue, then he can pick up the phone and 
work out a solution with Democrats in the Senate.
  Last week at the White House, I pressed the President to get involved 
in order to prevent the student interest rates from going up--a goal we 
all share. Think about it. If the President wants to pass this bill so 
badly, then why on Earth hasn't he picked up the phone and called the 
chairman or ranking Republican of the relevant committee? As with so 
many pressing issues, the President has not led on this issue. He has 
campaigned on it, but he has not worked to actually fix it.
  The American people are tired of the posturing and the games. It is 
time for the President to lead. It is time for Senate Democrats to stop 
the political theater and to find a real solution.


                         Thanking Senator Enzi

  Mr. President, on another matter, I wish to take a moment to thank my 
good friend, the senior Senator from Wyoming, Mike Enzi, for the work 
he has done shepherding the FDA bill through the markup and across the 
Senate floor. This is an incredibly complex piece of legislation that 
strikes a difficult balance of protecting consumers while avoiding the 
stifling regulation that slows the process of bringing lifesaving drugs 
and devices to market.
  Throughout a lengthy process, Mike has shown the command of complex 
topics, steady leadership, and interest in his colleagues' priorities 
that have characterized his tenure at the HELP Committee. For that, 
those of us on this side of the aisle would like to thank him very 
much.


                       Honoring Our Armed Forces

                       Specialist David W. Taylor

  Mr. McCONNELL. Mr. President, I wish to address one other matter. I 
have a sad task today of informing my colleagues that a valued and 
honorable Kentuckian who enlisted in the U.S. Army has fallen in the 
performance of his duty. On March 29, 2012, SPC David W. Taylor of 
Dixon, KY, died from injuries sustained in an accident at an 
ammunitions supply point in Kandahar Province, Afghanistan. He was 20 
years old.
  For his service in uniform, Specialist Taylor received several 
awards, medals, and decorations, including the Army Commendation Medal, 
the Army Good Conduct Medal, the National Defense Service Medal, the 
Afghanistan Campaign Medal with Bronze Service Star, the Global War on 
Terrorism Service Medal, the Army Service Ribbon, the Overseas Service 
Ribbon, the NATO Medal, the Parachutist Badge, and the Overseas Service 
Bar.
  After his tragic death at entirely too young an age, one of 
Specialist Taylor's commanders, Sergeant Addington, delivered a tribute 
to his fallen brother in arms. This is what he said:

       When his country called for young lives to offer themselves 
     up for the preservation of freedom, young David Taylor 
     answered the call and said, ``Here am I, take me.'' 
     Specialist Taylor was my soldier, my battle buddy, and my 
     friend. He was a fast learner and my greatest student. He 
     sacrificed himself so we might be free.

  Before he was a soldier, his mother Sarah Taylor recalled that David 
was a compassionate, dedicated young man. From a young age, he was 
always looking for ways to help others. Sarah says of her son: ``One 
Christmas he had received a large amount of gifts.''
  David asked his parents ``if he could give some of his gifts to a 
classmate of his who he knew would not receive many items.''
  David was a great athlete who played football and soccer and ran 
track. He loved to hunt and hunted turkey and deer, but his real 
passion was for duck hunting. He had many friends, was the life of the 
party, and he was popular with the girls. David ``would change outfits 
multiple times before going to school, as his hair and clothes had to 
be perfect,'' Sarah says.
  David was also very dedicated to physical fitness. He worked out 
multiple times a week to stay in shape. Perhaps that is because young 
David knew his body was his instrument, and he had made up his mind to 
join the military by age 14.
  David's high school did not have an ROTC program, so David worked 
hard to graduate 6 months early and eagerly enlisted. He skipped both 
the prom and graduation to take up his more important pursuit, 
enlisting in January 2010. He even waived his signing bonus saying, 
``It is every young man's duty to serve.''
  David planned to make the military his career and hoped to go into 
the medical field. He dedicated himself to the military handbook and 
doing everything ``by the book.'' He went on to serve as a paratrooper 
in a parachute infantry regiment, one of the most demanding specialties 
in the Army.
  LT Eric Fitzgerald was Specialist Taylor's platoon leader. He says:

       David was one of the most outstanding paratroopers in the 
     whole platoon, just striving to be the best. When you wanted 
     something done, when you wanted it done right, you went to 
     Taylor for it.

  CPT Brian Bifulco, David's company commander, concurs:

       It was evident since the day I met him that David had all 
     the qualities desirable in a paratrooper: Smart, aggressive, 
     committed, and reliable. He displayed them readily in 
     everything he did.

  David maintained his rigorous workout schedule in the Army by 
following the Crossfit physical fitness programs 5 to 6 days a week so 
he could excel at the Army's physical fitness test. He could run his 2-
mile fitness test in a full minute faster than anyone else in his 
platoon. Specialist Taylor was assigned to D Company, 2nd Battalion, 
508th Parachute Infantry Regiment, 82nd Airborne Division, based out of 
Fort Bragg, NC. He deployed to Afghanistan for Operation Enduring 
Freedom in February of this year for what would be his first and only 
deployment.
  David's fellow soldiers from his platoon named the small gym in their 
Afghanistan outpost in his honor as a remembrance of David's commitment 
to excellence. Nearly every soldier in the platoon wears a metal 
bracelet honoring Specialist Taylor. SFC Russ Kelley had this to say:

       For many of the guys, this is the first friend they've ever 
     lost to combat. They wear the bracelets to remember.

  At this time we are thinking of SPC David W. Taylor's family and his 
friends as I recount his story for the Senate, including his mother 
Sarah Taylor, his grandmother Laura Klutey,

[[Page S3540]]

and many other beloved family members and friends. David was preceded 
in death by his father Kevin Taylor.
  David's mother Sarah says David loved the Army and was excited to be 
in Afghanistan.
  Sergeant Addington remembers:

       David seemed to live for the job, and while others would 
     whine and complain in the field, David would just sling up 
     his hammock and settle in. He was at home in the woods, a 
     natural outdoorsman.
       David, who grew up in the woods, fit in perfectly. He 
     seemed born to do this job, and I felt sorry for any Taliban 
     that he was bound to run into in Afghanistan. The Taliban got 
     lucky this time.

  Even if that is the case, the tragedy of Specialist Taylor's death is 
certainly not lucky for anyone else, most of all not for the family he 
has left behind or his friends and fellow soldiers.
  I know it is small solace in place of what they have lost, but I want 
them to know this Senate holds SPC David W. Taylor in the highest 
regard for his service on behalf of our country. We are honored, just a 
few days before Memorial Day, to recognize his enormous sacrifice on 
behalf of this Nation.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from New Jersey is 
recognized.
  Mr. MENENDEZ. Mr President, I rise in strong support of the 
underlying bill we are debating, the Food and Drug Administration 
Safety and Innovation Act.
  This legislation, which has been the model of bipartisanship and 
effective legislating on the part of Chairman Harkin and Ranking Member 
Enzi, is critically important to the people of New Jersey and the 
Nation.
  This bill is about more than drug safety. It is about more than 
protecting patients. It is about improving the approval process to 
speed access to new lifesaving, life-enhancing drugs and devices, and 
making sure the FDA is a partner in the production of safe and 
effective products.
  This bill does this and accomplishes several key goals that are 
critically important to our Nation's health care system. Not only does 
it reauthorize the key user fee agreements for prescription drugs and 
medical devices, but it establishes agreements for generic drugs and 
generic biologic drugs called biosimilars.
  Together, these user fee agreements will provide the FDA with the 
resources necessary to improve the drug and device approval process to 
more quickly and efficiently bring new products to market. It will 
enhance communication between manufacturers and the agency to foster a 
more cooperative environment, and it will allow for better and more 
thorough postmarket reviews to ensure continued patient safety and 
product efficacy.
  There is more to this bill than the FDA user fees.
  It permanently reauthorizes two vital programs that are a lifeline to 
our Nation's children--the Best Pharmaceuticals for Children Act and 
the Pediatric Research Equity Act, which are incredibly important to 
our children. It helps reduce and mitigate the ongoing problem of drug 
shortages we have heard about throughout the country. It provides for 
enhancements to the prescription drug supply chain and increases the 
accountability and transparency of the Food and Drug Administration.
  It is good for children. It is good for business. It is good for 
patients. It makes the FDA a more effective partner in the process, and 
it demonstrates that we can reach across the aisle and work together to 
tackle tough issues and find solutions that benefit the people we 
collectively represent.
  This just touches the surface of what this bill will accomplish. 
However, this incredibly hard work could very easily be unraveled by 
some of the amendments being considered.


                           Amendment No. 2107

  It seems that, once again, despite the countless times--the countless 
times--the Senate has rejected the policy my friend from Arizona 
pursues, he has brought us an amendment that I believe puts Americans 
at risk, undermines FDA's authority, and would have a devastating 
ripple effect throughout our country's drug supply by allowing 
untraceable foreign pharmaceuticals into our country.
  This amendment would ostensibly only allow drugs from Canada into the 
United States. However, nothing in the amendment comes close to 
ensuring that is the case. In fact, this amendment would easily allow 
Web-based pharmacies within Canada to provide untraceable, 
unaccountable drugs from all over the globe into the U.S. market 
without any FDA oversight whatsoever.
  This amendment does not provide the FDA with any additional resources 
to monitor the drugs coming in from Canada, and even the Canadian 
authorities have said they cannot be expected to monitor all the drugs 
coming through their country and into ours. Once one of those drugs 
hits and causes consequences to some family, then we will all be 
running and saying: How did we allow that to happen?
  The Senate has soundly and repeatedly voted against this type of drug 
importation because we understand the implications it has on bringing 
counterfeit and dangerous products into our Nation. As we work to 
strengthen the FDA, I ask my colleagues to join me in opposing this 
amendment, which would significantly weaken the agency and put 
Americans at risk.


                           Amendment No. 2109

  Additionally, I wish to address another critically important issue 
brought up by my friend from Vermont. The Sanders amendment would lead 
to a radical change in how our Nation's biotech and pharmaceutical 
industry achieves the process of bringing lifesaving, life-enhancing 
drugs into the marketplace.
  I certainly respect the passion for the issues he pursues. But there 
are over 200,000 people in New Jersey who work in the biopharmaceutical 
industry every day who take pride in the work they do creating 
breakthrough, lifesaving, life-enhancing drugs, and I take issue with 
this characterization of an industry which is responsible for some of 
the world's most important medical breakthroughs that have saved 
millions of lives. If you are one of those people waiting for one of 
those drugs to come to the marketplace, hoping that for your mother's 
Alzheimer's--the Alzheimer's that took my mother's life--we will 
finally have a breakthrough; that for your husband with Parkinson's, we 
will finally have a breakthrough; that for your loved one with cancer, 
we will finally have a breakthrough, you want to see that come to the 
marketplace.
  This industry is responsible for finding the cures and treatments for 
diseases that kill people and destroy family incomes. This is the 
industry that has more than 1,600 active clinical trials in New Jersey 
on drugs to treat cancer, cardiovascular disease, diabetes, HIV/AIDS, 
mental and behavior disorders, and, especially important to me 
personally, trials for drugs treating Alzheimer's and other forms of 
dementia. Families look forward to those breakthroughs coming to the 
market to help cure their loved ones.
  This work is what keeps our Nation competitive and on the cutting 
edge of medical science, providing billions of dollars in economic 
impact annually--roughly $900 billion nationally and more than $35 
billion in New Jersey--and it provides countless people across the 
globe with lifesaving medications.
  The amendment being offered could have a chilling effect on all 
this--all the hope for new treatments and perhaps new cures for 
diseases, having an opportunity for that to be turned around, to stop 
having those families lose a loved one who succumbs to a disease, 
ruining countless lives. It has the potential to dry up investment in 
the next cure and severely curtail the number of high-skill, high-
paying jobs and billions of dollars in economic investment in 
the biopharmaceutical industry.

  I know my friend from Vermont wants to prevent fraudulent behavior, 
and I wholeheartedly agree that bad actors who willfully commit fraud 
need to be punished, which is why we have the most incredible, stiff 
civil and criminal penalties in current law to prosecute those who 
commit fraud. But ultimately taking away the incentives we have in 
place to attract investment in this important research, especially when 
the penalties could be triggered by a minor, unrelated offense--the way 
the amendment is written--is just plain and simple bad policy. It is 
akin to having the death penalty for a simple assault.

[[Page S3541]]

  The current intellectual property laws that protect pharmaceutical 
products provide researchers and their investors with a stable and 
predictable timeline that allows them to recoup the risky investments 
in research and development of new drugs.
  We only think about the drugs that have success. But remember, out of 
every 5,000 to 10,000 potential drug compounds identified, only 1--only 
1--of those 5,000 to 10,000 potential drug compounds will result in a 
new medicine on the market.
  Do we want the companies not to take the risk of going through all 
those thousands and thousands of compounds to come up with the one that 
can be the cure for so many lives and save so much money in the 
government under Medicare and Medicaid and in our entire health care 
system? That is risky investing by anybody's standard, so removing 
incentives is bad policy for the public health of the United States.
  This amendment will lead to uncertainty among investors. It will dry 
up capital. It will further delay access to new medical products. It 
will pull us back from the cutting-edge research and development that 
has always made this Nation great.
  As I have said--and as my friends who are managing this bill have 
said--this FDA reauthorization is too important not to pass. So I urge 
my colleagues to reject these harmful amendments so we can move forward 
and have an FDA that has the ability to do its job on behalf of the 
American people to create a process that will be safe but will give us 
the lifesaving, life-enhancing cures that ultimately will lead to a 
better life for all of us.
  With that, I yield the floor and suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. HARKIN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. HARKIN. Mr. President, I ask unanimous consent that the time in 
quorum calls be evenly divided on the McCain amendment.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. HARKIN. Mr. President, I again say we are rapidly coming to a 
close. Again, the sooner we can get to voting, the sooner we will close 
out the business for the day and probably for the week.
  I again would point out that we have Senator Bingaman's amendment No. 
2111 yet to be called up. Senator Portman has two amendments--Nos. 2146 
and 2145. Those basically are the only ones left to be brought up. So I 
would urge them to come and others who have indicated they want to come 
and speak on the amendments that are pending. The McCain amendment, the 
Sanders amendment, the Murkowski amendment, the Durbin amendment, and 
the Paul amendment are still pending. People have indicated they want 
to come over and speak on these various amendments. I would hope they 
would do so, so we can perhaps get to voting on the amendments and 
final passage of the bill sooner rather than later.
  With that, I suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. GRASSLEY. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.


                           Amendment No. 2107

  Mr. GRASSLEY. Mr. President, I support Senator McCain's amendment. 
That amendment would allow drug importation from approved pharmacies in 
Canada. I have been a long-time proponent of safe drug importation. I 
am currently a cosponsor of the Pharmaceutical Market Access and Drug 
Safety Act, a bill I have worked on for many years with Senator Snowe 
and Senator McCain.
  In 2002 and 2003, I supported amendments similar to the one before us 
today that would permit the importation of prescription drugs from 
Canada. In the year 2004, the late Senator Kennedy and I worked 
together on a bill that would authorize drug importation, but it did 
not survive the partisan politics of this Chamber.
  I then introduced my own comprehensive drug importation bill in 2004. 
I entitled that bill the Reliable Entry of Medicine and Everyday 
Discounts Through the Importation of Effective Safeguard Act, and that 
naturally works out to an acronym. we called it the REMEDIES Act.
  In 2005, I combined that bill with the proposal sponsored by then-
Senator Dorgan and Senator Snowe. And in 2007 and 2009, we reintroduced 
the version of that legislation with hopes that our combined efforts 
would finally lower the cost of prescription drugs for all Americans.
  During the health care reform debate in 2009, drug importation had a 
much better chance to pass than ever before. We had a Democratic 
supermajority in Congress and we had a Democratic President who 
supported drug importation in the past. But in backroom deals between 
the Obama White House and the pharmaceutical industry, those deals 
prevented us from finally lowering the drug costs for all Americans.
  So after all of this decade-and-a-half effort, we are back here again 
trying to accomplish the same goal with Senator McCain's amendment. I 
have always considered drug importation a free-trade issue. Imports 
create competition and keep domestic industry more responsive to 
consumers. Consumers in the United States pay far more for prescription 
drugs than those in other countries.
  For instance, U.S. prices are, on average, 52\1/2\ percent higher 
than Canadian pharmacy prices. If Americans could legally and safely 
access drugs outside the United States, then drug companies would be 
forced to reevaluate their pricing strategies. They would no longer be 
able to gouge American consumers by making them pay more than their 
fair share for the high cost of research and development. Because that 
is a fact. We pay for most of the research and development of new drugs 
because other countries are getting by dirt cheap and there is not 
enough money coming in from those countries to pay for all of the 
research it takes, because, as you know, most of the cost of a drug is 
the research and development, it is not the manufacture of that little 
pill or a big pill, for that matter.
  In the United States, it is a fact. We import everything consumers 
want. So why not pharmaceuticals? In fact, I look back at all my years 
working on trying to free up trade around the world through efforts to 
pass free-trade agreements, through efforts to get the President trade 
promotion authority, everything that would make global policies 
available to American consumers, and I can only think of two things our 
law prevents consumers in America from importing from other countries 
when everything else the consumers buy they can buy anywhere in the 
world if they want to--but not for pharmaceuticals or not for Cuban 
cigars.
  Some opponents of this amendment have concerns about what drug 
importation would mean to the safety of drugs. Obviously, we have to be 
concerned about drug safety because that is what the FDA is all about--
two things, making sure drugs are safe, and, No. 2, to make sure they 
are effective.
  Everyone who knows me knows I care deeply about the safety of drugs. 
I would not be standing here today urging support for Senator McCain's 
amendment if I did not think it would properly protect the safety of 
the Nation's prescription drug supply chain. The fact is that the 
unsafe situation is what we have today. Today patients who need a 
cheaper alternative are ordering drugs over the Internet from who knows 
where, and the FDA does not have the resources to do much of anything 
about it. The fact is the McCain amendment would not only help to lower 
the cost of prescription drugs for all Americans but will also 
establish a system where American patients can be certain that the 
drugs they are importing are safe.
  The amendment has requirements that a pharmacy must meet before the 
Secretary may approve them for participation. This includes product 
testing in labs designated by the Secretary. A list of approved 
pharmacies

[[Page S3542]]

will be published on the FDA Web site. Patients who are already forced 
to purchase their medications outside the United States would be able 
to access the list to choose a safe option. Additionally, the amendment 
lays out criteria that must be met before any patient may import drugs 
from an FDA-approved pharmacy. Patients must have a valid prescription 
from a physician licensed to practice in our country. The purchase must 
be for personal use, and the drug must have the same active ingredient, 
route of administration, dosage form, and strength as a prescription 
drug approved by the Secretary of HHS.
  The McCain amendment would improve drug safety, it would not threaten 
drug safety. It would open trade to lower-cost drugs, and it would make 
other consumers around the world start paying for some of the research 
and development the American consumer is paying such a high price to 
provide. We should do all we can to get miracle drugs originated and 
developed, but the American consumer should not be paying the entire 
bill. We need to make sure Americans have even greater, more affordable 
access to lifesaving drugs by opening the doors to competition in the 
global pharmaceutical industry.
  Obviously, after a decade and a half, I am continuing to urge my 
colleagues to join in this effort on the importation of drugs, and in 
this particular area to give support to Senator McCain and support his 
amendment. I applaud him for the leadership he has shown in this area 
over a long period of time.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I rise in opposition to the McCain amendment 
No. 2107, which would facilitate the importation of prescription drugs 
from Canada. We are not talking about bus trips of seniors to reputable 
brick-and-mortar pharmacies right across the border. We are talking 
Canadian Internet pharmacies, which may not even be in Canada, which 
pose a significant threat to American patient safety.
  This amendment would require the Food and Drug Administration to 
allow individuals to import prescription drugs into the United States 
from Canada, notwithstanding any other provision of the Federal Food 
Drug and Cosmetic Act.
  Drugs that supposedly come from Canada can originate in any country 
in the world, and merely be shipped to the United States from Canada. 
Canadian law does not prohibit the shipment of drugs from any country 
into Canada and then into the United States. They do not care.
  In 2005, FDA conducted an investigation of drugs that American 
patients thought they were ordering from Canada. Eighty-five percent of 
the drugs represented as coming from Canada actually came from 27 other 
countries. A number of drugs were found to be counterfeit.
  A letter from Assistant Deputy Minister of Health, Canada, to the 
U.S. Surgeon General again said that Canada does not assure that 
products being sold to U.S. citizens are safe, effective, and of high 
quality, and does not intend to do so in the future.
  The pending amendment would allow importation from Canadian Internet 
pharmacies. Canadian Internet pharmacies openly acknowledge they obtain 
most of their drugs from other countries. The specific language of the 
pending amendment gives rise to the additional safety concerns. For 
example, it will not prevent the importation of drugs that need special 
handling, such as refrigerated or photosensitive drugs. It would not 
prevent the importation of special drugs, such as those inhaled during 
surgery or administered intravenously.
  The pending amendment would not require Canadian wholesalers that 
would be involved in the importation to be licensed or registered in 
any way. There would be a list but not a licensing or registration. Do 
we want anyone, even someone under investigation or with a suspended or 
revoked license, to be in the business of importing drugs, given the 
well-known risks?
  FDA advises consumers that some imported drugs, including those that 
bear the name of U.S.-approved products, may, in fact, be counterfeit 
versions that are unsafe or completely ineffective. You know, they can 
have all of the ingredients to it, but if it is not put together the 
right way, it will not even dissolve as it goes through the body, and 
therefore there would be no benefit from that drug, even though it 
looked like the real thing, it tasted like the real thing, it went down 
like the real thing. But if it is not the real thing, it can cause some 
real trouble with people's health.
  This is not a hypothetical concern. Last year Homeland Security 
Secretary Napolitano testified that counterfeit drugs are a growing 
problem. Two months ago, FDA testified about the dangers of purchasing 
counterfeit, unapproved, or diverted prescription drugs on line. My 
colleague Senator Mikulski has highlighted the growing involvement of 
organized crime in this area. Prescription drug counterfeiting can be 
dramatically more profitable than narcotic smuggling. Imported drugs 
pose additional dangers because their labels may lack important 
information or warnings.
  FDA advises consumers that an imported medication may lack 
information allowing patients to be promptly and correctly treated for 
dangerous side effects.
  We know imported drugs pose severe risks to American patients. The 
FDA and the Department of Health and Human Services have repeatedly 
said they cannot assure the safety of imported drugs. A side-by-side 
amendment that we used to put on this all the time was that you could 
import drugs as long as the Secretary of Health and Human Services said 
it was safe. Well, there hasn't been a Secretary of Health and Human 
Services who has been willing to sign that drugs imported from 
anywhere--even Canada--are safe.
  FDA's Web site advises consumers that imported drugs--including drugs 
imported from Canada--may not have been manufactured under quality 
assurance procedures designed to produce a safe and effective product. 
That is the FDA Web site.
  The Federal Food, Drug, and Cosmetic Act represents over 100 years of 
lawmaking to protect the public health. It gives the FDA authority to 
make sure drugs are properly approved, manufactured, labeled, shipped, 
handled, and stored, that factories are inspected, and that numerous 
other protections are in place for American patients. Adopting this 
amendment would endanger American patients, and I therefore urge my 
colleagues to oppose it.
  There is a lot more that could be said. I have been saying this for 
years and trying to find a way it could be done. At the present time, 
the safety of it makes me oppose this particular amendment. They keep 
revising the amendment. It is still online and everybody knows how 
things online can be redone. They talked about putting an official seal 
on each Web site, but I know fourth graders who can duplicate any seal 
you can put on the Internet. Any list can be changed--and who checks 
lists, anyway? The problem is not knowing where the drugs come from 
that go through Canada to the United States. If they are counterfeit, 
they can sell them for less. The Canadian secretary of health also 
doesn't want to be the pharmaceutical supplier to the United States. 
They have a little different system up there. It is a way of driving 
prices down, which is something we would not stand for in the United 
States, a mechanism where they have to bid on the drugs. The people who 
make hard medicine bid against each other, and your doctor might prefer 
the one that doesn't win the bid. That is how they drive the price 
down. It is probably something we would not allow in the United States.
  I ask my colleagues to oppose the amendment.
  I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from Arizona.
  Mr. KYL. Mr. President, I will speak about two amendments that we 
will vote on later.


                           Amendment No. 2111

  First is the Bingaman amendment. I urge my colleagues to oppose it. 
It ignores fundamental economic realities of pharmaceutical patent 
litigation, and it would ultimately result in fewer generic drugs being 
brought to market and delays in the launch of many of the generic drugs 
that do go to market.
  Under current law, a generic drug company that is the first to file 
an abbreviated new drug application for an

[[Page S3543]]

existing patented drug is entitled to 180 days of market exclusivity 
once the generic drug is approved. In other words, they have the 
exclusive market on it for half a year. This creates a powerful 
incentive for drug companies to bring generic drugs to market.
  The present amendment would dilute this right of 180 days of 
exclusivity and potentially require the exclusivity period to be shared 
with another drug company's product. Under the amendment, the only way 
a generic drug company that files the first ANDA could be assured of 
getting 180 days of market exclusivity is by litigating a challenge to 
the validity of the branded drug's patent all the way to a final 
judgment.
  This is not a sound approach. First of all, patent litigation is very 
expensive. Full litigation of a drug patent suit typically costs 
between $3 million and $5 million. Second, most drug patents are 
ultimately found by the courts to be not invalid; that is, most 
validity challenges to these patents fail.
  Generic drug companies, as everyone else, have limited litigation 
budgets. As a practical matter, if we force them to litigate every 
patent case to a final judgment in order to preserve their exclusivity 
rights, they will pursue fewer abbreviated new drug applications, and 
fewer ANDAs means fewer generic drugs and higher costs for consumers.
  Finally, it is often the case that part way into a drug patent 
lawsuit, the generic drug company comes to the conclusion that the 
brand's patent is strong and that the challenge to the patent is likely 
to lose. In such a situation, everyone is better off if the suit is 
settled. Typically, such settlements allow the generic drug to go to 
market somewhat earlier but still preserve the bulk of the patent term. 
Obviously if the generic drug company is forced to litigate this all 
the way to judgment in order to potentially receive exclusivity and 
they lose, the full patent term will run and there will be no early 
generic market entry. This hurts both the generic drug companies and, 
more importantly, the consumers.
  For these reasons, I urge my colleagues to oppose the Bingaman 
amendment.


                           Amendment No. 2109

  Second, I urge my colleagues to oppose the Sanders amendment. This 
amendment would undermine the government's ability to fight fraud and 
will harm patients and U.S. competitiveness by eviscerating existing 
incentives to invest in medical innovation.
  The Sanders amendment would result in the automatic revocation of any 
remaining regulatory exclusivity on a product when a company is 
convicted or even enters into a settlement agreement for certain 
violations of the Food, Drug, and Cosmetic Act, or any violations of 
the False Claims Act or several other listed statutes.
  There are several reasons why this is the wrong approach. First and 
foremost, the amendment will result in less lifesaving drugs ever 
getting to patients. Obviously, we should be fighting for lifesaving 
drugs getting to patients even faster. We provide these periods for 
exclusivity, as I mentioned earlier, for a reason: to enable companies 
to recoup the significant investments they make--as high as $1.2 
billion per drug--to develop new medicines. Some of the exclusivities 
the amendment would revoke are those we enacted to encourage companies 
to ensure the safe use of pharmaceuticals in children or to find a cure 
for rare diseases that affect a very small number of people.
  Indeed, orphan drug exclusivity is a great example of how these 
exclusivity periods benefit patients. Since 1983, the year the Orphan 
Drug Act was signed into law, more than 350 medicines have been 
approved to treat rare diseases, compared to fewer than 10 in the 
1970s. Why would we want to jeopardize such a great success story?
  Second, reduced investment in U.S. drug development is not only bad 
for patients but for the economy. Because the Sanders amendment would 
create a disincentive to invest in drug development, the National 
Venture Capital Association has already expressed concerns, stating 
that the amendment has ``the potential to inadvertently undermine 
innovation and undermine decades of policies enacted by Congress with 
the goal of fostering medical innovation.'' Defined periods of 
exclusivity provide some small measure of predictability in what is 
otherwise a risky process, and companies and venture capitalists rely 
on these periods of exclusivity to make development and investment 
decisions.

  By threatening the elimination of exclusivities for conduct that is 
likely many years removed from the development process, the Sanders 
amendment would introduce even greater uncertainty into the R 
process.
  Let me restate that we need to reconsider the overall favorability of 
the environment for innovation in the United States. Yet here we are 
considering an amendment that, if enacted, would make the U.S. 
investment climate far less attractive for these companies, even as 
other countries are actively courting the biopharmaceutical industry.
  Third, while the amendment purports to fight fraud, in reality it 
would actually undermine the ability of the government to fight fraud 
by undermining its ability to settle cases. The Sanders amendment would 
revoke exclusivity not only upon conviction--even if that conviction is 
later overturned on appeal--but also upon settlement. This is a huge 
problem because it creates a disincentive for companies to ever settle, 
as it would make more sense to drag out the district court litigation 
while any relevant exclusivity period is still running for the company.
  Fourth, and finally, the amendment is not even necessary because the 
outcome called for by the Sanders amendment can already be achieved 
under current law in appropriate cases, because the government can, and 
does, have the power to negotiate the relinquishment of exclusivity as 
a condition of settlement. It can already do this. For example, this 
past January, the Department of Justice negotiated the relinquishment 
of a company's 180-day exclusivity as part of a settlement for 
violations of the Food, Drug, and Cosmetic Act. Mandating this serious 
outcome in every case undermines the government's ability to use it as 
leverage to negotiate settlements.
  Large penalties already apply for violations of the statutes listed 
in the Sanders amendment. The world of drug manufacturing and marketing 
is very heavily regulated, and noncompliance is subject to considerable 
penalties under current law. This amendment is not necessary. Rather 
than being outraged by settlements that occur, perhaps we ought to take 
them as an indicator that the government is doing a good job of using 
existing authority to go after those who seek to defraud the health 
care system.
  I urge my colleagues to oppose the Sanders amendment.
  The ACTING PRESIDENT pro tempore. The Senator from Maine is 
recognized.
  Ms. SNOWE. Mr. President, I rise to speak in support of the amendment 
offered by the Senator from Arizona.


                         Nuclear Submarine Fire

  Before I do that, I want to recognize and acknowledge the tremendous 
and outstanding and remarkable work done by the crew at the Portsmouth 
Naval Shipyard and the local firefighters from numerous departments 
from the State of Maine, as well as from New Hampshire, because of the 
fire that occurred on the nuclear-powered submarine at the shipyard 
last evening, which was burning for more than 9 hours.
  It was the extraordinary teamwork and coordination among all of the 
crews, as well as the firefighters and departments from both States, 
that managed to put out the fire. It is now smoldering. I offer my 
commendations and congratulations to those who did the exceptional and 
outstanding work, which exemplifies the kind of teamwork that already 
occurs at that shipyard. I wanted to offer my recognition to that 
extraordinary work in a very difficult circumstance.


                           Amendment No. 2107

  I rise in support of the amendment offered by the Senator from 
Arizona, Senator McCain, in authorizing a very limited drug importation 
program, whereby Americans can purchase medications from accredited 
online Canadian pharmacies. I am supporting this amendment, as I have 
in the past. In fact, we have had broader amendments offered on the 
floor of the Senate for almost more than a decade with respect to 
allowing importation of prescriptions from other countries that offer 
more competitive prices.
  I applaud Senator McCain, who obviously has been a very valuable ally 
in

[[Page S3544]]

this effort for many years. But he proposed a very limited approach to 
address those who have concerns with the idea of importing prescription 
drugs. I, for one, cannot understand why there is such a fundamental 
concern about this issue because, first of all, Americans have been 
facing tremendous increases in prescription drug prices for far too 
long. I think it is at a point at which Congress should address this 
issue, and precisely on this particular piece of legislation that is 
before us today. It could not be more appropriate to have this 
amendment offered on this legislation.
  In 2010, AARP found that retail prices for the most popular brandname 
drugs increased 41.5 percent, while the Consumer Price Index rose just 
13 percent. In other words, the cost of prescription drugs rose more 
than three times as much as the inflation rate. That is completely 
unacceptable.
  What has occurred as a result of this trend? First of all, American 
consumers are increasingly choosing to risk living without taking 
critical medications. According to the Commonwealth Fund, in 2010, 48 
million Americans did not fill a prescription due to high costs. That 
represents an increase of 66 percent since 2001.
  If the Senate and the overall Congress were to adopt the McCain 
amendment, it would allow Americans to purchase safe medications at a 
lower price than they are available for us in this country. We could 
begin to turn this disturbing trend around. I know people in Maine 
deserve access to affordable drug prices. Millions of Americans, and 
certainly those in Maine, have purchased drugs from Canada safely, at a 
significant savings over the years. They have had to go to great 
lengths in order to purchase lower price medications. They have taken 
bus trips to Canada to purchase that medication because that was the 
only way they could have access to the prescriptions they so 
desperately need. The McCain amendment builds on that foundation.

  If we look at this first chart, Mr. President, an April 27, 2012, 
survey comparing average Canadian drug prices against major U.S. retail 
pharmacy prices, we find the average U.S. price for a 90-day supply of 
Nexium, which is a common blood thinner, is $560 in America but only 
$265 in Canada. So Americans are paying twice as much for Nexium as 
Canadians do. I think that is simply outrageous. Why should American 
consumers pay twice as much for a medication that so many Americans 
depend upon?
  Here is another example of a drug that is a blood-thinning drug that 
is also very crucial in this process, and that is Plavix. That costs 
$585 in the United States versus $398 in Canada for a 90-day supply. 
So, again, American consumers are paying 50 percent higher costs for 
the same prescription drugs as Canadians do.
  Then let's look at the very popular anticholesterol medication 
Lipitor. This chart illustrates, again, what Lipitor costs the American 
consumer. The cost is $478 in the United States as compared to $278 in 
Canada for a 90-day supply.
  So for patients who are already trying to make ends meet in this very 
difficult economy by rationing their medications, splitting their 
pills, or even skipping medications entirely, why would we deny them 
access to safe drug products at these dramatically lower prices? That 
is why I have cosponsored Senator McCain's amendment. It would allow 
Americans to import medication from accredited Canadian pharmacies from 
a list approved by the Secretary of Health and Human Services. These 
accredited pharmacies must commit to ongoing quality assurance programs 
and product testing to determine the safety and efficacy of these 
products.
  This amendment is more narrowly focused than even the one that our 
former colleague Senator Dorgan and I had offered previously. This 
provides a pathway to a more limited approach for Americans to access 
affordable medications. In fact, there has been a very recent study 
conducted by Roger Bate of the American Enterprise Institute entitled 
``Unveiling the Mystery of Online Pharmacies: An Audit Study.'' Let me 
quote from him as to what he discovered:

       If some foreign Web sites sell safe prescription drugs with 
     substantial price discounts, but American consumers are 
     guided to buy from U.S. Web sites only, the FDA could 
     potentially discourage price competition between the U.S. and 
     foreign pharmacies and, thereby, reduce drug affordability 
     within the United States. The danger of reducing price 
     competition depends on whether consumers can distinguish 
     trustworthy Web sites from the vast pool of foreign Web 
     sites.

  So here we have the documentation by a very significant study that 
talks about how Americans can access these affordable medications. We 
shouldn't be discouraging price competition, as this study illustrates. 
That is one of the points I have been arguing over the years; that the 
real problem in this country with respect to prices for prescriptions 
is that we don't have competition within the industry and competition 
for those medications.
  Americans have learned that citizens in other countries use the very 
same medications as we do. They are made in the very same plants. Yet 
they pay less. We talk about injecting greater free market competition 
in the health care marketplace as a way of achieving greater 
affordability, and this amendment attempts to address that very issue. 
As we look at what other countries do, when we are talking about 
accessing cheaper medications, we know in Canada that is the case, and 
it is certainly true in other industrialized nations.
  I should add, in fact, they pay 35 to 55 percent less for their drugs 
because of the higher prices Americans pay, which is about $90 billion 
more for prescription drugs every year than we would otherwise. I think 
that is totally unacceptable. Why should American consumers be paying 
35 to 55 percent more or nearly $90 billion more than consumers in 
other countries for the very same medications? It simply doesn't make 
sense.
  According to former Pfizer CEO Hank McKinnell--looking at the quote 
on this chart:

       Competition is good medicine for economies. . . . Name an 
     industry in which competition is allowed to flourish--
     computers, telecommunications, small package shipping, 
     retailing, entertainment--and I will show you lower prices, 
     higher quality, more innovation, and better customer service. 
     There's nary an exception. Okay, there's one. So far, the 
     health care industry seems immune to the discipline of 
     competition.

  When we last considered the legislation I introduced along with 
former colleague Senator Dorgan, we allowed importation only from 
Canada, the European Union, Australia, New Zealand, and Japan, and the 
Congressional Budget Office estimated the Federal Government would save 
almost $20 billion--$20 billion--if we allowed the importation of those 
medications. So we know for a fact allowing drug importation generates 
considerable cost savings to the government, to individuals, and 
businesses that provide health insurance coverage to their employees.
  The bottom line is where nations institute safe, regulated trade in 
pharmaceuticals they achieve results. When Sweden entered the European 
Union system of trade, they saw a reduction of 12 to 19 percent in the 
price of traded drugs. In fact, Europe has had parallel trading for 
more than 30 years and has never had an incident.
  Industries see the advantage in being a part of the global market 
when it comes to manufacturing costs. For example, according to a Pew 
study in 2011, the number of prescription drugs made at non-U.S. sites 
doubled between 2001 and 2008. That means they doubled at a sizable 
increase with respect to the number of prescription drugs that are made 
at non-U.S. sites. There are more than 50 plants where our medications 
are manufactured, and not all of those facilities are even inspected--
not even inspected. Yet those are medications we use in this country 
because they are manufactured at other plants in other countries. As I 
said, there are more than 50 countries in which we have our 
prescriptions manufactured.
  So let me see if I have this straight. It is fine for some foreign 
countries to manufacture drugs in their own plants for the U.S. market, 
ship those drugs here where the American people are given the privilege 
of paying higher prices than anywhere else in the world, but somehow we 
can't safely import those very drugs into the United States directly. 
It simply doesn't make sense.
  The American taxpayer is underwriting more than $30 billion of 
research--basic and applied research--at the National Institutes of 
Health alone, so consumers in all those other

[[Page S3545]]

nations are benefiting from the investments the American taxpayer is 
making with respect to research. That U.S. research produces these 
medications and these prescriptions that other nations pay 35 to 55 
percent less for than the American consumer. The American taxpayer is 
paying more for those drugs, as I said, and also paying more of their 
tax dollars for the research that is ongoing at the National Institutes 
of Health. It simply doesn't make sense.

  With all of the additional profit, industry invests nearly equally in 
R in the United States and in Europe and is increasingly moving 
research to low-cost Asian countries. So paying the world's highest 
prices for drugs doesn't ensure us more research, but it decreases our 
access to drugs. So that is the contradiction that Americans confront 
each and every day when they are purchasing their medications at a much 
higher cost than consumers in other countries.
  The amendment that is offered by the Senator from Arizona is allowing 
importation solely from Canada, and it is for online pharmacies based 
on a list that has been drafted by the Department of Health and Human 
Services. That is a very prescribed, targeted, limited approach to 
allowing American consumers to benefit from those lower priced drugs 
that are offered in Canada.
  It is very important we take this step. It is important for American 
consumers who otherwise are not going to be able to afford these 
medications when they are paying two to three times more than their 
counterparts in Canada, for example. The prices are rising five times 
more than the inflation rate year after year, so the compounding effect 
is significant and overwhelming for most American consumers and 
families. So what I hope is we will support the amendment that has been 
offered by Senator McCain.
  Some have suggested that providing support for the McCain amendment 
will hinder efforts to quickly move on the underlying legislation for 
the FDA. That concern is certainly not persuasive because the McCain 
amendment is a very narrowly focused approach. It represents a good-
faith effort to find common ground. It has included strong safety-
related measures and is done under very limited circumstances so the 
American consumer can take advantage of the lower prices I have 
demonstrated today with regard to some of the commonly used drugs, such 
as the anticholesterol medication Lipitor and the drug-thinning drugs 
such as Plavix. It is explicitly designed to make it more broadly 
acceptable to those who might have concerns in taking the approach of 
drug importation.
  We must create a more competitive, more affordable health care system 
for the American people. The prescription drug market needs 
competition. Competition will lower prices. For some reason, even 
though we are underwriting all of the research that benefits consumers 
in so many other countries, and even though our medications are 
manufactured at other plants in 50 countries, the American consumers 
are paying up to 55 percent more than their counterparts around the 
world. It simply doesn't make sense. In fact, I would suggest it is 
outrageous.
  So that is why I am supporting this amendment. We need to take this 
limited, modest first step that I think goes a long way to addressing 
any reservations anyone might have in this Chamber with respect to the 
issue of importation. I hope we will allow American consumers to 
benefit from the much lower prices, especially during these very 
difficult economic times. This is a first step toward a larger system 
of safe, regulated drug importation.
  I commend the Senator from Arizona for offering this amendment, and I 
hope the Senate will adopt it.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Brown of Ohio). The Senator from Iowa.


  Amendments Nos. 2142, as Modified, 2145, As Modified, and 2146, as 
                            Modified En Bloc

  Mr. HARKIN. Mr. President, prior to Senator Bingaman bringing up his 
amendment, I ask unanimous consent that the following amendments be in 
order and made pending: Leahy No. 2142, as modified, with the changes 
that are at the desk; Portman No. 2145, as modified, with the changes 
that are at the desk; and Portman No. 2146, as modified, with the 
changes that are at the desk.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Iowa [Mr. Harkin], for himself, Mr. Leahy, 
     Mr. Portman, Mr. Whitehouse, and Mr. Schumer, proposes 
     amendments en bloc numbered 2142, as modified, 2145, as 
     modified, and 2146, as modified.

  The amendments, as modified, are as follows:


                    AMENDMENT NO. 2142, AS MODIFIED

  (Purpose: To modify and limit certain exemptions to the Freedom of 
                            Information Act)

       On page 192, strike line 10 through line 21 and insert the 
     following:
       (2) by adding at the end the following:
       ``(b) Ability to Receive and Protect Confidential 
     Information Obtained From Foreign Governments.--
       ``(1) In general.--The Secretary shall not be required to 
     disclose under section 552 of title 5, United States Code 
     (commonly referred to as the Freedom of Information Act), or 
     any other provision of law, any information described in 
     subsection (c)(3) obtained from a foreign government agency, 
     if--
       ``(A) the information is provided or made available to the 
     United States Government voluntarily and on the condition 
     that the information not be released to the public; and
       ``(B) the information is covered by, and subject to, a 
     certification and written agreement under subsections (c)(1) 
     and (c)(2).
       ``(2) Time limitations.--The written agreement described in 
     subsection (c)(2) shall specify the time period for which the 
     non-disclosure requirements under paragraph (1) shall apply 
     to the voluntarily disclosed information. The non-disclosure 
     requirements under paragraph (1) shall not apply after the 
     date specified, but all other applicable legal protections, 
     including section 552 of title 5, United States Code and 
     section 319L(e)(1) of the Public Health Service Act, shall 
     continue to apply to such information, as appropriate. If no 
     date is specified in the written agreement, the non-
     disclosure protections described in paragraph (1) shall not 
     exceed 3 years.
       ``(3) Disclosures not affected.--Nothing in this section 
     authorizes any official to withhold, or to authorize the 
     withholding of, information from Congress or information 
     required to be disclosed pursuant to an order of a court of 
     the United States.
       ``(4) Public information.--For purposes of section 552 of 
     title 5, United States Code, this subsection shall be 
     considered a statute described in section 552(b)(3)(B).''.


                    amendment no. 2145, as modified

     (Purpose: To facilitate the development of recommendations on 
  interoperability standards to inform and facilitate the exchange of 
              prescription information across State lines)

       At the end of title XI, add the following:

     SEC. 11__. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

       (a) In General.--The Attorney General and the Secretary of 
     Health and Human Services may collaborate to facilitate the 
     development of recommendations on interoperability standards 
     to inform and facilitate the exchange of prescription 
     information across State lines by States receiving grant 
     funds under--
       (1) the Harold Rogers Prescription Drug Monitoring Program 
     established under the Departments of Commerce, Justice, and 
     State, the Judiciary, and Related Agencies Appropriations 
     Act, 2002 (Public Law 107 77; 115 Stat. 748); and
       (2) the Controlled Substance Monitoring Program established 
     under section 399O of the Public Health Service Act (42 
     U.S.C. 280g 3).
       (b) Requirements.--The Attorney General and the Secretary 
     of Health and Human Services shall consider the following in 
     facilitating the development of recommendations on 
     interoperability of prescription drug monitoring programs 
     under subsection (a)--
       (1) open standards that are freely available, without cost 
     and without restriction, in order to promote broad 
     implementation;
       (2) the use of exchange intermediaries, or hubs, as 
     necessary to facilitate interstate interoperability by 
     accommodating State-to-hub and direct State-to-State 
     communication;
       (3) the support of transmissions that are fully secured as 
     required, using industry standard methods of encryption, to 
     ensure that Protected Health Information and Personally 
     Identifiable Information are not compromised at any point 
     during such transmission; and
       (4) access control methodologies to share protected 
     information solely in accordance with State laws and 
     regulations.
       (c) Report.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Attorney General, in consultation 
     with the Secretary of Health and Human Services, shall submit 
     to the Committee on the Judiciary and the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on the Judiciary and the Committee on Energy and 
     Commerce of the House of Representatives a report on 
     enhancing the interoperability of State prescription

[[Page S3546]]

     monitoring programs with other technologies and databases 
     used for detecting and reducing fraud, diversion, and abuse 
     of prescription drugs.
       (2) Contents.--The report required under paragraph (1) 
     shall include--
       (A) an assessment of legal, technical, fiscal, privacy, or 
     security challenges that have an impact on interoperability;
       (B) a discussion of how State prescription monitoring 
     programs could increase the production and distribution of 
     unsolicited reports to prescribers and dispensers of 
     prescription drugs, law enforcement officials, and health 
     professional licensing agencies, including the enhancement of 
     such reporting through interoperability with other States and 
     relevant technology and databases; and
       (C) any recommendations for addressing challenges that 
     impact interoperability of State prescription monitoring 
     programs in order to reduce fraud, diversion, and abuse of 
     prescription drugs.


                    amendment no. 2146, as modified

  (Purpose: To amend the Controlled Substances Act to place synthetic 
                          drugs in Schedule I)

       At the end of title XI, insert the following:

                      Subtitle D--Synthetic Drugs

     SECTION 1141. SHORT TITLE.

       This subtitle may be cited as the ``Synthetic Drug Abuse 
     Prevention Act of 2012''.

     SEC. 1142. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE 
                   CONTROLLED SUBSTANCES ACT.

       (a) Cannabimimetic Agents.--Schedule I, as set forth in 
     section 202(c) of the Controlled Substances Act (21 U.S.C. 
     812(c)) is amended by adding at the end the following:
       ``(d)(1) Unless specifically exempted or unless listed in 
     another schedule, any material, compound, mixture, or 
     preparation which contains any quantity of cannabimimetic 
     agents, or which contains their salts, isomers, and salts of 
     isomers whenever the existence of such salts, isomers, and 
     salts of isomers is possible within the specific chemical 
     designation.
       ``(2) In paragraph (1):
       ``(A) The term `cannabimimetic agents' means any substance 
     that is a cannabinoid receptor type 1 (CB1 receptor) agonist 
     as demonstrated by binding studies and functional assays 
     within any of the following structural classes:
       ``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at 
     the 5-position of the phenolic ring by alkyl or alkenyl, 
     whether or not substituted on the cyclohexyl ring to any 
     extent.
       ``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole 
     by substitution at the nitrogen atom of the indole ring, 
     whether or not further substituted on the indole ring to any 
     extent, whether or not substituted on the naphthoyl or 
     naphthyl ring to any extent.
       ``(iii) 3-(1-naphthoyl)pyrrole by substitution at the 
     nitrogen atom of the pyrrole ring, whether or not further 
     substituted in the pyrrole ring to any extent, whether or not 
     substituted on the naphthoyl ring to any extent.
       ``(iv) 1-(1-naphthylmethylene)indene by substitution of the 
     3-position of the indene ring, whether or not further 
     substituted in the indene ring to any extent, whether or not 
     substituted on the naphthyl ring to any extent.
       ``(v) 3-phenylacetylindole or 3-benzoylindole by 
     substitution at the nitrogen atom of the indole ring, whether 
     or not further substituted in the indole ring to any extent, 
     whether or not substituted on the phenyl ring to any extent.
       ``(B) Such term includes--
       ``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (CP 47,497);
       ``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP 47,497 
     C8-homolog);
       ``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH 018 and AM678);
       ``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH 073);
       ``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH 019);
       ``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole 
     (JWH 200);
       ``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH 250);
       ``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH 
     081);
       ``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH 122);
       ``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH 398);
       ``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
       ``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
       ``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR 19 and 
     RCS 4);
       ``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 
     (SR 18 and RCS 8); and
       ``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH 
     203).''.
       (b) Other Drugs.--Schedule I of section 202(c) of the 
     Controlled Substances Act (21 U.S.C. 812(c)) is amended in 
     subsection (c) by adding at the end the following:
       ``(18) 4-methylmethcathinone (Mephedrone).
       ``(19) 3,4-methylenedioxypyrovalerone (MDPV).
       ``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C E).
       ``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C D).
       ``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C C).
       ``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C I).
       ``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C 
     T 2).
       ``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 
     (2C T 4).
       ``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C H).
       ``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C N).
       ``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C 
     P).''.

     SEC. 1143. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO 
                   PUBLIC SAFETY EXPANSION.

       Section 201(h)(2) of the Controlled Substances Act (21 
     U.S.C. 811(h)(2)) is amended--
       (1) by striking ``one year'' and inserting ``2 years''; and
       (2) by striking ``six months'' and inserting ``1 year''.

     SEC. 1144. PROHIBITION ON IMPOSING MANDATORY MINIMUM 
                   SENTENCES.

       Section 401(b)(1)(C) of the Controlled Substances Act (21 
     U.S.C. 841(b)(1)(C)) is amended by adding at the end the 
     following: ``Any mandatory minimum term of imprisonment 
     required to be imposed under this subparagraph shall not 
     apply with respect to any controlled substance added to 
     schedule I by the Synthetic Drug Abuse Prevention Act of 
     2012.''.


                            synthetic drugs

  Mr. LEAHY. Mr. President, I ask to engage in a colloquy with Senator 
Harkin.
  I thank the Senator from Iowa for his hard work as chairman of the 
Committee on Health, Education, Labor, and Pensions and, in particular, 
on the Food and Drug Administration Safety and Innovation Act that the 
Senate is now considering. I appreciate Senator Harkin reaching out to 
me about those amendments to his bill that fall within the jurisdiction 
of the Judiciary Committee. One of those amendments concerns the issue 
of synthetic drugs--a major problem that the committee has been 
addressing.
  Mr. HARKIN. Amendment 2146, as modified, filed by Senator Portman, 
places a number of synthetic drugs within schedule I under the 
Controlled Substances Act.
  Mr. LEAHY. Yes. That amendment is the same in substance as three 
bills that the Senate Judiciary Committee passed last year--the 
Combating Dangerous Synthetic Stimulants Act, S. 409; the Combating 
Designer Drugs Act, S. 839; and the Dangerous Synthetic Drug Control 
Act, S. 605. It addresses substances commonly known as bath salts and 
other synthetic drugs that have no legitimate use and can too easily be 
obtained under current law. Bath salts have resulted in a number of 
reports of individuals acting violently in the United States, including 
in Vermont, and have led to injuries to those using them and to others.
  Mr. HARKIN. I am glad that those bills and, therefore, the substance 
of this amendment have already been given careful consideration by the 
Senate Judiciary Committee. That gives me comfort in including this 
amendment among those to which the managers of the bill consent.
  Mr. LEAHY. I agree. I want to be sure that the amendment to be 
included will be Senator Portman's amendment that corresponds precisely 
to the bills that were considered by the Judiciary Committee. Adding 
chemicals to schedule I of the Controlled Substances Act has serious 
consequences and is not a step that we should undertake without careful 
consideration. Do you understand that the consent to include Senator 
Portman's amendment is not consent to further amend the Controlled 
Substances Act, that it is limited to these chemicals and matters 
contained in that amendment, and that have been considered and approved 
by the Senate Judiciary Committee?
  Mr. HARKIN. Absolutely.
  Mr. LEAHY. It is unfortunate that the three synthetic drug bills that 
the Judiciary Committee passed last summer have been unable to move on 
the Senate floor because they have been held up by one Senator. They 
have been cleared for Senate passage on the Democratic side for some 
time.
  Mr. HARKIN. It is too bad that so much progress has been blocked by 
so few in this Congress. I am glad that the Food and Drug 
Administration Safety and Innovation Act may provide an opportunity to 
make progress on this important issue.
  Mr. LEAHY. I thank the Senator for his assistance on this matter.

[[Page S3547]]

  Mr. HARKIN. Mr. President, I ask unanimous consent that the following 
pending amendments be agreed to: Leahy No. 2142, as modified; Portman 
No. 2145, as modified; and Coburn No. 2131; and that the Coburn 
amendment No. 2132 be withdrawn.
  The PRESIDING OFFICER (Mr. Brown of Ohio). Is there objection? 
Without objection, it is so ordered.


                    amendment no. 2142, as modified

  Mr. LEAHY. Mr. President, I commend the Senate for unanimously 
adopting my amendment to address Freedom of Information Act, FOIA, 
concerns with section 708 of the Food and Drug Administration Safety 
and Innovation Act. I especially thank Senators Harkin and Enzi--the 
distinguished Chairman and Ranking Member of the HELP Committee--for 
working with me to protect the American public's ability to access 
important health and safety information under FOIA.
  My amendment improves the bill by allowing the Food and Drug 
Administration, FDA, to obtain important information about drug 
inspections and drug investigations undertaken by foreign governments, 
while at the same time ensuring that the American public has access to 
information about potential health and safety dangers. Specifically, 
the amendment narrows the scope of the FOIA exemption in the original 
bill to No. 1 cover only information obtained from foreign government 
agencies and No. 2 clarify that the information to be withheld must be 
voluntarily provided to the FDA pursuant to a written Memorandum of 
Understanding. The amendment also preserves the right of the Congress 
to obtain this information. Lastly, the amendment places a 3 year time 
limit for withholding information pursuant to the exemption, unless a 
different time period is specified by the foreign government agency--so 
that the information will not automatically be shielded from the public 
indefinitely.
  For more than four decades, the Freedom of Information Act has been 
an indispensible tool for the public to obtain Government information. 
This law carefully balances the need for the Government to keep some 
information confidential, with the need to ensure free flow of 
information in our Democratic society. I am pleased that by unanimously 
adopting my amendment, the Senate has worked in a bipartisan manner to 
ensure that this careful balance is maintained regarding FDA drug 
inspections and investigations.
  I thank the many open government and consumer groups--including 
OpenTheGovernment.org and Public Citizen--that supported this 
amendment. Again, I also thank and congratulate the lead sponsors of 
this bill on the passage of this important legislation.


                    Amendment No. 2146, as Modified

  Mr. HARKIN. Mr. President, it is my understanding that we are ready 
to act on the Portman amendment No. 2146, as modified.
  The PRESIDING OFFICER. Is there further debate on the amendment? If 
there is no further debate, the question is on the adoption of the 
amendment.
  The amendment (No. 2146), as modified, was agreed to.
  Mr. HARKIN. Mr. President, I yield the floor.
  The PRESIDING OFFICER. The senior Senator from New Mexico.


                           Amendment No. 2111

 (Purpose: To provide substantial savings in health care costs to the 
Federal government and consumers by fostering competition among generic 
 pharmaceutical manufacturers and ensuring that anti-competitive ``pay-
 for-delay'' settlements between brand-name and generic pharmaceutical 
   manufacturers do not block generic drugs from entering the market)

  Mr. BINGAMAN. Mr. President, I call up amendment No. 2111.
  The PRESIDING OFFICER. The clerk will report the amendment by number.
  The assistant legislative clerk read as follows:

       The Senator from New Mexico [Mr. Bingaman], for himself, 
     Mr. Vitter, Mr. Franken, Mrs. Shaheen, Mr. Kohl, Mr. Udall of 
     New Mexico, Mr. Johnson of South Dakota, Ms. Klobuchar, Mr. 
     Merkley, and Mr. Sanders, proposes an amendment numbered 
     2111.

  Mr. BINGAMAN. I ask unanimous consent that the reading be dispensed 
with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in the Record of Thursday, May 17, 2012 
under ``Text of Amendments.'')
  Mr. BINGAMAN. Mr. President, this amendment is one that is a 
bipartisan amendment. Senator Vitter is cosponsoring this with me, also 
Senators Franken, Shaheen, Kohl, Tom Udall, Tim Johnson, Klobuchar, 
Merkley, Sanders, and the Presiding Officer, Senator Brown.
  This amendment addresses the very same issue that the Senator from 
Maine was talking about; that is, how do we bring down the price of 
prescription drugs? How do we get competition into the market for 
prescription drugs?
  We have a circumstance today in which an anticompetitive, 
anticonsumer practice is engaged in, and our amendment will change the 
law so that practice can no longer be engaged in. The practice I am 
talking about is the entering into so-called pay-for-delay settlements 
between brand-name drugs--brand-name pharmaceutical companies and 
generic manufacturers.
  These pay-for-delay settlements have the effect of delaying timely 
access to generic drugs. These agreements between companies shield 
billions of dollars in sales each year from effective competition. The 
pharmaceutical companies benefit from this lack of competition and they 
do so at the expense of consumers and they do so at the expense of the 
Federal Government, since the Federal Government is a very large 
consumer and purchases a substantial amount of prescription drugs for 
the military and in other ways.
  A preliminary estimate from the CBO indicates that this amendment 
will reduce direct spending by hundreds of millions of dollars at a 
minimum. Frankly, I believe it will, in fact, save us billions of 
dollars annually at the Federal Government level. The CBO also 
indicates that the amendment will reduce the average cost for 
prescription drugs and lower the cost of health insurance plans.
  Early access to generic drugs is a key to saving money in the health 
care system. Kaiser Family Foundation has found this. They concluded 
that spending in the United States for prescription drugs reached 
$259.1 billion in 2010. That is nearly six times as much as we spent on 
prescription drugs in 1990. Since generic drugs are on average four 
times less expensive--or another way to put that is one-quarter of the 
cost of the brand-name alternatives--they can be a very important 
source for reducing the cost in our health care system. To actually 
receive these savings, consumers have to have access to these generic 
drugs and have access to them in a timely manner.
  In 1984, Congress passed the bipartisan Hatch-Waxman Act to create 
market-based incentives for generic pharmaceutical companies to bring 
their drugs to market as quickly as possible. The purpose of the law 
was to incentivize the early generic drug competition while preserving 
incentives for pioneer companies to develop innovative new medicines. 
Unfortunately, pay-for-delay settlements between brand-name drugs that 
already have their products in the market and generic pharmaceutical 
manufacturers who have not yet brought their products to market have 
become commonplace, and these agreements, these so-called settlements, 
have stifled competition and delayed access to generic drugs at a 
significant cost to everyone who is involved in the health care system.
  There is a table I want to put up. It relates to three particular 
drugs, and I will talk about the second two of these drugs because this 
gives some context to what I am concerned about.
  This second drug is Lipitor. Everybody knows about Lipitor. It is a 
cholesterol-lowering drug. It is familiar to most people. It is the 
best-selling pharmaceutical ever in the history of the world.
  According to a 2008 New York Times report, a pay-for-delay settlement 
delayed generic entry into that market--the entry of a generic version 
of Lipitor--by 20 months. The same report stated the generic version of 
the drug was estimated to sell for less than one-third the cost of the 
brand-name Lipitor. It pointed out that the brand-named Lipitor had 
earned $12.7 billion in sales the year before.
  According to a letter sent to the FDA Director Hamburg last year from 
some of my colleagues in the Senate indicating that the Federal 
Government was spending $2.4 billion a year on

[[Page S3548]]

Lipitor, they estimated that bringing a generic version to market would 
generate somewhere between $4 billion and $6.7 billion in savings 
annually to people who are purchasing this drug in this country.
  The second example is Provigil. This is a sleep disorder drug. Due to 
the pay-for-delay settlement entered into there, a generic version of 
Provigil just came to market this year. Had this amendment we are 
offering as part of this bill been law, generics very likely would have 
entered the market 6 years ago with the expiration of exclusivity.
  The chief executive officer of Cephalon--which is the brand-name 
manufacturer of Provigil--is quoted as saying:

       We were able to get six more years of patent protection. 
     That's $4 billion in sales that no one expected.

  In other words, the Provigil case represents 6 years and millions of 
dollars of lost savings to consumers, the largest consumer being the 
U.S. Government and particularly the U.S. military.
  I have a chart that relates to the U.S. military's potential savings 
from this amendment. This translates this into dollars that are being 
paid out by the U.S. military as part of the defense budget, which we 
are going to be passing later this year.
  Assuming that a generic version of Provigil would have been released 
in 2006, the Department of Defense alone would have saved $159 million 
from this one drug between 2006 and 2011. That is over $150 million 
from a single prescription drug.
  If enacted, this amendment would foster more generic competition, 
would bring generic drugs to the market sooner, and would do so in a 
manner that is consistent with the original intent of the Hatch-Waxman 
Act. Passage of the amendment would significantly cut prescription drug 
costs for American consumers and help reduce the Federal deficit.

  Let me also allude to an article on the front page of the New York 
Times. I know some of my colleagues take exception to the New York 
Times occasionally, but this is an article entitled ``New Fervor for 
Cutting Costs Among Hospitals and Insurers.'' The reporter is Reed 
Abelson. About three paragraphs into the article, he states:

       After years of self-acknowledged profligacy, hospitals, 
     doctors and health insurers say there is a strong effort 
     under way to bring medical costs under control.

  I was struck by that phrase ``self-acknowledged profligacy in the 
health care system.'' I think that is what we have engaged in, in the 
Congress, frankly, is self-acknowledged profligacy in the health care 
system. This amendment will help to correct that.
  The amendment has the strong support of AARP, of Families USA, 
Consumer Federation of America, U.S. PIRG, Consumers Union, the Center 
for Medicare Advocacy, AFL CIO, AFSME, Walmart, the National Committee 
to Preserve Social Security and Medicare, among other groups and 
organizations.
  If my colleagues favor competition, this amendment helps to promote 
competition. If we want to see reduced costs to the taxpayer for health 
care, then this amendment helps to reduce the cost to the taxpayer. If 
we want to reduce what patients and hospitals and insurance companies 
have to pay for prescription drugs, this amendment helps to do that as 
well.
  I think this is something that is long past time we corrected this 
problem. This is a great opportunity for us to do so. I believe it is 
one of the first amendments that will be considered on this 
legislation. I hope my colleagues will put aside whatever other 
considerations they might have had in the past and go ahead and vote 
for this correction in Federal law. This is a problem, frankly, that we 
passed legislation that provided the opportunity--unfortunately. It was 
not intended. But an unintended consequence of the earlier legislation 
that we passed, the Hatch-Waxman Act, was to allow this kind of 
blocking, these kinds of pay-for-delay settlements to be entered into. 
We can correct that today. I hope very much we will.
  I urge my colleagues to support the amendment, and I yield the floor.
  Mr. SCHUMER addressed the Chair.
  The PRESIDING OFFICER. On whose time is the Senator speaking?
  Mr. SCHUMER. I am speaking on the majority's time.
  The PRESIDING OFFICER. On the Bingaman amendment?
  Mr. SCHUMER. No. I am speaking on the McCain amendment.
  The PRESIDING OFFICER. The senior Senator from New York is 
recognized.


                           Amendment No. 2146

  Mr. SCHUMER. Mr. President, I am going to speak for a brief moment on 
the amendment No. 2146 and then on a different issue, which is the 
reaction of some to the proposal Senator Casey and I made about Eduardo 
Saverin and others who renounced their citizenship for tax purposes.
  First, on 2146. I am glad this amendment has now finally passed the 
Senate. It places synthetic drugs on schedule I of the Controlled 
Substances Act as totally banned substances, which are where they 
belong.
  These synthetic substances are also known as bath salts or, in the 
case of synthetic marijuana, Spice incense. Synthetic drugs aren't sold 
on street corners by slingers who keep hidden stashes; instead, these 
drugs are legal--even though they are dangerous--and can be found in 
local corner stores across the country. They are as easy to buy as a 
lollipop or a carton of milk but far more dangerous, even more 
dangerous than the common illegal drug on which they are based.
  By passing this amendment, we finally get these poisonous drugs off 
our shelves and keep our Nation's youth out of emergency rooms.
  I wish to thank Senators Klobuchar and Grassley for working with me 
on this amendment, as well as Chairman Harkin and Senator Enzi, 
Chairman Leahy, Senator Grassley, and Senator Feinstein for their 
leadership, and I want to thank Senator Harkin and Enzi particularly 
for getting us in this package and Senator Portman for working with us 
on this amendment.


                            Eduardo Saverin

  On the issue of Eduardo Saverin, last week, Senator Casey and I 
introduced the Ex-Patriot Act. It is a bill that makes sure that people 
that renounce their citizenship for tax purposes do not escape what 
they owe and cannot come back without repaying all that they avoided 
paying this great country.

  It is a modest proposal, made in response to the regrettable effort 
by a person named Eduardo Saverin, who renounced his American 
citizenship to avoid paying even the historically low level of 15 
percent on capital gains for the several billion dollars in windfall 
profit he is set to receive from the Facebook IPO.
  Mr. Saverin is no longer involved in the day-to-day running of the 
company, and it bears mentioning that the current, active leadership of 
Facebook is comprised of responsible corporate citizens who meet all of 
their responsibilities and obligations.
  Mr. Saverin, on the other hand, has chosen to disown the United 
States to save some money on his taxes.
  Senator Casey and I have proposed a response. Our bill would bar 
Saverin--and others like him--from reentering the country. It would 
also re-impose taxes on investment income earned in the United States 
even if an expatriate is living abroad.
  I believe that the vast majority of Americans, of all parties and 
persuasions, think that renouncing citizenship in America to avoid 
taxes is troubling, unwarranted and ungrateful.
  It is upsetting, to say the least, when a person who has benefitted 
so thoroughly from being an American--a person who accessed and enjoyed 
so many exceptional aspects of American society--just takes the money 
and runs, rather than doing the right thing and repaying the debt he 
owes to a nation that nurtured, facilitated and cheered his success.
  And I think that the vast majority of Americans are receptive to 
suggestions for how we can address this kind of unacceptable behavior.
  Look, nobody enjoys paying taxes, but Americans know that we would 
not have a functioning society without them. We argue and debate about 
the proper rates, and what is fair, and what level will sustain and 
grow our economy and our middle class.
  But I think that most Americans agree that paying a mere 15 percent 
in capital gains taxes on a sum of $3 billion or $4 billion is not too 
much to ask a person, especially a person who fled

[[Page S3549]]

their own homeland because their native society could not provide a 
reasonable level of security to their family.
  While the real point here is not just about this one case--our bill 
addresses a small group of evaders over the last decade or so--it is 
worth pointing out that in this particular case the Saverin family 
found security here thanks to taxpayer funded cops and stability thanks 
to a taxpayer funded military, and a world-class university system, 
like that at Harvard--again underpinned by public support.
  And they also found an expansive middle class that would become the 
market for his product. And a dynamic, entrepreneurial, free market 
economy that allows for significant accumulation of wealth. And 
functioning capital markets that were recently saved from the brink of 
catastrophic collapse through who? The American taxpayer.
  And they found a government that invests in research and development, 
in things like creating the internet, and the web, and GPS, and 
microprocessors, all of which are necessary precursors to what Saverin 
and his cohorts created via Facebook.
  And let's not forget, a non-corrupt legal system, which decided a 
case in his favor that made him a billionaire.
  Yes, Eduardo Saverin did well by being in America.
  And I think that most Americans know full well that what he 
accomplished was not done in a vacuum and that his success is the also 
the outgrowth of his participation in an extraordinary American 
society--a society that we collectively support.
  No one gets rich in America on their own. And when people do well in 
America, they should do well by America.
  I believe the vast majority of Americans believe this, too. So when I 
introduced our legislation I was sure it would garner wide and deep 
support, and in general, it has.
  That is why it is baffling that extreme right wing Republicans, 
people like Grover Norquist, the de-facto leader of the Republican 
Party on tax matters, would rush to the defense of a man who is turning 
his back on America by dodging taxes.
  Amazingly, the extreme right-wing echo chamber has made Saverin into 
a cause celebre, defending his decision to disown the country as 
somehow ``heroic''--Their words, not mine.
  I was amazed. Just amazed. I took it as a given that citizenship--and 
all that it implies in terms of loyalty and duty to America--was 
axiomatic.
  But that is no longer the case. Here is just some of what was said.
  Forbes said that ``For De-Friending The U.S., Facebook's Eduardo 
Saverin Is An American Hero.'' An American hero? Renouncing your 
citizenship now qualifies as heroic for the hard right wing? George 
Washington was heroic. Rosa Parks was heroic. John McCain and Gabby 
Giffords are heroic. Navy SEALS are heroic. Eduardo Saverin is not.
  National Review's Mario Loyola says, ``It is the foolish and counter-
productive tax policies of the left that are chasing Eduardo Saverin to 
another country. . . .'' I'm sorry. 15 percent capital gains rate on 
several billion dollars is so onerous that it is chasing him away? I am 
sure any American worker would love to have that rate.
  And if 15 percent is too high, what does Mr. Loyola or Mr. Norquist 
think the proper capital gains rate should be? Do they think we should 
have even lower taxes on capital gains, which disproportionately goes 
to the highest income earners?
  What is the proper capital gains rate, Mr. Norquist? Should we make 
it 10 percent? 5 percent? Or should it be zero?
  They won't say. Because if they did, they would be laughed out of 
town.
  The Wall Street Journal says we are ``oppressive and demagogic.''
  No. In America, You are free to leave. But if you leave to purposely 
avoid paying your fair share, then we will attach a consequence to that 
dodge.
  Right wing blog after blog--from the American Thinker to the Daily 
Caller--echoes that, ``punishing Saverin for tax dodging is un-
American.''
  Really? Silly me. I thought that renouncing one's citizenship was un-
American.
  While on right wing radio they ask:

       If it's a more favorable tax haven than you can find 
     elsewhere, why is it automatic that you are unpatriotic? Why 
     is it automatic that you are a coward?

  Because, my fellow Americans, when you renounce your nation to fatten 
your bank account, you are--by definition--being greedy and 
unpatriotic.
  Grover Norquist: says our bill is like fascist Nazi Germany or 
apartheid South Africa or communist Soviet Union, while in American 
Thinker we of erecting a ``Berlin Wall.'' And In the Examiner they are 
accused say we are ``totalitarian.''
  The comparisons are absurd on their face and burden on the odious.
  The law Mr. Norquist references in Nazi Germany was purely; 
discriminatory. It targeted a particular race of people--the Jewish 
people--and--punished them for nothing other than being Jewish and 
exercising freedom of movement. It was meant to constrain that freedom 
by forcing Jews to reside inside Germany.
  Our proposal targets no single race, creed or class. It doesn't 
punish you for factors beyond your control, like who your parents were. 
It applies based on actions you take--namely, disowning the United 
States to avoid taxes. Our law is not triggered by a wish to travel 
beyond America's borders, or even reside permanently in a foreign 
country. It is the act of renouncing one's U.S. citizenship--for the 
purpose of avoiding taxes--that triggers our bill.
  Another right wing opinion piece asks: ``If you leave to protest 
heavy taxation why must you pay a penalty?''
  I am sorry, gentlemen, but Mr. Saverin is not protesting anything If 
he was protesting, he would stay here, and fight for a lower tax rate--
not simply exempt himself and leave others like him to continue paying 
a rate he considers too high. What he is doing is free-riding on 
America, dodging paying his fair share, and pocketing the billions from 
an IPO windfall.
  Yet another right wing blog says we are engaged in ``class warfare to 
vilify people that create wealth-just like the Nazi's did with the 
Jews.''--I know a thing or two about what Nazi's did--some of my 
relatives were killed by them--and saying that a person who made their 
fortune specifically because of the positive elements of American 
society, in turn, has a responsibility to do right by America is not 
even on the same planet as comparing to what the Nazis did to the Jews. 
That comparison is odious, but it is in a bunch of these right-wing 
blogs.
  On and on it goes. The whole torrent of vitriol is absurd. Just 
absurd.
  Mr. Saverin is, in essence, an economic tax dodger.
  And once upon a time, the right wing castigated draft dodgers for 
failing to heed their nation's call. Those who fled the country were 
vilified by the right wing as cowards, as self-absorbed, as traitors.
  Yet, in this case, the exact same kind of unpatriotic, un-American 
behavior is actually being defended by the extreme right wing.
  It is off the deep end.
  And when a view this irrational has overtaken one end of the 
political spectrum, it has serious, negative consequences for our 
ability to solve our nation's problems.
  If those on the other side of the negotiating table are this 
obsessive on taxes--that they consider their minimization a higher 
priority than preserving our national identity--then it is no wonder a 
grand bargain on taxes and spending has been so out of reach.
  In the last several years, the far right has disregarded one 
historically conservative priority after another in favor of an all-
consuming obsession with protecting low tax rates for the wealthiest 
Americans.
  First, it was the deficit. The Republicans have for years claimed 
that deficit reduction was their top priority. But that has since been 
exposed as a myth.
  Every independent economist will tell you that the deficit problem 
cannot be solved except through both spending cuts and revenue 
increases. In fact, preserving tax cuts for the very wealthy is 
counterproductive to the goal of reducing our annual deficits.
  Yet the far right marches on in defense of tax cuts for millionaires, 
deficits be damned.
  Last August, our Nation's creditworthiness became a second casualty 
of the far right's insistence on low taxes for the wealthy. The right 
wing was so dug in against any reasonable fiscal

[[Page S3550]]

compromise that they forced a manufactured crisis over raising the 
Nation's debt limit. This caused the first-ever downgrade of our 
Nation's credit rating.
  Unbelievably, the far right prioritized millionaire tax breaks over 
our Nation's full faith and credit.
  Despite that unreasonableness, we thought we had finally figured out 
a way to force the far right to come to grips with the need to deal 
with revenues. We come up with a mechanism called the sequester that 
would trigger harsh defense cuts if the Republicans continued to refuse 
any new revenues.
  Surely, if there was one thing conservatives prized as much as tax 
cuts, it was defense spending, right?
  Wrong. As we speak, the far right remains unwilling to cede an inch 
on revenues, no matter what it means for the Pentagon. The deficit; the 
Nation's creditworthiness; National security--all of these have taken a 
backseat to the far right's idolatry on taxes. Now they have gone so 
far, they have taken this idolatry all the way to its extreme end point 
by making Eduardo Saverin into their patron saint.
  In the name of low taxes for the wealthy, they have lionized an 
inherently unpatriotic person.
  The hero worship of Saverin is Norquist's extreme right wing anti-tax 
agenda being carried to its logical conclusion. And it is a scary, 
absurd place where even a tax dodger who renounces America for his own 
30 pieces of silver is celebrated as a patriot and an American hero.
  It is perverse.
  Reasonable Republicans rightly seem wary to embrace taking things 
this far. House Speaker John Boehner labeled Saverin's move 
``absolutely outrageous'' and said he would support legislation to stop 
wealthy ex-pats relocating to avoid taxes.
  Others have been quiet, perhaps cowed by fears of being the next 
target of the right wing echo chamber.
  Shouldn't loyalty to America--and the broader responsibilities and 
duty of citizenship--trump base, non-essential financial self-interest?
  Sadly, the answer of the extreme right is no.
  The Wall Street Journal attacked the thrust of our proposed 
legislation as an example of the ``age of envy.'' Well, it is not envy. 
In fact, I am happy those who intended and invested in Facebook got 
very rich. Having an idea and succeeding and maybe getting rich off 
this great idea is the American way. More power to them.
  However, what is not the American way is taking a free ride on all 
the exceptional aspects of American society. What is not the American 
way is deriving massive advantage from various publicly supported 
elements of that society and then skipping town when you hit the 
jackpot. Yes, you are free to leave. You have a right to be selfish--
even greedy--when renouncing this Nation.
  I understand this will make you more money and there is a rational, 
simplistic argument to be made in favor of doing it--if the only factor 
that mattered was always getting richer and all other values were 
irrelevant. But we Americans have other values too.
  America is special for many reasons. It is secure, it offers freedom 
of expression, it is diverse and tolerant, it is entrepreneurial, and 
it is economically and culturally dynamic. Looking out for the common 
good is in our blood. It is a part of our shared history and vision of 
our Founding Fathers.
  We provide for the common defense. We promote the general welfare. We 
are not just out for ourselves. No. We look to secure the blessings of 
liberty not just for ourselves but for our posterity. It is this, and 
so much more, that makes America an exceptional society.
  I am appalled by the reaction. I am not appalled by a debate on tax 
policy. I am appalled by making heroic a man who renounces his 
citizenship to escape a tax rate, capital gains of 15 percent.
  Too often I think every action and dilemma we face is now reduced to 
a question of whether this means bigger government or smaller 
government. Since those on the extreme right believe we must have 
smaller government at all costs, they vehemently oppose all taxes. But 
sometimes, as with this case and others like it, it is not just about 
the size of government. It is about doing what is fair and right and 
just based on your responsibilities as a citizen.
  Citizenship is not simply a business decision, it is not just a 
transaction. Those on the right, such as Grover Norquist, defending 
this economic draft dodger are saying something very different. They 
are saying the social contract somehow excludes the accumulation of 
money. We know we give up certain rights and freedoms to live in a 
place like America, but we cannot just carry out vigilantism to pursue 
justice.
  So in conclusion, being an American is not a one-way street. There 
are enormous benefits to being a citizen of our Nation and a member of 
the amazing society that has spawns. But there are also 
responsibilities and duties, such as patriotism, service, contributing 
your fair share, and commitment to community and family.
  As we approach critical debates on the matters of taxation and 
fairness and job creation so critical to keeping America, the greatest 
Nation on the face of the Earth, I certainly hope it is these values, 
not glorified self-interest, that drowns out all other values that 
guide our actions.
  Thank you. I yield the floor.
  The PRESIDING OFFICER. The senior Senator from Wyoming.
  Mr. ENZI. Mr. President, while I agree with much of what the Senator 
has said, I hope this doesn't encourage other partisan diatribes to 
come to the floor when we are on a bipartisan bill and trying to solve 
getting necessary pharmaceuticals to the market as soon as possible. We 
have a limited time of debate, and we need to stay on the subject. So I 
hope others are not encouraged to come down to counter anything they 
may have heard or to make different charges.
  We have some time left on Bingaman and some others, but I hope we can 
move forward on the bill.
  I yield the floor to the Chair.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Mr. President, I concur with Senator Enzi on that, to 
stick to the bill.
  I ask unanimous consent, notwithstanding the previous order, the 
Senate proceed to votes in relation to the following amendments at 12 
noon with all other provisions of the previous order remaining in 
effect: Bingaman amendment No. 2111, Murkowski amendment No. 2108, and 
Paul amendment No. 2143.
  The PRESIDING OFFICER. Is there objection?
  Mr. VITTER addressed the Chair.
  The PRESIDING OFFICER. The Senator from Louisiana.
  Mr. VITTER. Mr. President, reserving the right to object, I will not 
object. I want to ensure that I will have 10 minutes in support of the 
Bingaman-Vitter amendment prior to the vote as was promised to me.
  The PRESIDING OFFICER. The Senator from Louisiana is notified that 
there is not 10 minutes remaining in support of that amendment.
  Mr. VITTER. Mr. President, may I inquire to the Chair how much time 
is remaining.
  The PRESIDING OFFICER. There are 3 minutes left in support of the 
Bingaman-Vitter amendment.
  Mr. VITTER. Mr. President, I ask unanimous consent that as part of 
this agreement that I be given 7 minutes before the vote.
  The PRESIDING OFFICER. Is there objection?
  Mr. HARKIN. Mr. President, I would modify my unanimous consent 
request to have the vote start at 12:05.
  The PRESIDING OFFICER. Is there objection? Without objection, it is 
so ordered.
  The assistant majority leader is recognized.
  Mr. DURBIN. Mr. President, I think that accommodation was to allow 
the Senator from Louisiana for 7 minutes, and I would ask for 5 minutes 
before the votes begin.
  The PRESIDING OFFICER. Without objection, the Senator from Louisiana 
will be given 7 minutes and the assistant majority leader will be given 
5 minutes and the vote will begin at 12:05. Is there objection? Without 
objection, it is so ordered.
  The assistant majority leader.


                           Amendment No. 2127

  Mr. DURBIN. Mr. President, today we are considering a bill that will 
improve the FDA's ability to assure the

[[Page S3551]]

safety of drugs in our medicine cabinets and medical devices in our 
hospitals. The FDA is an essential guardian of the public's health and 
safety. In the past few years, FDA has faced obstacles that call on the 
agency to adapt and respond to the evolving nature of reviewing, 
manufacturing, and distributing drugs and devices.
  Some of those obstacles and challenges are addressed in the 
reauthorizations of the Prescription Drug User Fee Act and the Medical 
Device User Fee Act, which are set to expire at the end of September 
2012.
  Last fall, I visited Cook Medical's medical device plant in Canton, 
Illinois, and representatives expressed concern about the amount of 
time it takes medical devices to be reviewed. The FDA needs sufficient 
time to review medical devices, in order to ensure their safety and 
effectiveness. However, inefficiencies and insufficient resources can 
result in longer review times, which mean patients have to wait longer 
to benefit from new medical devices.
  This bill makes key changes to maintain the safety of devices and 
preserve our country's leadership in biomedical innovation. The bill 
will authorize the FDA to collect almost $600 million in user fees over 
5 years. The FDA can use these additional resources to help hire and 
train staff.
  Furthermore, the bill makes important improvements by streamlining 
the review process for devices and increasing communication between the 
FDA and device manufacturers throughout the review process. These 
changes to the review of medical devices will not only help innovative 
device companies get their product to market faster, but will prevent 
patients from having to wait extra weeks and months to benefit from a 
new device.
  In addition to reauthorizing the Prescription Drug and Medical Device 
User Fee Acts, this bill also establishes the Drug User Fee Act and 
Biosimilar User Fee Act, which gives the FAA new authority to collect 
user fees for generic and biosimilar drugs. Currently the FDA does not 
collect user fees to support the review of generic drugs, and it takes 
about 30 months for the agency to review generic drug applications. 
This extra time reduces access to safe, affordable generic drugs and 
leaves patients and taxpayers paying the tab for brand-name drugs that 
lack competition from generics.
  Since the first Prescription Drug User Fee Act was enacted in 1992, 
the FDA began collecting user fees to support the review of 
applications. The FDA has cut the review time for new drugs by 60%, 
from 2 years to a little over 1 year. Similarly, the Generic Drug User 
Fee Act will give the FDA the support it needs to cut the current 30-
month review time for generic drugs down to 10 months. This improvement 
will promote competition in the marketplace and save money by reducing 
the amount of time patients have to wait for less expensive generic 
alternatives to brand name drugs. The process of negotiating and 
drafting this legislation started 18 months ago and the result is a 
comprehensive bill that improves the safety and quality of drugs and 
medical devices.
  Chairman Harkin and Senator Enzi have put together a bill that 
responds to many of these challenges, including one that is of 
particular interest to me----the national shortage of critical drugs. 
Between 2006 and 2010 the drug shortage increased 200 percent from 56 
to 178 drugs. Currently the drug shortage includes over 200 drugs, like 
intravenous nutrition supplements, cancer treating drugs, and 
anesthesia.
  Over the past few months, I have held three roundtable discussions at 
hospitals across Illinois to learn about the drug shortage and how it 
is affecting providers and patients. From these discussions it is clear 
that the drug shortage is being felt at most hospitals and those 
Illinois hospitals, providers, and pharmacists are working around the 
clock to ensure patients maintain access to drugs and safe treatments.
  At Advocate Hospital in Libertyville, a doctor shared that he learned 
just days before starting a patient on chemotherapy that the drug was 
not available. Unfortunately, this is a common scenario across the 
country as doctors learn days before starting a treatment or even once 
the patient is on the hospital bed that a drug is not available. 
Pharmacists now spend part of each day scrambling to find drugs or an 
alternative treatment.
  Recently I learned that a young woman on my staff here in D.C. is all 
too familiar with the drug shortage. She is a smart and hard-working 
woman who has been taking Concerta to treat her ADD since she was 14. 
Like most people with severe ADD, she must take her medicine at a 
certain time every day in order to keep her ADD symptoms from impeding 
basic life and work responsibilities. And while there are several ADD 
drugs on the market, each drug works differently and can have different 
side effects, so switching to a new prescription is not without risk.
  Last year, the local CVS where she usually had her prescription 
filled started telling her they didn't have her drug in stock. She 
didn't think much of it as she would wake up early and walk to another 
CVS in the morning where she was usually able to get the prescription. 
Over time, she grew accustomed to going between these two CVS 
pharmacies to fill her prescription.
  Until one month, when she carried her prescription with her for 3 
days and was unable to find a pharmacy with enough Concerta to fill her 
30-day prescription.
  By the end of day 3, she was out of her supply. She woke up early and 
rode her bike to four or five CVS pharmacies until she was able to find 
a pharmacy that could fill her prescription. But by then it was 12 
o'clock and past the prescribed time to take the drug.
  The shortage of ADD drugs impacts children, adults, parents, and 
employees across the country. Congress needs to take action to address 
the drug shortage.

  The FDA Safety and Innovation Act builds on Senator Klobuchar's bill 
with key provisions to curb the national drug shortage. First, the bill 
requires drug manufacturers to notify the FDA 6 months in advance for 
certain drug shortages. With this much notice, the FDA can work with 
manufacturers to try to avoid a shortage and, when necessary, identify 
alternative sources of the drug to ensure we maintain a supply for 
patients.
  This winter, thanks to open communication between the FDA and drug 
companies, the FDA successfully avoided a shortage of methotrexate, a 
vital drug to treat leukemia in children. The FDA collaborated with 
Illinois-based generic drug manufacturer, Hospira, to increase 
production of this live-saving drug when another company halted 
production. Requiring 6 months advance notice of a drug shortage will 
help the FDA to work with companies to avoid shortages of critical 
drugs.
  Furthermore, the bill requires FDA to enhance the agency's response 
to shortages and will improve reporting of shortages by allowing third-
parties to report drug shortages to the FDA.
  This bill also takes steps to improve the safety of drugs and the 
drug supply chain.
  In 2008, serious injuries and 81 deaths were linked to contamination 
of the crucial blood thinning drug heparin. The source of the 
contamination was a facility in China that intentionally adulterated 
the drug. This was a horrible illustration of what happens when 
adulterated and counterfeit drugs make their way into the drug supply 
chain and ultimately to patients. This case has also raised serious 
questions about the global manufacturing practices of drugs and drug 
ingredients and the FDA's responsibility to protect the drug supply 
chain.
  Since the heparin incident, the global nature of the drug supply 
chain has only grown. Today 80 percent of active pharmaceutical 
ingredients are manufactured outside of the United States. This bill 
improves the safety of our supply chain, both domestically and 
internationally by requiring foreign manufacturers to register their 
facilities with the FDA. The bill also places greater responsibility on 
U.S. drug manufacturers to know their international suppliers and 
increases penalties for intentionally contaminating or counterfeiting 
drug. Counterfeit and adulterated drugs can have deadly consequences, 
yet the penalty for committing these crimes is less than the penalty 
for selling a counterfeit designer purse.
  Currently, the penalty for intentionally counterfeiting or 
adulterating a drug is no more than 3 years in prison or a $10,000 fine 
or both.

[[Page S3552]]

  This bill raises the penalty for intentionally adulterating a drug to 
no more than 20 years in prison or a $1 million fine or both.
  And the penalty for intentionally counterfeiting drugs is raised to 
no more than 20 years in prison or a $4 million fine or both.
  This bill addresses the drug shortage, reduces the review time for 
medical devices and drugs, improves the pipeline for antibiotics and 
pediatric drugs, and helps secure the supply chain for prescription 
drugs.
  I would like to thank Chairman Harkin and Senator Enzi for their 
extraordinary leadership and hard work on this bill.
  The amendment we will face this afternoon is one I am offering 
relative to dietary supplements. I want to make it clear what this is 
about.
  If someone walked into their neighborhood drugstore and looked at 
everything on the shelf, here is what they can say: All the 
prescription drugs the pharmacy has access to have been reviewed by the 
Food and Drug Administration that they are safe and effective. All of 
the over-the-counter drugs have been reviewed and registered with the 
Food and Drug Administration to make certain they are safe and have 
been precleared before they can be sold. Now when they move back to the 
vitamin counter, all bets are off. Those are called dietary 
supplements. They are not subject to the same level of scrutiny, 
inspection, testing or regulation. It is an entirely different world.
  It is understandable that there are those of us who want to be able 
to walk in and buy vitamins, for example, without a prescription. That 
is our right as Americans. But we also want to make sure that whatever 
is on the shelf at the pharmacy is not dangerous or at least we know it 
is there.
  There are between 55,000 and 75,000 dietary supplements in America. 
We don't know the exact number. They include the obvious, vitamins and 
minerals, but they also go further. They include energy drinks. Ever 
heard of the 5-Hour Energy Drink, Monster Energy Drink? Those are not 
sold as colas, sodas, or beverages. They are sold as dietary 
supplements. Why? Because there is no regulation in terms of their 
contents.
  We had a sad story I told on the Senate floor 2 days ago, with the 
family in the gallery, about a 16-year-old girl from Hagerstown, MD, 
who drank two Monster Energy Drinks within a 24-hour period and went 
into cardiac arrest. It was too much for her heart. She died. That was 
a dietary supplement.
  My amendment says if they want to sell a dietary supplement in the 
United States, they have to do one basic thing: They have to go to the 
Food and Drug Administration and say: This is the name of my company. 
This is the name of my product and the ingredients in it. And here is a 
copy of the label. That is it.
  So is it important that we know this? There will be 1,000 new 
products bought and sold in the United States as dietary supplements 
every year. Just in case we think knowing the dietary supplement 
facility company has been registered is enough, hang on tight. These 
dietary supplements are coming from all over the world. Sadly, a lot of 
them turn out to be dangerous.
  In 2009 the FDA announced that Super Slim, a dietary supplement 
manufactured in China, contained the pharmaceutical ingredient 
sibutramine, which is no longer available in the United States and 
found to increase the risk of heart attack or stroke. If the 
manufacturers had registered this dietary supplement so we knew the 
ingredient, we could protect American consumers.
  The same thing was true in 2001. Another Chinese-based weight-loss 
ingredient, aristolochic acid, was found to cause kidney damage and to 
be a potent carcinogen. Isn't it important for us to know this? Is it 
too much to ask the dietary supplement companies to go to the FDA and 
at least register their products before they put them on the shelves 
across America? Don't American families have the right to scrutiny and 
at least some basic knowledge of the sale of these products?
  The industry is against this. They don't want to report it. They 
basically say: It is none of your business. We will sell what we want 
to sell, and that is the way it will be. If we want to volunteer the 
information, so be it. But we don't want to be required to disclose the 
information.
  There are groups that see it differently. I ask unanimous consent to 
have printed in the Record letters that support my amendment. The 
Center for Science and Public Interest and the Consumers Union are in 
support of this amendment.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                             Center for Science in


                                          the Public Interest,

                                     Washington, DC, May 24, 2012.
     Senator Dick Durbin,
     Attn.: Binta Beard, U.S. Senate, Washington, DC.
       Dear Senator Durbin: The Center for Science in the Public 
     Interest is pleased that you are introducing an amendment to 
     the Food, Drug, and Cosmetic Act that would help improve 
     public confidence in dietary supplements. Supplements are 
     poorly tested, may be contaminated, can sometimes interact 
     with pharmaceuticals, and are marketed with more hype than 
     just about any other consumer product. Your amendment would 
     do the minimum to protect both consumers and conscientious 
     companies: require disclosure to the Food and Drug 
     Administration of all ingredients, build a repository of 
     labels, and require registration with the FDA. Much more 
     really should be done to assure safety and efficacy, but we 
     hope your amendment will receive widespread support.
           Sincerely,
                                              Michael F. Jacobson,
     Ph.D., Executive Director.
                                  ____

                                                     May 21, 2012.
     Senator Richard J. Durbin,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senator Durbin: Consumers Union applauds your efforts 
     to strengthen dietary supplement safety by requiring 
     manufacturers to register their products with the Food and 
     Drug Administration (FDA). Specifically, your proposed 
     amendment to the Food and Drug Administration Safety and 
     Innovation Act (S. 3187) would require manufacturers to 
     provide the FDA with accurate and up-to-date information 
     regarding each dietary supplement product they manufacture, a 
     list of ingredients included in those products, and a copy of 
     the product labels.
       Although many dietary supplements on the market may be safe 
     and healthful, there are numerous ingredients that may pose 
     significant dangers to consumers. Some supplement ingredients 
     could, for example, interact with prescription drugs to 
     produce dangerous side effects. Others can change the 
     effectiveness of prescription drugs. Still others could be 
     generally safe for most consumers, but have hazardous health 
     effects for certain population subgroups, such as pregnant 
     women or children.
       Dietary supplement manufacturers are currently subject to 
     limited registration requirements as food-processing 
     facilities. However, these entities are not required to 
     register their products with the FDA, in order to facilitate 
     timely action in the event of a safety alert. As noted by the 
     U.S. Government Accountability Office (GAO) in its 2009 
     report, FDA ``lacks complete information on the names and 
     location of dietary supplement firms within the agency's 
     jurisdiction,'' and does not have a comprehensive database of 
     products currently being sold in the marketplace, and the 
     ingredients they contain. This leaves the FDA without 
     adequate marketplace information, should it need to take 
     prompt or immediate action regarding supplement ingredients 
     that are dangerous or found to be adulterated.
       Requiring manufacturers to submit a list of products sold, 
     product ingredients, and product labels to FDA on a regular 
     basis would ensure that the agency can appropriately assess 
     potential safety issues and quickly respond as they arise. 
     The FDA's post-marketing surveillance of dietary supplements 
     will be much more effective if the FDA has accurate, timely 
     information about supplement products currently available in 
     the U.S. marketplace.
       Consumers Union believes this amendment will advance the 
     safety of dietary supplements for consumers. We thank you for 
     taking on this critically important issue, and look forward 
     to working with you to support the amendment.
           Sincerely,
     Chuck Bell,
       Programs Director Consumers Union.
     Ioana Rusu,
       Regulatory Counsel Consumers Union.

  Mr. DURBIN. I ask my colleagues when this vote comes before us, 
before we have another death in America from a dietary supplement from 
China, India, Mexico, or even in the United States, shouldn't we 
require the most basic information so we know the name of the company, 
the ingredients in the product, and what the label looks like?
  The FDA has asked for this information. They asked expressly for this 
information. To say it is a burden on them, they already asked for it.

[[Page S3553]]

  I ask my colleagues when this amendment comes up later this afternoon 
that they support this in the best interest of protecting American 
families and consumers.
  I yield the floor.
  The PRESIDING OFFICER (Mrs. Hagan). The Senator from Louisiana.


                           Amendment No. 211

  Mr. VITTER. Madam President, I rise to strongly support the upcoming 
Bingaman-Vitter amendment, which is basically an amendment form that 
Bingaman-Vitter Fair Generics Act would stop an escalating trend in the 
drug industry which has pay-for-delay deals between a generic 
manufacturer and a big pharmaceutical manufacturer.
  Over the last several years we have seen a huge increase, and we have 
seen this trend grow from modest to a raging trend, and it is 
anticompetitive. It is pay-for-delay deals in which the brand-name drug 
dealer pays off or settles with the first-to-file generic drugmaker, 
often restricting generic market entry for years into the future.
  As prescription drug prices explode, they put real pressure and 
burdens on many Americans' budgets because they are making medications 
that should be more affordable in terms of coming onto the market. They 
are postponing those drugs, paying for the delay, and holding them off 
the market longer and longer.
  The FTC has compiled data and made clear that this trend is 
happening, and the FTC, an official government agency, said:

       The continued trends of record numbers of brands and 
     generics resolving patent litigation prior to a final court 
     decision [yields] significant numbers of such settlements 
     potentially involving pay-for-delay.

  Those were the FTC's words.
  In 2004 the FTC had identified zero of those sorts of pay-for-delay 
deals. In 2006 it was up to 14. In 2011 it doubled to 28. Clearly it is 
a big trend. That is ``28 final settlements (that) contain both 
compensation to the generic manufacturer and a restriction on the 
generic manufacturer's ability to market its product.''
  This fair generics bill, through this amendment, fixes the problem. 
That was the intent of the original Hatch-Waxman language, but there 
was a loophole that has been exploited in this pay-for-delay deal 
because the first filer is granted exclusivity even if the first filer 
is paid off and settles and doesn't pursue its ability to enter the 
market.
  The Fair Generics Act would fix that, and it would basically outlaw 
that sort of marketing of generics. It would realign and reaffirm the 
incentive and reward not just for filing first but for successfully 
challenging and invalidating a patent. So we would move the first 
filing exclusivity to a reward for filing and also successfully 
invalidating a patent.
  It is a realistic proposal. It would allow the first filer to follow 
through on that filing. It would encourage it, but also if that is not 
going to happen, it would allow subsequent filers to litigate and 
validate the patent and thereby gain ability to enter the 
marketplace. I really think this was the intent of Hatch-Waxman.

  Unfortunately, there is a loophole that has been exploited in Hatch-
Waxman that has led to these serious pay-for delay cases. Again, this 
is an escalating trend that is still growing. I have no doubt that when 
we get the number for 2012, it is going to be significantly above the 
2011 number of 28.
  So to simplify it, if the first filer does not enter into a 
settlement with the restricted and delayed market entry date and if it 
does diligently challenge and invalidate a patent, nothing changes 
under present law. The current 6-month market exclusivity reward 
remains. So that incentive, that reward absolutely remains. However, if 
that doesn't happen and the first filer just wants to settle or park 
its filing and is generic, a subsequent filer would have the ability to 
step up and challenge the patent and, if it won, it would have market 
access.
  This solution provides more litigation certainty. We propose 
basically a use-it-or-lose-it statute for the brand name to sue the 
generic within the 45-day window. Current law provides a brand 
manufacturer a 30-month stay if they sue the generic within the 45-day 
window but still allows a suit after.
  So, again, I believe this is a reasonable and measured approach. This 
is not as Draconian or dramatic an approach as other proposals in the 
Senate. I believe this is the middle ground, and I believe this honors 
and gets us back to the original intent on this subject of Hatch-
Waxman. But it is a measured response to this escalating trend that we 
clearly see, that the FTC has objectively identified and measured--a 
so-called pay-for-delay arrangement.
  In conclusion, the goal of Hatch-Waxman was to bring generics to the 
market more quickly. This approach, the FAIR Generics Act, will do 
that. There are anticompetitive deals that are being struck more and 
more often--pay for delay--and they are becoming much more prevalent, 
and they are hurting American families.
  The mega-lobbyist pharmaceutical industry, of course, opposes this 
reform because, quite frankly, those pay-for-delay deals are a way to 
buy more exclusivity and keep generics off the market longer. But that 
is not in the interests of the consumer. It is time to stand up to 
them. It is time to have some courage, to stand up to Big Pharma and 
say: We are going to preserve your exclusivity for developing a drug, 
but we are not going to let you buy off generics and unfairly extend 
that time period. We are going to let generics come to market in a 
reasonable time. We are going to create incentives to make sure that 
happens.
  I urge all of my colleagues to support that proposal, which is 
embodied in the Bingaman-Vitter amendment, the FAIR Generics Act.
  I yield the floor.
  The PRESIDING OFFICER. There is now 2 minutes of debate equally 
divided on the Bingaman amendment.
  Mr. HARKIN. Madam President, first I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There appears to be a sufficient second.
  The yeas and nays are ordered.
  The Senator from New Mexico.
  Mr. BINGAMAN. Madam President, I thank Senator Vitter for his 
comments and for his strong support of this amendment. I thank all of 
the other cosponsors of the legislation.
  If we are interested in promoting competition in the health care 
field so that we can keep prices down, then we need to support this 
amendment. That is exactly what this does.
  Under our law in this country, we provide exclusive rights to a 
company that develops a drug to sell that drug during the time the 
patent is in effect. But what we are concerned with here is that after 
that patent is no longer valid, companies are still extending their 
exclusivity, extending their time when they don't have any competition 
by entering into these agreements. So we think they can settle their 
disputes--we don't have a problem there--but they cannot keep other 
generic manufacturers from coming to the market who also have 
demonstrated the invalidity of a patent.
  If we are worried about the cost of health care to the Federal 
Government--the Federal Government is paying too much for prescription 
drugs because of this flaw in the Hatch-Waxman Act that we are trying 
to correct. If we are worried about keeping prices down for hospitals, 
insurance companies, and consumers, this amendment will help to do 
that.
  I urge my colleagues to support the amendment.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Madam President, I rise today to oppose the amendment 
addressing the patent settlements for generic claims.
  I am sympathetic to the intent of the sponsors of this amendment. I 
believe that some drug patent settlements may be improper and could be 
unfairly increasing drug prices for consumers. If that is in fact 
happening, we should stop the bad settlements and encourage the ones 
that work.
  The problem with this amendment, however, is that its scope is much 
broader and could lead to unintended consequences that could harm 
consumers and increase costs. That is why I must oppose it. The 
amendment uses a machete when a scalpel might solve the problem. Not 
all patent settlements are abusive. They do not all lead to higher 
costs. In fact, some settlements can actually expedite generic drugs 
coming to market. According to

[[Page S3554]]

one recent study by RBC Capital Markets, patent settlements helped 
expedite 24 of the 37 most recent generic drug approvals.
  The amendment would allow competing generic manufacturers, in certain 
cases, to share the 180 days of exclusivity provided under the drug 
patent law known as Hatch-Waxman. This period of exclusivity was 
intended to create a market incentive for generic manufacturers to be 
the first to file a generic drug application with FDA.
  The amendment is intended to discourage generic manufacturers from 
reaching settlements with brand manufacturers to delay generic 
competition. Unfortunately, it may also have the unintended consequence 
of discouraging generic competition generally.
  The Hatch-Waxman statute, which first established our current system 
of brand and generic drug approvals, was a careful compromise of 
competing interests. It struck a balance between encouraging research 
and development of new cures and promoting competition to lower costs. 
By all accounts, this law has been a success. Our Nation leads the 
world in the creation of new drugs and therapies that improve the lives 
of countless patients across the world. At the same time, generic drugs 
have promoted competition and lowered costs to American patients. 
According to one recent estimate, generic drugs have saved the American 
health care system over $930 billion over the last decade.
  This amendment would disrupt that system and reduce the incentives 
that currently encourage manufacturers to file generic drug 
applications with the FDA. Allowing competitors to share the 180 days 
of exclusivity will undermine the market incentives for manufacturers 
to make such filings. It will also create uncertainty about whether 
generic manufacturers will ultimately be able to recoup their 
investments and could mean that there will be fewer generic drugs.
  That is why the generic drug manufacturers oppose this amendment. 
While I genuinely appreciate the desire to prevent abusive settlements, 
I believe that we must be very careful in disrupting a system that has 
worked so well for patients and consumers.
  We should hold hearings in the HELP Committee to hear from all of the 
stakeholders who have a role in this system. We need to learn how any 
proposal will impact the incentives to encourage competition. We also 
need to learn how any proposed solutions will affect settlements and 
patent litigation.
  This is clearly an important and very complex issue, but this 
amendment could have serious and detrimental consequences for patients. 
This is why I would urge my colleagues to oppose this amendment.
  I yield the floor.
  The PRESIDING OFFICER. The question is on agreeing to the amendment.
  The yeas and nays have been ordered.
  This is a 60-vote threshold vote.
  The clerk will call the roll.
  The assistant bill clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Connecticut (Mr. 
Blumenthal) and the Senator from Maryland (Ms. Mikulski) are 
necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Idaho (Mr. Crapo), the Senator from Texas (Mrs. Hutchison), and 
the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 28, nays 67, as follows:

                      [Rollcall Vote No. 105 Leg.]

                                YEAS--28

     Akaka
     Bingaman
     Boxer
     Brown (OH)
     Cardin
     Conrad
     Durbin
     Feinstein
     Franken
     Gillibrand
     Inouye
     Johnson (SD)
     Klobuchar
     Kohl
     Levin
     McCain
     Merkley
     Pryor
     Reed
     Sanders
     Schumer
     Shaheen
     Snowe
     Udall (CO)
     Udall (NM)
     Vitter
     Webb
     Whitehouse

                                NAYS--67

     Alexander
     Ayotte
     Barrasso
     Baucus
     Begich
     Bennet
     Blunt
     Boozman
     Brown (MA)
     Burr
     Cantwell
     Carper
     Casey
     Chambliss
     Coats
     Coburn
     Cochran
     Collins
     Coons
     Corker
     Cornyn
     DeMint
     Enzi
     Graham
     Grassley
     Hagan
     Harkin
     Hatch
     Heller
     Hoeven
     Inhofe
     Isakson
     Johanns
     Johnson (WI)
     Kerry
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Lee
     Lieberman
     Lugar
     Manchin
     McCaskill
     McConnell
     Menendez
     Moran
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Paul
     Portman
     Reid
     Risch
     Roberts
     Rockefeller
     Rubio
     Sessions
     Shelby
     Stabenow
     Tester
     Thune
     Toomey
     Warner
     Wicker
     Wyden

                             NOT VOTING--5

     Blumenthal
     Crapo
     Hutchison
     Kirk
     Mikulski
  The PRESIDING OFFICER. Under the previous order requiring 60 votes 
for the adoption of this amendment, the amendment is rejected.


                           Amendment No. 2108

  Mr. HARKIN. Madam President, I inquire what the next vote would be 
on?
  The PRESIDING OFFICER. The Murkowski amendment No. 2108.
  Mr. HARKIN. Madam President, I ask that that vote be a 10-minute 
vote.
  The PRESIDING OFFICER. That is already the order.
  There are now 2 minutes equally divided.
  Ms. MURKOWSKI. Madam President, I ask for support of the amendment 
that is before us. This is an amendment that will actually strengthen 
the role of NOAA as the Federal agency that has oversight over our 
fisheries.
  Currently the FDA is considering an application for a genetically 
engineered fish, a fish that takes DNA from one salmon and an ell pout 
to accelerate the growth unnaturally. The FDA is not looking at 
labeling this fish. The FDA is not considering the environmental impact 
of escapement on this fish into the marine environment.
  What we are asking for with this amendment is as the FDA proceeds in 
its process that the agency that has oversight of our fisheries be 
allowed to participate and weigh in as to whether there are any 
environmental consequences that may come about as a consequence of a 
release into a marine environment.
  This is a situation where people have a right to know about the 
quality of their fish, where it comes from, what it is made of. What I 
am asking is for the agency that has oversight of our fisheries to have 
a role in this process. I urge Members to support the amendment.
  The PRESIDING OFFICER. The majority leader.
  Mr. REID. Madam President, the time, as usual, did not run as quickly 
as we wanted. I ask unanimous consent that we only have two votes prior 
to lunch today, and that the next vote start at 5 minutes until 2 today 
after we complete this vote.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Kansas.
  Mr. HARKIN. Regular order, please.
  The PRESIDING OFFICER. For what purpose does the Senator seek 
recognition?
  Mr. ROBERTS. Madam President, I rise in opposition to speak for 1 
minute.
  The PRESIDING OFFICER. There is 1 minute in opposition. The Senator 
is recognized.
  Mr. ROBERTS. Madam President, I fear this legislation would insert 
Congress in the scientific process of approving applications that we 
have entrusted to the FDA. This application has been pending at FDA for 
over 15 years. We should allow the FDA to complete their scientific 
review of the product and not interfere with the ongoing reviews.
  We have a science-based system that allows for complete review. We 
should allow that process to continue. This amendment sets up a two-
tiered, two-agency approval system. That is not good. We know the FDA 
has already conferred with NOAA regarding the pending application.
  Basically, Members of the Senate should not put on lab coats and tell 
the FDA to approve or deny the pending application. We should allow 
them to act on the statutory authority that is given to them. I 
reluctantly oppose the amendment of my colleague from Alaska.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KERRY. Madam President, this would be the first time Congress has 
ever interfered in an FDA-based, science-based approval process. If we 
open that, we would be opening an extraordinary can of worms.

[[Page S3555]]

  I urge my colleagues to oppose this amendment.
  The PRESIDING OFFICER. The question is on agreeing to the amendment.
  Mr. MERKLEY. Madam President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The clerk will call the roll.
  The bill clerk called the roll.
  Mr. DURBIN. I announce the Senator from Connecticut (Mr. Blumenthal) 
is necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Idaho (Mr. Crapo), the Senator from Texas (Mrs. Hutchison), and 
the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 46, nays 50, as follows:

                      [Rollcall Vote No. 106 Leg.]

                                YEAS--46

     Akaka
     Ayotte
     Baucus
     Begich
     Bennet
     Bingaman
     Boxer
     Cantwell
     Cardin
     Coburn
     Cochran
     Collins
     Conrad
     Durbin
     Feinstein
     Gillibrand
     Graham
     Johnson (SD)
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Manchin
     Menendez
     Merkley
     Mikulski
     Murkowski
     Murray
     Nelson (FL)
     Portman
     Reed
     Reid
     Rockefeller
     Sanders
     Schumer
     Shaheen
     Snowe
     Stabenow
     Tester
     Udall (CO)
     Udall (NM)
     Warner
     Whitehouse
     Wicker
     Wyden

                                NAYS--50

     Alexander
     Barrasso
     Blunt
     Boozman
     Brown (MA)
     Brown (OH)
     Burr
     Carper
     Casey
     Chambliss
     Coats
     Coons
     Corker
     Cornyn
     DeMint
     Enzi
     Franken
     Grassley
     Hagan
     Harkin
     Hatch
     Heller
     Hoeven
     Inhofe
     Inouye
     Isakson
     Johanns
     Johnson (WI)
     Kerry
     Klobuchar
     Kohl
     Kyl
     Lee
     Lugar
     McCain
     McCaskill
     McConnell
     Moran
     Nelson (NE)
     Paul
     Pryor
     Risch
     Roberts
     Rubio
     Sessions
     Shelby
     Thune
     Toomey
     Vitter
     Webb

                             NOT VOTING--4

     Blumenthal
     Crapo
     Hutchison
     Kirk
  The amendment (No. 2108) was rejected.
  The PRESIDING OFFICER. Under the previous order requiring 60 votes 
for the adoption of the amendment, the amendment is rejected.
  The Senator from Tennessee.
  Mr. CORKER. Madam President, I understand I have 3 or 4 minutes to 
speak about the GAIN Act.
  The PRESIDING OFFICER. How much time does the Senator wish to speak?
  Mr. CORKER. About 3 or 4 minutes.
  The PRESIDING OFFICER. On an amendment or on the bill?
  Mr. CORKER. On the bill.
  Mr. HARKIN. Madam President, parliamentary inquiry.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. There is a lot of commotion going on. I want to know 
where the time is coming from for the Senator from Tennessee.
  The PRESIDING OFFICER. The Senator said he was speaking on the bill.
  Mr. HARKIN. Madam President, how much time is left on the bill?
  The PRESIDING OFFICER. The Senator from Iowa controls 15 minutes, and 
the Senator from Wyoming controls 22 minutes.
  Mr. HARKIN. How much time does the Senator from Tennessee need?
  Mr. CORKER. Three minutes.
  Mr. HARKIN. OK, that is fine.
  Mr. ENZI. Madam President, I yield 3 minutes to the Senator from 
Tennessee.
  Mr. HARKIN. I will, too, if he needs it.
  Mr. CORKER. Madam President, I rise to thank both the majority and 
minority leaders of the bill for their great effort. I am pleased to 
speak about a provision in the FDA Safety Innovation Act that addresses 
a growing public threat in Tennessee and Connecticut and across the 
Nation.
  Several months ago, Senator Blumenthal and I introduced the GAIN Act, 
which is a bipartisan provision that provides a meaningful market 
incentive and reduces regulatory burdens to encourage development of 
new antibiotics that will help save lives and reduce health care costs.
  Drug-resistant bacteria, or ``superbugs'' as we call them, are 
becoming harder to treat because we lack new antibiotics capable of 
combating these infections. Not only do these infections take a toll on 
patients and their families, but they also run up health care spending 
to the tune of $35 billion to $45 billion annually.
  It is crucial that these new antibiotics are discovered in order to 
stay ahead of the growing trend of drug resistance. Drug discoveries do 
not happen overnight, so we must act now to ensure that we have 
lifesaving medications when we need them.
  The GAIN Act is a straightforward, commonsense bill that provides 
market incentives to encourage innovation without putting Federal 
dollars at stake, and it is included in this FDA reauthorization. 
Antibiotic resistance is a growing issue that we need to address now to 
properly prepare for the future.
  Dr. William Evans, director and CEO of St. Jude's Hospital in 
Tennessee, wrote a letter supporting this bill, which says:

       We don't want to find ourselves in a situation in which we 
     have been able to save a child's life after a cancer 
     diagnosis only to lose them to an untreatable multi-drug 
     resistant infection.

  I thank Senator Blumenthal from Connecticut for his leadership on 
this bill. I especially thank Senators Harkin and Enzi for working with 
us the way they have to include this provision in the FDA Safety and 
Innovation Act.
  I think I have stayed within my time limit.
  I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  The Senator from Wyoming.
  Mr. ENZI. Madam President, I yield 5 minutes to the Senator from 
Ohio.
  The PRESIDING OFFICER. The Senator from Ohio.


                     Amendments Nos. 2145 and 2146

  Mr. PORTMAN. Madam President, I thank the ranking member and 
congratulate him for the good work today on this legislation.
  There are a couple of amendments that are part of the bill I want to 
speak about. First is on prescription drug abuse--a problem we all face 
as representatives of our States. I particularly thank Senator 
Whitehouse for his partnership on this important bill.
  In the last decade, unfortunately, prescription drug abuse has 
reached epidemic proportions in States such as Ohio, and in so many 
other States around the country. In doing so, it has devastated the 
lives of so many individuals but also the well-being of our 
communities, and of course affected their families, affected our 
economy, and it has caused a big spike in crimes, including theft, as 
addicts look for ways to support their addictions. This crime, of 
course, has doubly strained law enforcement, which has already had to 
contend with the increase in drug trafficking with constrained budgets. 
It has also served as a gateway to other drug use, including heroin 
use, which tends to be less expensive and causes additional public 
health challenges.
  Amazingly, since 2007, drug overdoses have now moved ahead of car 
accidents as the leading cause of accidental death in my home State of 
Ohio. Again, we have seen this, unfortunately, too often around the 
country. We have had record levels of hepatitis C infection from needle 
sharing. In one county on the Ohio River, in southern Ohio, 10 percent 
of the babies born in 2010 had drugs in their system.
  The good news is progress is being made in places such as Scioto 
County and around the country thanks to the good work of health 
professionals, law enforcement, local, State, and Federal officials, 
along with community groups, families, schools, churches, and others. 
But they need some help. More work needs to be done, and one critical 
tool they are looking for in the fight against prescription drug abuse 
is a better way to monitor prescription drug use. There are databases 
around the country called prescription drug monitoring programs. They 
allow States to monitor and track the dispensing of prescription drug 
medications by health care providers to be able to identify and stop 
the abuse of people getting prescriptions for these drugs in various 
different doctors' offices and in what have been called pill mills. 
Preliminary research has shown monitoring programs are highly effective 
in stemming the tide of abuse. That is why 48 States and 1 territory

[[Page S3556]]

now have them, with 41 of them operational.
  There is a problem, however. Different States' monitoring programs 
can't communicate with one another, so one State doesn't know what the 
other State is doing, and drug trafficking is an interstate problem. 
This is especially true in places such as Scioto County in southern 
Ohio, right across the river from Kentucky and bordering West Virginia. 
We want these States to be able to work together, and that is why 
Senator Whitehouse and I have offered this amendment, No. 2145, as a 
Federal solution to providing a framework for monitoring programs to 
participate in data sharing across State lines.
  This amendment also supports collaboration between the Department of 
Health and Human Services and the Bureau of Justice Assistance in order 
to further their research to assess challenges that have an impact on 
States' interoperability.
  Some have called for a national monitoring program--one Federal 
program. I don't think that is necessary. I don't think it will work as 
well. A lot of States have programs that are working extremely well and 
they have put a lot of money into them. There are differing protected 
health standards State by State. So rather than trying to federalize 
it, our amendment gets these disparate programs to work together 
securely, reliably, and efficiently without undermining or jeopardizing 
the State's autonomy in this area. States should remain free to 
establish laws that determine user eligibility and reporting 
requirements. So this amendment is to help, again, give these 
communities the tools they need to fight this prescription drug abuse.
  Finally, I would say that our amendment has no effect on direct 
spending or revenues over the 10-year period.
  The other amendment I want to mention also has to do with substance 
abuse--about the dangers of what we unfortunately all here in this 
Chamber have heard about--and that is synthetic drug abuse, including 
K2 Spice, bath salts, and herbal incense. Today we have an opportunity 
to do something about this problem. Let's prohibit these drugs from 
getting into the hands of our children, our service men and women, and 
others.
  This amendment addresses the growing use and misuse of synthetic 
drugs by placing 15 cannabinoids, 2 stimulants, and 9 hallucinogens in 
Schedule I to expose those who manufacture, distribute, possess, 
import, and export synthetic drugs without proper authority to the full 
spectrum of criminal, civil, and administrative penalties, sanctions, 
and regulatory controls.
  I want to give special thanks to the people who led this effort over 
the years--Senators Grassley, Schumer, and Klobuchar. They have worked 
hard on this issue, and we are all pleased this is part of the 
underlying legislation. It was Senator Grassley, as well as the folks 
from the Community Anti-Drug Coalition, who originally introduced me to 
the prevalence of designer drugs. I was told of the story of David 
Mitchell Rozga and many others who have suffered, and of some of the 
deaths that have occurred around the country.
  This amendment, again, would have no significant effect on direct 
spending or revenues over a 10-year period and is a good, commonsense 
approach to trying to get our hands around this issue and help the 
constituents we represent and help our communities fight to stem this 
particular substance abuse that is affecting us all.
  Madam President, I yield the remainder of my time, and I yield the 
floor.
  Mr. HARKIN. Madam President, if I may inquire of the Senator how much 
time she wishes.
  Mrs. HAGAN. I would request 6 minutes.
  Mr. HARKIN. I yield 6 minutes off the bill.
  The PRESIDING OFFICER (Mrs. McCaskill). The Senator from North 
Carolina.
  Mrs. HAGAN. First, Madam President, I do want to applaud the hard 
work of the Senate HELP Committee chairman Tom Harkin and the ranking 
member Senator Mike Enzi. This bill is truly one of the most bipartisan 
efforts I have had the opportunity to be a part of in the 3 years I 
have served in the Senate. It ought to be a reminder that, yes, when we 
work together across the aisle, the Senate can get things done.
  I am particularly proud to support this bill because of what it will 
mean for patients who are suffering with diseases, who do not have 
access to adequate treatments, or who do not have access to any 
treatment at all. This bill we are voting on includes key provisions of 
the TREAT Act--the Transforming the Regulatory Environment to 
Accelerate Access to Treatments Act--which I introduced in February. 
These important provisions will expedite the review of treatments for 
serious or life-threatening diseases without compromising the FDA's 
already high standards for safety and effectiveness.
  I introduced the TREAT Act after meeting with a family whose child 
suffered from spinal muscular atrophy or SMA. This is an incurable 
neuromuscular disease and is the leading genetic cause of infant 
deaths. Of course, that family was not alone. There are 30 million 
Americans suffering from rare diseases, and I have had the honor to 
meet a number of them. Their stories are both heartbreaking and 
inspiring.
  When I visited the North Carolina Children's Hospital last month, I 
met with Megan and Jarrod Hendren of Lumberton, NC, whose 13-month-old 
twins Logan and Lucas suffer from Gaucher's disease. This disease is a 
painful and potentially debilitating metabolic disorder for which 
currently there is no cure.
  I also met with 8-year-old Ashley Burnette from Raleigh, who is 
resilient and wise beyond her years, but who is suffering from 
neuroblastoma.
  For the families and patients like these, suffering from these rare 
diseases for which there are no approved medications, medical advances 
cannot come fast enough. There are so many rare diseases, but fewer 
than 250 have FDA-approved therapies. The provisions of the TREAT Act 
that have been included in this bill take great steps toward resolving 
the problem.
  There is currently a pathway at the FDA to expedite the review of 
drugs for illnesses that are serious or life-threatening and for which 
there is no adequate treatment. This is called the Accelerated approval 
pathway. Since the early 1990s, it has been successfully used to 
advance treatments for patients with HIV and cancer by leaps and 
bounds. However, it has not been applied regularly or consistently to 
the review of drugs to treat other diseases.
  This inconsistency is why I introduced the TREAT Act. My bill will 
broaden the application of the accelerated approval pathway beyond HIV/
AIDS and cancer to a wider range of diseases, with a particular focus 
on rare diseases. That is why my proposal enjoys broad support from 
patient advocates, including the National Organization of Rare 
Diseases, Us Against Alzheimers, Parkinson's Action Network, the 
Huntington's Disease Society of America, and many more.
  By providing for consistent application, we will help the FDA 
implement these provisions, assist drug sponsors to navigate the 
approval process, and, hopefully, bring safe and effective treatments 
more rapidly to the patients who need them.
  I am also proud to have played a critical role in the legislation 
that led to the negotiations of the first biosimilars user fee 
agreement, which is also included in the bill before us. Last Congress, 
we passed the Biologics Price Competition and Innovation Act to 
facilitate the introduction of lower cost alternatives to biologic 
drugs, while ensuring continued research and development into 
innovative biologics which can save or improve the lives of millions of 
Americans.
  The user fees negotiated by the industry and the FDA will provide the 
necessary funding for the review of these critical therapies. The 
biosimilars industry is in the earliest stages of development, and the 
biosimilars user fee agreement will help facilitate this industry's 
growth.
  In addition, the FDA Safety and Innovation Act provides the necessary 
regulatory updates to keep pace with the rapid innovations of the 
biopharmaceutical industry. This is imperative for creating jobs in 
States such as mine--in North Carolina--and maintaining America's 
competitive edge in the global economy.
  Companies with footprints in North Carolina are partnering with our 
world-class universities to improve the health of people all across the 
globe

[[Page S3557]]

every day by researching, discovering, and developing lifesaving 
treatments for those suffering from these devastating diseases.
  Passing the FDA Safety and Innovation Act for States such as North 
Carolina, and for our Nation, to remain global leaders is important. It 
is especially important if we are to help attract the jobs of the 
future.
  The American public also expects the FDA to be the world's gold 
standard when it comes to ensuring the supply, the safety, and the 
integrity of our drug supply. By sending the FDA Safety and Innovation 
Act to the President's desk, we will establish a clear and effective 
pathway for turning ideas into cures and cures into treatments. And we 
will have shown the foresight and flexibility required to maintain our 
country's position at the top of the medical treatment and device 
industries.
  I thank the Chair and I urge my colleagues to join in supporting the 
FDA Safety and Innovation Act.
  I yield the floor.
  Ms. MIKULSKI. Madam President, I rise in opposition to the McCain 
amendment No. 2107. I appreciate the intent of Senator McCain to make 
lower cost drugs available to the American people, but I have many 
flashing lights about this amendment. I bring this from knowledge of 
being both on the Intelligence Committee and also in working with the 
FBI as the chair of the Subcommittee on Commerce, Justice, and Science.
  This amendment allows individuals to import FDA approved drugs from 
Canada. It sounds great, but we don't know if the drug was made in 
Canada. No HHS Secretary has been able to demonstrate that importation 
will be safe. It is ironic that some faux populists who oppose a public 
option, who oppose allowing Medicare to negotiate drug prices, support 
importing price controls from Canada. This amendment doesn't guarantee 
cost savings for consumers, Medicare, Medicaid, or insurers.
  I oppose this amendment for four reasons. First, it is a budget 
buster. Enforcing this will take enormous amounts of resources, and the 
amendment doesn't give the FDA the human resources, the financial 
resources, or the technological resources to ensure the safety of these 
drugs for U.S. consumers. It doesn't give FDA the resources to inspect 
and certify the brick-and-mortar and Internet-based Canadian 
pharmacies, nor does it give FDA the resources to verify that these 
pharmacies comply with Canada's laws. We all know that FDA needs more 
money to carry out its existing responsibilities overseas and 
domestically. The agency doesn't need another unfunded mandate.
  The second reason I oppose this amendment is because I am concerned 
about organized crime and counterfeiting. We have a history of phony 
drugs coming from rogue Web sites. We cannot be sure that the drugs 
coming from Canada are not a counterfeit, lethal drug. There is no 
guarantee that these drugs originate from the legitimate supply chain. 
Where there is compelling, compassionate human need, there is greed. 
Where there is greed, there are scams and schemes. In this case, the 
scams and schemes can be lethal.
  The third reason I oppose this amendment is that it doesn't exempt 
biologics. Biologics are different from chemical drugs. There is no way 
to ensure that the supply chain remains intact and that the product 
that reaches your doorstep will be effective. Because biologics tend to 
be more expensive than chemical drugs, criminals will make more money 
by counterfeiting them.
  The final reason I oppose this amendment is because it doesn't 
guarantee that the drug you buy will be bioequivalent to the FDA-
approved drug. How will consumers be assured that the drug they buy 
online is metabolized the same way? Also, what guarantee is there that 
the packaging and labeling will be identical?
  We have examples of awful things that have happened. Interpol and the 
United States have seized millions of counterfeit pills. These drugs 
were made in unsanitary conditions and were deadly and ineffective. 
Remember the contaminated Heparin from China that killed over 150 
people. Then there was cough syrup made from antifreeze instead of 
glycerin. Seventy-eight people died. There are also the ineffective 
drugs that may not kill you but certainly won't improve your health. I 
could list more, but I urge my colleagues to go talk to the FDA, FBI, 
and Customs and Border Protection and hear firsthand what they have 
experienced.
  Counterfeiting is a real threat. It is a matter of life and death. We 
have to make affordable drugs in our own country, and we did so by 
closing the doughnut hole in health reform. Today we are doing so 
again. The FDA user fee reauthorization before us creates the first 
ever generic drug user fee program. It will speed generic drug entry 
into the U.S. market so that consumers get safe FDA approved drugs more 
quickly and cheaply.
  If you want safety, then defeat the McCain amendment.
  Mr. BENNET. Mr. President, I come to the floor today to support the 
goal of my friend and colleague from New Mexico of delivering lower 
cost medicines to Americans. But, unfortunately, I cannot support his 
underlying amendment, No. 2111 to S. 3187. I agree that we should 
increase access to generic drugs wherever we can, and I agree that the 
path to market for generic products is fraught with legal challenges. 
But I have several concerns about the amendment. First, as convoluted 
as it seems, the Hatch-Waxman law that created the pathway to bring 
generic drugs to market has been a tremendous success in doing just 
that. Eighty percent of the drugs on the market now are generic, and 
over the last decade consumers have saved $931 billion on their drug 
costs as a result. There is clearly a balance in the system, and 
mechanisms within that system are working to bring generics to market.
  As I understand it, a key element of generic entry into the market is 
the incentive to challenge brand-name patents. The underlying amendment 
changes the key incentive for generic manufacturers--the 180 days of 
market exclusivity. The amendment allows late filers to now share in 
the exclusivity, significantly reducing the incentive for companies to 
file early and ensuring that products get to market as quickly as 
possible. Generic manufacturers have a limited window for market 
advantage, and it is the revenues gained during this incentive period 
that fuel additional product development. There is a balance here. If 
we need to adjust that balance, I think it needs to be done in a 
broader context. We need to be sure that any changes that we might make 
do not disrupt the balance and inadvertently harm consumers.
  While other aspects of the amendment are well-meaning, they may also 
have unintended consequences. I look forward to continuing the dialog 
on this issue with my colleague and others as we all work collectively 
to provide lower cost medicines to our constituents while maintaining 
an appropriate incentive for companies to innovate and develop the 
therapies that patients need.
  Mr. HARKIN. I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. HARKIN. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. HARKIN. Madam President, I suggest the absence of a quorum, and I 
ask unanimous consent that the time during the quorum call be taken off 
of the Burr amendment and be equally divided on both sides.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. CARPER. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. CARPER. I ask unanimous consent to be recognized for 10 minutes 
and that the time be taken from the Burr amendment and equally divided.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 2131

  Mr. CARPER. Madam President, we have three counties in Delaware. The

[[Page S3558]]

southernmost county is called Sussex County. Several years ago, I was 
privileged to visit a Methodist Church there and speak as a lay speaker 
to try to encourage people to become mentors.
  The minister that day was a great old guy, Reverend Reynolds. He is 
now deceased, but he said to me that day these words, and I have never 
forgotten them. He said, ``The main thing is to keep the main thing the 
main thing.''
  That is what he said. ``The main thing is to keep the main thing the 
main thing.''
  At first I wasn't sure what he was talking about, but the more I 
thought about it I thought: Boy, this guy is smart. And if I am smart, 
I will keep the main thing the main thing.
  For us in the Senate and in Congress, the main thing for the voters 
of this country is they want us to work together--well, maybe the two 
main things are they want us to work together--they want Democrats and 
Republicans to work together--and they want us to get things done. One 
of the things they want us to get done is to create what I call a 
nurturing environment for job creation and job preservation. They want 
us to do things that are going to help encourage the creation of jobs 
and the preservation of jobs.
  Little known to a lot of folks across the country, we actually have 
been doing some of that in the Senate for much of this year, and we 
have worked productively across party lines to pass a series of bills 
that I think do help create a more nurturing environment for job 
preservation and job creation.
  Just a couple examples, if I could: One, the reauthorization of the 
Federal Aviation Administration to establish a new source of additional 
revenues to modernize and update airports across the country, to bring 
the air traffic control system of our country into the 21st century 
where we had kind of an analogue system, and to bring it into the 
digital age.
  Patent reform was another significant step forward earlier this year, 
where we said enough of this patent patrol--people who come in after 
someone has filed for a patent and say: Oh, no, that was my idea, and 
just botch things up and drag things out in the courts. Under patent 
reform legislation, if you are first to file, you are first to file, 
and that is your patent. Also provided in the same legislation are the 
resources needed in the Patent Office to more expeditiously process 
patent applicants.
  Free-trade agreements. One of our roles as the government is to try 
to make sure we have access to foreign markets. If our goods and 
services are being closed out in those foreign markets, then we have to 
open them up. We agreed by a broad bipartisan proposal this year--three 
of them, actually, three free-trade agreements--one with South Korea, 
one with Colombia, one with Panama negotiated originally by the George 
W. Bush administration and embraced by the Obama administration, which 
is now the law of the land, to make sure when businesses have the 
opportunity to export, the barriers that have maybe kept them out in 
the past are knocked down or eliminated, and to make sure if American 
businesses need financing and help to finance their exports, that they 
have that kind of help through the Export-Import Bank, which we have 
reauthorized and extended into the future.
  Another one that we worked on this year together, a bipartisan bill 
and supported by the President, is something called the JOBS Act. What 
it is all about is trying to make sure companies have better access to 
capital, and if a small or medium privately held company wants to go 
public, to make sure they can do it through something called an IPO 
onramp as opposed to just trying to jump into it and get it done all at 
once. Or for companies that want to stay privately held, for them to be 
capped at 1964 levels, 500 shareholders, to say they can go up to 
1,000, 2,000 shareholders to enable them to have that access to capital 
to continue to grow and to create jobs.
  Other examples of bipartisan legislation we worked on, in one case 
the Transportation bill--land transportation: roads, highways, bridges, 
and transit--we passed a good bill in the Senate, paid for, to help 
over the next couple of years to meet our transportation needs and make 
sure the 3 million people who are working on transportation and transit 
projects across the country don't basically get laid off in a month or 
two. We passed a good bill. I give a lot of credit to Senators Boxer 
and Inhofe for helping to lead the bipartisan approach.
  Also, 7 or 8 million jobs depend on the Postal Service. The Postal 
Service is in tough straits, running out of money and losing $125 
million a day. We are hoping that the House of Representatives will 
pass the bill--they need to--so we can go to conference and help fix 
that problem. But there is good bipartisan legislation here to effect 
positively 7 or 8 million jobs that depend on the Postal Service. All 
that stuff, in terms of the American people wanting us to work 
together, and we have been. Those are just a couple examples.

  In terms of actually doing things that help create jobs and preserve 
jobs, every one of the items I just mentioned does create a more 
nurturing environment for job creation and job preservation. In the 
coming weeks, we also want to work on agricultural legislation--a 
bipartisan bill, again, out of the Agriculture Committee that will save 
billions of dollars on the deficit side. It will also help to 
strengthen our agricultural economy.
  We need to get to work on a national flood insurance update, and that 
legislation helps to bolster the home building industry in this country 
which is struggling, as we know, and we have the opportunity for those 
things that are on our to-do list, to get them done.
  Today the Senate is considering another bipartisan piece of 
legislation, as we know, the Food and Drug Administration Safety and 
Innovation Act, affectionately known by its acronym. I don't like 
acronyms, but I love this one. It is called PDUFA. So it is the FDA and 
how we make sure the FDA has the resources they need to do their job. 
As the other bills passed by the Senate I just talked about, this bill 
helps create a more nurturing environment for those businesses to 
thrive. Those businesses include the pharmaceutical business and 
businesses that make and sell medical devices. But just as important, 
this bill helps to ensure that Americans get access to lifesaving 
medications and medical devices that are developed in this country as 
soon and as safely as possible.
  This bill reflects a strong bipartisan, bicameral effort, for which 
Chairman Harkin and ranking member Mike Enzi deserve enormous praise, 
and I praise them even though they are not in the Chamber right now. 
They have done great work, and I thank them and their staffs for 
bringing it to this point today.
  The legislation builds upon the successful current user fee programs. 
For a number of years, the companies have paid a user fee if they want 
the FDA to approve a drug or medical device, and we are making progress 
to actually have more resources for the FDA to do this than we used to. 
But they need some additional help, and this legislation would do that, 
paid for by the industries that are seeking the consideration of their 
new pharmaceuticals and their new medical devices.
  The legislation also adds important new user fees for generic and 
biological drugs. The user fees are paid, again, by the prescription 
drug and medical device industries to help cover the FDA's costs for 
reviewing new drugs and medical devices.
  What this means is safer drugs and a speedier process to bring new 
and less expensive drugs and medical devices to markets for consumers, 
and I think it is a win-win for just about everybody.
  As a result of the FDA legislation affectionately known as PDUFA, the 
FDA's drug review times have already been cut in half. That is good. If 
these user fees, these user programs are not reauthorized, though, the 
FDA would have to lay off, I am told, about 2,000 employees, which 
would put them back in the ditch, if you will, and begin to delay 
approval of new drugs. We don't want to see that happen. That would 
threaten patent access to new therapies, as well as pharmaceutical and 
medical device industry jobs, and America's global leadership in 
biomedical innovation.
  This bill also makes medicines safer for millions of children, 
improves the FDA's tools to police the global drug supply chain, and 
reduces the risk of drug shortages. There are a number of amendments 
that are being offered to the bill--we have voted on a couple of

[[Page S3559]]

those--and one of the amendments that we will be voting on, I believe, 
a little later this afternoon is legislation that would, in my view, 
weaken or contaminate our country's supply of prescription drugs and 
put our patients and our health care system at risk.
  Some of my colleagues have proposed to include a measure in this bill 
that ostensibly would lower prescription drug prices. This amendment, 
in my view, however, is not without unintended consequences, and we 
always have to be careful of those.
  The PRESIDING OFFICER. The Senator's time has expired.
  Mr. CARPER. I ask unanimous consent for 3 more minutes equally 
divided.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. CARPER. Unfortunately, it would open our borders to increased 
numbers of contaminated and adulterated drugs.
  The proposal to import drugs from Canada would allow drugs to be 
imported wholesale, often from illegal Internet pharmacies with no 
protection against abuse or contamination.
  Also, though this measure is supposed to be about importing drugs 
from Canada, in truth it would allow drugs to come from countries that 
don't have the kind of strong inspection and policing of prescription 
drugs that we have in the United States.
  Instead of going down that road, we should work to increase the FDA's 
abilities to protect and regulate our drug supply. While doing so, we 
should reject any proposals to import drugs from Canada that undermine 
our ability to ensure that prescription drugs are safe and effective.
  One last thing I want to mention is there is an amendment that is 
going to be offered today--or maybe already has been, but I am going to 
mention this anyway--that deals with generic drugs and concern about 
the ability for larger pharmaceutical companies to work with and pay 
off, buy out the generic drug companies so they don't bring their 
generic version of the name-brand drug to market. I just want to say 
that we need to be careful what we are doing here.
  I came out of the Navy and came to this Congress in 1983 as a 
freshman Congressman. In 1982, 20 percent of the prescriptions being 
filled in this country were generic drugs. This year, 80 percent of the 
medicines or prescriptions that are being filled are generic. One of 
the well-intentioned amendments to have been offered today is one that 
says we are not making enough progress toward allowing the generics to 
grow. Say that again?
  We have gone from 20 percent generic penetration in 1982 to, today, 
80 percent. I would suggest that we should declare victory, and as time 
goes by, even that 80 percent will become 85 percent or 90 percent. But 
we have come a long way. As a result of that, people who need to buy 
medicine can find a generic version of almost any medicine that is 
being sold in this country. I think the system is working just fine, 
and we ought to allow it to continue to work.
  In closing, the main thing is the main thing. The main thing is to 
keep the main thing the main thing.
  For us, the main thing is to work together. We are in a whole host of 
ways--including under the great leadership of Senator Harkin and 
Senator Enzi--working to make sure our pharmaceutical industry is 
vibrantly strong, the medical device industry is vitally strong, but 
also that patients are not disadvantaged, that they are actually 
advantaged by all of that.
  So responding to folks in Delaware and Iowa and across the country, 
we are working together. We are not just working together on a couple 
of things but on a whole host of things, a whole litany of provisions 
and laws and proposals that do what: help us to create a more nurturing 
environment for job creation and job preservation. That is a good 
thing. That is a very good thing.
  I thank Senator Harkin for giving me a chance to say a few words and 
for the great work that he and Senator Enzi have done. I am happy to 
follow their leadership here today.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Madam President, I appreciate the remarks made by my good 
friend from Delaware. I thank him and his staff for their input on this 
bill. Again, this bill is the work of a lot of different people, and I 
want to thank the Senator from Delaware for helping us get to the point 
where we have a good consensus bill.
  Madam President, is there any time remaining on the Burr amendment?
  The PRESIDING OFFICER. There is no time remaining on the Burr 
amendment.
  Mr. HARKIN. Madam President, I yield 6 minutes off of the McCain 
amendment, on our side, to the Senator from New Jersey.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 2107

  Mr. LAUTENBERG. Madam President, I rise to speak against amendment 
No. 2107, the one that talks about pharmaceutical products, medicines. 
We know how important the prescription medicines are in improving 
health in this country and the need to make sure those drugs are safe 
and affordable. Prescription drugs have brought great advances in 
health outcomes. Just look at how much longer people are living. Over 
the past century, life expectancy increased from 49 years to 77 years. 
We know that beneficial drugs need to be more affordable and more 
readily available. But allowing drugs to enter into the United States 
from other countries is not the answer.
  The Department of Health and Human Services found that importing 
prescription drugs might save 1 to 2 percent on their prescription 
drugs--and I am not describing that as insignificant--but these are 
modest savings compared to what the outcome might be.
  Importing risky prescription drugs from other countries could cause 
more health problems, more suffering, and in the final analysis, more 
expensive treatments. Americans buy medicine to lower their 
cholesterol, fight cancer, prevent heart disease. Some of these have 
had remarkable effects. Heart disease is much less threatening. It is 
still a dangerous disease but much less than it was years ago. Imagine 
what would happen to a mother or a child if they were relying on 
imported drugs only to find out that the drugs were unsafe. We need to 
be absolutely certain that we are not putting Americans' lives at risk.
  That is why I am opposing amendment No. 2107, the McCain amendment, 
which would allow potentially unsafe prescription drugs to be shipped 
across our border, directly into the medicine cabinets of homes 
throughout America. Instead of safeguarding American patients, this 
amendment could bring potentially dangerous and ineffective drugs from 
Canada. I say that because, though Canadian drugs may seem safe, we 
already know that drugs that claim to be from Canada are not always 
reliable. They are not worth the risk. An FDA investigation found that 
85 percent of drugs imported from Canadian Internet pharmacies were 
actually from 27 other countries. Many of these were pure counterfeit.
  The Senate already recognized the danger that imported drugs pose to 
Americans. On five previous occasions, this Chamber has asked the 
Department of Health and Human Services to certify that importation 
will not put people at risk. The Secretary still has not been able to 
confirm that imported drugs would be safe.
  I wish to make another observation. I find it kind of amusing to 
watch Republican colleagues talk about how wonderful the Canadian 
health system is. Last I checked, Canada's health care system is 
socialized medicine. During the health care reform debate these same 
colleagues were decrying the Canadian system as a horrible socialist 
experiment. My colleagues need to make up their minds. Do they prefer 
socialized medicine? If so, it comes with some risks.
  I am proud that many of our country's drugs originate in the State of 
New Jersey, commonly known as the Medicine Chest State. In fact, there 
are over 46,000 highly skilled people in my home State working to 
produce lifesaving drugs. It would be wrong to undercut the hard work 
of these trained New Jerseyans, only to put Americans in danger.
  Right now the drugs in our country are safe and effective, as we have 
seen by the results. Thanks to Senator Harkin and Senator Enzi, this 
bill will even make our drugs more safe. Americans deserve real peace 
of mind. When

[[Page S3560]]

they open the pill bottle and swallow their medicine, they have to know 
the product is safe and effective.
  I urge my colleagues to support keeping medicine in our country safe 
and affordable. I urge the drug companies, the medicine companies, to 
do whatever they can to make drugs, medicines, more available at 
cheaper prices. I urge my colleagues to vote against amendment No. 
2107.
  I yield the floor.
  Mr. HARKIN. Madam President, I yield 6 minutes to the Senator from 
West Virginia, again off the opposition to the McCain amendment time.
  The PRESIDING OFFICER. The Senator from West Virginia is recognized.
  Mr. MANCHIN. Madam President, I wish to say to the chairman that I 
appreciate his hard work on this bill, a very important piece of 
legislation.
  I would like to address an issue that touches all of us: Democrats 
and Republicans, rich and poor, young and old, West Virginians and New 
Yorkers.
  As you know, the prescription drug epidemic is destroying communities 
across this nation, wreaking havoc on our education system, devastating 
our workforce and our economy, and tearing our families apart.
  Prescription drug abuse is the fastest growing drug problem in the 
United States, and it is claiming the lives of thousands of Americans 
every year. According to a report issued by the Centers for Disease 
Control in November, the death toll from overdoses of prescription 
painkillers has more than tripled in the past decade. More than 40 
people die every day--every single day--from overdoses involving 
narcotic pain relievers. These prescription painkillers kill more 
Americans than heroin and cocaine combined.
  It's especially tough in my home state of West Virginia, which has 
the highest rate of drug overdose deaths in the country. Nearly 90 
percent of those deaths are linked to prescription drug abuse.
  For months now, I have been going out and listening to the stories of 
so many people in my State--law enforcement, business owners, school 
teachers, pastors, and especially the children who ask for help getting 
their parents off the stuff. So I worked with all of them to offer an 
amendment to this bill that would make it harder for anyone to abuse 
prescription drugs. That bipartisan amendment was submitted on behalf 
of the countless West Virginians and Americans whose lives have been 
cut short by drug abuse and the families who are picking up the pieces, 
and it is on their behalf that I thank my colleagues in the Senate for 
passing it unanimously.
  Last night I was so moved and encouraged to see the Members of the 
U.S. Senate come together across party lines and unanimously approve 
that measure, to take a serious step to fight this prescription drug 
epidemic. I strongly urge our friends in the House to do the same, and 
the President to sign this important bill.

  This measure is not the work of just one person, however. I would 
like to thank the cosponsors of this bill, who all believe so strongly 
in it: Senator Mark Kirk of Illinois, Senator Kirsten Gillibrand of New 
York, Senator Chuck Schumer of New York and, of course, Senator Jay 
Rockefeller of my home State of West Virginia.
  I also thank Governor Earl Ray Tomblin and Congressman Nick Rahall 
for their tireless work on this issue, along with Congressman Vern 
Buchanan of Florida, who is doing excellent work to end pill mills. As 
we all know, last night's vote gives this amendment a solid step 
forward, but there is much work remaining to give our communities the 
right tools to fight this epidemic.
  That's because all too often, we all hear stories like this one, 
which the Ohio County Substance Abuse Prevention Coalition in my State 
shared with me.

       A young boy was injured and was prescribed prescription 
     pain killers containing hydrocodone. After the injury he 
     began using the opiates with the other teens in school. They 
     began by taking pills and eventually by graduation, snorting 
     the pills on a daily basis. One day he was convinced by a 
     friend to try IV use. He was married and was able to hold 
     down a job until he began using IV. His wife was addicted to 
     pain killers and their child was born addicted to drugs. He 
     wanted more than anything to be a hard-working father and 
     husband. He wanted to live and to amend his past behaviors. 
     He completed treatment but eventually began using pain 
     killers again. This man in his mid-twenties overdosed and 
     died.

  Think about it. This young man was snorting pills by high school 
graduation and dead in his mid-20s. Unfortunately, that story is more 
common than we would all like to believe.
  A 2012 study by the National Institute on Drug Abuse found that 8 
percent of high school seniors had admitted to abusing Vicodin in the 
past year. The Centers for Disease Control has found that about 
12 million Americans have reported non-medical use of prescription 
painkillers in the past year.

  Unlike many illegal drugs, prescription drugs are not produced in 
basement labs or smuggled across the border--they are found in our own 
medicine cabinets and are often prescribed for medically necessary 
reasons. And that makes it much easier for people to become addicted or 
abuse these medications.
  In 2010 alone, pharmacies dispensed the equivalent of 42 tons of pure 
hydrocodone--that is enough to give every man, woman and child in the 
United States 24 Vicodin pills.
  The fact is, that number is just too high. People are getting these 
pills because it is just too easy.
  That is why this amendment would make it harder to get addictive 
prescription drugs, by moving them to a more restrictive category in 
our official drug classification system.
  Practically, this means that patients would need an original 
prescription for refills and pills would have to be stored more 
securely.
  Let me me close by sharing a few more personal stories about this 
problem--stories that show on a human level the urgency we need to put 
a stop to prescription drug abuse and why I am committed to this fight.
  This is a problem that hits very close to home in my office. A member 
of my staff, a very bright young girl from Wyoming County who is doing 
very good work has lost three friends to drug abuse, all in their 20s. 
Theirs were lives full of promise, but they were tragically cut short 
by drug abuse.
  In the past 7 years, more than 120 people have died from drug 
overdoses in Wyoming County alone, including 41 in 2011 and 12 just 
this year.
  I visited Wyoming County in October to speak with a group of students 
at Oceana Middle School who are working very hard to take on the drug 
abuse crisis in their community.
  These students were part of a letter writing campaign, organized by 
the faith-based group ``One Voice,'' which works to help addicts and 
their families. I want to share with you a few excerpts from some of 
these letters:

       ``My town, Oceana, has an issue about drugs. I write this 
     letter to you because I hope that you can do something about 
     it. In 2006, my godmother died of an overdose. She was the 
     only person I could talk to. Drugs make people act in bad 
     ways and if something doesn't happen about them then our town 
     will be in worse shape.

  I will give just one more example:

       I am 13 years old and I am a student at Oceana Middle 
     School. I have witnessed drug deals, prostitution and 
     homeless people in our town. I have medicine I take for ADHD 
     and here recently some of my meds were stolen. I will 
     graduate high school in 7 years. If nothing is done about 
     these issues it'll be worse in the future.

  I visited with these students in person. They want a better life for 
their parents, their siblings, their friends, their communities--and 
themselves. They are willing to fight, and they are asking for our 
help.
  The amendment that passed last night with unanimous bipartisan 
support is a good step toward reaching their dream, and I offer my 
heartfelt thanks to my colleagues on behalf of all the people in West 
Virginia who have been affected by prescription drug abuse. And I urge 
my colleagues in the House to support this measure and the President to 
sign it--for the good of all the 12-year-old girls who are asking us to 
help get their daddies off this stuff.
  The PRESIDING OFFICER. The time of the Senator has expired.
  Mr. MANCHIN. I would like to say to both chairmen on both sides of 
the aisle, thank you for legislation that is much needed. Thank you for 
an amendment agreed upon, voted on unanimously, and accepted last 
night. This will go a long way to fight drug abuse in America and save 
countless children's lives. I thank both Senators so much.
  The PRESIDING OFFICER. The Senator from Iowa.

[[Page S3561]]

  Mr. HARKIN. Madam President, how much time remains on the McCain 
opposition?
  The PRESIDING OFFICER. There is 3 minutes.
  Mr. HARKIN. Madam President, I yield myself that time and a couple of 
minutes off the bill.
  The PRESIDING OFFICER. The Senator is recognized.
  Mr. HARKIN. Madam President, I wish Senators to know that we will 
start voting here in 9 or 10 minutes, and these will be 10-minute 
votes.
  The first vote will be on the amendment offered by the Senator from 
Kentucky, Mr. Paul, followed by Senator McCain's amendment, Senator 
Sanders' amendment, Senator Durbin's amendment, and then final passage.
  By an earlier consent, all of those votes will be 10-minute votes. I 
wanted to make sure that people knew what the lay of the land was here.
  We are rapidly approaching the final passage of this bill. We have 
had great cooperation from all Senators on both sides in moving this 
legislation forward here on the floor. We have had good debates. They 
have not been drawn out endlessly, but we have had good debates and a 
good airing of the amendments on the bill. I thank all Senators for 
that, and hopefully we can move rapidly to wrap up this bill and move 
on.
  This bill is the product of 18 months of very hard work by Senator 
Enzi and all of the Senators on our committee on both sides of the 
aisle. It is a true compromise and bipartisan bill. As I mentioned 
earlier, it has the support of a broad spectrum of stakeholders, from 
the pharmaceutical companies to pharmacists to consumer organizations, 
across the broad spectrum who support this bill, and it is necessary 
that we get it done. That is why we have urged everyone to 
expeditiously get this done before the break period coming up for 
Memorial Day so the Food and Drug Administration won't have to start 
sending pink slips out to people this summer, and so there will not be 
any disruptions. It will allow them to get on with the business of 
making sure we get drugs and devices to patients expeditiously but 
safely, making sure our drugs and our devices are safe.
  It is a good bill, and it is the result of a lot of hard work by a 
lot of people, so I hope we can move these amendments rapidly and move 
to final passage this afternoon.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Madam President, I ask unanimous consent that when we begin 
the next vote, Senator Paul, who has 7 minutes left on his item, be 
given 2 minutes so he may explain his bill in exchange for those 7 
minutes.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  The Senator from Iowa.
  Mr. HARKIN. Madam President, I yield myself as much time as I may 
consume off the bill.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Amendment No. 2143

  Mr. HARKIN. Madam President, we are rapidly approaching a vote on the 
Paul amendment, and I know the Senator wants to have a couple of 
minutes to speak on that.
  I rise in opposition to the Paul amendment. I oppose it for several 
reasons. Perhaps the most important reason is that this is a drug bill. 
This bill deals with drugs and devices. It does not deal with food. We 
dealt with dietary supplements and vitamins and things such as that in 
the food safety bill that we passed 2 years ago and that bill, again, 
was a consensus bill that has been through the committee structure. We 
brought it to the floor and had a lot of debate on it. We made 
modifications at that time to the whole area of vitamins, minerals, and 
supplements, and that is the proper place to address it, not on a bill 
such as this. This bill is a bill on drugs, not on supplements and 
food, so that is the most important reason.
  I will make that same argument on the Durbin amendment. That should 
not be here because this is a drug bill.
  On substance, I would say this bill kind of turns food law on its 
head. It would allow supplements to be sold with claims to cure any 
disease, such as AIDS or cancer, without any kind of FDA review 
whatsoever. I take a backseat to no one in terms of my support for the 
vitamin, mineral, and supplement industry and their products. Senator 
Hatch and I were the two people who put through the DSHEA bill, the 
Dietary Supplementary Health and Education Act in 1994. If I might say, 
we have sort of been protectors of it in working to make sure it has 
been implemented correctly since that time.
  But the Paul amendment would go way too far. It is not consensus 
policy. In fact, it is strongly opposed by even the dietary supplement 
industry. I would note that the Natural Products Association, United 
Natural Products Alliance, and the Council on Responsible Nutrition, 
all three are big umbrella groups that oppose the Paul amendment. This 
would open this industry to snake oil salesmen.
  Again, those of us who want to make sure people have unfettered 
access to safe products and to good, nutritious vitamins, minerals, and 
supplements, the last thing we want to see is people in their garages 
mixing it up and selling it as snake oil. This is not good for America, 
it is not good for people who want to take vitamins and supplements and 
minerals for their own health. It would throw this thing open and turn 
the clock back 50 years or more where anybody could make any claim they 
want and the FDA would have no way of reviewing it whatsoever.
  I will move to table the amendment at the appropriate time, but I 
urge all Senators to oppose the Paul amendment.
  I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  Mr. ENZI. Madam President, I yield the Senator from Kentucky the time 
he is already entitled to.
  The PRESIDING OFFICER. The Senator from Kentucky is recognized for 2 
minutes under the previous order.
  Mr. PAUL. My amendment is to rein in the FDA. I believe they have 
gotten overzealous in their duties. They do have important duties, but 
I think they have gotten overblown. My amendment has three parts.
  First, it attempts to stop the FDA's overzealous regulation of 
vitamins, foods, and supplements by codifying the first amendment 
prohibition on prior restraint. What this means is the first amendment 
says we cannot restrain speech before it happens. This amendment also 
helps to make explicit that commercial speech is speech and should be 
protected.
  Under current rules, the FDA prevents even the manufacturer of prune 
juice from saying that prune juice relieves constipation. I think that 
is an FDA that has gotten a little bit out of hand. I think that 
vitamin supplement manufacturers and distributors should be allowed to 
give us information and that the buyers should be allowed to review 
that information in making decisions about the product and that this 
speech should not be restricted.
  Second, my amendment says the FDA doesn't need to be carrying 
weapons. I don't need to see bureaucrats carrying automatic weapons. If 
there are police officers necessary in the operation of their duties, I 
would rather have the FBI. The FDA does not need to be sending armed 
agents to the Amish farms to arrest a farmer for selling milk from the 
cow.
  Third, my amendment fixes what needs to be fixed in a lot of 
regulatory crimes. We need to add in the component of mens rea. Mens 
rea means that when a person commits a crime and they put that person 
in jail, they have to prove that person had a guilty mind and had 
intent to commit a crime. So we add two words. If they are going to 
accuse a person of a crime, it has to be knowing and willful. These are 
very simple words, but they change the burden of the government. If the 
government is going to accuse a person of the crime, they need to know 
this. If Congress is going to criminalize conduct at a Federal level, 
as it does in the FDA Act, then the least we can do is add in the mens 
rea requirement.
  Thank you. I urge support for my amendment.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Madam President, I move to table the amendment by the 
Senator from Kentucky and ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There appears to be a sufficient second.
  The question is agreeing to the motion.

[[Page S3562]]

  The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Hawaii (Mr. Akaka), the 
Senator from Connecticut (Mr. Blumenthal), the Senator from California 
(Mrs. Boxer), and the Senator from Michigan (Ms. Stabenow) are 
necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Nevada (Mr. Heller), the Senator from Texas (Mrs. Hutchison), and 
the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER (Mr. Sanders). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 78, nays 15, as follows:

                      [Rollcall Vote No. 107 Leg.]

                                YEAS--78

     Alexander
     Barrasso
     Baucus
     Begich
     Bennet
     Bingaman
     Blunt
     Brown (MA)
     Brown (OH)
     Burr
     Cantwell
     Cardin
     Carper
     Casey
     Chambliss
     Coats
     Cochran
     Collins
     Conrad
     Coons
     Corker
     Durbin
     Enzi
     Feinstein
     Franken
     Gillibrand
     Graham
     Grassley
     Hagan
     Harkin
     Hatch
     Hoeven
     Inhofe
     Inouye
     Isakson
     Johnson (SD)
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lugar
     Manchin
     McCain
     McCaskill
     McConnell
     Menendez
     Merkley
     Mikulski
     Moran
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Portman
     Pryor
     Reed
     Reid
     Roberts
     Rockefeller
     Rubio
     Sanders
     Schumer
     Sessions
     Shaheen
     Shelby
     Snowe
     Tester
     Udall (CO)
     Udall (NM)
     Warner
     Webb
     Whitehouse
     Wyden

                                NAYS--15

     Ayotte
     Boozman
     Coburn
     Cornyn
     Crapo
     DeMint
     Johanns
     Johnson (WI)
     Lee
     Paul
     Risch
     Thune
     Toomey
     Vitter
     Wicker

                             NOT VOTING--7

     Akaka
     Blumenthal
     Boxer
     Heller
     Hutchison
     Kirk
     Stabenow
  The motion was agreed to.


                           Amendment No. 2107

  The PRESIDING OFFICER. Under the previous order, there will now be 2 
minutes of debate equally divided prior to a vote in relation to 
amendment No. 2107, offered by the Senator from Arizona, Mr. McCain.
  Who wishes the floor?
  The Senator from Arizona.
  Mr. McCAIN. Mr. President, this amendment is a simple one. It creates 
a safe individual drug importation program only from approved Canadian 
pharmacies, overseen by the Secretary of Health and Human Services.
  In a normal world, this would probably require a voice vote. But what 
we are about to see is the incredible influence of the special 
interests, particularly PhRMA, here in Washington, where people who 
cannot afford it will have to make a choice between eating and 
medicine. They will not be allowed to purchase a medication at less 
than half the price, many times, than they will in American pharmacies 
in Canada.
  So what you are about to see is the reason for the cynicism the 
American people have about the way we do business in Washington. 
PhRMA--one of the most powerful lobbies in Washington--will exert its 
influence again at the expense of average low-income Americans who 
will, again, have to choose between medication and eating.
  The PRESIDING OFFICER. The Senator from New Jersey.
  Mr. MENENDEZ. Mr. President, it is not the special interests that 
have caused the Senate countless times to reject this policy. It is an 
amendment that puts Americans at risk, undermines the FDA's authority, 
and would have a devastating ripple effect throughout the country's 
drug supply by allowing foreign pharmaceuticals into the country.
  It is not simply about Canada. The Canadians themselves have said 
they cannot be expected to monitor all the drugs coming through Canada 
and into our country, and all the Web-based opportunities would allow 
untraceable drugs to come through Canada into the United States.
  This is about the health and security of the American people. That is 
why time after time the Senate has rejected it. It is why it should be 
rejected once again.
  The PRESIDING OFFICER. The majority leader.
  Mr. REID. Mr. President, I have had, during this short period of 
time, four different Senators come to me and say: Please hold the votes 
to 10 minutes, with the 5-minute penalty. So we are going to do that. A 
number of Senators already missed votes today. We are going to cut 
those votes off. If you are not here, there is no excuse. These votes 
have been scheduled since yesterday. So we are going to turn in these 
votes exactly at 15 minutes. The clerks understand that. If a Senator 
is late, they are late.
  The PRESIDING OFFICER. Under the previous order, this amendment is 
subject to a 60-vote threshold. The question is on agreeing to the 
amendment.
  The yeas and nays have been ordered.
  The clerk will call the roll.
  The bill clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Connecticut (Mr. 
Blumenthal) is necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER (Mr. Wyden). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 43, nays 54, as follows:

                      [Rollcall Vote No. 108 Leg.]

                                YEAS--43

     Begich
     Bingaman
     Boozman
     Boxer
     Brown (OH)
     Cardin
     Collins
     Conrad
     DeMint
     Feinstein
     Franken
     Graham
     Grassley
     Heller
     Johnson (SD)
     Klobuchar
     Kohl
     Leahy
     Lee
     Levin
     McCain
     McCaskill
     Merkley
     Murkowski
     Nelson (NE)
     Nelson (FL)
     Paul
     Pryor
     Reed
     Rockefeller
     Sanders
     Sessions
     Shaheen
     Shelby
     Snowe
     Stabenow
     Thune
     Toomey
     Udall (NM)
     Vitter
     Webb
     Whitehouse
     Wyden

                                NAYS--54

     Akaka
     Alexander
     Ayotte
     Barrasso
     Baucus
     Bennet
     Blunt
     Brown (MA)
     Burr
     Cantwell
     Carper
     Casey
     Chambliss
     Coats
     Coburn
     Cochran
     Coons
     Corker
     Cornyn
     Crapo
     Durbin
     Enzi
     Gillibrand
     Hagan
     Harkin
     Hatch
     Hoeven
     Inhofe
     Inouye
     Isakson
     Johanns
     Johnson (WI)
     Kerry
     Kyl
     Landrieu
     Lautenberg
     Lieberman
     Lugar
     Manchin
     McConnell
     Menendez
     Mikulski
     Moran
     Murray
     Portman
     Reid
     Risch
     Roberts
     Rubio
     Schumer
     Tester
     Udall (CO)
     Warner
     Wicker

                             NOT VOTING--3

     Blumenthal
     Hutchison
     Kirk
  The PRESIDING OFFICER. Under the previous order requiring 60 votes 
for the adoption of this amendment, the amendment is rejected.


                           Amendment No. 2109

  Under the previous order, there will now be 2 minutes of debate 
equally divided prior to a vote in relation to amendment No. 2109, 
offered by the Senator from Vermont, Mr. Sanders.
  Mr. SANDERS. Mr. President, this amendment is supported by Public 
Citizen, U.S. PIRG, the National Committee to Preserve Social Security 
and Medicare, and the National Women's Health Network.
  In the United States, we pay by far the highest prices in the world 
for prescription drugs--much higher than Canada, much higher than 
Europe. There are a number of reasons for that. One of the reasons is 
the widespread fraud, systemic fraud being perpetrated on the American 
people by virtually every major drug company in this country.
  In the last few years, companies such as Abbott, Pfizer, Johnson & 
Johnson, Merck, GlaxoSmithKline, and many others combined have paid 
billions of dollars in fines because they are ripping off Medicare, 
they are ripping off Medicaid, and they are ripping off the American 
consumer. It is high time we said that fraud cannot be perpetrated as a 
business model by some of the major corporations in this country.
  I ask for a ``yes'' vote.
  The PRESIDING OFFICER. The Senator from Wyoming
  Mr. ENZI. Mr. President, I would oppose this amendment. We do need to 
combat health care fraud, but this amendment goes too far in several 
aspects. First and most important, it would discourage any settlement 
agreements. People would fight it to the death if they are going to 
lose their exclusivity.

[[Page S3563]]

  Second, as drafted, the amendment would require companies to forfeit 
exclusivity anytime there is a civil or criminal liability under the 
Federal Food, Drug, and Cosmetic Act. It is disproportionate. This 
could be triggered by a misdemeanor. In addition, such liability may 
not reflect fraud. The amendment would discourage the development of 
new cures for patients. If manufactures know they could lose 
exclusivity for even minor infractions, they will not invest the 
millions of dollars necessary to create new lifesaving therapies for 
patients.
  I ask that the Senate oppose the amendment.
  I yield the floor.
  The PRESIDING OFFICER. All time has expired.
  Under the previous order, this amendment is subject to a 60-vote 
threshold for adoption.
  The question is on agreeing to the amendment.
  Mr. HARKIN. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The clerk will call the roll.
  The assistant bill clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Connecticut (Mr. 
Blumenthal) is necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER (Mr. Sanders). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 9, nays 88, as follows:

                      [Rollcall Vote No. 109 Leg.]

                                YEAS--9

     Bennet
     Brown (OH)
     Durbin
     Franken
     Levin
     McCain
     Sanders
     Schumer
     Whitehouse

                                NAYS--88

     Akaka
     Alexander
     Ayotte
     Barrasso
     Baucus
     Begich
     Bingaman
     Blunt
     Boozman
     Boxer
     Brown (MA)
     Burr
     Cantwell
     Cardin
     Carper
     Casey
     Chambliss
     Coats
     Coburn
     Cochran
     Collins
     Conrad
     Coons
     Corker
     Cornyn
     Crapo
     DeMint
     Enzi
     Feinstein
     Gillibrand
     Graham
     Grassley
     Hagan
     Harkin
     Hatch
     Heller
     Hoeven
     Inhofe
     Inouye
     Isakson
     Johanns
     Johnson (SD)
     Johnson (WI)
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Lee
     Lieberman
     Lugar
     Manchin
     McCaskill
     McConnell
     Menendez
     Merkley
     Mikulski
     Moran
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Paul
     Portman
     Pryor
     Reed
     Reid
     Risch
     Roberts
     Rockefeller
     Rubio
     Sessions
     Shaheen
     Shelby
     Snowe
     Stabenow
     Tester
     Thune
     Toomey
     Udall (CO)
     Udall (NM)
     Vitter
     Warner
     Webb
     Wicker
     Wyden

                             NOT VOTING--3

     Blumenthal
     Hutchison
     Kirk
  The PRESIDING OFFICER. Under the previous order requiring 60 votes 
for the adoption of the amendment, the amendment is rejected.
  The Senator from North Carolina.


                      Amendment No. 2130 Withdrawn

  Mr. BURR. Mr. President, I ask unanimous consent to withdraw the Burr 
amendment No. 2130.
  The PRESIDING OFFICER. Is there objection? Without objection, it is 
so ordered.
  Mr. BURR. I thank the Chair.


                           Amendment No. 2127

  The PRESIDING OFFICER. Under the previous order, there will now be 2 
minutes of debate equally divided prior to a vote in relation to 
amendment No. 2127, offered by the Senator from Illinois, Mr. Durbin.
  Mr. DURBIN. Mr. President, this is a very simple amendment. If you go 
into the drugstore and look at the prescription drugs, every one of 
them has been registered with the FDA. The over-the-counter drugs have 
all been registered. When you go to the dietary supplement section, 
there is no requirement under the law for the company selling those 
products to register the name of the product, the ingredients of it, or 
a copy of the label.
  The GAO did a study in 2009, and the FDA said we need this 
information to protect American consumers. From what? One of them is an 
example on this chart. This is a Chinese product that was imported into 
the United States, put up for sale, and then we discovered that one of 
the ingredients was life-threatening. It was never registered with the 
FDA, and there was no disclosure of its ingredients.
  If you want to sell from the counters in America, shouldn't you be 
required, whether you are from China, India, Mexico, or anywhere in the 
United States, to register your product, the ingredients in it, and a 
copy of the label? The FDA says they need this information to keep 
America safe.
  The PRESIDING OFFICER. The Senator from Iowa.
  Mr. HARKIN. Mr. President, first of all, this is a drug and device 
bill, not a food bill. We addressed food issues in the food safety bill 
2 years ago. That doesn't solve the problem Senator Durbin talked 
about. This bill is a very delicate balance. We have worked on this for 
18 months. Stakeholders all over the country, consumers, the 
pharmaceutical industry, and pharmacists all support this bill. This 
would upset that delicate balance.
  I say to the Senator that every supplement has a label, the 
ingredients, and the potency, by law, on every single item sold as a 
supplement. This is a drug bill, not a food bill.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. HATCH. Mr. President, I strongly oppose this amendment. I will be 
voting to table it, and I encourage my colleagues to do the same. It 
would impose another layer of regulations on an industry that already 
has a workable regulatory framework. It is totally unnecessary, and it 
will only increase costs for those who use dietary supplements.
  I wish to make a few points clear.
  First, HHS already has authority to impose an immediate ban on any 
dietary supplement that poses imminent hazard to public health.
  Second, four previous FDA Commissioners and a former Deputy 
Commissioner agree that DSHEA already provides sufficient oversight of 
this industry. This amendment would strap the FDA with a huge burden at 
a time when the agency is already struggling to perform its current 
core responsibilities.
  Third, it unnecessarily expands registration requirements without 
adding any additional consumer protections.
  All this amendment does is penalize good companies, while doing 
nothing to go after the bad.
  In the end, as a result of this amendment, consumers will suffer by 
paying higher prices for their supplements.
  This amendment is bad for the FDA and bad for consumers. The Senate 
should reject it.
  We already have a regulatory framework under DSHEA that works. A new 
intrusive regulatory regime is totally unnecessary. I urge my 
colleagues to vote with me to table this amendment.
  Mr. DURBIN. Mr. President, I ask unanimous consent to have the same 
amount of time given on the other side.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN. Mr. President, the FDA asked for this knowledge and 
information. What am I asking them to disclose? The name of the 
product, the ingredients of it, and a copy of the label. If a Chinese 
manufacturer wants to sell a dietary supplement in Des Moines, IA, 
shouldn't they have to report to the FDA the name of the product and 
its ingredients? It is not required by law now. Let's give the FDA this 
extra information to keep Americans safe.
  Mr. HARKIN. Madam President, I move to table the Durbin amendment, 
and I ask for the yeas and nays.
  The PRESIDING OFFICER (Mrs. Hagan). Is there a sufficient second?
  There is a sufficient second.
  The question is on agreeing to the motion.
  The clerk will call the roll.
  The bill clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Connecticut (Mr. 
Blumenthal) is necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 77, nays 20, as follows:

                      [Rollcall Vote No. 110 Leg.]

                                YEAS--77

     Akaka
     Alexander
     Ayotte
     Barrasso
     Begich
     Bennet
     Blunt
     Boozman
     Brown (MA)

[[Page S3564]]


     Brown (OH)
     Burr
     Cantwell
     Carper
     Casey
     Chambliss
     Coats
     Coburn
     Cochran
     Collins
     Coons
     Corker
     Cornyn
     Crapo
     DeMint
     Enzi
     Graham
     Grassley
     Hagan
     Harkin
     Hatch
     Heller
     Hoeven
     Inhofe
     Inouye
     Isakson
     Johanns
     Johnson (SD)
     Johnson (WI)
     Kerry
     Kohl
     Kyl
     Landrieu
     Lee
     Levin
     Lieberman
     Lugar
     Manchin
     McCain
     McConnell
     Menendez
     Merkley
     Mikulski
     Moran
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Paul
     Portman
     Risch
     Roberts
     Rubio
     Sessions
     Shaheen
     Shelby
     Snowe
     Stabenow
     Tester
     Thune
     Toomey
     Udall (CO)
     Udall (NM)
     Vitter
     Warner
     Whitehouse
     Wicker
     Wyden

                                NAYS--20

     Baucus
     Bingaman
     Boxer
     Cardin
     Conrad
     Durbin
     Feinstein
     Franken
     Gillibrand
     Klobuchar
     Lautenberg
     Leahy
     McCaskill
     Pryor
     Reed
     Reid
     Rockefeller
     Sanders
     Schumer
     Webb

                             NOT VOTING--3

     Blumenthal
     Hutchison
     Kirk
  The motion was agreed to.
  Mr. HARKIN. Madam President, I move to reconsider the vote and to lay 
that motion on the table.
  The motion to lay on the table was agreed to.


                     Prescription Drug Information

  Mrs. GILLIBRAND. Madam President, earlier this week I introduced the 
Cody Miller Initiative for Safe Prescriptions Act. The legislation 
would require the Food and Drug Administration to issue regulations to 
ensure patients receive timely, consistent, and accurate information 
with their prescription drugs. The legislation would ensure patient 
medication information is regularly updated as new information becomes 
available and ensure that common information is applied consistently 
across similar products. Most importantly, the legislation would ensure 
patients are kept up to date about potential adverse side effects and 
dangerous drug interactions.
  Mr. HARKIN. I applaud the work of the Senator from New York on this 
legislation and share her commitment to ensuring patients receive 
standardized and accurate information about their prescription drugs. 
While verbal counseling by a pharmacist is still critical, the patient 
medication information is also an important resource to help patients 
use medications safely.
  Mrs. GILLIBRAND. I appreciate the Chairman's support and hope to work 
with him to advance this legislation. I also hope he will join me in 
calling on the FDA to use its existing authority to ensure patient 
medication information is uniform, accurate, and up-to-date. The FDA is 
currently engaged in efforts to revise the patient education materials 
that are distributed to patients. However, the FDA's current plan falls 
short of ensuring that consumers will receive unbiased and accurate 
information about their prescription drugs. It also fails to ensure 
that patient medication information is consistent for identical or 
similar products.
  Mr. HARKIN. I agree we need to take steps to improve the information 
patients receive and look forward to working with the Senator on this 
issue.


                       ACCELERATED PATIENT ACCESS

  Mrs. HAGAN. Section 901 of the managers' amendment to S. 3187, 
Enhancement of Accelerated Patient Access to New Medical Treatments 
states that an accelerated approval under section 506(b) of the Federal 
Food, Drug, and Cosmetic Act is subject to certain limitations, 
including the requirement that the sponsor conduct appropriate post- 
approval studies to verify and describe the predicted effect on 
irreversible morbidity or mortality or other clinical benefit. Does the 
lack of an explicit reference to postapproval validation of surrogate 
endpoints, as described in current law, in any way restrict the 
Secretary's existing authority to require such validation postapproval?
  Mr. HARKIN. The managers' amendment to 3187 revises section 506(b), 
removing the explicit language in current law requiring postapproval 
validation of surrogate endpoints. However, this is not intended to 
restrict the Secretary's current ability to require such validation 
postapproval, if appropriate. Equally important, the change likewise is 
not intended to suggest that any such validation should now occur prior 
to approval under section 506(b). Rather, in keeping with current 
practice, the bill's new language continues to permit the Secretary to 
require postapproval studies to verify the effect on the surrogate 
endpoint or predicted clinical outcome, i.e., verification of the 
predicted clinical benefit. In addition, it continues to allow the 
Secretary to withdraw an accelerated approval if the required studies 
fail to verify and describe the predicted effect.
  Mr. ENZI. To receive accelerated approval, the managers' amendment 
requires that FDA determine that a surrogate or clinical endpoint is 
reasonably likely to be predictive of an effect on clinical benefit or 
on a clinical endpoint that can be measured earlier than irreversible 
morbidity or mortality as of the time of granting accelerated approval 
and the standards under section 505(c) of the FDCA or section 351(a) of 
the Public Health Service Act are met. In meeting such a requirement, 
it is appropriate for the Secretary to seek data and information to 
show that the surrogate or clinical endpoint is reasonably likely to 
predict an effect on irreversible morbidity or mortality or other 
clinical benefit.
  I would just like to reiterate that nothing in these amendments to 
section 506(b) is intended to alter the FDA's historical practice of 
utilizing unvalidated surrogates to grant accelerated approval in 
appropriate cases or its practice of granting traditional approval 
under section 505(b) based on validated surrogates in appropriate 
cases.
  Mr. LEAHY. Madam President, Senator Manchin's amendment, amendment 
2151 to the Food and Drug Administration Safety and Innovation Act, 
seeks to address the problem of prescription opiate drugs by tightening 
restrictions on hydrocodone. Opiate prescription drugs like hydrocodone 
have been a tremendous and growing problem in Vermont, as they have in 
West Virginia. I thank Senator Manchin for working with me to make the 
amendment better.
  The scourge of prescription drug abuse has had a devastating effect 
in communities across the country. I heard about the lives destroyed by 
this epidemic and the violence and other ills it has brought with it in 
several hearings in Vermont in recent years. Senator Manchin's 
amendment seeks to make it more difficult for prescription drugs to get 
into the hands of those who would abuse them by requiring prescriptions 
more comprehensively and by restricting storage and transportation. I 
hope these steps will be helpful.
  I am glad Senator Manchin was willing to work with me to modify the 
amendment so that it did not cause as many sentencing increases, and 
particularly to eliminate what would have been a new mandatory minimum 
sentence. Those who work on the problem of prescription drugs every day 
have not identified a lack of adequate criminal sentences to be part of 
the problem, so a significant change in the sentencing scheme was not 
needed or intended.
  Indeed, the proliferation of severe sentences for drug offenses and 
of mandatory minimum sentences in particular is a large part of what 
has led to the serious problem we face now in having too many people in 
prison for too long. These sentences have contributed to the runaway 
prison costs that are so crippling to Federal and State budgets.
  Overwhelming prison costs take resources away from programs focusing 
on drug prevention, drug treatment, and strong law enforcement, all of 
which are more effective in helping communities take on prescription 
drug problems than are lengthy sentences. I am glad that we could work 
to ensure that this amendment would help to address our prescription 
drug problem without contributing to the overincarceration of drug 
offenders.
  I know some doctors in Vermont and elsewhere continue to have 
concerns about the effect this amendment will have on getting 
prescriptions to those who need them. I hope we can continue working 
together to ensure that we tackle the difficult problem of prescription 
drug addiction without hindering crucial medical care.
  I thank Senator Manchin for his leadership on this issue.
  Mr. REED. Madam President, I am pleased that last night, my 
amendment, No. 2126, which would ensure that there are no future delays 
on the

[[Page S3565]]

implementation of new sunscreen labeling and testing standards, was 
adopted as part of the Food and Drug Administration Safety and 
Innovation Act.
  Because sunscreens have been considered a cosmetic, they have largely 
avoided government oversight and the FDA hasn't changed its 
recommendations for sunscreen standards in over 30 years.
  However, last June, after years of prodding by our former colleague 
Senator Dodd, me, and others, the FDA finally acted.
  The agency finalized comprehensive new sunscreen regulations that 
were scheduled to go into effect on June 18, just a few weeks from now 
and in time for summer. Indeed, this was considered a victory for 
families across the country that spend more time outdoors and under the 
sun's harmful UVA and UVB rays during the summer months.
  But just 2 weeks ago, the FDA announced it is now giving the industry 
an extra 6 months to make changes, meaning the standards will take 
effect in mid-December instead of this summer.
  For too long the FDA has allowed manufacturers to get away with 
inaccurate claims about sun protection. My amendment will protect 
against any future delays and ensure the new sunscreen safety and 
labeling standards go into effect no later than the end of this year.
  I am pleased that the Environmental Working Group supports this 
amendment, and the Consumer Health Care Products Association, which 
represents sunscreen manufacturers, has agreed to the amendment's 
inclusion in this bill. Finally, the Congressional Budget Office has 
informed me that my amendment would not result in any additional cost 
to the Federal government.
  I thank Chairman Harkin and Senator Enzi for reviewing this amendment 
and including it in this FDA reauthorization bill.
  Mr. LEVIN. Madam President, I will support final passage of the Food 
and Drug Administration Safety and Innovation Act which will 
reauthorize the user fee agreements that govern the fees paid by the 
pharmaceutical and medical device industries to the Food and Drug 
Administration, FDA, to expedite the drug and device approval process.
  These fees are an important funding source that provides the FDA with 
resources necessary to ensure potentially lifesaving drugs and medical 
devices can be reviewed and ultimately brought to market quickly and 
safely. I understand this legislation is the product of a tremendous 
amount of work by the chairman and ranking member of the HELP 
Committee, in conjunction with various stakeholders, and enjoys broad 
support from industry, the FDA, and consumer groups.
  For the first time, this bill will also create new user fee 
agreements for generic drug manufacturers; manufacturers of biologics; 
and would make permanent the Best Pharmaceuticals for Children Act and 
the Pediatric Research Equity Act. These two laws together help improve 
the safety and efficacy of pharmaceuticals for children.
  Of particular interest, the bill aims to address drug shortages by 
requiring all manufactures of certain drugs to provide advance 
notification of possible supply disruptions and any permanent 
discontinuance of these products to the Health and Human Services 
Secretary. In addition, it will also require HHS to establish a task 
force to address possible drug shortages and will grant the secretary 
the authority to expedite the inspection and review process of 
substitute products that could mitigate a shortage.
  The bill will allow the FDA to continue to collect fees from 
pharmaceutical manufacturers and medical device manufacturers through 
2017. I am pleased to join with colleagues from both sides of the aisle 
in voting in favor of this important legislation.
  Ms. MIKULSKI. Madam President, I applaud the effort underway between 
the FDA and industry to develop a transitional pathway for the 
regulation of emerging diagnostic tests. In addition, I am pleased that 
the FDA expressed its commitment to work with industry on this 
important initiative in the MDUFA III commitment letter.
  Many new diagnostic tests serve as the missing link to improved 
health care through better detection, treatment, and monitoring of 
disease. Thus, it is critical for public health that FDA's premarket 
review system for diagnostics be modernized in a manner that supports 
advances in the sciences and promotes patient access.
  I look forward to developments with respect to the agency's plans to 
develop a transitional in vitro diagnostics pathway and steps taken 
related to its implementation.
  I also wish to talk about two massively important laws that work to 
ensure that medications used in children are tested and labeled 
correctly--the Best Pharmaceuticals for Children Act, known as BPCA, 
and the Pediatric Research Equity Act, known as PREA.
  Taken together, these two laws encourage and require drug companies 
to study their products in children. They have been hugely successful 
in ensuring that physicians and parents have information needed to best 
treat our Nation's children.
  Most drugs on the market have never been tested in children, largely 
because manufacturers face economic, mechanical, ethical, and legal 
obstacles that work to discourage pediatric testing.
  With respect to economic obstacles, the pediatric drug marketplace is 
generally small, with little economic incentive for manufacturers to 
commit resources to testing in children when they could just test in 
the much larger adult population.
  With respect to mechanical obstacles, young children often cannot 
swallow pills. This presents a challenge for drug manufacturers, who 
often then have to develop alternate formulations, such as liquids or 
chewable tablets. Finally, even for adults, ethical and legal 
requirements for participation in a clinical trial are incredibly 
complex and challenging. Trying to recruit children for trials is even 
more difficult. Parents don't want their kids used in experiments, and 
drug companies face added liability concerns.
  We understand these challenges, but doctors still must treat 
children--many with serious and life-threatening conditions. And, too 
often, doctors are forced to prescribe drugs that have never been 
studied in kids. So in 2002 and 2003 Congress passed laws that serve as 
a carrot and stick to generate more pediatric drug information. We 
passed the Pediatric Research Equity Act, which requires safety and 
efficacy studies in children for all new drugs. For drugs that were on 
the market before PREA was enacted, the law allows FDA to go back and 
mandate child studies where appropriate.
  We also passed the Best Pharmaceuticals for Children Act, which 
rewards drug companies with 6 months additional exclusivity if they 
complete additional pediatric testing requested by FDA.
  As a result of BPCA and PREA, over 425 drug labels have been revised 
with important pediatric information. Before BPCA and PREA, more than 
80 percent of drugs used in kids were used off-label without data on 
safety and efficacy. Today, that number has been reduced to 
approximately 50 percent. New pediatric studies conducted as result of 
BPCA and PREA have resulted in new dosing information, new indications 
of use, new safety information, and new data on effectiveness in 
children.
  The Food and Drug Administration Safety and Innovation Act removes 
the 5-year sunsets for BPCA and PREA, giving biopharmaceutical 
companies a more predictable regulatory path and providing certainty 
that these programs will still be up and running when companies 
complete their pediatric trials.
  This bill also makes important pediatric information publicly 
available. The last reauthorization of BPCA and PREA ensured that 
certain pediatric studies were made publicly available but did not 
ensure the availability of pre-2007 studies. This bill ensures that 
pediatric studies conducted between 2002 and 2007, which resulted in a 
labeling change, are made publicly available for physicians, 
researchers, and parents.
  Finally, this bill gives FDA new tools to ensure that studies 
required by PREA are completed on time, unless there is an appropriate 
reason for delay.
  Children are not small adults. They have different medical needs. The 
only way to improve the health of current and future generations of 
children is to

[[Page S3566]]

better understand how drugs work in pediatric populations. We need to 
help doctors by getting them more information so that treatment of 
pediatric diseases is less of a guessing game and more of an informed 
practice. I believe these two pediatric programs have been incredibly 
successful, and I am very encouraged by the improvements we make in the 
bill before us today.
  Finally Madam President, I wish to talk about the safety of our 
Nation's prescription drug supply. Today, there are many challenges and 
obstacles facing our families--from trying to find or keep a job, to 
figuring out how to pay off crushing student loans, to obtaining 
affordable health insurance. One thing that our families shouldn't have 
to worry about is whether the drug they are taking or whether the drug 
their loved one is taking to cure or treat an illness is going to harm 
them instead of help them.
  When the modern FDA was first established in 1938, most of our 
medical products were developed and manufactured within our own 
borders. That is no longer the case. Nearly 40 percent of drugs 
Americans rely upon are made outside our borders. About 80 percent of 
the active ingredients used in drugs made in the United States come 
from 150 other countries. The increased globalization of our drug 
industry, coupled with the fact that we have not given our Federal 
agencies additional authorities to keep pace, has created great 
challenges for FDA and industry and great danger to patients in need.
  Where there is need, there is greed. Where there is greed, there is 
scam and schemes. In this case, we know that increased globalization 
and insufficient authorities to regulate at a Federal level has created 
a dangerous opportunity for bad actors to take advantage. And they have 
taken advantage--from adulteration, to counterfeiting, to cargo theft, 
to manufacturing drugs in unsanitary conditions, to mislabeled 
products. We have seen it all in recent years and the consequences have 
been deadly.
  In recent years, a highly toxic solvent, known as DEG, added to fever 
medicine, cough syrup, and teething products resulted in the deaths of 
children and adults in Panama, Haiti, and Nigeria.
  In 2007, pet food adulterated with melamine and acid sickened several 
thousand pets in the United States. Melamine and acid was added to 
infant formula in China, poisoning and killing six babies and sickening 
300,000 others.
  In 2008, contaminated Heparin from China killed and sickened hundreds 
across the United States.
  In 2003, more than $20 million in illegally imported and counterfeit 
Lipitor was sold throughout the United States.
  In 2009, an estimated 46 drug cargo thefts occurred, valued at $184 
million.
  Many stolen drugs are then improperly stored or handled before being 
sold back to consumers, putting patients at risk. For instance, stolen 
insulin was reintroduced into the drug supply and caused adverse events 
in patients because it had not been refrigerated. I could go on and on 
with examples of how counterfeit, adulterated, and stolen drugs have 
sickened and killed people and animals worldwide.
  But, I am encouraged by the bill before us today. The FDA Safety and 
Innovation Act takes a number of important steps to improve the safety 
of our Nation's drug supply. For instance, this legislation requires 
every foreign establishment engaged in the manufacture of a drug or 
device imported into the United States, to electronically register with 
the FDA.
  Under current law, there are no requirements governing how often FDA 
must inspect foreign facilities. The bill before us requires FDA to set 
up a risk-based inspection frequency to ensure that we are getting in 
there and inspecting facilities that pose the greatest risks.
  This legislation gives the Secretary of Homeland Security the 
authority to refuse admission into the United States any drug or 
ingredient if it was manufactured, processed, packed, or held at an 
establishment that has refused or delayed inspection by FDA.
  This bill requires drug manufacturers and wholesalers to notify the 
FDA if they become aware that their drug has been counterfeited or has 
been stolen or lost in substantial quantities.
  Finally, this bill increases penalties for bad actors who knowingly 
adulterate or counterfeit drugs.
  In developing this legislation, the question we had to ask was this: 
Does the Federal agency tasked with ensuring the safety of our Nation's 
drugs have the resources and authorities necessary to do their job and 
protect the public health? The answer was no. But I believe the new 
authorities contained in the FDA Safety and Innovation Act--which we 
developed on a bipartisan basis in the Senate HELP committee--will help 
us ensure that the next time we ask this question, the answer will be 
yes.
  Mr. DURBIN. Madam President, today, we are considering a bill that 
will improve the FDA's ability to assure the safety of drugs in our 
medicine cabinets and medical devices in our hospitals.
  The FDA is an essential guardian of the public's health and safety.
  In the past few years, FDA has faced obstacles that call on the 
agency to adapt and respond to the evolving nature of reviewing, 
manufacturing, and distributing drugs and devices.
  Some of those obstacles and challenges are addressed in the 
reauthorizations of the Prescription Drug User Fee Act and the Medical 
Device User Fee Act, which are set to expire at the end of September 
2012.
  Last fall, I visited Cook Medical's medical device plant in Canton, 
IL, and representatives expressed concern about the amount of time it 
takes medical devices to be reviewed.
  FDA needs sufficient time to review medical devices in order to 
ensure their safety and effectiveness. However, inefficiencies and 
insufficient resources can result in longer review times, which means 
patients have to wait longer to benefit from new medical devices.
  This bill makes key changes to maintain the safety of devices and 
preserve our country's leadership in biomedical innovation.
  The bill will authorize the FDA to collect almost $600 million in 
user fees over 5 years. FDA can use these additional resources to help 
hire and train staff.
  Furthermore, the bill makes important improvements by streamlining 
the review process for devices and increasing communication between the 
FDA and device manufacturers throughout the review process.
  These changes to the review of medical devices will not only help 
innovative device companies get their product to market faster but will 
prevent patients from having to wait extra weeks and months to benefit 
from a new device.
  In addition to reauthorizing the Prescription Drug and Medical Device 
User Fee Acts, this bill also establishes the Generic Drug User Fee Act 
and Biosimilar User Fee Act, which give FDA new authority to collect 
user fees for generic and biosimilar drugs.
  Currently the FDA does not collect user fees to support the review of 
generic drugs, and it takes about 30 months for the agency to review 
generic drug applications. This extra time reduces access to safe, 
affordable generic drugs and leaves patients and taxpayers paying the 
tab for brand-name drugs that lack competition from generics.
  Since the first Prescription Drug User Fee Act was enacted in 1992, 
the FDA began collecting user fees to support the review of 
applications.
  FDA has cut the review time for new drugs by 60 percent, from 2 years 
to a little over 1 year.
  Similarly, the Generic Drug User Fee Act will give FDA the support it 
needs to cut the current 30-month review time for generic drugs down to 
10 months.
  This improvement will promote competition in the marketplace and save 
money by reducing the amount of time patients have to wait for less 
expensive generic alternatives to brand-name drugs.
  The process of negotiating and drafting this legislation started 18 
months ago, and the result is a comprehensive bill that improves the 
safety and quality of drugs and medical devices.
  Chairman Harkin and Senator Enzi have put together a bill that 
responds to many of these challenges, including one that is of 
particular interest to me--the national shortage of critical drugs.
  Between 2006 and 2010 the drug shortage increased 200 percent--from 
56 to

[[Page S3567]]

178 drugs. Currently the drug shortage includes over 200 drugs, such as 
intravenous nutrition supplements, cancer treating drugs, and 
anesthesia.
  Over the past few months, I have held three roundtable discussions at 
hospitals across Illinois to learn about the drug shortage and how it 
is affecting providers and patients. From these discussions it is clear 
that the drug shortage is being felt at most hospitals, and those 
Illinois hospitals, providers, and pharmacists are working around the 
clock to ensure patients maintain access to drugs and safe treatments.
  At Advocate Hospital in Libertyville, a doctor shared that he learned 
just days before starting a patient on chemotherapy that the drug was 
not available. Unfortunately, this is a common scenario across the 
country as doctors learn days before starting a treatment or even once 
the patient is on the hospital bed that a drug is not available.
  Pharmacists now spend part of each day scrambling to find drugs or an 
alternative treatment.
  I recently learned that a young woman on my staff here in DC is all 
too familiar with the drug shortage. She is a smart and hardworking 
woman who has been taking Concerta to treat her ADD since she was 14. 
Like most people with severe ADD, she must take her medicine at a 
certain time every day in order to keep their ADD symptoms from 
impeding basic life and work responsibilities. And while there are 
several ADD drugs on the market, each drug works differently and can 
have different side effects, so switching to a new prescription is not 
without risk.
  Last year, the local CVS where she usually had her prescription 
filled started telling her they didn't have her drug in stock. She 
didn't think much of it, as she would wake up early and walk to another 
CVS in the morning where she was usually able to get the prescription.
  Over time, she grew accustomed to going between these two CVS 
pharmacies to fill her prescription until one month when she carried 
her prescription with her for 3 days and was unable to find a pharmacy 
with enough Concerta to fill her 30-day prescription. By the end of day 
3, she was out of her supply. She woke up early and rode her bike to 
four or five CVS pharmacies until she was able to find a pharmacy that 
could fill her prescription. But by then it was 12 o'clock and past the 
prescribed time to take the drug.
  The shortage of ADD drugs impacts children, adults, parents, and 
employees across the country.
  Congress must take action to address the drug shortage.
  The FDA Safety and Innovation Act builds on Senator Klobuchar's bill, 
with key provisions to curb the national drug shortage.
  First, the bill requires drug manufacturers to notify the FDA 6 
months in advance for certain drug shortages.
  With this much notice, the FDA can work with manufacturers to try to 
avoid a shortage and, when necessary, identify alternative sources of 
the drug to ensure we maintain a supply for patients.
  This winter, thanks to open communication between the FDA and drug 
companies, the FDA successfully avoided a shortage of methotrexate, a 
vital drug to treat leukemia with children.
  FDA collaborated with Illinois-based generic drug manufacturer 
Hospira to increase production of this lifesaving drug when another 
company halted production.
  Requiring 6 months' advance notice of a drug shortage will help the 
FDA to work with companies to avoid shortages of critical drugs.
  Furthermore, the bill requires FDA to enhance the agency's response 
to shortages and will improve reporting of shortages by allowing third 
parties to report drug shortages to the FDA.
  This bill also takes steps to improve the safety of drugs and the 
drug supply chain.
  In 2008, serious injuries and 81 deaths were linked to contamination 
of the crucial blood thinning drug heparin. The source of the 
contamination was a facility in China that intentionally adulterated 
the drug. This was a horrible illustration of what happens when 
adulterated and counterfeit drugs make their way into the drug supply 
chain and ultimately to patients.
  This case has also raised serious questions about the global 
manufacturing practices of drugs and drug ingredients and the FDA's 
responsibility to protect the drug supply chain. Since the heparin 
incident, the global nature of the drug supply chain has only grown. 
Today, 80 percent of active pharmaceutical ingredients are manufactured 
outside of the United States.
  This bill improves the safety of our supply chain both domestically 
and internationally by requiring foreign manufacturers to register 
their facilities with the FDA.
  The bill also places greater responsibility on U.S. drug 
manufacturers to know their international suppliers and increases 
penalties for intentionally contaminating or counterfeiting drugs.
  Counterfeit and adulterated drugs can have deadly consequences, yet 
the penalty for committing these crimes is less than the penalty for 
selling a counterfeit designer purse. Currently, the penalty for 
intentionally counterfeiting or adulterating a drug is no more than 3 
ears in prison or a $10,000 fine or both. This bill raises the penalty 
for intentionally adulterating a drug to no more than 20 years in 
prison or a $1 million fine or both. And the penalty for intentionally 
counterfeiting drugs is raised to no more than 20 years in prison or a 
$4 million fine or both.
  This bill addresses the drug shortage, reduces the review time for 
medical devices and drugs, improves the pipeline for antibiotics and 
pediatric drugs, and helps secure the supply chain for prescription 
drugs.
  I thank Chairman Harkin and Senator Enzi for their extraordinary 
leadership and hard work on this bill.
  The PRESIDING OFFICER. The question is on the engrossment and the 
third reading of the bill.
  The bill was ordered to be engrossed for a third reading and was read 
the third time.
  The PRESIDING OFFICER. Under the previous order, there will now be 2 
minutes of debate equally divided prior to a vote on passage of the 
bill, as amended.
  The Senator from Iowa.
  Mr. HARKIN. Madam President, we have all put in a lot of work and 
benefited greatly by the constructive ideas and efforts of all the 
Members of this body. I sincerely thank all my colleagues, especially 
Senator Enzi, for their hard work on this must-pass legislation.
  This excellent bill is a shining example of what we can achieve when 
we all work together. Now we must keep our promise to patients and the 
biomedical industry and pass this critical bill.
  Today, with one vote, we can reauthorize the essential FDA's user fee 
agreements, systematically modernize FDA's medical product authority, 
and help to boost American innovation and ensure that patients have 
access to the therapies they need.
  So I urge my colleagues to join in this bipartisan spirit of 
cooperation and pass this important legislation, the FDA Safety and 
Innovation Act.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Madam President, the chairman has said it well. We 
appreciate the bipartisan spirit in which people have participated, 
especially in committee for a year and a half, working out amendments, 
working out ideas, and coming up with a bill that had a good consensus.
  I appreciate the action on the Senate floor, the people who were 
willing to do time limits on their amendments, and how quickly we have 
gotten through the votes.
  I particularly want to thank the chairman for the way he has handled 
this in committee and the process since then. We had a couple of issues 
that were outstanding and those got worked out.
  I also want to thank the staffs on both sides. Their dedication for a 
year and a half is what made this happen, and we have some outstanding 
staff on both sides. Every member of the committee and every committee 
member's staff helped on this one, and that makes a difference. So I 
ask everyone to support the bill.
  I yield the floor.
  The PRESIDING OFFICER. The question is, Shall the bill pass?
  Mr. HARKIN. Madam President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There appears to be a sufficient second.

[[Page S3568]]

  The clerk will call the roll.
  The assistant bill clerk called the roll.
  Mr. DURBIN. I announce that the Senator from Connecticut (Mr. 
Blumenthal) is necessarily absent.
  Mr. KYL. The following Senators are necessarily absent: the Senator 
from Texas (Mrs. Hutchison) and the Senator from Illinois (Mr. Kirk).
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 96, nays 1, as follows:

                      [Rollcall Vote No. 111 Leg.]

                                YEAS--96

     Akaka
     Alexander
     Ayotte
     Barrasso
     Baucus
     Begich
     Bennet
     Bingaman
     Blunt
     Boozman
     Boxer
     Brown (MA)
     Brown (OH)
     Burr
     Cantwell
     Cardin
     Carper
     Casey
     Chambliss
     Coats
     Coburn
     Cochran
     Collins
     Conrad
     Coons
     Corker
     Cornyn
     Crapo
     DeMint
     Durbin
     Enzi
     Feinstein
     Franken
     Gillibrand
     Graham
     Grassley
     Hagan
     Harkin
     Hatch
     Heller
     Hoeven
     Inhofe
     Inouye
     Isakson
     Johanns
     Johnson (SD)
     Johnson (WI)
     Kerry
     Klobuchar
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Lee
     Levin
     Lieberman
     Lugar
     Manchin
     McCain
     McCaskill
     McConnell
     Menendez
     Merkley
     Mikulski
     Moran
     Murkowski
     Murray
     Nelson (NE)
     Nelson (FL)
     Paul
     Portman
     Pryor
     Reed
     Reid
     Risch
     Roberts
     Rockefeller
     Rubio
     Schumer
     Sessions
     Shaheen
     Shelby
     Snowe
     Stabenow
     Tester
     Thune
     Toomey
     Udall (CO)
     Udall (NM)
     Vitter
     Warner
     Webb
     Whitehouse
     Wicker
     Wyden

                                NAYS--1

       
     Sanders
       

                             NOT VOTING--3

     Blumenthal
     Hutchison
     Kirk
  The bill (S. 3187), as amended, was passed, as follows:

                                S. 3187

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Safety and Innovation Act''.

     SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.

       (a) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset dates.
Sec. 208. Streamlined hiring authority to support activities related to 
              the process for the review of device applications.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority of the Food and Drug 
              Administration to support activities related to human 
              generic drugs.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Relationship between pediatric labeling and new clinical 
              investigation exclusivity.
Sec. 511. Pediatric rare diseases.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

Sec. 601. Reclassification procedures.
Sec. 602. Condition of approval studies.
Sec. 603. Postmarket surveillance.
Sec. 604. Sentinel.
Sec. 605. Recalls.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Unique device identifier.
Sec. 608. Clarification of least burdensome standard.
Sec. 609. Custom devices.
Sec. 610. Agency documentation and review of certain decisions 
              regarding devices.
Sec. 611. Good guidance practices relating to devices.
Sec. 612. Modification of de novo application process.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Reauthorization of third-party review and inspections.
Sec. 615. 510(k) device modifications.
Sec. 616. Health information technology.

                      TITLE VII--DRUG SUPPLY CHAIN

                     Subtitle A--Drug Supply Chain

Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product 
              listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Failure to allow foreign inspection.
Sec. 708. Exchange of information.
Sec. 709. Enhancing the safety and quality of the drug supply.
Sec. 710. Accreditation of third-party auditors for drug 
              establishments.
Sec. 711. Standards for admission of imported drugs.
Sec. 712. Notification.
Sec. 713. Protection against intentional adulteration.
Sec. 714. Enhanced criminal penalty for counterfeiting drugs.
Sec. 715. Extraterritorial jurisdiction.
Sec. 716. Compliance with international agreements.

           Subtitle B--Pharmaceutical Distribution Integrity

Sec. 721. Short title.
Sec. 722. Securing the pharmaceutical distribution supply chain.
Sec. 723. Independent assessment.

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. GAO study.
Sec. 805. Clinical trials.
Sec. 806. Regulatory certainty and predictability.

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

Sec. 901. Enhancement of accelerated patient access to new medical 
              treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted 
              therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container 
              labels by visually-impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Independent study on medical innovation inducement model.
Sec. 907. Orphan product grants program.
Sec. 908. Reporting of inclusion of demographic subgroups in clinical 
              trials and data analysis in applications for drugs, 
              biologics, and devices.

                        TITLE X--DRUG SHORTAGES

Sec. 1001. Drug shortages.

                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

Sec. 1101. Reauthorization of provision relating to exclusivity of 
              certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the Critical Path Public-Private 
              Partnerships.

               Subtitle B--Medical Gas Product Regulation

Sec. 1111. Regulation of medical gas products.
Sec. 1112. Regulations.
Sec. 1113. Applicability.

                  Subtitle C--Miscellaneous Provisions

Sec. 1121. Advisory committee conflicts of interest.
Sec. 1122. Guidance document regarding product promotion using the 
              Internet.
Sec. 1123. Electronic submission of applications.
Sec. 1124. Combating prescription drug abuse.
Sec. 1125. Tanning bed labeling.

[[Page S3569]]

Sec. 1126. Optimizing global clinical trials.
Sec. 1127. Advancing regulatory science to promote public health 
              innovation.
Sec. 1128. Information technology.
Sec. 1129. Reporting requirements.
Sec. 1130. Strategic integrated management plan.
Sec. 1131. Drug development and testing.
Sec. 1132. Patient participation in medical product discussions.
Sec. 1133. Nanotechnology regulatory science program.
Sec. 1134. Online pharmacy report to Congress.
Sec. 1135. Medication and device errors.
Sec. 1136. Compliance provision.
Sec. 1137. Ensuring adequate information regarding pharmaceuticals for 
              all populations, particularly underrepresented 
              subpopulations, including racial subgroups.
Sec. 1138. Report on small businesses.
Sec. 1139. Protections for the commissioned corps of the public health 
              service act.
Sec. 1140. Regulations on clinical trial registration; GAO Study of 
              clinical trial registration and reporting requirements.
Sec. 1141. Hydrocodone amendment.
Sec. 1142. Compliance date for rule relating to sunscreen drug products 
              for over-the-counter human use.
Sec. 1143. Recommendations on interoperability standards.

                      Subtitle D--Synthetic Drugs

Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled 
              Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public 
              safety expansion.
Sec. 1154. Prohibition on imposing mandatory minimum sentences.
       (b) References in Act.--Except as otherwise specified, 
     amendments made by this Act to a section or other provision 
     of law are amendments to such section or other provision of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.).

                    TITLE I--FEES RELATING TO DRUGS

     SEC. 101. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated toward 
     expediting the drug development process and the process for 
     the review of human drug applications, including postmarket 
     drug safety activities, as set forth in the goals identified 
     for purposes of part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act, in the letters from the 
     Secretary of Health and Human Services to the Chairman of the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Chairman of the Committee on Energy and 
     Commerce of the House of Representatives, as set forth in the 
     Congressional Record.

     SEC. 102. DEFINITIONS.

       Paragraph (7) of section 735 (21 U.S.C. 379g) is amended, 
     in the matter preceding subparagraph (A), by striking 
     ``incurred''.

     SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

       Section 736 (21 U.S.C. 379h) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2008'' and inserting ``fiscal year 2013'';
       (B) in paragraph (1), in clauses (i) and (ii) of 
     subparagraph (A), by striking ``subsection (c)(5)'' each 
     place such term appears and inserting ``subsection (c)(4)'';
       (C) in the matter following clause (ii) in paragraph 
     (2)(A)--
       (i) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(4)''; and
       (ii) by striking ``payable on or before October 1 of each 
     year'' and inserting ``due on the later of the first business 
     day on or after October 1 of each fiscal year or the first 
     business day after the enactment of an appropriations Act 
     providing for the collection and obligation of fees for such 
     fiscal year under this section''; and
       (D) in paragraph (3)--
       (i) in subparagraph (A)--

       (I) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(4)''; and
       (II) by striking ``payable on or before October 1 of each 
     year.'' and inserting ``due on the later of the first 
     business day on or after October 1 of each fiscal year or the 
     first business day after the enactment of an appropriations 
     Act providing for the collection and obligation of fees for 
     such fiscal year under this section.''; and

       (ii) by amending subparagraph (B) to read as follows:
       ``(B) Exception.--A prescription drug product shall not be 
     assessed a fee under subparagraph (A) if such product is--
       ``(i) identified on the list compiled under section 
     505(j)(7) with a potency described in terms of per 100 mL;
       ``(ii) the same product as another product that--

       ``(I) was approved under an application filed under section 
     505(b) or 505(j); and
       ``(II) is not in the list of discontinued products compiled 
     under section 505(j)(7);

       ``(iii) the same product as another product that was 
     approved under an abbreviated application filed under section 
     507 (as in effect on the day before the date of enactment of 
     the Food and Drug Administration Modernization Act of 1997); 
     or
       ``(iv) the same product as another product that was 
     approved under an abbreviated new drug application pursuant 
     to regulations in effect prior to the implementation of the 
     Drug Price Competition and Patent Term Restoration Act of 
     1984.'';
       (2) in subsection (b)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``fiscal years 2008 through 2012'' and inserting ``fiscal 
     years 2013 through 2017'';
       (ii) in subparagraph (A), by striking ``$392,783,000; and'' 
     and inserting ``$693,099,000;''; and
       (iii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) the dollar amount equal to the inflation adjustment 
     for fiscal year 2013 (as determined under paragraph (3)(A)); 
     and
       ``(C) the dollar amount equal to the workload adjustment 
     for fiscal year 2013 (as determined under paragraph 
     (3)(B)).''; and
       (B) by striking paragraphs (3) and (4) and inserting the 
     following:
       ``(3) Fiscal year 2013 inflation and workload 
     adjustments.--For purposes of paragraph (1), the dollar 
     amount of the inflation and workload adjustments for fiscal 
     year 2013 shall be determined as follows:
       ``(A) Inflation adjustment.--The inflation adjustment for 
     fiscal year 2013 shall be the sum of--
       ``(i) $652,709,000 multiplied by the result of an inflation 
     adjustment calculation determined using the methodology 
     described in subsection (c)(1)(B); and
       ``(ii) $652,709,000 multiplied by the result of an 
     inflation adjustment calculation determined using the 
     methodology described in subsection (c)(1)(C).
       ``(B) Workload adjustment.--Subject to subparagraph (C), 
     the workload adjustment for fiscal 2013 shall be--
       ``(i) $652,709,000 plus the amount of the inflation 
     adjustment calculated under subparagraph (A); multiplied by
       ``(ii) the amount (if any) by which a percentage workload 
     adjustment for fiscal year 2013, as determined using the 
     methodology described in subsection (c)(2)(A), would exceed 
     the percentage workload adjustment (as so determined) for 
     fiscal year 2012, if both such adjustment percentages were 
     calculated using the 5-year base period consisting of fiscal 
     years 2003 through 2007.
       ``(C) Limitation.--Under no circumstances shall the 
     adjustment under subparagraph (B) result in fee revenues for 
     fiscal year 2013 that are less than the sum of the amount 
     under paragraph (1)(A) and the amount under paragraph 
     (1)(B).'';
       (3) by striking subsection (c) and inserting the following:
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year by the 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     the process for the review of human drug applications (as 
     defined in section 735(6)) for the first 3 years of the 
     preceding 4 fiscal years; and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data, multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of the process for the review of human drug 
     applications (as defined in section 735(6)) for the first 3 
     years of the preceding 4 fiscal years.

     The adjustment made each fiscal year under this paragraph 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this paragraph.
       ``(2) Workload adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, after the fee revenues established 
     in subsection (b) are adjusted for a fiscal year for 
     inflation in accordance with paragraph (1), the fee revenues 
     shall be adjusted further for such fiscal year to reflect 
     changes in the workload of the Secretary for the process for 
     the review of human drug applications. With respect to such 
     adjustment:
       ``(A) The adjustment shall be determined by the Secretary 
     based on a weighted average of the change in the total number 
     of human drug applications (adjusted for changes in review 
     activities, as described in the notice that the Secretary is 
     required to publish in the Federal Register under this 
     subparagraph), efficacy supplements, and manufacturing 
     supplements submitted to the Secretary, and the change in the 
     total number of active commercial investigational new drug 
     applications (adjusted for changes in review activities, as 
     so described) during the most recent 12-month period for 
     which data on such submissions is available. The Secretary 
     shall publish in the Federal Register

[[Page S3570]]

     the fee revenues and fees resulting from the adjustment and 
     the supporting methodologies.
       ``(B) Under no circumstances shall the adjustment result in 
     fee revenues for a fiscal year that are less than the sum of 
     the amount under subsection (b)(1)(A) and the amount under 
     subsection (b)(1)(B), as adjusted for inflation under 
     paragraph (1).
       ``(C) The Secretary shall contract with an independent 
     accounting or consulting firm to periodically review the 
     adequacy of the adjustment and publish the results of those 
     reviews. The first review shall be conducted and published by 
     the end of fiscal year 2013 (to examine the performance of 
     the adjustment since fiscal year 2009), and the second review 
     shall be conducted and published by the end of fiscal year 
     2015 (to examine the continued performance of the 
     adjustment). The reports shall evaluate whether the 
     adjustment reasonably represents actual changes in workload 
     volume and complexity and present options to discontinue, 
     retain, or modify any elements of the adjustment. The reports 
     shall be published for public comment. After review of the 
     reports and receipt of public comments, the Secretary shall, 
     if warranted, adopt appropriate changes to the methodology. 
     If the Secretary adopts changes to the methodology based on 
     the first report, the changes shall be effective for the 
     first fiscal year for which fees are set after the Secretary 
     adopts such changes and each subsequent fiscal year.
       ``(3) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under this 
     paragraph and paragraphs (1) and (2), further increase the 
     fee revenues and fees established in subsection (b) if such 
     an adjustment is necessary to provide for not more than 3 
     months of operating reserves of carryover user fees for the 
     process for the review of human drug applications for the 
     first 3 months of fiscal year 2018. If such an adjustment is 
     necessary, the rationale for the amount of the increase shall 
     be contained in the annual notice establishing fee revenues 
     and fees for fiscal year 2017. If the Secretary has carryover 
     balances for such process in excess of 3 months of such 
     operating reserves, the adjustment under this paragraph shall 
     not be made.
       ``(4) Annual fee setting.--The Secretary shall, not later 
     than 60 days before the start of each fiscal year that begins 
     after September 30, 2012, establish, for the next fiscal 
     year, application, product, and establishment fees under 
     subsection (a), based on the revenue amounts established 
     under subsection (b) and the adjustments provided under this 
     subsection.
       ``(5) Limit.--The total amount of fees charged, as adjusted 
     under this subsection, for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for the process for the review of human drug applications.''; 
     and
       (4) in subsection (g)--
       (A) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) in clause (i), by striking ``shall be retained'' and 
     inserting ``subject to subparagraph (C), shall be collected 
     and available''; and
       (II) in clause (ii), by striking ``shall only be collected 
     and available'' and inserting ``shall be available''; and

       (ii) by adding at the end the following new subparagraph:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (C) in paragraph (3), by striking ``fiscal years 2008 
     through 2012'' and inserting ``fiscal years 2013 through 
     2017''; and
       (D) in paragraph (4)--
       (i) by striking ``fiscal years 2008 through 2010'' and 
     inserting ``fiscal years 2013 through 2015'';
       (ii) by striking ``fiscal year 2011'' and inserting 
     ``fiscal year 2016'';
       (iii) by striking ``fiscal years 2008 though 2011'' and 
     inserting ``fiscal years 2013 through 2016''; and
       (iv) by striking ``fiscal year 2012'' and inserting 
     ``fiscal year 2017''.

     SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 736B (21 U.S.C. 379h 2) is amended--
       (1) by amending subsection (a) to read as follows:
       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 101(b) of the Prescription Drug User Fee Amendments 
     of 2012 during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals. The 
     report under this subsection for a fiscal year shall include 
     information on all previous cohorts for which the Secretary 
     has not given a complete response on all human drug 
     applications and supplements in the cohort.'';
       (2) in subsection (b), by striking ``2008'' and inserting 
     ``2013''; and
       (3) in subsection (d), by striking ``2012'' each place it 
     appears and inserting ``2017''.

     SEC. 105. SUNSET DATES.

       (a) Authorization.--Sections 735 and 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 736B of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h 2) shall cease 
     to be effective January 31, 2018.
       (c) Previous Sunset Provision.--Section 106 of the 
     Prescription Drug User Fee Amendments of 2007 (Title I of 
     Public Law 110 85) is repealed.
       (d) Technical Clarifications.--
       (1) Effective September 30, 2007, section 509 of the 
     Prescription Drug User Fee Amendments Act of 2002 (Title V of 
     Public Law 107 188) is repealed.
       (2) Effective September 30, 2002, section 107 of the Food 
     and Drug Administration Modernization Act of 1997 (Public Law 
     105 115) is repealed.
       (3) Effective September 30, 1997, section 105 of the 
     Prescription Drug User Fee Act of 1992 (Public Law 102 571) 
     is repealed.

     SEC. 106. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act shall be assessed for all human drug 
     applications received on or after October 1, 2012, regardless 
     of the date of the enactment of this Act.

     SEC. 107. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 2 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, as in effect on the day before the date of the 
     enactment of this title, shall continue to be in effect with 
     respect to human drug applications and supplements (as 
     defined in such part as of such day) that on or after October 
     1, 2007, but before October 1, 2012, were accepted by the 
     Food and Drug Administration for filing with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2012.

                   TITLE II--FEES RELATING TO DEVICES

     SEC. 201. SHORT TITLE; FINDINGS.

       (a) Short Title.--This title may be cited as the ``Medical 
     Device User Fee Amendments of 2012''.
       (b) Findings.--The Congress finds that the fees authorized 
     under the amendments made by this title will be dedicated 
     toward expediting the process for the review of device 
     applications and for assuring the safety and effectiveness of 
     devices, as set forth in the goals identified for purposes of 
     part 3 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act in the letters from the Secretary of 
     Health and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record.

     SEC. 202. DEFINITIONS.

       Section 737 (21 U.S.C. 379i) is amended--
       (1) in paragraph (9), by striking ``incurred'' after 
     ``expenses'';
       (2) in paragraph (10), by striking ``October 2001'' and 
     inserting ``October 2011''; and
       (3) in paragraph (13), by striking ``is required to 
     register'' and all that follows through the end of paragraph 
     (13) and inserting the following: ``is registered (or is 
     required to register) with the Secretary under section 510 
     because such establishment is engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     device.''.

     SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

       (a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is 
     amended--
       (1) in paragraph (1), by striking ``fiscal year 2008'' and 
     inserting ``fiscal year 2013'';
       (2) in paragraph (2)(A)--
       (A) in the matter preceding clause (i)--
       (i) by striking ``subsections (d) and (e)'' and inserting 
     ``subsections (d), (e), and (f)'';
       (ii) by striking ``October 1, 2002'' and inserting 
     ``October 1, 2012''; and
       (iii) by striking ``subsection (c)(1)'' and inserting 
     ``subsection (c)''; and
       (B) in clause (viii), by striking ``1.84'' and inserting 
     ``2''; and
       (3) in paragraph (3)--
       (A) in subparagraph (A)--
       (i) by inserting ``and subsection (f)'' after 
     ``subparagraph (B)''; and
       (ii) by striking ``2008'' and inserting ``2013''; and
       (B) in subparagraph (C), by striking ``initial 
     registration'' and all that follows through ``section 510.'' 
     and inserting ``later of--
       ``(i) the initial or annual registration (as applicable) of 
     the establishment under section 510; or
       ``(ii) the first business day after the date of enactment 
     of an appropriations Act providing for the collection and 
     obligation of fees for such year under this section.''.
       (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--
       ``(1) In general.--Subject to subsections (c), (d), (e), 
     (f), and (i), for each of fiscal years 2013 through 2017, 
     fees under subsection (a) shall be derived from the base fee 
     amounts specified in paragraph (2), to generate the total 
     revenue amounts specified in paragraph (3).

[[Page S3571]]

       ``(2) Base fee amounts.--For purposes of paragraph (1), the 
     base fee amounts specified in this paragraph are as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Fiscal Year  Fiscal Year  Fiscal Year  Fiscal Year  Fiscal Year
                   ``Fee Type                        2013         2014         2015         2016         2017
----------------------------------------------------------------------------------------------------------------
Premarket Application..........................     $248,000     $252,960     $258,019     $263,180     $268,443
Establishment Registration.....................       $2,575       $3,200       $3,750       $3,872       $3,872
----------------------------------------------------------------------------------------------------------------

       ``(3) Total revenue amounts.--For purposes of paragraph 
     (1), the total revenue amounts specified in this paragraph 
     are as follows:
       ``(A) $97,722,301 for fiscal year 2013.
       ``(B) $112,580,497 for fiscal year 2014.
       ``(C) $125,767,107 for fiscal year 2015.
       ``(D) $129,339,949 for fiscal year 2016.
       ``(E) $130,184,348 for fiscal year 2017.''.
       (c) Annual Fee Setting; Adjustments.--Section 738(c) (21 
     U.S.C. 379j(c)) is amended--
       (1) in the subsection heading, by inserting ``; 
     Adjustments'' after ``setting'';
       (2) by striking paragraphs (1) and (2);
       (3) by redesignating paragraphs (3) and (4) as paragraphs 
     (4) and (5), respectively; and
       (4) by inserting before paragraph (4), as so redesignated, 
     the following:
       ``(1) In general.--The Secretary shall, 60 days before the 
     start of each fiscal year after September 30, 2012, establish 
     fees under subsection (a), based on amounts specified under 
     subsection (b) and the adjustments provided under this 
     subsection, and publish such fees, and the rationale for any 
     adjustments to such fees, in the Federal Register.
       ``(2) Inflation adjustments.--
       ``(A) Adjustment to total revenue amounts.--For fiscal year 
     2014 and each subsequent fiscal year, the Secretary shall 
     adjust the total revenue amount specified in subsection 
     (b)(3) for such fiscal year by multiplying such amount by the 
     applicable inflation adjustment under subparagraph (B) for 
     such year.
       ``(B) Applicable inflation adjustment to total revenue 
     amounts.--The applicable inflation adjustment for a fiscal 
     year is--
       ``(i) for fiscal year 2014, the base inflation adjustment 
     under subparagraph (C) for such fiscal year; and
       ``(ii) for fiscal year 2015 and each subsequent fiscal 
     year, the product of--

       ``(I) the base inflation adjustment under subparagraph (C) 
     for such fiscal year; and
       ``(II) the product of the base inflation adjustment under 
     subparagraph (C) for each of the fiscal years preceding such 
     fiscal year, beginning with fiscal year 2014.

       ``(C) Base inflation adjustment to total revenue amounts.--
       ``(i) In general.--Subject to further adjustment under 
     clause (ii), the base inflation adjustment for a fiscal year 
     is the sum of one plus--

       ``(I) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years, multiplied by 0.60; and
       ``(II) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by 0.40.

       ``(ii) Limitations.--For purposes of subparagraph (B), if 
     the base inflation adjustment for a fiscal year under clause 
     (i)--

       ``(I) is less than 1, such adjustment shall be considered 
     to be equal to 1; or
       ``(II) is greater than 1.04, such adjustment shall be 
     considered to be equal to 1.04.

       ``(D) Adjustment to base fee amounts.--For each of fiscal 
     years 2014 through 2017, the base fee amounts specified in 
     subsection (b)(2) shall be adjusted as needed, on a uniform 
     proportionate basis, to generate the total revenue amounts 
     under subsection (b)(3), as adjusted for inflation under 
     subparagraph (A).
       ``(3) Volume-based adjustments to establishment 
     registration base fees.--For each of fiscal years 2014 
     through 2017, after the base fee amounts specified in 
     subsection (b)(2) are adjusted under paragraph (2)(D), the 
     base establishment registration fee amounts specified in such 
     subsection shall be further adjusted, as the Secretary 
     estimates is necessary in order for total fee collections for 
     such fiscal year to generate the total revenue amounts, as 
     adjusted under paragraph (2).''.
       (d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j) 
     is amended by--
       (1) redesignating subsections (f) through (k) as 
     subsections (g) through (l), respectively; and
       (2) by inserting after subsection (e) the following new 
     subsection:
       ``(f) Fee Waiver or Reduction.--
       ``(1) In general.--The Secretary may, at the Secretary's 
     sole discretion, grant a waiver or reduction of fees under 
     subsection (a)(2) or (a)(3) if the Secretary finds that such 
     waiver or reduction is in the interest of public health.
       ``(2) Limitation.--The sum of all fee waivers or reductions 
     granted by the Secretary in any fiscal year under paragraph 
     (1) shall not exceed 2 percent of the total fee revenue 
     amounts established for such year under subsection (c).
       ``(3) Duration.--The authority provided by this subsection 
     terminates October 1, 2017.''.
       (e) Conditions.--Section 738(h)(1)(A) (21 U.S.C. 
     379j(h)(1)(A)), as redesignated by subsection (d)(1), is 
     amended by striking ``$205,720,000'' and inserting 
     ``$280,587,000''.
       (f) Crediting and Availability of Fees.--Section 738(i) (21 
     U.S.C. 379j(i)), as redesignated by subsection (d)(1), is 
     amended--
       (1) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (2) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``shall be retained'' and 
     inserting ``subject to subparagraph (C), shall be collected 
     and available''; and
       (ii) in clause (ii)--

       (I) by striking ``collected and'' after ``shall only be''; 
     and
       (II) by striking ``fiscal year 2002'' and inserting 
     ``fiscal year 2009''; and

       (B) by adding at the end, the following:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (3) by amending paragraph (3) to read as follows:
       ``(3) Authorizations of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equal to 
     the total revenue amount specified under subsection (b)(3) 
     for the fiscal year, as adjusted under subsection (c) and, 
     for fiscal year 2017 only, as further adjusted under 
     paragraph (4).''; and
       (4) in paragraph (4)--
       (A) by striking ``fiscal years 2008, 2009, and 2010'' and 
     inserting ``fiscal years 2013, 2014, and 2015'';
       (B) by striking ``fiscal year 2011'' and inserting ``fiscal 
     year 2016'';
       (C) by striking ``June 30, 2011'' and inserting ``June 30, 
     2016'';
       (D) by striking ``the amount of fees specified in aggregate 
     in'' and inserting ``the cumulative amount appropriated 
     pursuant to'';
       (E) by striking ``aggregate amount in'' before ``excess 
     shall be credited''; and
       (F) by striking ``fiscal year 2012'' and inserting ``fiscal 
     year 2017''.
       (g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C. 
     360e(c)(4)(A)) is amended by striking ``738(g)'' and 
     inserting ``738(h)''.

     SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j 1(b)) 
     is amended--
       (1) in paragraph (1), by striking ``2012'' and inserting 
     ``2017''; and
       (2) in paragraph (5), by striking ``2012'' and inserting 
     ``2017''.
       (b) Reports.--Section 738A(a) (21 U.S.C. 379j 1(a)) is 
     amended--
       (1) by striking ``2008 through 2012'' each place it appears 
     and inserting ``2013 through 2017''; and
       (2) by striking ``section 201(c) of the Food and Drug 
     Administration Amendments Act of 2007'' and inserting 
     ``section 201(b) of the Medical Device User Fee Amendments of 
     2012''.

     SEC. 205. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 3 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to submissions 
     described in section 738(a)(2)(A) of the Federal Food, Drug, 
     and Cosmetic Act (as in effect as of such day) that on or 
     after October 1, 2007, but before October 1, 2012, were 
     accepted by the Food and Drug Administration for filing with 
     respect to assessing and collecting any fee required by such 
     part for a fiscal year prior to fiscal year 2013.

     SEC. 206. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 3 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act shall be assessed for submissions described in 
     section 738(a)(2)(A) of the Federal Food, Drug, and Cosmetic 
     Act received on or after October 1, 2012, regardless of the 
     date of the enactment of this Act.

     SEC. 207. SUNSET DATES.

       (a) Authorizations.--Sections 737 and 738 (21 U.S.C. 739i; 
     739j) shall cease to be effective October 1, 2017.
       (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j 
     1) shall cease to be effective January 31, 2018.

[[Page S3572]]

       (c) Previous Sunset Provision.--Section 217 of the Medical 
     Device User Fee Amendments of 2007 (Title II of Public Law 
     110 85) is repealed.
       (d) Technical Clarification.--Effective September 30, 2007, 
     section 107 of the Medical Device User Fee and Modernization 
     Act of 2002 (Public Law 107 250) is repealed.

     SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 
                   RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE 
                   APPLICATIONS.

       Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is 
     amended by inserting after section 713 the following new 
     section:

     ``SEC. 714. STREAMLINED HIRING AUTHORITY.

       ``(a) In General.--In addition to any other personnel 
     authorities under other provisions of law, the Secretary may, 
     without regard to the provisions of title 5, United States 
     Code, governing appointments in the competitive service, 
     appoint employees to positions in the Food and Drug 
     Administration to perform, administer, or support activities 
     described in subsection (b), if the Secretary determines that 
     such appointments are needed to achieve the objectives 
     specified in subsection (c).
       ``(b) Activities Described.--The activities described in 
     this subsection are activities under this Act related to the 
     process for the review of device applications (as defined in 
     section 737(8)).
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are with respect to the activities under 
     subsection (b), the goals referred to in section 738A(a)(1).
       ``(d) Internal Controls.--The Secretary shall institute 
     appropriate internal controls for appointments under this 
     section.
       ``(e) Sunset.--The authority to appoint employees under 
     this section shall terminate on the date that is three years 
     after the date of enactment of this section.''.

               TITLE III--FEES RELATING TO GENERIC DRUGS

     SEC. 301. SHORT TITLE.

       (a) Short Title.--This title may be cited as the ``Generic 
     Drug User Fee Amendments of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to 
     human generic drug activities, as set forth in the goals 
     identified for purposes of part 7 of subchapter C of chapter 
     VII of the Federal Food, Drug, and Cosmetic Act, in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record.

     SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
     amended by adding at the end the following:

                ``PART 7--FEES RELATING TO GENERIC DRUGS

     ``SEC. 744A. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `abbreviated new drug application'--
       ``(A) means an application submitted under section 505(j), 
     an abbreviated application submitted under section 507 (as in 
     effect on the day before the date of enactment of the Food 
     and Drug Administration Modernization Act of 1997), or an 
     abbreviated new drug application submitted pursuant to 
     regulations in effect prior to the implementation of the Drug 
     Price Competition and Patent Term Restoration Act of 1984; 
     and
       ``(B) does not include an application for a positron 
     emission tomography drug.
       ``(2) The term `active pharmaceutical ingredient' means--
       ``(A) a substance, or a mixture when the substance is 
     unstable or cannot be transported on its own, intended--
       ``(i) to be used as a component of a drug; and
       ``(ii) to furnish pharmacological activity or other direct 
     effect in the diagnosis, cure, mitigation, treatment, or 
     prevention of disease, or to affect the structure or any 
     function of the human body; or
       ``(B) a substance intended for final crystallization, 
     purification, or salt formation, or any combination of those 
     activities, to become a substance or mixture described in 
     subparagraph (A).
       ``(3) The term `adjustment factor' means a factor 
     applicable to a fiscal year that is the Consumer Price Index 
     for all urban consumers (all items; United States city 
     average) for October of the preceding fiscal year divided by 
     such Index for October 2011.
       ``(4) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(5)(A) The term `facility'--
       ``(i) means a business or other entity--
       ``(I) under one management, either direct or indirect; and
       ``(II) at one geographic location or address engaged in 
     manufacturing or processing an active pharmaceutical 
     ingredient or a finished dosage form; and
       ``(ii) does not include a business or other entity whose 
     only manufacturing or processing activities are one or more 
     of the following: repackaging, relabeling, or testing.
       ``(B) For purposes of subparagraph (A), separate buildings 
     within close proximity are considered to be at one geographic 
     location or address if the activities in them are--
       ``(i) closely related to the same business enterprise;
       ``(ii) under the supervision of the same local management; 
     and
       ``(iii) capable of being inspected by the Food and Drug 
     Administration during a single inspection.
       ``(C) If a business or other entity would meet the 
     definition of a facility under this paragraph but for being 
     under multiple management, the business or other entity is 
     deemed to constitute multiple facilities, one per management 
     entity, for purposes of this paragraph.
       ``(6) The term `finished dosage form' means--
       ``(A) a drug product in the form in which it will be 
     administered to a patient, such as a tablet, capsule, 
     solution, or topical application;
       ``(B) a drug product in a form in which reconstitution is 
     necessary prior to administration to a patient, such as oral 
     suspensions or lyophilized powders; or
       ``(C) any combination of an active pharmaceutical 
     ingredient with another component of a drug product for 
     purposes of production of a drug product described in 
     subparagraph (A) or (B).
       ``(7) The term `generic drug submission' means an 
     abbreviated new drug application, an amendment to an 
     abbreviated new drug application, or a prior approval 
     supplement to an abbreviated new drug application.
       ``(8) The term `human generic drug activities' means the 
     following activities of the Secretary associated with generic 
     drugs and inspection of facilities associated with generic 
     drugs:
       ``(A) The activities necessary for the review of generic 
     drug submissions, including review of drug master files 
     referenced in such submissions.
       ``(B) The issuance of--
       ``(i) approval letters which approve abbreviated new drug 
     applications or supplements to such applications; or
       ``(ii) complete response letters which set forth in detail 
     the specific deficiencies in such applications and, where 
     appropriate, the actions necessary to place such applications 
     in condition for approval.
       ``(C) The issuance of letters related to Type II active 
     pharmaceutical drug master files which--
       ``(i) set forth in detail the specific deficiencies in such 
     submissions, and where appropriate, the actions necessary to 
     resolve those deficiencies; or
       ``(ii) document that no deficiencies need to be addressed.
       ``(D) Inspections related to generic drugs.
       ``(E) Monitoring of research conducted in connection with 
     the review of generic drug submissions and drug master files.
       ``(F) Postmarket safety activities with respect to drugs 
     approved under abbreviated new drug applications or 
     supplements, including the following activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on approved drugs, including adverse event 
     reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies) insofar as those activities relate to 
     abbreviated new drug applications.
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(G) Regulatory science activities related to generic 
     drugs.
       ``(9) The term `positron emission tomography drug' has the 
     meaning given to the term `compounded positron emission 
     tomography drug' in section 201(ii), except that paragraph 
     (1)(B) of such section shall not apply.
       ``(10) The term `prior approval supplement' means a request 
     to the Secretary to approve a change in the drug substance, 
     drug product, production process, quality controls, 
     equipment, or facilities covered by an approved abbreviated 
     new drug application when that change has a substantial 
     potential to have an adverse effect on the identity, 
     strength, quality, purity, or potency of the drug product as 
     these factors may relate to the safety or effectiveness of 
     the drug product.
       ``(11) The term `resources allocated for human generic drug 
     activities' means the expenses for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers and employees and to contracts with such 
     contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under subsection (a) and accounting 
     for resources allocated for

[[Page S3573]]

     the review of abbreviated new drug applications and 
     supplements and inspection related to generic drugs.
       ``(12) The term `Type II active pharmaceutical ingredient 
     drug master file' means a submission of information to the 
     Secretary by a person that intends to authorize the Food and 
     Drug Administration to reference the information to support 
     approval of a generic drug submission without the submitter 
     having to disclose the information to the generic drug 
     submission applicant.

     ``SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) One-time backlog fee for abbreviated new drug 
     applications pending on october 1, 2012.--
       ``(A) In general.--Each person that owns an abbreviated new 
     drug application that is pending on October 1, 2012, and that 
     has not received a tentative approval prior to that date, 
     shall be subject to a fee for each such application, as 
     calculated under subparagraph (B).
       ``(B) Method of fee amount calculation.--The amount of each 
     one-time backlog fee shall be calculated by dividing 
     $50,000,000 by the total number of abbreviated new drug 
     applications pending on October 1, 2012, that have not 
     received a tentative approval as of that date.
       ``(C) Notice.--Not later than October 31, 2012, the 
     Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fee required by subparagraph 
     (A).
       ``(D) Fee due date.--The fee required by subparagraph (A) 
     shall be due no later than 30 calendar days after the date of 
     the publication of the notice specified in subparagraph (C).
       ``(2) Drug master file fee.--
       ``(A) In general.--Each person that owns a Type II active 
     pharmaceutical ingredient drug master file that is referenced 
     on or after October 1, 2012, in a generic drug submission by 
     any initial letter of authorization shall be subject to a 
     drug master file fee.
       ``(B) One-time payment.--If a person has paid a drug master 
     file fee for a Type II active pharmaceutical ingredient drug 
     master file, the person shall not be required to pay a 
     subsequent drug master file fee when that Type II active 
     pharmaceutical ingredient drug master file is subsequently 
     referenced in generic drug submissions.
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall publish in the Federal Register a notice 
     announcing the amount of the drug master file fee for fiscal 
     year 2013.
       ``(ii) Fiscal year 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall publish in the Federal Register the 
     amount of the drug master file fee established by this 
     paragraph for such fiscal year.
       ``(D) Availability for reference.--
       ``(i) In general.--Subject to subsection (g)(2)(C), for a 
     generic drug submission to reference a Type II active 
     pharmaceutical ingredient drug master file, the drug master 
     file must be deemed available for reference by the Secretary.
       ``(ii) Conditions.--A drug master file shall be deemed 
     available for reference by the Secretary if--

       ``(I) the person that owns a Type II active pharmaceutical 
     ingredient drug master file has paid the fee required under 
     subparagraph (A) within 20 calendar days after the applicable 
     due date under subparagraph (E); and
       ``(II) the drug master file has not failed an initial 
     completeness assessment by the Secretary, in accordance with 
     criteria to be published by the Secretary.

       ``(iii) List.--The Secretary shall make publicly available 
     on the Internet Web site of the Food and Drug Administration 
     a list of the drug master file numbers that correspond to 
     drug master files that have successfully undergone an initial 
     completeness assessment, in accordance with criteria to be 
     published by the Secretary, and are available for reference.
       ``(E) Fee due date.--
       ``(i) In general.--Subject to clause (ii), a drug master 
     file fee shall be due no later than the date on which the 
     first generic drug submission is submitted that references 
     the associated Type II active pharmaceutical ingredient drug 
     master file.
       ``(ii) Limitation.--No fee shall be due under subparagraph 
     (A) for a fiscal year until the later of--

       ``(I) 30 calendar days after publication of the notice 
     provided for in clause (i) or (ii) of subparagraph (C), as 
     applicable; or
       ``(II) 30 calendar days after the date of enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section.

       ``(3) Abbreviated new drug application and prior approval 
     supplement filing fee.--
       ``(A) In general.--Each applicant that submits, on or after 
     October 1, 2012, an abbreviated new drug application or a 
     prior approval supplement to an abbreviated new drug 
     application shall be subject to a fee for each such 
     submission in the amount established under subsection (d).
       ``(B) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fees under subparagraph (A) for 
     fiscal year 2013.
       ``(ii) Fiscal years 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall publish in the Federal Register the 
     amount of the fees under subparagraph (A) for such fiscal 
     year.
       ``(C) Fee due date.--
       ``(i) In general.--Except as provided in clause (ii), the 
     fees required by subparagraphs (A) and (F) shall be due no 
     later than the date of submission of the abbreviated new drug 
     application or prior approval supplement for which such fee 
     applies.
       ``(ii) Special rule for 2013.--For fiscal year 2013, such 
     fees shall be due on the later of--

       ``(I) the date on which the fee is due under clause (i);
       ``(II) 30 calendar days after publication of the notice 
     referred to in subparagraph (B)(i); or
       ``(III) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of submission of the application or prior 
     approval supplement for which the fees under subparagraphs 
     (A) and (F) apply, 30 calendar days after the date that such 
     an appropriations Act is enacted.

       ``(D) Refund of fee if abbreviated new drug application is 
     not considered to have been received.--The Secretary shall 
     refund 75 percent of the fee paid under subparagraph (A) for 
     any abbreviated new drug application or prior approval 
     supplement to an abbreviated new drug application that the 
     Secretary considers not to have been received within the 
     meaning of section 505(j)(5)(A) for a cause other than 
     failure to pay fees.
       ``(E) Fee for an application the secretary considers not to 
     have been received, or that has been withdrawn.--An 
     abbreviated new drug application or prior approval supplement 
     that was submitted on or after October 1, 2012, and that the 
     Secretary considers not to have been received, or that has 
     been withdrawn, shall, upon resubmission of the application 
     or a subsequent new submission following the applicant's 
     withdrawal of the application, be subject to a full fee under 
     subparagraph (A).
       ``(F) Additional fee for active pharmaceutical ingredient 
     information not included by reference to type ii active 
     pharmaceutical ingredient drug master file.--An applicant 
     that submits a generic drug submission on or after October 1, 
     2012, shall pay a fee, in the amount determined under 
     subsection (d)(3), in addition to the fee required under 
     subparagraph (A), if--
       ``(i) such submission contains information concerning the 
     manufacture of an active pharmaceutical ingredient at a 
     facility by means other than reference by a letter of 
     authorization to a Type II active pharmaceutical drug master 
     file; and
       ``(ii) a fee in the amount equal to the drug master file 
     fee established in paragraph (2) has not been previously paid 
     with respect to such information.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Facilities identified, or intended to be 
     identified, in at least one generic drug submission that is 
     pending or approved to produce a finished dosage form of a 
     human generic drug or an active pharmaceutical ingredient 
     contained in a human generic drug shall be subject to fees as 
     follows:
       ``(i) Generic drug facility.--Each person that owns a 
     facility which is identified or intended to be identified in 
     at least one generic drug submission that is pending or 
     approved to produce one or more finished dosage forms of a 
     human generic drug shall be assessed an annual fee for each 
     such facility.
       ``(ii) Active pharmaceutical ingredient facility.--Each 
     person that owns a facility which produces, or which is 
     pending review to produce, one or more active pharmaceutical 
     ingredients identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     or in a Type II active pharmaceutical ingredient drug master 
     file referenced in such a generic drug submission, shall be 
     assessed an annual fee for each such facility.
       ``(iii) Facilities producing both active pharmaceutical 
     ingredients and finished dosage forms.--Each person that owns 
     a facility identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     to produce both one or more finished dosage forms subject to 
     clause (i) and one or more active pharmaceutical ingredients 
     subject to clause (ii) shall be subject to fees under both 
     such clauses for that facility.
       ``(B) Amount.--The amount of fees established under 
     subparagraph (A) shall be established under subsection (d).
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the 
     Secretary shall publish in the Federal Register a notice 
     announcing the amount of the fees provided for in 
     subparagraph (A) within the timeframe specified in subsection 
     (d)(1)(B).
       ``(ii) Fiscal years 2014 through 2017.--Within the 
     timeframe specified in subsection (d)(2), the Secretary shall 
     publish in the Federal Register the amount of the fees under 
     subparagraph (A) for such fiscal year.
       ``(D) Fee due date.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the fees 
     under subparagraph (A) shall be due on the later of--

       ``(I) not later than 45 days after the publication of the 
     notice under subparagraph (B); or

[[Page S3574]]

       ``(II) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of the publication of such notice, 30 days after 
     the date that such an appropriations Act is enacted.

       ``(ii) Fiscal years 2014 through 2017.--For each of fiscal 
     years 2014 through 2017, the fees under subparagraph (A) for 
     such fiscal year shall be due on the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section for such year.

       ``(5) Date of submission.--For purposes of this Act, a 
     generic drug submission or Type II pharmaceutical master file 
     is deemed to be `submitted' to the Food and Drug 
     Administration--
       ``(A) if it is submitted via a Food and Drug Administration 
     electronic gateway, on the day when transmission to that 
     electronic gateway is completed, except that a submission or 
     master file that arrives on a weekend, Federal holiday, or 
     day when the Food and Drug Administration office that will 
     review that submission is not otherwise open for business 
     shall be deemed to be submitted on the next day when that 
     office is open for business; or
       ``(B) if it is submitted in physical media form, on the day 
     it arrives at the appropriate designated document room of the 
     Food and Drug Administration.
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--
       ``(A) Fiscal year 2013.--For fiscal year 2013, fees under 
     subsection (a) shall be established to generate a total 
     estimated revenue amount under such subsection of 
     $299,000,000. Of that amount--
       ``(i) $50,000,000 shall be generated by the one-time 
     backlog fee for generic drug applications pending on October 
     1, 2012, established in subsection (a)(1); and
       ``(ii) $249,000,000 shall be generated by the fees under 
     paragraphs (2) through (4) of subsection (a).
       ``(B) Fiscal years 2014 through 2017.--For each of the 
     fiscal years 2014 through 2017, fees under paragraphs (2) 
     through (4) of subsection (a) shall be established to 
     generate a total estimated revenue amount under such 
     subsection that is equal to $299,000,000, as adjusted 
     pursuant to subsection (c).
       ``(2) Types of fees.--In establishing fees under paragraph 
     (1) to generate the revenue amounts specified in paragraph 
     (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each 
     of fiscal years 2014 through 2017, such fees shall be derived 
     from the fees under paragraphs (2) through (4) of subsection 
     (a) as follows:
       ``(A) 6 percent shall be derived from fees under subsection 
     (a)(2) (relating to drug master files).
       ``(B) 24 percent shall be derived from fees under 
     subsection (a)(3) (relating to abbreviated new drug 
     applications and supplements). The amount of a fee for a 
     prior approval supplement shall be half the amount of the fee 
     for an abbreviated new drug application.
       ``(C) 56 percent shall be derived from fees under 
     subsection (a)(4)(A)(i) (relating to generic drug 
     facilities). The amount of the fee for a facility located 
     outside the United States and its territories and possessions 
     shall be not less than $15,000 and not more than $30,000 
     higher than the amount of the fee for a facility located in 
     the United States and its territories and possessions, as 
     determined by the Secretary on the basis of data concerning 
     the difference in cost between inspections of facilities 
     located in the United States, including its territories and 
     possessions, and those located outside of the United States 
     and its territories and possessions.
       ``(D) 14 percent shall be derived from fees under 
     subsection (a)(4)(A)(ii) (relating to active pharmaceutical 
     ingredient facilities). The amount of the fee for a facility 
     located outside the United States and its territories and 
     possessions shall be not less than $15,000 and not more than 
     $30,000 higher than the amount of the fee for a facility 
     located in the United States, including its territories and 
     possessions, as determined by the Secretary on the basis of 
     data concerning the difference in cost between inspections of 
     facilities located in the United States and its territories 
     and possessions and those located outside of the United 
     States and its territories and possessions.
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year, by an 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent change in the cost, per 
     full-time equivalent position of the Food and Drug 
     Administration, of all personnel compensation and benefits 
     paid with respect to such positions for the first 3 years of 
     the preceding 4 fiscal years multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     human generic drug activities for the first 3 years of the 
     preceding 4 fiscal years; and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of human generic drug activities for the first 3 years 
     of the preceding 4 fiscal years.

     The adjustment made each fiscal year under this subsection 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this subsection.
       ``(2) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under paragraph 
     (1), further increase the fee revenues and fees established 
     in subsection (b) if such an adjustment is necessary to 
     provide for not more than 3 months of operating reserves of 
     carryover user fees for human generic drug activities for the 
     first 3 months of fiscal year 2018. Such fees may only be 
     used in fiscal year 2018. If such an adjustment is necessary, 
     the rationale for the amount of the increase shall be 
     contained in the annual notice establishing fee revenues and 
     fees for fiscal year 2017. If the Secretary has carryover 
     balances for such activities in excess of 3 months of such 
     operating reserves, the adjustment under this subparagraph 
     shall not be made.
       ``(d) Annual Fee Setting.--
       ``(1) Fiscal year 2013.--For fiscal year 2013--
       ``(A) the Secretary shall establish, by October 31, 2012, 
     the one-time generic drug backlog fee for generic drug 
     applications pending on October 1, 2012, the drug master file 
     fee, the abbreviated new drug application fee, and the prior 
     approval supplement fee under subsection (a), based on the 
     revenue amounts established under subsection (b); and
       ``(B) the Secretary shall establish, not later than 45 days 
     after the date to comply with the requirement for 
     identification of facilities in subsection (f)(2), the 
     generic drug facility fee and active pharmaceutical 
     ingredient facility fee under subsection (a) based on the 
     revenue amounts established under subsection (b).
       ``(2) Fiscal years 2014 through 2017.--Not more than 60 
     days before the first day of each of fiscal years 2014 
     through 2017, the Secretary shall establish the drug master 
     file fee, the abbreviated new drug application fee, the prior 
     approval supplement fee, the generic drug facility fee, and 
     the active pharmaceutical ingredient facility fee under 
     subsection (a) for such fiscal year, based on the revenue 
     amounts established under subsection (b) and the adjustments 
     provided under subsection (c).
       ``(3) Fee for active pharmaceutical ingredient information 
     not included by reference to type ii active pharmaceutical 
     ingredient drug master file.--In establishing the fees under 
     paragraphs (1) and (2), the amount of the fee under 
     subsection (a)(3)(F) shall be determined by multiplying--
       ``(A) the sum of--
       ``(i) the total number of such active pharmaceutical 
     ingredients in such submission; and
       ``(ii) for each such ingredient that is manufactured at 
     more than one such facility, the total number of such 
     additional facilities; and
       ``(B) the amount equal to the drug master file fee 
     established in subsection (a)(2) for such submission.
       ``(e) Limit.--The total amount of fees charged, as adjusted 
     under subsection (c), for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for human generic drug activities.
       ``(f) Identification of Facilities.--
       ``(1) Publication of notice; deadline for compliance.--Not 
     later than October 1, 2012, the Secretary shall publish in 
     the Federal Register a notice requiring each person that owns 
     a facility described in subsection (a)(4)(A), or a site or 
     organization required to be identified by paragraph (4), to 
     submit to the Secretary information on the identity of each 
     such facility, site, or organization. The notice required by 
     this paragraph shall specify the type of information to be 
     submitted and the means and format for submission of such 
     information.
       ``(2) Required submission of facility identification.--Each 
     person that owns a facility described in subsection (a)(4)(A) 
     or a site or organization required to be identified by 
     paragraph (4) shall submit to the Secretary the information 
     required under this subsection each year. Such information 
     shall--
       ``(A) for fiscal year 2013, be submitted not later than 60 
     days after the publication of the notice under paragraph (1); 
     and
       ``(B) for each subsequent fiscal year, be submitted, 
     updated, or reconfirmed on or before June 1 of the previous 
     year.
       ``(3) Contents of notice.--At a minimum, the submission 
     required by paragraph (2) shall include for each such 
     facility--
       ``(A) identification of a facility identified or intended 
     to be identified in an approved or pending generic drug 
     submission;
       ``(B) whether the facility manufactures active 
     pharmaceutical ingredients or finished dosage forms, or both;
       ``(C) whether or not the facility is located within the 
     United States and its territories and possessions;
       ``(D) whether the facility manufactures positron emission 
     tomography drugs solely, or in addition to other drugs; and
       ``(E) whether the facility manufactures drugs that are not 
     generic drugs.
       ``(4) Certain sites and organizations.--
       ``(A) In general.--Any person that owns or operates a site 
     or organization described in

[[Page S3575]]

     subparagraph (B) shall submit to the Secretary information 
     concerning the ownership, name, and address of the site or 
     organization.
       ``(B) Sites and organizations.--A site or organization is 
     described in this subparagraph if it is identified in a 
     generic drug submission and is--
       ``(i) a site in which a bioanalytical study is conducted;
       ``(ii) a clinical research organization;
       ``(iii) a contract analytical testing site; or
       ``(iv) a contract repackager site.
       ``(C) Notice.--The Secretary may, by notice published in 
     the Federal Register, specify the means and format for 
     submission of the information under subparagraph (A) and may 
     specify, as necessary for purposes of this section, any 
     additional information to be submitted.
       ``(D) Inspection authority.--The Secretary's inspection 
     authority under section 704(a)(1) shall extend to all such 
     sites and organizations.
       ``(g) Effect of Failure To Pay Fees.--
       ``(1) Generic drug backlog fee.--Failure to pay the fee 
     under subsection (a)(1) shall result in the Secretary placing 
     the person that owns the abbreviated new drug application 
     subject to that fee on an arrears list, such that no new 
     abbreviated new drug applications or supplement submitted on 
     or after October 1, 2012, from that person, or any affiliate 
     of that person, will be received within the meaning of 
     section 505(j)(5)(A) until such outstanding fee is paid.
       ``(2) Drug master file fee.--
       ``(A) Failure to pay the fee under subsection (a)(2) within 
     20 calendar days after the applicable due date under 
     subparagraph (E) of such subsection (as described in 
     subsection (a)(2)(D)(ii)(I)) shall result in the Type II 
     active pharmaceutical ingredient drug master file not being 
     deemed available for reference.
       ``(B)(i) Any generic drug submission submitted on or after 
     October 1, 2012, that references, by a letter of 
     authorization, a Type II active pharmaceutical ingredient 
     drug master file that has not been deemed available for 
     reference shall not be received within the meaning of section 
     505(j)(5)(A) unless the condition specified in clause (ii) is 
     met.
       ``(ii) The condition specified in this clause is that the 
     fee established under subsection (a)(2) has been paid within 
     20 calendar days of the Secretary providing the notification 
     to the sponsor of the abbreviated new drug application or 
     supplement of the failure of the owner of the Type II active 
     pharmaceutical ingredient drug master file to pay the drug 
     master file fee as specified in subparagraph (C).
       ``(C)(i) If an abbreviated new drug application or 
     supplement to an abbreviated new drug application references 
     a Type II active pharmaceutical ingredient drug master file 
     for which a fee under subsection (a)(2)(A) has not been paid 
     by the applicable date under subsection (a)(2)(E), the 
     Secretary shall notify the sponsor of the abbreviated new 
     drug application or supplement of the failure of the owner of 
     the Type II active pharmaceutical ingredient drug master file 
     to pay the applicable fee.
       ``(ii) If such fee is not paid within 20 calendar days of 
     the Secretary providing the notification, the abbreviated new 
     drug application or supplement to an abbreviated new drug 
     application shall not be received within the meaning of 
     505(j)(5)(A).
       ``(3) Abbreviated new drug application fee and prior 
     approval supplement fee.--Failure to pay a fee under 
     subparagraph (A) or (F) of subsection (a)(3) within 20 
     calendar days of the applicable due date under subparagraph 
     (C) of such subsection shall result in the abbreviated new 
     drug application or the prior approval supplement to an 
     abbreviated new drug application not being received within 
     the meaning of section 505(j)(5)(A) until such outstanding 
     fee is paid.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Failure to pay the fee under subsection 
     (a)(4) within 20 calendar days of the due date as specified 
     in subparagraph (D) of such subsection shall result in the 
     following:
       ``(i) The Secretary shall place the facility on a publicly 
     available arrears list, such that no new abbreviated new drug 
     application or supplement submitted on or after October 1, 
     2012, from the person that is responsible for paying such 
     fee, or any affiliate of that person, will be received within 
     the meaning of section 505(j)(5)(A).
       ``(ii) Any new generic drug submission submitted on or 
     after October 1, 2012, that references such a facility shall 
     not be received, within the meaning of section 505(j)(5)(A) 
     if the outstanding facility fee is not paid within 20 
     calendar days of the Secretary providing the notification to 
     the sponsor of the failure of the owner of the facility to 
     pay the facility fee under subsection (a)(4)(C).
       ``(iii) All drugs or active pharmaceutical ingredients 
     manufactured in such a facility or containing an ingredient 
     manufactured in such a facility shall be deemed misbranded 
     under section 502(aa).
       ``(B) Application of penalties.--The penalties under this 
     paragraph shall apply until the fee established by subsection 
     (a)(4) is paid or the facility is removed from all generic 
     drug submissions that refer to the facility.
       ``(C) Nonreceival for nonpayment.--
       ``(i) Notice.--If an abbreviated new drug application or 
     supplement to an abbreviated new drug application submitted 
     on or after October 1, 2012, references a facility for which 
     a facility fee has not been paid by the applicable date under 
     subsection (a)(4)(C), the Secretary shall notify the sponsor 
     of the generic drug submission of the failure of the owner of 
     the facility to pay the facility fee.
       ``(ii) Nonreceival.--If the facility fee is not paid within 
     20 calendar days of the Secretary providing the notification 
     under clause (i), the abbreviated new drug application or 
     supplement to an abbreviated new drug application shall not 
     be received within the meaning of section 505(j)(5)(A).
       ``(h) Limitations.--
       ``(1) In general.--Fees under subsection (a) shall be 
     refunded for a fiscal year beginning after fiscal year 2012, 
     unless appropriations for salaries and expenses of the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) are equal 
     to or greater than the amount of appropriations for the 
     salaries and expenses of the Food and Drug Administration for 
     the fiscal year 2009 (excluding the amount of fees 
     appropriated for such fiscal year) multiplied by the 
     adjustment factor (as defined in section 744A) applicable to 
     the fiscal year involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year and 
     if at a later date in such fiscal year the Secretary may 
     assess such fees, the Secretary may assess and collect such 
     fees, without any modification in the rate, for Type II 
     active pharmaceutical ingredient drug master files, 
     abbreviated new drug applications and prior approval 
     supplements, and generic drug facilities and active 
     pharmaceutical ingredient facilities at any time in such 
     fiscal year notwithstanding the provisions of subsection (a) 
     relating to the date fees are to be paid.
       ``(i) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts, subject to paragraph (2). Such fees are 
     authorized to remain available until expended. Such sums as 
     may be necessary may be transferred from the Food and Drug 
     Administration salaries and expenses appropriation account 
     without fiscal year limitation to such appropriation account 
     for salaries and expenses with such fiscal year limitation. 
     The sums transferred shall be available solely for human 
     generic drug activities.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--The fees authorized by this section--
       ``(i) subject to subparagraphs (C) and (D), shall be 
     collected and available in each fiscal year in an amount not 
     to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation for such fiscal year; 
     and
       ``(ii) shall be available for a fiscal year beginning after 
     fiscal year 2012 to defray the costs of human generic drug 
     activities (including such costs for an additional number of 
     full-time equivalent positions in the Department of Health 
     and Human Services to be engaged in such activities), only if 
     the Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $97,000,000 multiplied by the 
     adjustment factor, as defined in section 744A(3), applicable 
     to the fiscal year involved.
       ``(B) Compliance.--The Secretary shall be considered to 
     have met the requirements of subparagraph (A)(ii) in any 
     fiscal year if the costs funded by appropriations and 
     allocated for human generic activities are not more than 10 
     percent below the level specified in such subparagraph.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013 for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013, may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total revenue amount determined under subsection (b) 
     for the fiscal year, as adjusted under subsection (c), if 
     applicable, or as otherwise affected under paragraph (2) of 
     this subsection.
       ``(j) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 calendar days after it is due, such 
     fee shall be treated as a claim of the United States 
     Government subject to subchapter II of chapter 37 of title 
     31, United States Code.
       ``(k) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employees, and advisory committees not engaged in human 
     generic drug activities, be reduced to offset the number of 
     officers, employees, and advisory committees so engaged.

[[Page S3576]]

       ``(l) Positron Emission Tomography Drugs.--
       ``(1) Exemption from fees.--Submission of an application 
     for a positron emission tomography drug or active 
     pharmaceutical ingredient for a positron emission tomography 
     drug shall not require the payment of any fee under this 
     section. Facilities that solely produce positron emission 
     tomography drugs shall not be required to pay a facility fee 
     as established in subsection (a)(4).
       ``(2) Identification requirement.--Facilities that produce 
     positron emission tomography drugs or active pharmaceutical 
     ingredients of such drugs are required to be identified 
     pursuant to subsection (f).
       ``(m) Disputes Concerning Fees.--To qualify for the return 
     of a fee claimed to have been paid in error under this 
     section, a person shall submit to the Secretary a written 
     request justifying such return within 180 calendar days after 
     such fee was paid.
       ``(n) Substantially Complete Applications.--An abbreviated 
     new drug application that is not considered to be received 
     within the meaning of section 505(j)(5)(A) because of failure 
     to pay an applicable fee under this provision within the time 
     period specified in subsection (g) shall be deemed not to 
     have been `substantially complete' on the date of its 
     submission within the meaning of section 
     505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application 
     that is not substantially complete on the date of its 
     submission solely because of failure to pay an applicable fee 
     under the preceding sentence shall be deemed substantially 
     complete and received within the meaning of section 
     505(j)(5)(A) as of the date such applicable fee is 
     received.''.

     SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 7 of subchapter C of chapter VII, as added by section 
     302 of this Act, is amended by inserting after section 744B 
     the following:

     ``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 301(b) of the Generic Drug User Fee Amendments of 
     2012 during such fiscal year and the future plans of the Food 
     and Drug Administration for meeting the goals.
       ``(b) Fiscal Report.--Beginning with fiscal year 2013, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals, and plans 
     for meeting the goals, for human generic drug activities for 
     the first 5 fiscal years after fiscal year 2017, and for the 
     reauthorization of this part for such fiscal years, the 
     Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the generic drug industry.
       ``(2) Prior public input.--Prior to beginning negotiations 
     with the generic drug industry on the reauthorization of this 
     part, the Secretary shall--
       ``(A) publish a notice in the Federal Register requesting 
     public input on the reauthorization;
       ``(B) hold a public meeting at which the public may present 
     its views on the reauthorization, including specific 
     suggestions for changes to the goals referred to in 
     subsection (a);
       ``(C) provide a period of 30 days after the public meeting 
     to obtain written comments from the public suggesting changes 
     to this part; and
       ``(D) publish the comments on the Food and Drug 
     Administration's Internet Web site.
       ``(3) Periodic consultation.--Not less frequently than once 
     every month during negotiations with the generic drug 
     industry, the Secretary shall hold discussions with 
     representatives of patient and consumer advocacy groups to 
     continue discussions of their views on the reauthorization 
     and their suggestions for changes to this part as expressed 
     under paragraph (2).
       ``(4) Public review of recommendations.--After negotiations 
     with the generic drug industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(5) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (4), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.
       ``(6) Minutes of negotiation meetings.--
       ``(A) Public availability.--Before presenting the 
     recommendations developed under paragraphs (1) through (5) to 
     the Congress, the Secretary shall make publicly available, on 
     the Internet Web site of the Food and Drug Administration, 
     minutes of all negotiation meetings conducted under this 
     subsection between the Food and Drug Administration and the 
     generic drug industry.
       ``(B) Content.--The minutes described under subparagraph 
     (A) shall summarize any substantive proposal made by any 
     party to the negotiations as well as significant 
     controversies or differences of opinion during the 
     negotiations and their resolution.''.

     SEC. 304. SUNSET DATES.

       (a) Authorization.--The amendments made by section 302 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--The amendments made by section 
     303 cease to be effective January 31, 2018.

     SEC. 305. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this title, 
     whichever is later, except that fees under section 302 shall 
     be assessed for all human generic drug submissions and Type 
     II active pharmaceutical drug master files received on or 
     after October 1, 2012, regardless of the date of enactment of 
     this title.

     SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

       Section 502 (21 U.S.C. 352) is amended by adding at the end 
     the following:
       ``(aa) If it is a drug, or an active pharmaceutical 
     ingredient, and it was manufactured, prepared, propagated, 
     compounded, or processed in a facility for which fees have 
     not been paid as required by section 744A(a)(4) or for which 
     identifying information required by section 744B(f) has not 
     been submitted, or it contains an active pharmaceutical 
     ingredient that was manufactured, prepared, propagated, 
     compounded, or processed in such a facility.''.

     SEC. 307. STREAMLINED HIRING AUTHORITY OF THE FOOD AND DRUG 
                   ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO 
                   HUMAN GENERIC DRUGS.

       Section 714 of the Federal Food, Drug, and Cosmetic Act, as 
     added by section 208, is amended--
       (1) in subsection (b)--
       (A) by striking ``are activities'' and inserting ``are--
       ``(1) activities'';
       (B) by striking the period at the end and inserting ``; 
     and''; and
       (C) by adding at the end the following:
       ``(2) activities under this Act related to human generic 
     drug activities (as defined in section 744A).''; and
       (2) by amending subsection (c) to read as follows:
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are--
       ``(1) with respect to the activities under subsection 
     (b)(1), the goals referred to in section 738A(a)(1); and
       ``(2) with respect to the activities under subsection 
     (b)(2), the performance goals with respect to section 744A 
     (regarding assessment and use of human generic drug fees), as 
     set forth in the letters described in section 301(b) of the 
     Generic Drug User Fee Amendments of 2012.''.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     SEC. 401. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Biosimilar User Fee Act of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to 
     expediting the process for the review of biosimilar 
     biological product applications, including postmarket safety 
     activities, as set forth in the goals identified for purposes 
     of part 8 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act, in the letters from the Secretary of 
     Health and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record.

     SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

       Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
     amended by inserting after part 7, as added by title III of 
     this Act, the following:

[[Page S3577]]

       ``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     ``SEC. 744G. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `adjustment factor' applicable to a fiscal 
     year that is the Consumer Price Index for all urban consumers 
     (Washington-Baltimore, DC MD VA WV; Not Seasonally Adjusted; 
     All items) of the preceding fiscal year divided by such Index 
     for September 2011.
       ``(2) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(3) The term `biosimilar biological product' means a 
     product for which a biosimilar biological product application 
     has been approved.
       ``(4)(A) Subject to subparagraph (B), the term `biosimilar 
     biological product application' means an application for 
     licensure of a biological product under section 351(k) of the 
     Public Health Service Act.
       ``(B) Such term does not include--
       ``(i) a supplement to such an application;
       ``(ii) an application filed under section 351(k) of the 
     Public Health Service Act that cites as the reference product 
     a bovine blood product for topical application licensed 
     before September 1, 1992, or a large volume parenteral drug 
     product approved before such date;
       ``(iii) an application filed under section 351(k) of the 
     Public Health Service Act with respect to--
       ``(I) whole blood or a blood component for transfusion;
       ``(II) an allergenic extract product;
       ``(III) an in vitro diagnostic biological product; or
       ``(IV) a biological product for further manufacturing use 
     only; or
       ``(iv) an application for licensure under section 351(k) of 
     the Public Health Service Act that is submitted by a State or 
     Federal Government entity for a product that is not 
     distributed commercially.
       ``(5) The term `biosimilar biological product development 
     meeting' means any meeting, other than a biosimilar initial 
     advisory meeting, regarding the content of a development 
     program, including a proposed design for, or data from, a 
     study intended to support a biosimilar biological product 
     application.
       ``(6) The term `biosimilar biological product development 
     program' means the program under this part for expediting the 
     process for the review of submissions in connection with 
     biosimilar biological product development.
       ``(7)(A) The term `biosimilar biological product 
     establishment' means a foreign or domestic place of 
     business--
       ``(i) that is at one general physical location consisting 
     of one or more buildings, all of which are within five miles 
     of each other; and
       ``(ii) at which one or more biosimilar biological products 
     are manufactured in final dosage form.
       ``(B) For purposes of subparagraph (A)(ii), the term 
     `manufactured' does not include packaging.
       ``(8) The term `biosimilar initial advisory meeting'--
       ``(A) means a meeting, if requested, that is limited to--
       ``(i) a general discussion regarding whether licensure 
     under section 351(k) of the Public Health Service Act may be 
     feasible for a particular product; and
       ``(ii) if so, general advice on the expected content of the 
     development program; and
       ``(B) does not include any meeting that involves 
     substantive review of summary data or full study reports.
       ``(9) The term `costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications' means the expenses in connection with the 
     process for the review of biosimilar biological product 
     applications for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers employees and committees and to contracts with 
     such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies; and
       ``(D) collecting fees under section 744H and accounting for 
     resources allocated for the review of submissions in 
     connection with biosimilar biological product development, 
     biosimilar biological product applications, and supplements.
       ``(10) The term `final dosage form' means, with respect to 
     a biosimilar biological product, a finished dosage form which 
     is approved for administration to a patient without 
     substantial further manufacturing (such as lyophilized 
     products before reconstitution).
       ``(11) The term `financial hold'--
       ``(A) means an order issued by the Secretary to prohibit 
     the sponsor of a clinical investigation from continuing the 
     investigation if the Secretary determines that the 
     investigation is intended to support a biosimilar biological 
     product application and the sponsor has failed to pay any fee 
     for the product required under subparagraph (A), (B), or (D) 
     of section 744H(a)(1); and
       ``(B) does not mean that any of the bases for a `clinical 
     hold' under section 505(i)(3) have been determined by the 
     Secretary to exist concerning the investigation.
       ``(12) The term `person' includes an affiliate of such 
     person.
       ``(13) The term `process for the review of biosimilar 
     biological product applications' means the following 
     activities of the Secretary with respect to the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements:
       ``(A) The activities necessary for the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements.
       ``(B) Actions related to submissions in connection with 
     biosimilar biological product development, the issuance of 
     action letters which approve biosimilar biological product 
     applications or which set forth in detail the specific 
     deficiencies in such applications, and where appropriate, the 
     actions necessary to place such applications in condition for 
     approval.
       ``(C) The inspection of biosimilar biological product 
     establishments and other facilities undertaken as part of the 
     Secretary's review of pending biosimilar biological product 
     applications and supplements.
       ``(D) Activities necessary for the release of lots of 
     biosimilar biological products under section 351(k) of the 
     Public Health Service Act.
       ``(E) Monitoring of research conducted in connection with 
     the review of biosimilar biological product applications.
       ``(F) Postmarket safety activities with respect to 
     biologics approved under biosimilar biological product 
     applications or supplements, including the following 
     activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on biosimilar biological products, including 
     adverse-event reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies).
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(14) The term `supplement' means a request to the 
     Secretary to approve a change in a biosimilar biological 
     product application which has been approved, including a 
     supplement requesting that the Secretary determine that the 
     biosimilar biological product meets the standards for 
     interchangeability described in section 351(k)(4) of the 
     Public Health Service Act.

     ``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
                   BIOLOGICAL PRODUCT FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Biosimilar development program fees.--
       ``(A) Initial biosimilar biological product development 
     fee.--
       ``(i) In general.--Each person that submits to the 
     Secretary a meeting request described under clause (ii) or a 
     clinical protocol for an investigational new drug protocol 
     described under clause (iii) shall pay for the product named 
     in the meeting request or the investigational new drug 
     application the initial biosimilar biological product 
     development fee established under subsection (b)(1)(A).
       ``(ii) Meeting request.--The meeting request described in 
     this clause is a request for a biosimilar biological product 
     development meeting for a product.
       ``(iii) Clinical protocol for ind.--A clinical protocol for 
     an investigational new drug protocol described in this clause 
     is a clinical protocol consistent with the provisions of 
     section 505(i), including any regulations promulgated under 
     section 505(i), (referred to in this section as 
     `investigational new drug application') describing an 
     investigation that the Secretary determines is intended to 
     support a biosimilar biological product application for a 
     product.
       ``(iv) Due date.--The initial biosimilar biological product 
     development fee shall be due by the earlier of the following:

       ``(I) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.
       ``(II) The date of submission of an investigational new 
     drug application describing an investigation that the 
     Secretary determines is intended to support a biosimilar 
     biological product application.

       ``(v) Transition rule.--Each person that has submitted an 
     investigational new drug application prior to the date of 
     enactment of the Biosimilars User Fee Act of 2012 shall pay 
     the initial biosimilar biological product development fee by 
     the earlier of the following:

       ``(I) Not later than 60 days after the date of the 
     enactment of the Biosimilars User Fee Act of 2012, if the 
     Secretary determines that the investigational new drug 
     application describes an investigation that is intended to

[[Page S3578]]

     support a biosimilar biological product application.
       ``(II) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.

       ``(B) Annual biosimilar biological product development 
     fee.--
       ``(i) In general.--A person that pays an initial biosimilar 
     biological product development fee for a product shall pay 
     for such product, beginning in the fiscal year following the 
     fiscal year in which the initial biosimilar biological 
     product development fee was paid, an annual fee established 
     under subsection (b)(1)(B) for biosimilar biological product 
     development (referred to in this section as `annual 
     biosimilar biological product development fee').
       ``(ii) Due date.--The annual biosimilar biological product 
     development program fee for each fiscal year will be due on 
     the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.

       ``(iii) Exception.--The annual biosimilar development 
     program fee for each fiscal year will be due on the date 
     specified in clause (ii), unless the person has--

       ``(I) submitted a marketing application for the biological 
     product that was accepted for filing; or
       ``(II) discontinued participation in the biosimilar 
     biological product development program for the product under 
     subparagraph (C).

       ``(C) Discontinuation of fee obligation.--A person may 
     discontinue participation in the biosimilar biological 
     product development program for a product effective October 1 
     of a fiscal year by, not later than August 1 of the preceding 
     fiscal year--
       ``(i) if no investigational new drug application concerning 
     the product has been submitted, submitting to the Secretary a 
     written declaration that the person has no present intention 
     of further developing the product as a biosimilar biological 
     product; or
       ``(ii) if an investigational new drug application 
     concerning the product has been submitted, by withdrawing the 
     investigational new drug application in accordance with part 
     312 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       ``(D) Reactivation fee.--
       ``(i) In general.--A person that has discontinued 
     participation in the biosimilar biological product 
     development program for a product under subparagraph (C) 
     shall pay a fee (referred to in this section as `reactivation 
     fee') by the earlier of the following:

       ``(I) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting for the product (after the date on which such 
     participation was discontinued).
       ``(II) Upon the date of submission (after the date on which 
     such participation was discontinued) of an investigational 
     new drug application describing an investigation that the 
     Secretary determines is intended to support a biosimilar 
     biological product application for that product.

       ``(ii) Application of annual fee.--A person that pays a 
     reactivation fee for a product shall pay for such product, 
     beginning in the next fiscal year, the annual biosimilar 
     biological product development fee under subparagraph (B).
       ``(E) Effect of failure to pay biosimilar development 
     program fees.--
       ``(i) No biosimilar biological product development 
     meetings.--If a person has failed to pay an initial or annual 
     biosimilar biological product development fee as required 
     under subparagraph (A) or (B), or a reactivation fee as 
     required under subparagraph (D), the Secretary shall not 
     provide a biosimilar biological product development meeting 
     relating to the product for which fees are owed.
       ``(ii) No receipt of investigational new drug 
     applications.--Except in extraordinary circumstances, the 
     Secretary shall not consider an investigational new drug 
     application to have been received under section 505(i)(2) 
     if--

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and
       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee as required under subparagraph (D).

       ``(iii) Financial hold.--Notwithstanding section 505(i)(2), 
     except in extraordinary circumstances, the Secretary shall 
     prohibit the sponsor of a clinical investigation from 
     continuing the investigation if--

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and
       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee for the product as required under subparagraph (D).

       ``(iv) No acceptance of biosimilar biological product 
     applications or supplements.--If a person has failed to pay 
     an initial or annual biosimilar biological product 
     development fee as required under subparagraph (A) or (B), or 
     a reactivation fee as required under subparagraph (D), any 
     biosimilar biological product application or supplement 
     submitted by that person shall be considered incomplete and 
     shall not be accepted for filing by the Secretary until all 
     such fees owed by such person have been paid.
       ``(F) Limits regarding biosimilar development program 
     fees.--
       ``(i) No refunds.--The Secretary shall not refund any 
     initial or annual biosimilar biological product development 
     fee paid under subparagraph (A) or (B), or any reactivation 
     fee paid under subparagraph (D).
       ``(ii) No waivers, exemptions, or reductions.--The 
     Secretary shall not grant a waiver, exemption, or reduction 
     of any initial or annual biosimilar biological product 
     development fee due or payable under subparagraph (A) or (B), 
     or any reactivation fee due or payable under subparagraph 
     (D).
       ``(2) Biosimilar biological product application and 
     supplement fee.--
       ``(A) In general.--Each person that submits, on or after 
     October 1, 2012, a biosimilar biological product application 
     or a supplement shall be subject to the following fees:
       ``(i) A fee for a biosimilar biological product application 
     that is equal to--

       ``(I) the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application; 
     minus
       ``(II) the cumulative amount of fees paid, if any, under 
     subparagraphs (A), (B), and (D) of paragraph (1) for the 
     product that is the subject of the application.

       ``(ii) A fee for a biosimilar biological product 
     application for which clinical data (other than comparative 
     bioavailability studies) with respect to safety or 
     effectiveness are not required, that is equal to--

       ``(I) half of the amount of the fee established under 
     subsection (b)(1)(D) for a biosimilar biological product 
     application; minus
       ``(II) the cumulative amount of fees paid, if any, under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.

       ``(iii) A fee for a supplement for which clinical data 
     (other than comparative bioavailability studies) with respect 
     to safety or effectiveness are required, that is equal to 
     half of the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application.
       ``(B) Reduction in fees.--Notwithstanding section 404 of 
     the Biosimilars User Fee Act of 2012, any person who pays a 
     fee under subparagraph (A), (B), or (D) of paragraph (1) for 
     a product before October 1, 2017, but submits a biosimilar 
     biological product application for that product after such 
     date, shall be entitled to the reduction of any biosimilar 
     biological product application fees that may be assessed at 
     the time when such biosimilar biological product application 
     is submitted, by the cumulative amount of fees paid under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.
       ``(C) Payment due date.--Any fee required by subparagraph 
     (A) shall be due upon submission of the application or 
     supplement for which such fee applies.
       ``(D) Exception for previously filed application or 
     supplement.--If a biosimilar biological product application 
     or supplement was submitted by a person that paid the fee for 
     such application or supplement, was accepted for filing, and 
     was not approved or was withdrawn (without a waiver), the 
     submission of a biosimilar biological product application or 
     a supplement for the same product by the same person (or the 
     person's licensee, assignee, or successor) shall not be 
     subject to a fee under subparagraph (A).
       ``(E) Refund of application fee if application refused for 
     filing or withdrawn before filing.--The Secretary shall 
     refund 75 percent of the fee paid under this paragraph for 
     any application or supplement which is refused for filing or 
     withdrawn without a waiver before filing.
       ``(F) Fees for applications previously refused for filing 
     or withdrawn before filing.--A biosimilar biological product 
     application or supplement that was submitted but was refused 
     for filing, or was withdrawn before being accepted or refused 
     for filing, shall be subject to the full fee under 
     subparagraph (A) upon being resubmitted or filed over 
     protest, unless the fee is waived under subsection (c).
       ``(3) Biosimilar biological product establishment fee.--
       ``(A) In general.--Except as provided in subparagraph (E), 
     each person that is named as the applicant in a biosimilar 
     biological product application shall be assessed an annual 
     fee established under subsection (b)(1)(E) for each 
     biosimilar biological product establishment that is listed in 
     the approved biosimilar biological product application as an 
     establishment that manufactures the biosimilar biological 
     product named in such application.
       ``(B) Assessment in fiscal years.--The establishment fee 
     shall be assessed in each fiscal year for which the 
     biosimilar biological product named in the application is 
     assessed a fee under paragraph (4) unless the biosimilar 
     biological product establishment listed in the application 
     does not engage in the manufacture of the biosimilar 
     biological product during such fiscal year.
       ``(C) Due date.--The establishment fee for a fiscal year 
     shall be due on the later of--
       ``(i) the first business day on or after October 1 of such 
     fiscal year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such fiscal year under this section.
       ``(D) Application to establishment.--
       ``(i) Each biosimilar biological product establishment 
     shall be assessed only one fee

[[Page S3579]]

     per biosimilar biological product establishment, 
     notwithstanding the number of biosimilar biological products 
     manufactured at the establishment, subject to clause (ii).
       ``(ii) In the event an establishment is listed in a 
     biosimilar biological product application by more than one 
     applicant, the establishment fee for the fiscal year shall be 
     divided equally and assessed among the applicants whose 
     biosimilar biological products are manufactured by the 
     establishment during the fiscal year and assessed biosimilar 
     biological product fees under paragraph (4).
       ``(E) Exception for new products.--If, during the fiscal 
     year, an applicant initiates or causes to be initiated the 
     manufacture of a biosimilar biological product at an 
     establishment listed in its biosimilar biological product 
     application--
       ``(i) that did not manufacture the biosimilar biological 
     product in the previous fiscal year; and
       ``(ii) for which the full biosimilar biological product 
     establishment fee has been assessed in the fiscal year at a 
     time before manufacture of the biosimilar biological product 
     was begun,
     the applicant shall not be assessed a share of the biosimilar 
     biological product establishment fee for the fiscal year in 
     which the manufacture of the product began.
       ``(4) Biosimilar biological product fee.--
       ``(A) In general.--Each person who is named as the 
     applicant in a biosimilar biological product application 
     shall pay for each such biosimilar biological product the 
     annual fee established under subsection (b)(1)(F).
       ``(B) Due date.--The biosimilar biological product fee for 
     a fiscal year shall be due on the later of--
       ``(i) the first business day on or after October 1 of each 
     such year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.
       ``(C) One fee per product per year.--The biosimilar 
     biological product fee shall be paid only once for each 
     product for each fiscal year.
       ``(b) Fee Setting and Amounts.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall, 60 days before the start of each fiscal year that 
     begins after September 30, 2012, establish, for the next 
     fiscal year, the fees under subsection (a). Except as 
     provided in subsection (c), such fees shall be in the 
     following amounts:
       ``(A) Initial biosimilar biological product development 
     fee.--The initial biosimilar biological product development 
     fee under subsection (a)(1)(A) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(B) Annual biosimilar biological product development 
     fee.--The annual biosimilar biological product development 
     fee under subsection (a)(1)(B) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(C) Reactivation fee.--The reactivation fee under 
     subsection (a)(1)(D) for a fiscal year shall be equal to 20 
     percent of the amount of the fee established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(D) Biosimilar biological product application fee.--The 
     biosimilar biological product application fee under 
     subsection (a)(2) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a human drug 
     application described in section 736(a)(1)(A)(i) for that 
     fiscal year.
       ``(E) Biosimilar biological product establishment fee.--The 
     biosimilar biological product establishment fee under 
     subsection (a)(3) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a prescription 
     drug establishment for that fiscal year.
       ``(F) Biosimilar biological product fee.--The biosimilar 
     biological product fee under subsection (a)(4) for a fiscal 
     year shall be equal to the amount established under section 
     736(c)(4) for a prescription drug product for that fiscal 
     year.
       ``(2) Limit.--The total amount of fees charged for a fiscal 
     year under this section may not exceed the total amount for 
     such fiscal year of the costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications.
       ``(c) Application Fee Waiver for Small Business.--
       ``(1) Waiver of application fee.--The Secretary shall grant 
     to a person who is named in a biosimilar biological product 
     application a waiver from the application fee assessed to 
     that person under subsection (a)(2)(A) for the first 
     biosimilar biological product application that a small 
     business or its affiliate submits to the Secretary for 
     review. After a small business or its affiliate is granted 
     such a waiver, the small business or its affiliate shall 
     pay--
       ``(A) application fees for all subsequent biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business; and
       ``(B) all supplement fees for all supplements to biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business.
       ``(2) Considerations.--In determining whether to grant a 
     waiver of a fee under paragraph (1), the Secretary shall 
     consider only the circumstances and assets of the applicant 
     involved and any affiliate of the applicant.
       ``(3) Small business defined.--In this subsection, the term 
     `small business' means an entity that has fewer than 500 
     employees, including employees of affiliates, and does not 
     have a drug product that has been approved under a human drug 
     application (as defined in section 735) or a biosimilar 
     biological product application (as defined in section 
     744G(4)) and introduced or delivered for introduction into 
     interstate commerce.
       ``(d) Effect of Failure To Pay Fees.--A biosimilar 
     biological product application or supplement submitted by a 
     person subject to fees under subsection (a) shall be 
     considered incomplete and shall not be accepted for filing by 
     the Secretary until all fees owed by such person have been 
     paid.
       ``(e) Crediting and Availability of Fees.--
       ``(1) In general.--Subject to paragraph (2), fees 
     authorized under subsection (a) shall be collected and 
     available for obligation only to the extent and in the amount 
     provided in advance in appropriations Acts. Such fees are 
     authorized to remain available until expended. Such sums as 
     may be necessary may be transferred from the Food and Drug 
     Administration salaries and expenses appropriation account 
     without fiscal year limitation to such appropriation account 
     for salaries and expenses with such fiscal year limitation. 
     The sums transferred shall be available solely for the 
     process for the review of biosimilar biological product 
     applications.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--Subject to subparagraphs (C) and (D), 
     the fees authorized by this section shall be collected and 
     available in each fiscal year in an amount not to exceed the 
     amount specified in appropriation Acts, or otherwise made 
     available for obligation for such fiscal year.
       ``(B) Use of fees and limitation.--The fees authorized by 
     this section shall be available for a fiscal year beginning 
     after fiscal year 2012 to defray the costs of the process for 
     the review of biosimilar biological product applications 
     (including such costs for an additional number of full-time 
     equivalent positions in the Department of Health and Human 
     Services to be engaged in such process), only if the 
     Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $20,000,000, multiplied by the 
     adjustment factor applicable to the fiscal year involved.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013, for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013 may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total amount of fees assessed for such fiscal year 
     under this section.
       ``(f) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(g) Written Requests for Waivers and Refunds.--To qualify 
     for consideration for a waiver under subsection (c), or for a 
     refund of any fee collected in accordance with subsection 
     (a)(2)(A), a person shall submit to the Secretary a written 
     request for such waiver or refund not later than 180 days 
     after such fee is due.
       ``(h) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employers, and advisory committees not engaged in the process 
     of the review of biosimilar biological product applications, 
     be reduced to offset the number of officers, employees, and 
     advisory committees so engaged.''.

     SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 8 of subchapter C of chapter VII, as added by section 
     402, is further amended by inserting after section 744H the 
     following:

     ``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 401(b) of the Biosimilar User Fee Act of 2012 during 
     such fiscal year

[[Page S3580]]

     and the future plans of the Food and Drug Administration for 
     meeting such goals. The report for a fiscal year shall 
     include information on all previous cohorts for which the 
     Secretary has not given a complete response on all biosimilar 
     biological product applications and supplements in the 
     cohort.
       ``(b) Fiscal Report.--Not later than 120 days after the end 
     of fiscal year 2013 and each subsequent fiscal year for which 
     fees are collected under this part, the Secretary shall 
     prepare and submit to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       ``(c) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Study.--
       ``(1) In general.--The Secretary shall contract with an 
     independent accounting or consulting firm to study the 
     workload volume and full costs associated with the process 
     for the review of biosimilar biological product applications.
       ``(2) Interim results.--Not later than June 1, 2015, the 
     Secretary shall publish, for public comment, interim results 
     of the study described under paragraph (1).
       ``(3) Final results.--Not later than September 30, 2016, 
     the Secretary shall publish, for public comment, the final 
     results of the study described under paragraph (1).
       ``(e) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals described 
     in subsection (a), and plans for meeting the goals, for the 
     process for the review of biosimilar biological product 
     applications for the first 5 fiscal years after fiscal year 
     2017, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (2), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.''.

     SEC. 404. SUNSET DATES.

       (a) Authorization.--The amendment made by section 402 shall 
     cease to be effective October 1, 2017.
       (b) Reporting Requirements.--The amendment made by section 
     403 shall cease to be effective January 31, 2018.

     SEC. 405. EFFECTIVE DATE.

       (a) In General.--Except as provided under subsection (b), 
     the amendments made by this title shall take effect on the 
     later of--
       (1) October 1, 2012; or
       (2) the date of the enactment of this title.
       (b) Exception.--Fees under part 8 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act, as 
     added by this title, shall be assessed for all biosimilar 
     biological product applications received on or after October 
     1, 2012, regardless of the date of the enactment of this 
     title.

     SEC. 406. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 2 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act, as in effect on the day before the date of the 
     enactment of this title, shall continue to be in effect with 
     respect to human drug applications and supplements (as 
     defined in such part as of such day) that were accepted by 
     the Food and Drug Administration for filing on or after 
     October 1, 2007, but before October 1, 2012, with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2013.

     SEC. 407. CONFORMING AMENDMENT.

       Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by 
     striking ``or (k)''.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

     SEC. 501. PERMANENCE.

       (a) Pediatric Studies of Drugs.--Subsection (q) of section 
     505A (21 U.S.C. 355a) is amended--
       (1) in the subsection heading, by striking ``Sunset'' and 
     inserting ``Permanence'';
       (2) in paragraph (1), by striking ``on or before October 1, 
     2012,''; and
       (3) in paragraph (2), by striking ``on or before October 1, 
     2012,''.
       (b) Research Into Pediatric Uses for Drugs and Biological 
     Products.--Section 505B (21 U.S.C. 355c) is amended--
       (1) by striking subsection (m); and
       (2) by redesignating subsection (n) as subsection (m).

     SEC. 502. WRITTEN REQUESTS.

       (a) Federal Food, Drug, and Cosmetic Act.--Subsection (h) 
     of section 505A (21 U.S.C. 355a) is amended to read as 
     follows:
       ``(h) Relationship to Pediatric Research Requirements.--
     Exclusivity under this section shall only be granted for the 
     completion of a study or studies that are the subject of a 
     written request and for which reports are submitted and 
     accepted in accordance with subsection (d)(3). Written 
     requests under this section may consist of a study or studies 
     required under section 505B.''.
       (b) Public Health Service Act.--Section 351(m)(1) of the 
     Public Health Service Act (42 U.S.C. 262(m)(1)) is amended by 
     striking ``(f), (i), (j), (k), (l), (p), and (q)'' and 
     inserting ``(f), (h), (i), (j), (k), (l), (n), and (p)''.

     SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

       Not later than 1 year after the date of enactment of this 
     Act, the Secretary of Health and Human Services (referred to 
     in this title as the ``Secretary'') shall issue internal 
     standard operating procedures that provide for the review by 
     the internal review committee established under section 505C 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) 
     of any significant modifications to initial pediatric study 
     plans, agreed initial pediatric study plans, and written 
     requests under sections 505A and 505B of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355c). Such internal 
     standard operating procedures shall be made publicly 
     available on the Internet website of the Food and Drug 
     Administration.

     SEC. 504. ACCESS TO DATA.

       Not later than 3 years after the date of enactment of this 
     Act, the Secretary shall make available to the public, 
     including through posting on the Internet website of the Food 
     and Drug Administration, the medical, statistical, and 
     clinical pharmacology reviews of, and corresponding written 
     requests issued to an applicant, sponsor, or holder for, 
     pediatric studies submitted between January 4, 2002 and 
     September 27, 2007 under subsection (b) or (c) of section 
     505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a) for which 6 months of market exclusivity was granted 
     and that resulted in a labeling change. The Secretary shall 
     make public the information described in the preceding 
     sentence in a manner consistent with how the Secretary 
     releases information under section 505A(k) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).

     SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.

       (a) Extension of Deadline for Deferred Studies.--Section 
     505B (21 U.S.C. 355c) is amended--
       (1) in subsection (a)(3)--
       (A) by redesignating subparagraph (B) as subparagraph (C);
       (B) by inserting after subparagraph (A) the following:
       ``(B) Deferral extension.--
       ``(i) In general.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may grant an 
     extension of a deferral approved under subparagraph (A) for 
     submission of some or all assessments required under 
     paragraph (1) if--

       ``(I) the Secretary determines that the conditions 
     described in subclause (II) or (III) of subparagraph (A)(i) 
     continue to be met; and
       ``(II) the applicant submits a new timeline under 
     subparagraph (A)(ii)(IV) and any significant updates to the 
     information required under subparagraph (A)(ii).

       ``(ii) Timing and information.--If the deferral extension 
     under this subparagraph is requested by the applicant, the 
     applicant shall submit the deferral extension request 
     containing the information described in this subparagraph not 
     less than 90 days prior to the date that the deferral would 
     expire. The Secretary shall respond to such request not later 
     than 45 days after the receipt of such letter. If the 
     Secretary grants such an extension, the specified date shall 
     be the extended date. The sponsor of the required assessment 
     under paragraph (1) shall not be issued a letter described in 
     subsection (d) unless the specified or extended date of 
     submission for such required studies has passed or if the 
     request for an extension is pending. For a deferral that has 
     expired prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act or that will expire 
     prior to 270 days after the date of enactment of such Act, a 
     deferral extension shall be requested by an applicant not 
     later than 180 days after the date of enactment of such Act. 
     The Secretary shall respond to any such request as soon as 
     practicable, but not later than 1 year after the date of 
     enactment of such Act. Nothing in this clause shall prevent 
     the Secretary from updating the status of a study or studies 
     publicly if components of such study or studies are late or 
     delayed.''; and
       (C) in subparagraph (C), as so redesignated--
       (i) in clause (i), by adding at the end the following:

[[Page S3581]]

       ``(III) Projected completion date for pediatric studies.
       ``(IV) The reason or reasons why a deferral or deferral 
     extension continues to be necessary.''; and

       (ii) in clause (ii)--

       (I) by inserting ``, as well as the date of each deferral 
     or deferral extension, as applicable,'' after ``clause (i)''; 
     and
       (II) by inserting ``not later than 90 days after submission 
     to the Secretary or with the next routine quarterly update'' 
     after ``Administration''; and

       (2) in subsection (f)--
       (A) in the subsection heading, by inserting ``Deferral 
     Extensions,'' after ``Deferrals,'';
       (B) in paragraph (1), by inserting ``, deferral 
     extension,'' after ``deferral''; and
       (C) in paragraph (4)--
       (i) in the paragraph heading, by inserting ``deferral 
     extensions,'' after ``deferrals,''; and
       (ii) by inserting ``, deferral extensions,'' after 
     ``deferrals''.
       (b) Tracking of Extensions; Annual Information.--Section 
     505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as 
     follows:
       ``(D) aggregated on an annual basis--
       ``(i) the total number of deferrals and deferral extensions 
     requested and granted under this section and, if granted, the 
     reasons for each such deferral or deferral extension;
       ``(ii) the timeline for completion of the assessments; and
       ``(iii) the number of assessments completed and pending;''.
       (c) Action on Failure To Complete Studies.--
       (1) Issuance of letter.--Subsection (d) of section 505B (21 
     U.S.C. 355c) is amended to read as follows:
       ``(d) Submission of Assessments.--If a person fails to 
     submit a required assessment described in subsection (a)(2), 
     fails to meet the applicable requirements in subsection 
     (a)(3), or fails to submit a request for approval of a 
     pediatric formulation described in subsection (a) or (b), in 
     accordance with applicable provisions of subsections (a) and 
     (b), the following shall apply:
       ``(1) Beginning 270 days after the date of enactment of the 
     Food and Drug Administration Safety and Innovation Act, the 
     Secretary shall issue a non-compliance letter to such person 
     informing them of such failure to submit or meet the 
     requirements of the applicable subsection. Such letter shall 
     require the person to respond in writing within 45 calendar 
     days of issuance of such letter. Such response may include 
     the person's request for a deferral extension if applicable. 
     Such letter and the person's written response to such letter 
     shall be made publicly available on the Internet Web site of 
     the Food and Drug Administration 60 calendar days after 
     issuance, with redactions for any trade secrets and 
     confidential commercial information. If the Secretary 
     determines that the letter was issued in error, the 
     requirements of this paragraph shall not apply.
       ``(2) The drug or biological product that is the subject of 
     an assessment described in subsection (a)(2), applicable 
     requirements in subsection (a)(3), or request for approval of 
     a pediatric formulation, may be considered misbranded solely 
     because of that failure and subject to relevant enforcement 
     action (except that the drug or biological product shall not 
     be subject to action under section 303), but such failure 
     shall not be the basis for a proceeding--
       ``(A) to withdraw approval for a drug under section 505(e); 
     or
       ``(B) to revoke the license for a biological product under 
     section 351 of the Public Health Service Act.''.
       (2) Tracking of letters issued.--Subparagraph (D) of 
     section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by 
     subsection (b), is further amended--
       (A) in clause (ii), by striking ``; and'' and inserting a 
     semicolon;
       (B) in clause (iii), by adding ``and'' at the end; and
       (C) by adding at the end the following:
       ``(iv) the number of postmarket non-compliance letters 
     issued pursuant to subsection (d), and the recipients of such 
     letters;''.

     SEC. 506. PEDIATRIC STUDY PLANS.

       (a) In General.--Subsection (e) of section 505B (21 U.S.C. 
     355c) is amended to read as follows:
       ``(e) Pediatric Study Plans.--
       ``(1) In general.--An applicant subject to subsection (a) 
     shall submit to the Secretary an initial pediatric study plan 
     prior to the submission of the assessments described under 
     subsection (a)(2).
       ``(2) Timing; content; meeting.--
       ``(A) Timing.--An applicant shall submit an initial 
     pediatric study plan to the Secretary not later than 60 
     calendar days after the date of the end of phase II meeting 
     or such other equivalent time agreed upon between the 
     Secretary and the applicant. Nothing in this paragraph shall 
     preclude the Secretary from accepting the submission of an 
     initial pediatric study plan earlier than the date described 
     under the preceding sentence.
       ``(B) Content of initial plan.--The initial pediatric study 
     plan shall include--
       ``(i) an outline of the pediatric study or studies that the 
     applicant plans to conduct (including, to the extent 
     practicable study objectives and design, age groups, relevant 
     endpoints, and statistical approach);
       ``(ii) any request for a deferral, partial waiver, or 
     waiver under this section, if applicable, along with any 
     supporting information; and
       ``(iii) other information specified in the regulations 
     promulgated under paragraph (4).
       ``(C) Meeting.--The Secretary--
       ``(i) shall meet with the applicant to discuss the initial 
     pediatric study plan as soon as practicable, but not later 
     than 90 calendar days after the receipt of such plan under 
     subparagraph (A);
       ``(ii) may determine that a written response to the initial 
     pediatric study plan is sufficient to communicate comments on 
     the initial pediatric study plan, and that no meeting is 
     necessary; and
       ``(iii) if the Secretary determines that no meeting is 
     necessary, shall so notify the applicant and provide written 
     comments of the Secretary as soon as practicable, but not 
     later than 90 calendar days after the receipt of the initial 
     pediatric study plan.
       ``(3) Agreed initial pediatric study plan.--Not later than 
     90 calendar days following the meeting under paragraph 
     (2)(C)(i) or the receipt of a written response from the 
     Secretary under paragraph (2)(C)(iii), the applicant shall 
     document agreement on the initial pediatric study plan in a 
     submission to the Secretary marked `Agreed Initial Pediatric 
     Study Plan', and the Secretary shall confirm such agreement 
     to the applicant in writing not later than 30 calendar days 
     of receipt of such agreed initial pediatric study plan.
       ``(4) Deferral and waiver.--If the agreed initial pediatric 
     study plan contains a request from the applicant for a 
     deferral, partial waiver, or waiver under this section, the 
     written confirmation under paragraph (3) shall include a 
     recommendation from the Secretary as to whether such request 
     meets the standards under paragraphs (3) or (4) of subsection 
     (a).
       ``(5) Amendments to the plan.--At the initiative of the 
     Secretary or the applicant, the agreed initial pediatric 
     study plan may be amended at any time. The requirements of 
     paragraph (2)(C) shall apply to any such proposed amendment 
     in the same manner and to the same extent as such 
     requirements apply to an initial pediatric study plan under 
     paragraph (1). The requirements of paragraphs (3) and (4) 
     shall apply to any agreement resulting from such proposed 
     amendment in the same manner and to the same extent as such 
     requirements apply to an agreed initial pediatric study plan.
       ``(6) Internal committee.--The Secretary shall consult the 
     internal committee under section 505C on the review of the 
     initial pediatric study plan, agreed initial pediatric plan, 
     and any significant amendments to such plans.
       ``(7) Required rulemaking.--Not later than 1 year after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, the Secretary shall promulgate proposed 
     regulations and issue proposed guidance to implement the 
     provisions of this subsection.''.
       (b) Conforming Amendments.--Section 505B (21 U.S.C. 355c)is 
     amended--
       (1) by amending subclause (II) of subsection (a)(3)(A)(ii) 
     to read as follows:

       ``(II) a pediatric study plan as described in subsection 
     (e);''; and

       (2) in subsection (f)--
       (A) in the subsection heading, by striking ``pediatric 
     Plans,'' and inserting ``pediatric Study Plans,'';
       (B) in paragraph (1), by striking ``all pediatric plans'' 
     and inserting ``initial pediatric study plans, agreed initial 
     pediatric study plans,''; and
       (C) in paragraph (4)--
       (i) in the paragraph heading, by striking ``pediatric 
     Plans,'' and inserting ``pediatric Study Plans,''; and
       (ii) by striking ``pediatric plans'' and inserting 
     ``initial pediatric study plans, agreed initial pediatric 
     study plans,''.
       (c) Effective Dates.--
       (1) Pediatric study plans.--Subsection (e) of section 505B 
     of the Federal Food, Drug, and Cosmetic Act (other than 
     paragraph (4) of such subsection), as amended by subsection 
     (a), shall take effect 180 days after the date of enactment 
     of this Act, without regard to whether the Secretary has 
     promulgated final regulations under paragraph (4) of such 
     subsection by such date.
       (2) Conforming amendments.--The amendments made by 
     subsection (b) shall take effect 180 days after the date of 
     enactment of this Act.

     SEC. 507. REAUTHORIZATIONS.

       (a) Pediatric Advisory Committee.--Section 14(d) of the 
     Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) 
     is amended by striking ``Notwithstanding section 14 of the 
     Federal Advisory Committee Act, the advisory committee shall 
     continue to operate during the five-year period beginning on 
     the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007'' and inserting ``Section 14 of the 
     Federal Advisory Committee Act shall not apply to the 
     advisory committee''.
       (b) Pediatric Subcommittee of the Oncologic Drugs Advisory 
     Committee.--Section 15(a)(3) of the Best Pharmaceuticals for 
     Children Act (42 U.S.C. 284m note) is amended by striking 
     ``during the five-year period beginning on the date of the 
     enactment of the Best Pharmaceuticals for Children Act of 
     2007'' and inserting ``for the duration of the operation of 
     the Oncologic Drugs Advisory Committee''.
       (c) Humanitarian Device Exemption Extension.--Section 
     520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2012'' 
     and inserting ``2017''.

[[Page S3582]]

       (d) Demonstration Grants To Improve Pediatric Device 
     Availability.--Section 305(e) of Pediatric Medical Device 
     Safety and Improvement Act (Public Law 110 85; 42 U.S.C. 282 
     note)) is amended by striking ``$6,000,000 for each of fiscal 
     years 2008 through 2012'' and inserting ``$4,500,000 for each 
     of fiscal years 2013 through 2017''.
       (e) Program for Pediatric Study of Drugs in PHSA.--Section 
     409I(e)(1) of the Public Health Service Act (42 U.S.C. 
     284m(e)(1)) is amended by striking ``to carry out this 
     section'' and all that follows through the end of paragraph 
     (1) and inserting ``to carry out this section $25,000,000 for 
     each of fiscal years 2012 through 2017.''.

     SEC. 508. REPORT.

       (a) In General.--Not later than October 31, 2016, and at 
     the end of each subsequent 5-year period, the Secretary shall 
     submit to Congress a report that evaluates the effectiveness 
     of sections 505A and 505B of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the 
     Public Health Service Act (42 U.S.C. 284m) in ensuring that 
     medicines used by children are tested in pediatric 
     populations and properly labeled for use in children.
       (b) Contents.--The report under subsection (a) shall 
     include--
       (1) the number and importance of drugs and biological 
     products for children for which studies have been requested 
     or required (as of the date of such report) under 505A and 
     505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355a, 355c) and section 409I of the Public Health Service Act 
     (42 U.S.C. 284m), including--
       (A) the number of labeling changes made to drugs and 
     biological products pursuant to such sections since the date 
     of enactment of this Act; and
       (B) the importance of such drugs and biological products in 
     the improvement of the health of children;
       (2) the number of required studies under such section 505B 
     that have not met the initial deadline provided under such 
     section, including--
       (A) the number of deferrals and deferral extensions granted 
     and the reasons such extensions were granted;
       (B) the number of waivers and partial waivers granted; and
       (C) the number of letters issued under subsection (d) of 
     such section 505B;
       (3) the number of written requests issued, declined, and 
     referred to the National Institutes of Health under such 
     section 505A since the date of enactment of this Act 
     (including the reasons for such declination), and a 
     description and status of referrals made under subsection (n) 
     of such section 505A;
       (4) the number of proposed pediatric study plans submitted 
     and agreed to as identified in the marketing application 
     under such section 505B;
       (5) any labeling changes recommended by the Pediatric 
     Advisory Committee as a result of the review by such 
     Committee of adverse events reports;
       (6) the number and current status of pediatric 
     postmarketing requirements;
       (7) the number and importance of drugs and biological 
     products for children that are not being tested for use in 
     pediatric populations, notwithstanding the existence of the 
     programs under such sections 505A and 505B and section 409I 
     of the Public Health Service Act;
       (8) the possible reasons for the lack of testing reported 
     under paragraph (7);
       (9) the number of drugs and biological products for which 
     testing is being done (as of the date of the report) and for 
     which a labeling change is required under the programs 
     described in paragraph (7), including--
       (A) the date labeling changes are made;
       (B) which labeling changes required the use of the dispute 
     resolution process; and
       (C) for labeling changes that required such dispute 
     resolution process, a description of--
       (i) the disputes;
       (ii) the recommendations of the Pediatric Advisory 
     Committee; and
       (iii) the outcomes of such process; and
       (D) an assessment of the effectiveness in improving 
     information about pediatric uses of drugs and biological 
     products;
       (10)(A) the efforts made by the Secretary to increase the 
     number of studies conducted in the neonatal population 
     (including efforts made to encourage the conduct of 
     appropriate studies in neonates by companies with products 
     that have sufficient safety and other information to make the 
     conduct of the studies ethical and safe); and
       (B) the results of such efforts;
       (11)(A) the number and importance of drugs and biological 
     products for children with cancer that are being tested as a 
     result of the programs described in paragraph (7); and
       (B) any recommendations for modifications to such programs 
     that would lead to new and better therapies for children with 
     cancer, including a detailed rationale for each 
     recommendation;
       (12) an assessment of progress made in addressing the 
     recommendations and findings of any prior report issued by 
     the Comptroller General, the Institute of Medicine, or the 
     Secretary regarding the topics addressed in the report under 
     this section, including with respect to--
       (A) improving public access to information from pediatric 
     studies conducted under such sections 505A and 505B; and
       (B) improving the timeliness of pediatric studies and 
     pediatric study planning under such sections 505A and 505B;
       (13) any recommendations for modification to the programs 
     that would improve pediatric drug research and increase 
     pediatric labeling of drugs and biological products; and
       (14) an assessment of the successes of and limitations to 
     studying drugs for rare diseases under such sections 505A and 
     505B.
       (c) Consultation on Recommendations.--At least 180 days 
     before the report is due under subsection (a), and no sooner 
     than 4 years after the date of enactment of this Act, the 
     Secretary shall consult with representatives of patient 
     groups, including pediatric patient groups, consumer groups, 
     regulated industry, scientific and medical communities, 
     academia, and other interested parties to obtain any 
     recommendations or information relevant to the effectiveness 
     of the programs described in subsection (b)(7), including 
     suggestions for modifications to such programs.

     SEC. 509. TECHNICAL AMENDMENTS.

       (a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 
     U.S.C. 355a) is amended--
       (1) in subsection (k)(2), by striking ``subsection 
     (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
       (2) in subsection (n)--
       (A) in the subsection heading, by striking ``completed'' 
     and inserting ``submitted''; and
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``have not been completed'' and inserting ``have not been 
     submitted by the date specified in the written request issued 
     or if the applicant or holder does not agree to the 
     request'';
       (ii) in subparagraph (A)--

       (I) in the first sentence, by inserting ``, or for which a 
     period of exclusivity eligible for extension under subsection 
     (b)(1) or (c)(1) of this section or under subsection (m)(2) 
     or (m)(3) of section 351 of the Public Health Service Act has 
     not ended'' after ``expired''; and
       (II) by striking ``Prior to'' and all that follows through 
     the period at the end; and

       (iii) in subparagraph (B), by striking ``no listed patents 
     or has 1 or more listed patents that have expired,'' and 
     inserting ``no unexpired listed patents and for which no 
     unexpired periods of exclusivity eligible for extension under 
     subsection (b)(1) or (c)(1) of this section or under 
     subsection (m)(2) or (m)(3) of section 351 of the Public 
     Health Service Act apply,''; and
       (3) in subsection (o)(2), by amendment subparagraph (B) to 
     read as follows:
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, precautions, or other 
     information that the Secretary considers necessary to assure 
     safe use.''.
       (b) Research Into Pediatric Uses for Drugs and Biological 
     Projects in FFDCA.--Section 505B (21 U.S.C. 355c) is 
     amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by inserting 
     ``for a drug'' after ``(or supplement to an application)'';
       (ii) in subparagraph (A), by striking ``for a'' and 
     inserting ``, including, with respect to a drug, an 
     application (or supplement to an application) for a'';
       (iii) in subparagraph (B), by striking ``for a'' and 
     inserting ``, including, with respect to a drug, an 
     application (or supplement to an application) for a''; and
       (iv) in the matter following subparagraph (B), by inserting 
     ``(or supplement)'' after ``application''; and
       (B) in paragraph (4)(C)--
       (i) in the first sentence, by inserting ``partial'' before 
     ``waiver is granted''; and
       (ii) in the second sentence, by striking ``either a full 
     or'' and inserting ``such a'';
       (2) in subsection (b)(1), in the matter preceding 
     subparagraph (A), by striking ``After providing notice'' and 
     all that follows through ``studies), the'' and inserting 
     ``The'';
       (3) in subsection (g)--
       (A) in paragraph (1)(A), by inserting ``that receives a 
     priority review or 330 days after the date of the submission 
     of an application or supplement that receives a standard 
     review'' after ``after the date of the submission of the 
     application or supplement''; and
       (B) in paragraph (2), by striking ``the label of such 
     product'' and inserting ``the labeling of such product''; and
       (4) in subsection (h)(1)--
       (A) by inserting ``an application (or supplement to an 
     application) that contains'' after ``date of submission of''; 
     and
       (B) by inserting ``, if the application (or supplement) 
     receives a priority review, or not later than 330 days after 
     the date of submission of an application (or supplement to an 
     application) that contains a pediatric assessment under this 
     section, if the application (or supplement) receives a 
     standard review,'' after ``under this section,''.
       (c) Internal Review Committee.--The heading of section 505C 
     (21 U.S.C. 355d) is amended by inserting ``AND DEFERRAL 
     EXTENSIONS'' after ``DEFERRALS''.
       (d) Program for Pediatric Studies of Drugs.--Section 
     409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) 
     is amended--
       (1) in paragraph (1)--
       (A) in the matter preceding subparagraph (A), by inserting 
     ``or section 351(m) of this Act,'' after ``Cosmetic Act,'';
       (B) in subparagraph (A)(i), by inserting ``or section 
     351(k) of this Act'' after ``Cosmetic Act''; and
       (C) by amending subparagraph (B) to read as follows:

[[Page S3583]]

       ``(B) there remains no patent listed pursuant to section 
     505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and 
     every three-year and five-year period referred to in 
     subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 
     (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 
     505 of the Federal Food, Drug, and Cosmetic Act, or 
     applicable twelve-year period referred to in section 
     351(k)(7) of this Act, and any seven-year period referred to 
     in section 527 of the Federal Food, Drug, and Cosmetic Act 
     has ended for at least one form of the drug; and''; and
       (2) in paragraph (2)--
       (A) in the paragraph heading, by striking ``for drugs 
     lacking exclusivity''; and
       (B) by striking ``under section 505 of the Federal Food, 
     Drug, and Cosmetic Act''; and
       (C) by striking ``505A of such Act'' and inserting ``505A 
     of the Federal Food, Drug, and Cosmetic Act or section 351(m) 
     of this Act''.
       (e) Pediatric Subcommittee of the Oncologic Advisory 
     Committee.--Section 15(a) of the Best Pharmaceuticals for 
     Children Act (Public Law 107 109), as amended by section 
     502(e) of the Food and Drug Administration Amendments Act of 
     2007 (Public Law 110 85), is amended in paragraph (1)(D), by 
     striking ``section 505B(f)'' and inserting `` `section 505C' 
     ''.
       (f) Foundation of National Institutes of Health.--Section 
     499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
     290b(c)(1)(C)) is amended by striking ``for which the 
     Secretary issues a certification in the affirmative under 
     section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 
     Act''.
       (g) Application.--Notwithstanding any provision of section 
     505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a, 355c) stating that a provision applies beginning 
     on the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007 or the date of the enactment of the 
     Pediatric Research Equity Act of 2007, any amendment made by 
     this title to such a provision applies beginning on the date 
     of the enactment of this Act.

     SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC LABELING AND NEW 
                   CLINICAL INVESTIGATION EXCLUSIVITY.

       (a) In General.--Section 505 (21 U.S.C. 351) is amended by 
     adding at the end the following:
       ``(w) Relationship Between Pediatric Labeling and New 
     Clinical Investigation Exclusivity.--The period of market 
     exclusivity described in clauses (iii) and (iv) of subsection 
     (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) 
     shall not apply to a pediatric study conducted under section 
     505A or 505B that results, pursuant to section 505B(g)(2), in 
     the inclusion in the labeling of the product a determination 
     that the product is not indicated for use in pediatric 
     populations or subpopulations or information indicating that 
     the results of a study were inconclusive or did not 
     demonstrate that the product is safe or effective in 
     pediatric populations or subpopulations.''.
       (b) Pediatric Studies of Drugs.--Section 505A(m) (21 U.S.C. 
     355a(m)) is amended--
       (1) by striking ``(m) Clarification of Interaction of 
     Market Exclusivity Under This Section and Market Exclusivity 
     Awarded to an Applicant for Approval of A Drug Under Section 
     505(j).--If a'' and all that follows through the end of the 
     matter that precedes paragraph (1) and inserting the 
     following:
       ``(m) Clarification of Interaction of Market Exclusivity 
     Under This Section and Market Exclusivity Awarded to an 
     Application or Supplement Under Subsection (c) or (j) of 
     Section 505.--
       ``(1) 180-day exclusivity period.--If a 180-day period 
     under section 505(j)(5)(B)(iv) overlaps with a 6-month 
     exclusivity period under this section, so that the applicant 
     for approval of a drug under section 505(j) entitled to the 
     180-day period under that section loses a portion of the 180-
     day period to which the applicant is entitled for the drug, 
     the 180-day period shall be extended from--'';
       (2) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B) and moving such subparagraphs, as 
     so redesignated, 2 ems to the right; and
       (3) by adding at the end the following:
       ``(2) 3-year exclusivity period.--The 3-year period of 
     exclusivity under clauses (iii) and (iv) of subsection 
     505(c)(3)(E) and clauses (iii) and (iv) of subsection 
     505(j)(5)(F) are not available for approval of applications 
     or supplements to applications based on reports of pediatric 
     studies conducted under sections 505A or 505B that resulted, 
     pursuant to section 505A(j) or 505B(g)(2), in the inclusion 
     in the labeling of the product a determination that the 
     product is not indicated for use in pediatric populations or 
     subpopulations or information indicating that the results of 
     an assessment were inconclusive or did not demonstrate that 
     the product is safe or effective in pediatric populations or 
     subpopulation.''.
       (c) Prompt Approval of Drugs.--Section 505A(o) (21 U.S.C. 
     355a(o)) is amended--
       (1) in the heading, by striking ``section 505(j)'' and 
     inserting ``subsections (c) and (j) of Section 505'';
       (2) in paragraph (1), by striking ``under section 505(j)'' 
     and inserting ``under subsection (b)(2), (c), or (j) of 
     section 505'';
       (3) in paragraph (2), in the matter preceding subparagraph 
     (A), by inserting ``clauses (iii) and (iv) of section 
     505(c)(3)(E) or'' after ``Notwithstanding''; and
       (4) in paragraph (3)--
       (A) in subparagraph (B), by inserting ``that differ from 
     adult formulations'' before the semicolon at the end; and
       (B) in subparagraph (C)--
       (i) by striking ``under section 505(j)'' and inserting 
     ``under subsection (c) or (j) of section 505''; and
       (ii) by inserting ``clauses (iii) or (iv) of section 
     505(c)(3)(E) or'' after ``exclusivity under''.

     SEC. 511. PEDIATRIC RARE DISEASES.

       (a) Public Meeting.--Not later than 18 months after the 
     date of enactment of this Act, the Secretary shall hold a 
     public meeting to discuss ways to encourage and accelerate 
     the development of new therapies for pediatric rare diseases.
       (b) Report.--Not later than 180 days after the date of the 
     public meeting under subsection (a), the Secretary shall 
     issue a report that includes a strategic plan for encouraging 
     and accelerating the development of new therapies for 
     treating pediatric rare diseases.

            TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS

     SEC. 601. RECLASSIFICATION PROCEDURES.

       (a) Classification Changes.--
       (1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1)) 
     is amended to read as follows:
       ``(e)(1)(A) Based on new information respecting a device, 
     the Secretary may, upon the initiative of the Secretary or 
     upon petition of an interested person, change the 
     classification of such device, and revoke, on account of the 
     change in classification, any regulation or requirement in 
     effect under section 514 or 515 with respect to such device, 
     by administrative order published in the Federal Register 
     following publication of a proposed reclassification order in 
     the Federal Register, a meeting of a device classification 
     panel described in subsection (b), and consideration of 
     comments to a public docket, notwithstanding subchapter II of 
     Chapter 5 of title 5 of the United States Code. An order 
     under this subsection changing the classification of a device 
     from class III to class II may provide that such 
     classification shall not take effect until the effective date 
     of a performance standard established under section 514 for 
     such device.
       ``(B) Authority to issue such administrative order shall 
     not be delegated below the Commissioner. The Commissioner 
     shall issue such an order as proposed by the Director of the 
     Center for Devices and Radiological Health unless the 
     Commissioner, in consultation with the Office of the 
     Secretary of Health and Human Services, concludes that the 
     order exceeds the legal authority of the Food and Drug 
     Administration or that the order would be lawful, but 
     unlikely to advance the public health.''.
       (2) Technical and conforming amendments.--
       (A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by 
     striking ``regulation promulgated'' and inserting ``an order 
     issued''.
       (B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by 
     striking ``under a regulation under section 513(e) but such 
     regulation'' and inserting ``under an administrative order 
     under section 513(e) (or a regulation promulgated under such 
     section prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act) but such order (or 
     regulation)'';
       (C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by 
     striking ``or changing the classification of a device to 
     class I'' and inserting ``, an administrative order changing 
     the classification of a device to class I,''.
       (3) Devices reclassified prior to the date of enactment of 
     this act.--
       (A) In general.--The amendments made by this subsection 
     shall have no effect on a regulation promulgated with respect 
     to the classification of a device under section 513(e) of the 
     Federal Food, Drug, and Cosmetic Act prior to the date of 
     enactment of this Act.
       (B) Applicability of other provisions.--In the case of a 
     device reclassified under section 513(e) of the Federal Food, 
     Drug, and Cosmetic Act by regulation prior to the date of 
     enactment of this Act, section 517(a)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to 
     such regulation promulgated under section 513(e) of such Act 
     with respect to such device in the same manner such section 
     517(a)(1) applies to an administrative order issued with 
     respect to a device reclassified after the date of enactment 
     of this Act.
       (b) Devices Marketed Before May 28, 1976.--
       (1) Premarket approval.--Section 515 (21 U.S.C. 360e) is 
     amended--
       (A) in subsection (a), by striking ``regulation promulgated 
     under subsection (b)'' and inserting ``an order issued under 
     subsection (b) (or a regulation promulgated under such 
     subsection prior to the date of enactment of the Food and 
     Drug Administration Safety and Innovation Act)'';
       (B) in subsection (b)--
       (i) in paragraph (1)--

       (I) in the heading, by striking ``Regulation'' and 
     inserting ``Order''; and
       (II) in the matter following subparagraph (B)--

       (aa) by striking ``by regulation, promulgated in accordance 
     with this subsection'' and inserting ``by administrative 
     order following publication of a proposed order in the 
     Federal Register, a meeting of a device classification panel 
     described in section 513(b), and consideration of comments 
     from all affected stakeholders, including patients, payors, 
     and providers, notwithstanding subchapter II of chapter 5 of 
     title 5, United States Code''; and
       (bb) by adding at the end the following:


[[Page S3584]]


     ``Authority to issue such administrative order shall not be 
     delegated below the Commissioner. Before publishing such 
     administrative order, the Commissioner shall consult with the 
     Office of the Secretary. The Commissioner shall issue such an 
     order as proposed by the Director of the Center for Devices 
     and Radiological Health unless the Commissioner, in 
     consultation with the Office of the Secretary, concludes that 
     the order exceeds the legal authority of the Food and Drug 
     Administration or that the order would be lawful, but 
     unlikely to advance the public health.'';
       (ii) in paragraph (2)--

       (I) by striking subparagraph (B); and
       (II) in subparagraph (A)--

       (aa) by striking ``(2)(A) A proceeding for the promulgation 
     of a regulation under paragraph (1) respecting a device shall 
     be initiated by the publication in the Federal Register of a 
     notice of proposed rulemaking. Such notice shall contain--'' 
     and inserting ``(2) A proposed order required under paragraph 
     (1) shall contain--'';
       (bb) by redesignating clauses (i) through (iv) as 
     subparagraphs (A) through (D), respectively;
       (cc) in subparagraph (A), as so redesignated, by striking 
     ``regulation'' and inserting ``order''; and
       (dd) in subparagraph (C), as so redesignated, by striking 
     ``regulation'' and inserting ``order'';
       (iii) in paragraph (3)--

       (I) by striking ``proposed regulation'' each place such 
     term appears and inserting ``proposed order'';
       (II) by striking ``paragraph (2) and after'' and inserting 
     ``paragraph (2),'';
       (III) by inserting ``and a meeting of a device 
     classification panel described in section 513(b),'' after 
     ``such proposed regulation and findings,'';
       (IV) by striking ``(A) promulgate such regulation'' and 
     inserting ``(A) issue an administrative order under paragraph 
     (1)'';
       (V) by striking ``paragraph (2)(A)(ii)'' and inserting 
     ``paragraph (2)(B)''; and
       (VI) by striking ``promulgation of the regulation'' and 
     inserting ``issuance of the administrative order''; and

       (iv) by striking paragraph (4); and
       (C) in subsection (i)--
       (i) in paragraph (2)--

       (I) in the matter preceding subparagraph (A)--

       (aa) by striking ``December 1, 1995'' and inserting ``the 
     date that is 2 years after the date of enactment of the Food 
     and Drug Administration Safety and Innovation Act''; and
       (bb) by striking ``publish a regulation in the Federal 
     Register'' and inserting ``issue an administrative order 
     following publication of a proposed order in the Federal 
     Register, a meeting of a device classification panel 
     described in section 513(b), and consideration of comments 
     from all affected stakeholders, including patients, payors, 
     and providers, notwithstanding subchapter II of chapter 5 of 
     title 5, United States Code,'';

       (II) in subparagraph (B), by striking ``final regulation 
     has been promulgated under section 515(b)'' and inserting 
     ``administrative order has been issued under subsection (b) 
     (or no regulation has been promulgated under such subsection 
     prior to the date of enactment of the Food and Drug 
     Administration Safety and Innovation Act)'';
       (III) in the matter following subparagraph (B), by striking 
     ``regulation requires'' and inserting ``administrative order 
     issued under this paragraph requires''; and
       (IV) by striking the third and fourth sentences; and

       (ii) in paragraph (3)--

       (I) by striking ``regulation requiring'' each place such 
     term appears and inserting ``order requiring''; and
       (II) by striking ``promulgation of a section 515(b) 
     regulation'' and inserting ``issuance of an administrative 
     order under subsection (b)''.

       (2) Technical and conforming amendments.--Section 501(f) 
     (21 U.S.C. 351(f)) is amended--
       (A) in subparagraph (1)(A)--
       (i) in subclause (i), by striking ``a regulation 
     promulgated'' and inserting ``an order issued''; and
       (ii) in subclause (ii), by striking ``promulgation of such 
     regulation'' and inserting ``issuance of such order'';
       (B) in subparagraph (2)(B)--
       (i) by striking ``a regulation promulgated'' and inserting 
     ``an order issued''; and
       (ii) by striking ``promulgation of such regulation'' and 
     inserting ``issuance of such order''; and
       (C) by adding at the end the following:
       ``(3) In the case of a device with respect to which a 
     regulation was promulgated under section 515(b) prior to the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, a reference in this subsection to an 
     order issued under section 515(b) shall be deemed to include 
     such regulation.''.
       (3) Approval by regulation prior to the date of enactment 
     of this act.--The amendments made by this subsection shall 
     have no effect on a regulation that was promulgated prior to 
     the date of enactment of this Act requiring that a device 
     have an approval under section 515 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360e) of an application for 
     premarket approval.
       (c) Reporting.--The Secretary of Health and Human Services 
     shall annually post on the Internet website of the Food and 
     Drug Administration--
       (1) the number and type of class I and class II devices 
     reclassified as class II or class III in the previous 
     calendar year under section 513(e)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1));
       (2) the number and type of class II and class III devices 
     reclassified as class I or class II in the previous calendar 
     year under such section 513(e)(1); and
       (3) the number and type of devices reclassified in the 
     previous calendar year under section 515 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360e).

     SEC. 602. CONDITION OF APPROVAL STUDIES.

       Section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is 
     amended--
       (1) by striking ``(ii)'' and inserting ``(ii)(I)''; and
       (2) by adding at the end the following:
       ``(II) An order approving an application for a device may 
     require as a condition to such approval that the applicant 
     conduct a postmarket study regarding the device.''.

     SEC. 603. POSTMARKET SURVEILLANCE.

       Section 522 (21 U.S.C. 360l) is amended--
       (1) in subsection (a)(1)(A), in the matter preceding clause 
     (i), by inserting ``, at the time of approval or clearance of 
     a device or at any time thereafter,'' after ``by order''; and
       (2) in subsection (b)(1), by inserting ``The manufacturer 
     shall commence surveillance under this section not later than 
     15 months after the day on which the Secretary issues an 
     order under this section.'' after the second sentence.

     SEC. 604. SENTINEL.

       Section 519 (21 U.S.C. 360i) is amended by adding at the 
     end the following:
       ``(h) Inclusion of Devices in the Postmarket Risk 
     Identification and Analysis System.--
       ``(1) In general.--
       ``(A) Application to devices.--The Secretary shall amend 
     the procedures established and maintained under clauses (i), 
     (ii), (iii), and (v) of section 505(k)(3)(C) in order to 
     expand the postmarket risk identification and analysis system 
     established under such section to include and apply to 
     devices.
       ``(B) Exception.--Subclause (II) of clause (i) of section 
     505(k)(3)(C) shall not apply to devices.
       ``(C) Clarification.--With respect to devices, the private 
     sector health-related electronic data provided under section 
     505(k)(3)(C)(i)(III)(bb) may include medical device 
     utilization data, health insurance claims data, and procedure 
     and device registries.
       ``(2) Data.--In expanding the system as described in 
     paragraph (1)(A), the Secretary shall use relevant data with 
     respect to devices cleared under section 510(k) or approved 
     under section 515, including claims data, patient survey 
     data, and any other data deemed appropriate by the Secretary.
       ``(3) Stakeholder input.--To help ensure effective 
     implementation of the system described in paragraph (1)(A), 
     the Secretary shall engage outside stakeholders in 
     development of the system through a public hearing, advisory 
     committee meeting, public docket, or other like public 
     measures, as appropriate.
       ``(4) Voluntary surveys.--Chapter 35 of title 44, United 
     States Code, shall not apply to the collection of voluntary 
     information from health care providers, such as voluntary 
     surveys or questionnaires, initiated by the Secretary for 
     purposes of postmarket risk identification for devices.''.

     SEC. 605. RECALLS.

       (a) Assessment of Device Recall Information.--
       (1) In general.--
       (A) Assessment program.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall enhance the Food and Drug Administration's recall 
     program to routinely and systematically assess--
       (i) information submitted to the Secretary pursuant to a 
     device recall order under section 518(e) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360h(e)); and
       (ii) information required to be reported to the Secretary 
     regarding a correction or removal of a device under section 
     519(g) of such Act (21 U.S.C. 360i(g)).
       (B) Use.--The Secretary shall use the assessment of 
     information described under subparagraph (A) to proactively 
     identify strategies for mitigating health risks presented by 
     defective or unsafe devices.
       (2) Design.--The program under paragraph (1) shall, at a 
     minimum, identify--
       (A) trends in the numbers and types of device recalls;
       (B) the types of devices in each device class that are most 
     frequently recalled;
       (C) the causes of device recalls; and
       (D) any other information as the Secretary determines 
     appropriate.
       (b) Audit Check Procedures.--The Secretary shall clarify 
     procedures for conducting device recall audit checks to 
     improve the ability of investigators to perform these checks 
     in a consistent manner.
       (c) Assessment Criteria.--The Secretary shall develop 
     explicit criteria for assessing whether a person subject to a 
     recall order under section 518(e) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360h(e)) or to a requirement 
     under section 519(g) of such Act (21 U.S.C. 360i(g)) has 
     performed an effective recall under such section 518(e) or an 
     effective correction or removal action under such section 
     519(g), respectively.

[[Page S3585]]

       (d) Termination of Recalls.--The Secretary shall document 
     the basis for the termination by the Food and Drug 
     Administration of--
       (1) an individual device recall ordered under section 
     518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360h(e)); and
       (2) any correction or removal action for which a report is 
     required to be submitted to the Secretary under section 
     519(g) of such Act (21 U.S.C. 360i(g)).

     SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE 
                   EXEMPTIONS.

       Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at 
     the end the following:
       ``(8)(A) At any time, the Secretary may prohibit the 
     sponsor of an investigation from conducting the investigation 
     (referred to in this paragraph as a `clinical hold') if the 
     Secretary makes a determination described in subparagraph 
     (B). The Secretary shall specify the basis for the clinical 
     hold, including the specific information available to the 
     Secretary which served as the basis for such clinical hold, 
     and confirm such determination in writing.
       ``(B) For purposes of subparagraph (A), a determination 
     described in this subparagraph with respect to a clinical 
     hold is a determination that--
       ``(i) the device involved represents an unreasonable risk 
     to the safety of the persons who are the subjects of the 
     clinical investigation, taking into account the 
     qualifications of the clinical investigators, information 
     about the device, the design of the clinical investigation, 
     the condition for which the device is to be investigated, and 
     the health status of the subjects involved; or
       ``(ii) the clinical hold should be issued for such other 
     reasons as the Secretary may by regulation establish.
       ``(C) Any written request to the Secretary from the sponsor 
     of an investigation that a clinical hold be removed shall 
     receive a decision, in writing and specifying the reasons 
     therefor, within 30 days after receipt of such request. Any 
     such request shall include sufficient information to support 
     the removal of such clinical hold.''.

     SEC. 607. UNIQUE DEVICE IDENTIFIER.

       Section 519(f) (21 U.S.C. 360i(f)) is amended--
       (1) by striking ``The Secretary shall promulgate'' and 
     inserting ``Not later than December 31, 2012, the Secretary 
     shall issue proposed''; and
       (2) by adding at the end the following: ``The Secretary 
     shall finalize the proposed regulations not later than 6 
     months after the close of the comment period and shall 
     implement the final regulations with respect to devices that 
     are implantable, life-saving, and life sustaining not later 
     than 2 years after the regulations are finalized.''.

     SEC. 608. CLARIFICATION OF LEAST BURDENSOME STANDARD.

       (a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C. 
     360c(a)(3)(D)) is amended--
       (1) by redesignating clause (iii) as clause (v); and
       (2) by inserting after clause (ii) the following:
       ``(iii) For purposes of clause (ii), the term `necessary' 
     means the minimum required information that would support a 
     determination by the Secretary that an application provides 
     reasonable assurance of the effectiveness of the device.
       ``(iv) Nothing in this subparagraph shall alter the 
     criteria for evaluating an application for premarket approval 
     of a device.''.
       (b) Premarket Notification Under Section 510(k).--Section 
     513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
       (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
     Whenever''; and
       (2) by adding at the end the following:
       ``(ii) For purposes of clause (i), the term `necessary' 
     means the minimum required information that would support a 
     determination of substantial equivalence between a new device 
     and a predicate device.
       ``(iii) Nothing in this subparagraph shall alter the 
     standard for determining substantial equivalence between a 
     new device and a predicate device.''.

     SEC. 609. CUSTOM DEVICES.

       Section 520(b) (21 U.S.C. 360j(b)) is amended to read as 
     follows:
       ``(b) Custom Devices.--
       ``(1) In general.--The requirements of sections 514 and 515 
     shall not apply to a device that--
       ``(A) is created or modified in order to comply with the 
     order of an individual physician or dentist (or any other 
     specially qualified person designated under regulations 
     promulgated by the Secretary after an opportunity for an oral 
     hearing);
       ``(B) in order to comply with an order described in 
     subparagraph (A), necessarily deviates from an otherwise 
     applicable performance standard under section 514 or 
     requirement under section 515;
       ``(C) is not generally available in the United States in 
     finished form through labeling or advertising by the 
     manufacturer, importer, or distributor for commercial 
     distribution;
       ``(D) is designed to treat a unique pathology or 
     physiological condition that no other device is domestically 
     available to treat;
       ``(E)(i) is intended to meet the special needs of such 
     physician or dentist (or other specially qualified person so 
     designated) in the course of the professional practice of 
     such physician or dentist (or other specially qualified 
     person so designated); or
       ``(ii) is intended for use by an individual patient named 
     in such order of such physician or dentist (or other 
     specially qualified person so designated);
       ``(F) is assembled from components or manufactured and 
     finished on a case-by-case basis to accommodate the unique 
     needs described in clause (i) or (ii) of subparagraph (E); 
     and
       ``(G) may have common, standardized design characteristics, 
     chemical and material compositions, and manufacturing 
     processes as commercially distributed devices.
       ``(2) Limitations.--Paragraph (1) shall apply to a device 
     only if--
       ``(A) such device is for the purpose of treating a 
     sufficiently rare condition, such that conducting clinical 
     investigations on such device would be impractical;
       ``(B) production of such device under paragraph (1) is 
     limited to no more than 5 units per year of a particular 
     device type, provided that such replication otherwise 
     complies with this section; and
       ``(C) the manufacturer of such device created or modified 
     as described in paragraph (1) notifies the Secretary on an 
     annual basis, in a manner prescribed by the Secretary, of the 
     manufacture of such device.
       ``(3) Exception.--Paragraph (1) shall not apply to oral 
     facial devices.
       ``(4) Guidance.--Not later than 2 years after the date of 
     enactment of this section, the Secretary shall issue final 
     guidance on replication of multiple devices described in 
     paragraph (2)(B).''.

     SEC. 610. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN 
                   DECISIONS REGARDING DEVICES.

       Chapter V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 517 the following:

     ``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN 
                   DECISIONS REGARDING DEVICES.

       ``(a) Documentation of Rationale for Denial.--If the 
     Secretary renders a final decision to deny clearance of a 
     premarket notification under section 510(k) or approval of a 
     premarket application under section 515, or when the 
     Secretary disapproves an application for an investigational 
     exemption under 520(g), the written correspondence to the 
     applicant communicating that decision shall provide a 
     substantive summary of the scientific and regulatory 
     rationale for the decision.
       ``(b) Review of Denial.--
       ``(1) In general.--A person who has submitted a report 
     under section 510(k), an application under section 515, or an 
     application for an exemption under section 520(g) and for 
     whom clearance of the report or approval of the application 
     is denied may request a supervisory review of the decision to 
     deny such clearance or approval. Such review shall be 
     conducted by an individual at the organizational level above 
     the organization level at which the decision to deny the 
     clearance of the report or approval of the application is 
     made.
       ``(2) Submission of request.--A person requesting a 
     supervisory review under paragraph (1) shall submit such 
     request to the Secretary not later than 30 days after such 
     denial and shall indicate in the request whether such person 
     seeks an in-person meeting or a teleconference review.
       ``(3) Timeframe.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the Secretary shall schedule an in-person or teleconference 
     review, if so requested, not later than 30 days after such 
     request is made. The Secretary shall issue a decision to the 
     person requesting a review under this subsection not later 
     than 45 days after the request is made under paragraph (1), 
     or, in the case of a person who requests an in-person meeting 
     or teleconference, 30 days after such meeting or 
     teleconference.
       ``(B) Exception.--Subparagraph (A) shall not apply in cases 
     that involve consultation with experts outside of the Food 
     and Drug Administration, or in cases in which the sponsor 
     seeks to introduce evidence not already in the administrative 
     record at the time the denial decision was made.''.

     SEC. 611. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.

       Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) 
     is amended--
       (1) by striking ``(C) For guidance documents'' and 
     inserting ``(C)(i) For guidance documents''; and
       (2) by adding at the end the following:
       ``(ii) With respect to devices, if a notice to industry 
     guidance letter, a notice to industry advisory letter, or any 
     similar notice sets forth initial interpretations of a 
     regulation or policy or sets forth changes in interpretation 
     or policy, such notice shall be treated as a guidance 
     document for purposes of this subparagraph.''.

     SEC. 612. MODIFICATION OF DE NOVO APPLICATION PROCESS.

       (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) 
     is amended--
       (1) by redesignating subparagraphs (B) and (C) as 
     subparagraphs (C) and (D), respectively;
       (2) by amending subparagraph (A) to read as follows:
       ``(A) In the case of a type of device that has not 
     previously been classified under this Act, a person may do 
     one of the following:
       ``(i) Submit a report under section 510(k), and, if the 
     device is classified into class III under paragraph (1), such 
     person may request, not later than 30 days after receiving

[[Page S3586]]

     written notice of such a classification, the Secretary to 
     classify the device under the criteria set forth in 
     subparagraphs (A) through (C) of subsection (a)(1). The 
     person may, in the request, recommend to the Secretary a 
     classification for the device. Any such request shall 
     describe the device and provide detailed information and 
     reasons for the recommended classification.
       ``(ii) Submit a request for initial classification of the 
     device under this subparagraph, if the person declares that 
     there is no legally marketed device upon which to base a 
     substantial equivalence determination as that term is defined 
     in subsection (i). Subject to subparagraph (B), the Secretary 
     shall classify the device under the criteria set forth in 
     subparagraphs (A) through (C) of subsection (a)(1). The 
     person submitting the request for classification under this 
     subparagraph may recommend to the Secretary a classification 
     for the device and shall, if recommending classification in 
     class II, include in the request an initial draft proposal 
     for applicable special controls, as described in subsection 
     (a)(1)(B), that are necessary, in conjunction with general 
     controls, to provide reasonable assurance of safety and 
     effectiveness and a description of how the special controls 
     provide such assurance. Requests under this clause shall be 
     subject to the electronic copy requirements of section 
     745A(b).'';
       (3) by inserting after subparagraph (A) the following:
       ``(B) The Secretary may decline to undertake a 
     classification request submitted under clause (2)(A)(ii) if 
     the Secretary identifies a legally marketed device that could 
     provide a reasonable basis for review of substantial 
     equivalence under paragraph (1), or when the Secretary 
     determines that the device submitted is not of low-moderate 
     risk or that general controls would be inadequate to control 
     the risks and special controls to mitigate the risks cannot 
     be developed.''; and
       (4) in subparagraph (C), as so redesignated--
       (A) in clause (i), by striking ``Not later than 60 days 
     after the date of the submission of the request under 
     subparagraph (A),'' and inserting ``Not later than 120 days 
     after the date of the submission of the request under 
     subparagraph (A)(i) or 150 days after the date of the 
     submission of the request under subparagraph (A)(ii),''; and
       (B) in clause (ii), by inserting ``or is classified in'' 
     after ``remains in''.
       (b) GAO Report.--Not later than 2 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall complete a study and submit to Congress a report 
     on the effectiveness of the review pathway under section 
     513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as 
     amended by this Act.
       (c) Conforming Amendment.--Section 513(f)(1)(B) (21 U.S.C. 
     360c(f)(1)(B)) is amended by inserting ``a request under 
     paragraph (2) or'' after ``response to''.

     SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.

       (a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is 
     amended--
       (1) in paragraph (6)--
       (A) in subparagraph (A)--
       (i) by striking clause (i) and inserting the following:
       ``(i) The device with respect to which the exemption is 
     granted--
       ``(I) is intended for the treatment or diagnosis of a 
     disease or condition that occurs in pediatric patients or in 
     a pediatric subpopulation, and such device is labeled for use 
     in pediatric patients or in a pediatric subpopulation in 
     which the disease or condition occurs; or
       ``(II) is intended for the treatment or diagnosis of a 
     disease or condition that does not occur in pediatric 
     patients or that occurs in pediatric patients in such numbers 
     that the development of the device for such patients is 
     impossible, highly impracticable, or unsafe.''; and
       (ii) by striking clause (ii) and inserting the following:
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year under each exemption granted 
     under this subsection does not exceed the annual distribution 
     number for such device. In this paragraph, the term `annual 
     distribution number' means the number of such devices 
     reasonably needed to treat, diagnose, or cure a population of 
     4,000 individuals in the United States. The Secretary shall 
     determine the annual distribution number when the Secretary 
     grants such exemption.''; and
       (B) by amending subparagraph (C) to read as follows:
       ``(C) A person may petition the Secretary to modify the 
     annual distribution number determined by the Secretary under 
     subparagraph (A)(ii) with respect to a device if additional 
     information arises, and the Secretary may modify such annual 
     distribution number.'';
       (2) in paragraph (7), by striking ``regarding a device'' 
     and inserting ``regarding a device described in paragraph 
     (6)(A)(i)(I)''; and
       (3) in paragraph (8), by striking ``of all devices 
     described in paragraph (6)'' and inserting ``of all devices 
     described in paragraph (6)(A)(i)(I)''.
       (b) Applicability To Existing Devices.--A sponsor of a 
     device for which an exemption was approved under paragraph 
     (2) of section 520(m) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360j(m)) before the date of enactment of this 
     Act may seek a determination under subclause (I) or (II) of 
     section 520(m)(6)(A)(i) (as amended by subsection (a)). If 
     the Secretary of Health and Human Services determines that 
     such subclause (I) or (II) applies with respect to a device, 
     clauses (ii), (iii), and (iv) of subparagraph (A) and 
     subparagraphs (B), (C), (D), and (E) of paragraph (6) of such 
     section 520(m) shall apply to such device, and the Secretary 
     shall determine the annual distribution number for purposes 
     of clause (ii) of such subparagraph (A) when making the 
     determination under this subsection.
       (c) Report.--Not later than January 1, 2017, the 
     Comptroller General of the United States shall submit to 
     Congress a report that evaluates and describes--
       (1) the effectiveness of the amendments made by subsection 
     (a) in stimulating innovation with respect to medical 
     devices, including any favorable or adverse impact on 
     pediatric device development;
       (2) the impact of such amendments on pediatric device 
     approvals for devices that received a humanitarian use 
     designation under section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of 
     enactment of this Act;
       (3) the status of public and private insurance coverage of 
     devices granted an exemption under paragraph (2) of such 
     section 520(m) (as amended by subsection (a)) and costs to 
     patients of such devices;
       (4) the impact that paragraph (4) of such section 520(m) 
     has had on access to and insurance coverage of devices 
     granted an exemption under paragraph (2) of such section 
     520(m); and
       (5) the effect of the amendments made by subsection (a) on 
     patients described in such section 520(m).

     SEC. 614. REAUTHORIZATION OF THIRD-PARTY REVIEW AND 
                   INSPECTIONS.

       (a) Third Party Review.--Section 523(c) (21 U.S.C. 360m(c)) 
     is amended by striking ``2012'' and inserting ``2017''.
       (b) Third Party Inspections.--Section 704(g)(11) (21 U.S.C. 
     374(g)(11)) is amended by striking ``2012'' and inserting 
     ``2017''.

     SEC. 615. 510(K) DEVICE MODIFICATIONS.

       Having acknowledged to Congress potential unintended 
     consequences that may result from the implementation of the 
     Food and Drug Administration guidance entitled ``Guidance for 
     Industry and FDA Staff--510(k) Device Modifications: Deciding 
     When to Submit a 510(k) for a Change to an Existing Device'', 
     the Secretary of Health and Human Services shall withdraw 
     such guidance promptly and ensure that, before any future 
     guidance document on this issue is made final, affected 
     stakeholders are provided with an opportunity to comment.

     SEC. 616. HEALTH INFORMATION TECHNOLOGY.

       (a) Limitation.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services (referred to 
     in this section as the ``Secretary'') may issue final 
     guidance on medical mobile applications only after the 
     requirements under subsections (b) and (c) are met.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary, in consultation with 
     the Commissioner of Food and Drugs, the National Coordinator 
     for Health Information Technology, and the Chairman of the 
     Federal Communications Commission, shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report that contains a proposed strategy 
     and recommendations on an appropriate, risk-based regulatory 
     framework pertaining to medical device regulation and health 
     information technology software, including mobile 
     applications, that promotes innovation and protects patient 
     safety.
       (c) Working Group.--
       (1) In general.--In carrying out subsection (b), the 
     Secretary shall convene a working group of external 
     stakeholders and experts to provide appropriate input on the 
     strategy and recommendations required for the report under 
     subsection (b).
       (2) Representatives.--The Secretary shall determine the 
     number of representatives participating in the working group, 
     and shall ensure that the working group is geographically 
     diverse and includes representatives of patients, consumers, 
     health care providers, startup companies, health plans or 
     other third-party payers, venture capital investors, 
     information technology vendors, small businesses, purchasers, 
     employers, and other stakeholders with relevant expertise, as 
     determined by the Secretary.
       (3) Other requirements.--
       (A) FACA.--The Federal Advisory Committee Act (5 U.S.C. 
     App.) shall apply to the working group under this section.
       (B) FFDCA advisory committees.--The requirements for 
     advisory committees under section 712 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379d 1), as amended by 
     section 1121, shall not apply to the working group under this 
     section.

                      TITLE VII--DRUG SUPPLY CHAIN

                     Subtitle A--Drug Supply Chain

     SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.

       Section 510 (21 U.S.C. 360) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1), by striking ``On or before'' and all 
     that follows through the period at the end and inserting the 
     following: ``During the period beginning on October 1 and 
     ending on December 31 of each year, every person who owns or 
     operates any establishment in any State engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug or drugs shall register with the 
     Secretary--

[[Page S3587]]

       ``(A) the name of such person, places of business of such 
     person, all such establishments, the unique facility 
     identifier of each such establishment, and a point of contact 
     e-mail address; and
       ``(B) the name and place of business of each importer that 
     takes physical possession of and supplies a drug (other than 
     an excipient) to such person, including all establishments of 
     each such drug importer, the unique facility identifier of 
     each such drug importer establishment, and a point of contact 
     e-mail address for each such drug importer.''; and
       (B) by adding at the end the following:
       ``(3) The Secretary may specify the unique facility 
     identifier system that shall be used by registrants under 
     paragraph (1).''; and
       (2) in subsection (c), by striking ``with the Secretary his 
     name, place of business, and such establishment'' and 
     inserting ``with the Secretary--
       ``(1) with respect to drugs, the information described 
     under subsection (b)(1); and
       ``(2) with respect to devices, the information described 
     under subsection (b)(2).''.

     SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.

       (a) Enforcement of Registration of Foreign 
     Establishments.--Section 502(o) (21 U.S.C. 352(o)) is amended 
     by striking ``in any State''.
       (b) Registration of Foreign Drug Establishments.--Section 
     510(i) (U.S.C. 360(i)) is amended--
       (1) in paragraph (1)--
       (A) by amending the matter preceding subparagraph (A) to 
     read as follows: ``Every person who owns or operates any 
     establishment within any foreign country engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug or device that is imported or offered 
     for import into the United States shall, through electronic 
     means in accordance with the criteria of the Secretary--'';
       (B) by amending subparagraph (A) to read as follows:
       ``(A) upon first engaging in any such activity, immediately 
     submit a registration to the Secretary that includes--
       ``(i) with respect to drugs, the name and place of business 
     of such person, all such establishments, the unique facility 
     identifier of each such establishment, a point of contact e-
     mail address, the name of the United States agent of each 
     such establishment, the name and place of business of each 
     drug importer with which such person conducts business to 
     import or offer to import drugs into the United States, 
     including all establishments of each such drug importer, the 
     unique facility identifier of each such establishment, and a 
     point of contact e-mail address for each such drug importer; 
     and
       ``(ii) with respect to devices, the name and place of 
     business of the establishment, the name of the United States 
     agent for the establishment, the name of each importer of 
     such device in the United States that is known to the 
     establishment, and the name of each person who imports or 
     offers for import such device to the United States for 
     purposes of importation; and''; and
       (C) by amending subparagraph (B) to read as follows:
       ``(B) each establishment subject to the requirements of 
     subparagraph (A) shall thereafter register with the Secretary 
     during the period beginning on October 1 and ending on 
     December 31 of each year.''; and
       (2) by adding at the end the following:
       ``(4) The Secretary may specify the unique facility 
     identifier system that shall be used by registrants under 
     paragraph (1) with respect to drugs.''.

     SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH 
                   PRODUCT LISTING.

       Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amended--
       (1) in subparagraph (C), by striking ``; and'' and 
     inserting a semicolon;
       (2) in subparagraph (D), by striking the period at the end 
     and inserting ``; and''; and
       (3) by adding at the end the following:
       ``(E) in the case of a drug contained in the applicable 
     list, the name and place of business of each manufacturer of 
     an excipient of the listed drug with which the person listing 
     the drug conducts business, including all establishments used 
     in the production of such excipient, the unique facility 
     identifier of each such establishment, and a point of contact 
     e-mail address for each such excipient manufacturer.''.

     SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.

       Section 510(p) (21 U.S.C. 360(p)) is amended--
       (1) by striking ``(p) Registrations and listings'' and 
     inserting the following:
       ``(p) Electronic Registration and Listing.--
       ``(1) In general.--Registration and listing''; and
       (2) by adding at the end the following:
       ``(2) Electronic database.--Not later than 2 years after 
     the Secretary specifies a unique facility identifier system 
     under subsections (b) and (i), the Secretary shall maintain 
     an electronic database, which shall not be subject to 
     inspection under subsection (f), populated with the 
     information submitted as described under paragraph (1) that--
       ``(A) enables personnel of the Food and Drug Administration 
     to search the database by any field of information submitted 
     in a registration described under paragraph (1), or 
     combination of such fields; and
       ``(B) uses the unique facility identifier system to link 
     with other relevant databases within the Food and Drug 
     Administration, including the database for submission of 
     information under section 801(r).
       ``(3) Risk-based information and coordination.--The 
     Secretary shall ensure the accuracy and coordination of 
     relevant Food and Drug Administration databases in order to 
     identify and inform risk-based inspections under section 
     510(h).''.

     SEC. 705. RISK-BASED INSPECTION FREQUENCY.

       Section 510(h) (21 U.S.C. 360(h)) is amended to read as 
     follows:
       ``(h) Inspections.--
       ``(1) In general.--Every establishment that is required to 
     be registered with the Secretary under this section shall be 
     subject to inspection pursuant to section 704.
       ``(2) Biennial inspections for devices.--Every 
     establishment described in paragraph (1), in any State, that 
     is engaged in the manufacture, propagation, compounding, or 
     processing of a device or devices classified in class II or 
     III shall be so inspected by one or more officers or 
     employees duly designated by the Secretary, or by persons 
     accredited to conduct inspections under section 704(g), at 
     least once in the 2-year period beginning with the date of 
     registration of such establishment pursuant to this section 
     and at least once in every successive 2-year period 
     thereafter.
       ``(3) Risk-based schedule for drugs.--The Secretary, acting 
     through one or more officers or employees duly designated by 
     the Secretary, shall inspect establishments described in 
     paragraph (1) that are engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     drug or drugs (referred to in this subsection as `drug 
     establishments') in accordance with a risk-based schedule 
     established by the Secretary.
       ``(4) Risk factors.--In establishing the risk-based 
     scheduled under paragraph (3), the Secretary shall inspect 
     establishments according to the known safety risks of such 
     establishments, which shall be based on the following 
     factors:
       ``(A) The compliance history of the establishment.
       ``(B) The record, history, and nature of recalls linked to 
     the establishment.
       ``(C) The inherent risk of the drug manufactured, prepared, 
     propagated, compounded, or processed at the establishment.
       ``(D) The certifications described under sections 801(r) 
     and 809 for the establishment.
       ``(E) Whether the establishment has been inspected in the 
     preceding 4-year period.
       ``(F) Any other criteria deemed necessary and appropriate 
     by the Secretary for purposes of allocating inspection 
     resources.
       ``(5) Effect of status.--In determining the risk associated 
     with an establishment for purposes of establishing a risk-
     based schedule under paragraph (3), the Secretary shall not 
     consider whether the drugs manufactured, prepared, 
     propagated, compounded, or processed by such establishment 
     are drugs described in section 503(b).
       ``(6) Annual report on inspections of establishments.--Not 
     later than February 1 of each year, the Secretary shall 
     submit a report to Congress regarding--
       ``(A)(i) the number of domestic and foreign establishments 
     registered pursuant to this section in the previous fiscal 
     year; and
       ``(ii) the number of such domestic establishments and the 
     number of such foreign establishments that the Secretary 
     inspected in the previous fiscal year;
       ``(B) with respect to establishments that manufacture, 
     prepare, propagate, compound, or process an active ingredient 
     of a drug, a finished drug product, or an excipient of a 
     drug, the number of each such type of establishment; and
       ``(C) the percentage of the budget of the Food and Drug 
     Administration used to fund the inspections described under 
     subparagraph (A).
       ``(7) Public availability of annual reports.--The Secretary 
     shall make the report required under paragraph (6) available 
     to the public on the Internet Web site of the Food and Drug 
     Administration.''.

     SEC. 706. RECORDS FOR INSPECTION.

       Section 704(a) (21 U.S.C. 374(a)) is amended by adding at 
     the end the following:
       ``(4)(A) Any records or other information that the 
     Secretary is entitled to inspect under this section from a 
     person that owns or operates an establishment that is engaged 
     in the manufacture, preparation, propagation, compounding, or 
     processing of a drug shall, upon the request of the 
     Secretary, be provided to the Secretary by such person within 
     a reasonable time frame, within reasonable limits and in a 
     reasonable manner, and in electronic form, at the expense of 
     such person. The Secretary's request shall include a clear 
     description of the records requested.
       ``(B) Upon receipt of the records requested under 
     subparagraph (A), the Secretary shall provide to the person 
     confirmation of the receipt of such records.
       ``(C) Nothing in this paragraph supplants the authority of 
     the Secretary to conduct inspections otherwise permitted 
     under this Act in order to ensure compliance by an 
     establishment with this Act.''.

     SEC. 707. FAILURE TO ALLOW FOREIGN INSPECTION.

       Section 801(a) (21 U.S.C. 381(a)) is amended by adding at 
     the end the following: ``Notwithstanding any other provision 
     of this subsection, the Secretary of Homeland Security shall, 
     upon request from the Secretary of

[[Page S3588]]

     Health and Human Services refuse to admit into the United 
     States any article if the article was manufactured, prepared, 
     propagated, compounded, processed, or held at an 
     establishment that has refused to permit the Secretary of 
     Health and Human Services to enter or inspect the 
     establishment in the same manner and to the same extent as 
     the Secretary may inspect establishments under section 
     704.''.

     SEC. 708. EXCHANGE OF INFORMATION.

       Section 708 (21 U.S.C. 379) is amended--
       (1) by striking ``confidential information'' and all that 
     follows through ``The Secretary'' and inserting 
     ``CONFIDENTIAL INFORMATION.
       ``(a) Contractors.--The Secretary''; and
       (2) by adding at the end the following:
       ``(b) Ability To Receive and Protect Confidential 
     Information Obtained From Foreign Governments.--
       ``(1) In general.--The Secretary shall not be required to 
     disclose under section 552 of title 5, United States Code 
     (commonly referred to as the Freedom of Information Act), or 
     any other provision of law, any information described in 
     subsection (c)(3) obtained from a foreign government agency, 
     if--
       ``(A) the information is provided or made available to the 
     United States Government voluntarily and on the condition 
     that the information not be released to the public; and
       ``(B) the information is covered by, and subject to, a 
     certification and written agreement under subsections (c)(1) 
     and (c)(2).
       ``(2) Time limitations.--The written agreement described in 
     subsection (c)(2) shall specify the time period for which the 
     non-disclosure requirements under paragraph (1) shall apply 
     to the voluntarily disclosed information. The non-disclosure 
     requirements under paragraph (1) shall not apply after the 
     date specified, but all other applicable legal protections, 
     including section 552 of title 5, United States Code and 
     section 319L(e)(1) of the Public Health Service Act, shall 
     continue to apply to such information, as appropriate. If no 
     date is specified in the written agreement, the non-
     disclosure protections described in paragraph (1) shall not 
     exceed 3 years.
       ``(3) Disclosures not affected.--Nothing in this section 
     authorizes any official to withhold, or to authorize the 
     withholding of, information from Congress or information 
     required to be disclosed pursuant to an order of a court of 
     the United States.
       ``(4) Public information.--For purposes of section 552 of 
     title 5, United States Code, this subsection shall be 
     considered a statute described in section 552(b)(3)(B).
       ``(c) Authority To Enter Into Memoranda of Understanding 
     for Purposes of Information Exchange.--The Secretary may 
     enter into written agreements regarding the exchange of 
     information referenced in section 301(j) subject to the 
     following criteria:
       ``(1) Certification.--The Secretary may only enter into 
     written agreements under this subsection with foreign 
     governments that the Secretary has certified as having the 
     authority and demonstrated ability to protect trade secret 
     information from disclosure. Responsibility for this 
     certification shall not be delegated to any officer or 
     employee other than the Commissioner.
       ``(2) Written agreement.--The written agreement under this 
     subsection shall include a commitment by the foreign 
     government to protect information exchanged under this 
     subsection from disclosure unless and until the sponsor gives 
     written permission for disclosure or the Secretary makes a 
     declaration of a public health emergency pursuant to section 
     319 of the Public Health Service Act that is relevant to the 
     information.
       ``(3) Information exchange.--The Secretary may provide to a 
     foreign government that has been certified under paragraph 
     (1) and that has executed a written agreement under paragraph 
     (2) information referenced in section 301(j) in the following 
     circumstances:
       ``(A) Information concerning the inspection of a facility 
     may be provided if--
       ``(i) the Secretary reasonably believes, or that the 
     written agreement described in paragraph (2) establishes, 
     that the government has authority to otherwise obtain such 
     information; and
       ``(ii) the written agreement executed under paragraph (2) 
     limits the recipient's use of the information to the 
     recipient's civil regulatory purposes.
       ``(B) Information not described in subparagraph (A) may be 
     provided as part of an investigation, or to alert the foreign 
     government to the potential need for an investigation, if the 
     Secretary has reasonable grounds to believe that a drug has a 
     reasonable probability of causing serious adverse health 
     consequences or death to humans or animals.
       ``(4) Effect of subsection.--Nothing in this subsection 
     affects the ability of the Secretary to enter into any 
     written agreement authorized by other provisions of law to 
     share confidential information.''.

     SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE DRUG 
                   SUPPLY.

       Section 501 (21 U.S.C. 351) is amended by adding at the end 
     the following flush text:
     ``For purposes of subsection (a)(2)(B), the term `current 
     good manufacturing practice' includes the implementation of 
     oversight and controls over the manufacture of drugs to 
     ensure quality, including managing the risk of and 
     establishing the safety of raw materials, materials used in 
     the manufacturing of drugs, and finished drug products.''.

     SEC. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG 
                   ESTABLISHMENTS.

       (a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG 
                   ESTABLISHMENTS.

       ``(a) Definitions.--In this section:
       ``(1) Accreditation body.--The term `accreditation body' 
     means an authority that performs accreditation of third-party 
     auditors.
       ``(2) Accredited third-party auditor.--The term `accredited 
     third-party auditor' means a third-party auditor (which may 
     be an individual) accredited by an accreditation body to 
     conduct drug safety and quality audits.
       ``(3) Audit agent.--The term `audit agent' means an 
     individual who is an employee or agent of an accredited 
     third-party auditor and, although not individually 
     accredited, is qualified to conduct drug safety and quality 
     audits on behalf of an accredited third-party auditor.
       ``(4) Consultative audit.--The term `consultative audit' 
     means an audit of an eligible entity intended for internal 
     purposes only to determine whether an establishment is in 
     compliance with the provisions of this Act and applicable 
     industry practices, or any other such service.
       ``(5) Drug safety and quality audit.--The term `drug safety 
     and quality audit'--
       ``(A) means an audit of an eligible entity to certify that 
     the eligible entity meets the requirements of this Act 
     applicable to drugs, including the requirements of section 
     501 with respect to drugs; and
       ``(B) is not a consultative audit.
       ``(6) Eligible entity.--The term `eligible entity' means an 
     entity, including a foreign drug establishment registered 
     under section 510(c), in the drug supply chain that chooses 
     to be audited by an accredited third-party auditor or the 
     audit agent of such accredited third-party auditor.
       ``(7) Third-party auditor.--The term `third-party auditor' 
     means a foreign government, agency of a foreign government or 
     any other third party (which may be an individual), as the 
     Secretary determines appropriate in accordance with the 
     criteria described in subsection (c)(1), that is eligible to 
     be considered for accreditation to conduct drug safety and 
     quality audits.
       ``(b) Accreditation System.--
       ``(1) Recognition of accreditation bodies.--
       ``(A) In general.--Not later than 2 years after date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall establish a system for 
     the recognition of accreditation bodies that accredit third-
     party auditors to conduct drug safety and quality audits.
       ``(B) Direct accreditation.--
       ``(i) In general.--If, by the date that is 2 years after 
     the date of establishment of the system described in 
     subparagraph (A), the Secretary has not identified and 
     recognized an accreditation body to meet the requirements of 
     this section, the Secretary may directly accredit third-party 
     auditors.
       ``(ii) Certain direct accreditations.--Notwithstanding 
     subparagraph (A) or clause (i), the Secretary may directly 
     accredit any foreign government or any agency of a foreign 
     government as a third-party auditor at any time after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act.
       ``(2) Notification.--Each accreditation body recognized by 
     the Secretary shall submit to the Secretary--
       ``(A) a list of all accredited third-party auditors 
     accredited by such body (including the name, contact 
     information, and scope and duration of accreditation for each 
     such auditor), and the audit agents of such auditors; and
       ``(B) updated lists as needed to ensure the list held by 
     the Secretary is accurate.
       ``(3) Revocation of recognition as an accreditation body.--
     The Secretary shall promptly revoke, after the opportunity 
     for an informal hearing, the recognition of any accreditation 
     body found not to be in compliance with the requirements of 
     this section.
       ``(4) Reinstatement.--The Secretary shall establish 
     procedures to reinstate recognition of an accreditation body 
     if the Secretary determines, based on evidence presented by 
     such accreditation body, that revocation was inappropriate or 
     that the body meets the requirements for recognition under 
     this section.
       ``(5) Model accreditation standards.--
       ``(A) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall develop model standards, 
     including standards for drug safety and quality audit 
     results, reports, and certifications, and each recognized 
     accreditation body shall ensure that third-party auditors and 
     audit agents of such auditors meet such standards in order to 
     qualify such third-party auditors as accredited third-party 
     auditors under this section.
       ``(B) Content.--The standards developed under subparagraph 
     (A) may--
       ``(i) include a description of required standards relating 
     to the training procedures, competency, management 
     responsibilities, quality control, and conflict of interest 
     requirements of accredited third-party auditors; and

[[Page S3589]]

       ``(ii) set forth procedures for the periodic renewal of the 
     accreditation of accredited third-party auditors.
       ``(C) Requirement to provide results and reports to the 
     secretary.--An accreditation body (or, in the case of direct 
     accreditation under subsection (b)(1)(B), the Secretary) may 
     not accredit a third-party auditor unless such third-party 
     auditor agrees to provide to the Secretary, upon request, the 
     results and reports of any drug safety and quality audit 
     conducted pursuant to the accreditation provided under this 
     section.
       ``(6) Disclosure.--The Secretary shall maintain on the 
     Internet Web site of the Food and Drug Administration a list 
     of recognized accreditation bodies and accredited third-party 
     auditors under this section.
       ``(c) Accredited Third-party Auditors.--
       ``(1) Requirements for accreditation as a third-party 
     auditor.--
       ``(A) Foreign governments.--Prior to accrediting a foreign 
     government or an agency of a foreign government as an 
     accredited third-party auditor, the accreditation body (or, 
     in the case of direct accreditation under subsection 
     (b)(1)(B), the Secretary) shall perform such reviews and 
     audits of drug safety programs, systems, and standards of the 
     government or agency of the government as the Secretary deems 
     necessary, including requirements under the standards 
     developed under subsection (b)(5), to determine that the 
     foreign government or agency of the foreign government is 
     capable of adequately ensuring that eligible entities or 
     drugs certified by such government or agency meet the 
     requirements of this Act.
       ``(B) Other third parties.--Prior to accrediting any other 
     third party to be an accredited third-party auditor, the 
     accreditation body (or, in the case of direct accreditation 
     under subsection (b)(1)(B), the Secretary) shall perform such 
     reviews and audits of the training and qualifications of 
     audit agents used by that party and conduct such reviews of 
     internal systems and such other investigation of the party as 
     the Secretary deems necessary, including requirements under 
     the standards developed under subsection (b)(5), to determine 
     that the third-party auditor is capable of adequately 
     ensuring that an eligible entity or drug certified by such 
     third-party auditor meets the requirements of this Act.
       ``(2) Use of audit agents.--An accredited third-party 
     auditor may conduct drug safety and quality audits and may 
     employ or use audit agents to conduct drug safety and quality 
     audits, but must ensure that such audit agents comply with 
     all requirements the Secretary deems necessary, including 
     requirements under paragraph (1) and subsection (b)(5).
       ``(3) Revocation of accreditation.--
       ``(A) In general.--The Secretary shall promptly revoke, 
     after the opportunity for an informal hearing, the 
     accreditation of an accredited third-party auditor--
       ``(i) if, following an evaluation, the Secretary finds that 
     the accredited third-party auditor is not in compliance with 
     the requirements of this section; or
       ``(ii) following a refusal to allow United States officials 
     to conduct such audits and investigations as may be necessary 
     to determine compliance with the requirements set forth in 
     this section.
       ``(B) Additional basis for revocation of accreditation.--
     The Secretary may revoke accreditation from an accredited 
     third-party auditor in the case that such third-party auditor 
     is accredited by an accreditation body for which recognition 
     as an accreditation body under subsection (b)(3) is revoked, 
     if the Secretary determines that there is good cause for the 
     revocation of accreditation.
       ``(4) Reaccreditation.--The Secretary shall establish 
     procedures to reinstate the accreditation of a third-party 
     auditor for which accreditation has been revoked under 
     paragraph (3)--
       ``(A) if the Secretary determines, based on evidence 
     presented, that--
       ``(i) the third-party auditor satisfies the requirements of 
     this section; and
       ``(ii) adequate grounds for revocation no longer exist; and
       ``(B) in the case of a third-party auditor accredited by an 
     accreditation body for which recognition as an accreditation 
     body is revoked under subsection (b)(3)--
       ``(i) if the third-party auditor becomes accredited not 
     later than 1 year after revocation of accreditation under 
     paragraph (3), through direct accreditation under subsection 
     (b)(1)(B), or by an accreditation body in good standing; or
       ``(ii) under such other conditions as the Secretary may 
     require.
       ``(5) Requirement to issue certification of eligible 
     entities for compliance with current good manufacturing 
     practice.--
       ``(A) In general.--An accreditation body (or, in the case 
     of direct accreditation under subsection (b)(1)(B), the 
     Secretary) may not accredit a third-party auditor unless such 
     third-party auditor agrees to issue a written and, as 
     appropriate, electronic, document or certification, as the 
     Secretary may require under this Act, regarding compliance 
     with section 501. The Secretary may consider any such 
     document or certification to satisfy requirements under 
     section 801(r) and to target inspection resources under 
     section 510(h).
       ``(B) Requirements for issuing certification.--
       ``(i) In general.--An accredited third-party auditor shall 
     issue a drug certification described in subparagraph (A) only 
     after conducting a drug safety and quality audit and such 
     other activities that may be necessary to establish 
     compliance with the provisions of section 501.
       ``(ii) Provision of certification.--Only an accredited 
     third-party auditor or the Secretary may provide a drug 
     certification described in subparagraph (A).
       ``(C) Records.--Following any accreditation of a third-
     party auditor, the Secretary may, at any time, require the 
     accredited third-party auditor or any audit agent of such 
     auditor to submit to the Secretary a drug safety and quality 
     audit report and such other reports or documents required as 
     part of the drug safety and quality audit process, for any 
     eligible entity for which the accredited third-party auditor 
     or audit agent of such auditor performed a drug safety and 
     quality audit. The Secretary may require documentation that 
     the eligible entity is in compliance with any applicable 
     registration requirements.
       ``(D) Limitation.--The requirement under subparagraph (C) 
     shall not include any report or other documents resulting 
     from a consultative audit, except that the Secretary may 
     access the results of a consultative audit in accordance with 
     section 704.
       ``(E) Declaration of audit type.--Before an accredited 
     third-party auditor begins any audit or provides any 
     consultative service to an eligible entity, both the 
     accredited third-party auditor and eligible entity shall 
     establish in writing whether the audit is intended to be a 
     drug safety and quality audit. Any audit, inspection, or 
     consultative service of any type provided by an accredited 
     third-party auditor on behalf of an eligible entity shall be 
     presumed to be a drug safety and quality audit in the absence 
     of such a written agreement. Once a drug safety and quality 
     audit is initiated, it shall be subject to the requirements 
     of this section, and no person may withhold from the 
     Secretary any document subject to subparagraph (C) on the 
     grounds that the audit was a consultative audit or otherwise 
     not a drug safety and quality audit.
       ``(F) Rule of construction.--Nothing in this section shall 
     be construed to limit the authority of the Secretary under 
     section 704.
       ``(6) Requirements regarding serious risks to the public 
     health.--If, at any time during a drug safety and quality 
     audit, an accredited third-party auditor or an audit agent of 
     such auditor discovers a condition that could cause or 
     contribute to a serious risk to the public health, such 
     auditor shall immediately notify the Secretary of--
       ``(A) the identity and location of the eligible entity 
     subject to the drug safety and quality audit; and
       ``(B) such condition.
       ``(7) Limitations.--
       ``(A) In general.--An audit agent of an accredited third-
     party auditor may not perform a drug safety and quality audit 
     of an eligible entity if such audit agent has performed a 
     drug safety and quality audit or consultative audit of such 
     eligible entity during the previous 13-month period.
       ``(B) Waiver.--The Secretary may waive the application of 
     subparagraph (A) if the Secretary determines that there is 
     insufficient access to accredited third-party auditors in a 
     country or region or that the use of the same audit agent or 
     accredited third-party auditor is otherwise necessary.
       ``(8) Conflicts of interest.--
       ``(A) Accreditation bodies.--A recognized accreditation 
     body shall--
       ``(i) not be owned, managed, or controlled by any person 
     that owns or operates a third-party auditor to be accredited 
     by such body;
       ``(ii) in carrying out accreditation of third-party 
     auditors under this section, have procedures to ensure 
     against the use of any officer or employee of such body that 
     has a financial conflict of interest regarding a third-party 
     auditor to be accredited by such body; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such body and the officers 
     and employees of such body have maintained compliance with 
     clauses (i) and (ii) relating to financial conflicts of 
     interest.
       ``(B) Accredited third-party auditors.--An accredited 
     third-party auditor shall--
       ``(i) not be owned, managed, or controlled by any person 
     that owns or operates an eligible entity to be certified by 
     such auditor;
       ``(ii) in carrying out drug safety and quality audits of 
     eligible entities under this section, have procedures to 
     ensure against the use of any officer or employee of such 
     auditor that has a financial conflict of interest regarding 
     an eligible entity to be certified by such auditor; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such auditor and the 
     officers and employees of such auditor have maintained 
     compliance with clauses (i) and (ii) relating to financial 
     conflicts of interest.
       ``(C) Audit agents.--An audit agent shall--
       ``(i) not own or operate an eligible entity to be audited 
     by such agent;
       ``(ii) in carrying out audits of eligible entities under 
     this section, have procedures to ensure that such agent does 
     not have a financial conflict of interest regarding an 
     eligible entity to be audited by such agent; and
       ``(iii) annually make available to the Secretary 
     disclosures of the extent to which such agent has maintained 
     compliance with clauses (i) and (ii) relating to financial 
     conflicts of interest.
       ``(d) False Statements.--Any statement or representation 
     made--

[[Page S3590]]

       ``(1) by an employee or agent of an eligible entity to an 
     accredited third-party auditor or audit agent; or
       ``(2) by an accreditation body, accredited third-party 
     auditor, or audit agent of such auditor to the Secretary, 
     shall be subject to section 1001 of title 18, United States 
     Code.
       ``(e) Monitoring.--To ensure compliance with the 
     requirements of this section, the Secretary--
       ``(1) shall periodically, or at least once every 4 years, 
     reevaluate the accreditation bodies described in subsection 
     (b)(1);
       ``(2) shall periodically, or at least once every 4 years, 
     evaluate the performance of each accredited third-party 
     auditor, through the review of regulatory audit reports by 
     such auditors, the compliance history as available of 
     eligible entities certified by such auditors, and any other 
     measures deemed necessary by the Secretary;
       ``(3) may at any time, conduct an onsite audit of any 
     eligible entity certified by an accredited third-party 
     auditor, with or without the auditor present; and
       ``(4) shall take any other measures deemed necessary by the 
     Secretary.
       ``(f) Effect of Audit.--The results of a drug safety and 
     quality audit by an accredited third-party auditor under this 
     section--
       ``(1) may be used by the eligible entity--
       ``(A) as documentation of compliance with section 
     501(a)(2)(B) or section 801(r); and
       ``(B) for other purposes as determined appropriate by the 
     Secretary; and
       ``(2) shall be used by the Secretary in establishing the 
     risk-based inspection schedules under section 510(h).
       ``(g) Costs.--
       ``(1) Authorized fees of secretary.--The Secretary may 
     assess fees on accreditation bodies and accredited third-
     party auditors in such an amount necessary to establish and 
     administer the recognition and accreditation program under 
     this section. The Secretary may require accredited third-
     party auditors and audit agents to reimburse the Food and 
     Drug Administration for the work performed to carry out this 
     section. The Secretary shall not generate surplus revenue 
     from such a reimbursement mechanism. Fees authorized under 
     this paragraph shall be collected and available for 
     obligation only to the extent and in the amount provided in 
     advance in appropriation Acts. Such fees are authorized to 
     remain available until expended.
       ``(2) Authorized fees for recognized accreditation 
     bodies.--An accreditation body recognized by the Secretary 
     under subsection (b) may assess a reasonable fee to accredit 
     third-party auditors.
       ``(h) Limitations.--
       ``(1) No effect on section 704 inspections.--The drug 
     safety and quality audits performed under this section shall 
     not be considered inspections under section 704.
       ``(2) No effect on inspection authority.--Nothing in this 
     section affects the authority of the Secretary to inspect any 
     eligible entity pursuant to this Act.
       ``(i) Regulations.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this section.
       ``(2) Procedure.--In promulgating the regulations 
     implementing this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Content.--Such regulations shall include--
       ``(A) requirements that, to the extent practicable, drug 
     safety and quality audits performed under this section be 
     unannounced;
       ``(B) a structure to decrease the potential for conflicts 
     of interest, including timing and public disclosure, for fees 
     paid by eligible entities to accredited third-party auditors; 
     and
       ``(C) appropriate limits on financial affiliations between 
     an accredited third-party auditor or audit agents of such 
     auditor and any person that owns or operates an eligible 
     entity to be audited by such auditor, as described in 
     subparagraphs (A) and (B).
       ``(4) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2).''.
       (b) Report on Accredited Third-party Auditors.--Not later 
     than January 20, 2017, the Comptroller General of the United 
     States shall submit to Congress a report that addresses the 
     following, with respect to the period beginning on the date 
     of implementation of section 809 of the Federal Food, Drug, 
     and Cosmetic Act (as added by subsection (a)) and ending on 
     the date of such report:
       (1) The extent to which drug safety and quality audits 
     completed by accredited third-party auditors under such 
     section 809 are being used by the Secretary of Health and 
     Human Services (referred to in this subsection as the 
     ``Secretary'') in establishing or applying the risk-based 
     inspection schedules under section 510(h) of such Act (as 
     amended by section 705).
       (2) The extent to which drug safety and quality audits 
     completed by accredited third-party auditors or agents are 
     assisting the Food and Drug Administration in evaluating 
     compliance with sections 501(a)(2)(B) of such Act (21 U.S.C. 
     351(a)(2)(B)) and 801(r) of such Act (as added by section 
     711).
       (3) Whether the Secretary has been able to access drug 
     safety and quality audit reports completed by accredited 
     third-party auditors under such section 809.
       (4) Whether accredited third-party auditors accredited 
     under such section 809 have adhered to the conflict of 
     interest provisions set forth in such section.
       (5) The extent to which the Secretary has audited 
     recognized accreditation bodies or accredited third-party 
     auditors to ensure compliance with the requirements of such 
     section 809.
       (6) The number of waivers under subsection (c)(7)(B) of 
     such section 809 issued during the most recent 12-month 
     period and the official justification by the Secretary for 
     each determination that there was insufficient access to an 
     accredited third-party auditor.
       (7) The number of times a manufacturer has used the same 
     accredited third-party auditor for 2 or more consecutive drug 
     safety and quality audits under such section 809.
       (8) Recommendations to Congress regarding the accreditation 
     program under such section 809, including whether Congress 
     should continue, modify, or terminate the program.

     SEC. 711. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.

       Section 801 (21 U.S.C. 381) is amended--
       (1) in subsection (o), by striking ``drug or''; and
       (2) by adding at the end the following:
       ``(r)(1) The Secretary may require, as a condition of 
     granting admission to a drug imported or offered for import 
     into the United States, that the importer electronically 
     submit information demonstrating that the drug complies with 
     applicable requirements of this Act.
       ``(2) The information described under paragraph (1) may 
     include--
       ``(A) information demonstrating the regulatory status of 
     the drug, such as the new drug application, abbreviated new 
     drug application, or investigational new drug or drug master 
     file number;
       ``(B) facility information, such as proof of registration 
     and the unique facility identifier;
       ``(C) indication of compliance with current good 
     manufacturing practice, testing results, certifications 
     relating to satisfactory inspections, and compliance with the 
     country of export regulations; and
       ``(D) any other information deemed necessary and 
     appropriate by the Secretary to assess compliance of the 
     article being offered for import.
       ``(3) Information requirements referred to in paragraph 
     (2)(C) may, at the discretion of the Secretary, be 
     satisfied--
       ``(A) by certifications from accredited third parties, as 
     described under section 809;
       ``(B) through representation by a foreign government, if 
     such inspection is conducted using standards and practices as 
     determined appropriate by the Secretary; or
       ``(C) other appropriate documentation or evidence as 
     described by the Secretary.
       ``(4)(A) Not later than 18 months after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this subsection. Such requirements shall be 
     appropriate for the type of import, such as whether the drug 
     is for import into the United States for use in preclinical 
     research or in a clinical investigation under an 
     investigational new drug exemption under 505(i).
       ``(B) In promulgating the regulations implementing this 
     subsection, the Secretary shall--
       ``(i) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(ii) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(iii) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(C) Notwithstanding any other provision of law, the 
     Secretary shall promulgate regulations implementing this 
     subsection only as described in subparagraph (B).''.

     SEC. 712. NOTIFICATION.

       (a) Prohibited Acts.--Section 301 (21 U.S.C. 331) is 
     amended by adding at the end the following:
       ``(aaa) The failure to notify the Secretary in violation of 
     section 568.''.
       (b) Notification.--
       (1) In general.--Subchapter E of chapter V (21 U.S.C. 
     360bbb et seq.) is amended by adding at the end the 
     following:

     ``SEC. 568. NOTIFICATION.

       ``(a) Notification to Secretary.--With respect to a drug, 
     the Secretary may require notification to the Secretary by a 
     covered person if the covered person knows--
       ``(1) of a substantial loss or theft of such drug; or
       ``(2) that such drug--
       ``(A) has been or is being counterfeited; and
       ``(B)(i) is a counterfeit product in commerce in the United 
     States; or
       ``(ii) is offered for import into the United States.
       ``(b) Manner of Notification.--Notification under this 
     section shall be made in a reasonable time, in such 
     reasonable manner, and by such reasonable means as the 
     Secretary may require by regulation or specify in guidance.
       ``(c) Definition.--In this section, the term `covered 
     person' means--

[[Page S3591]]

       ``(1) a person who is required to register under section 
     510 with respect to an establishment engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug; or
       ``(2) a person engaged in the wholesale distribution (as 
     defined in section 503(e)(3)(B)) of a drug.''.
       (2) Applicability.--Notifications under section 568 of the 
     Federal Food, Drug, and Cosmetic Act (as added by paragraph 
     (1)) apply to losses, thefts, or counterfeiting, as described 
     in subsection (a) of such section 568, that occur on or after 
     the date of enactment of this Act.

     SEC. 713. PROTECTION AGAINST INTENTIONAL ADULTERATION.

       Section 303(b) (21 U.S.C. 333(b)) is amended by adding at 
     the end the following:
       ``(7) Notwithstanding subsection (a)(2), any person that 
     knowingly and intentionally adulterates a drug such that the 
     drug is adulterated under subsection (a)(1), (b), (c), or (d) 
     of section 501 and has a reasonable probability of causing 
     serious adverse health consequences or death to humans or 
     animals shall be imprisoned for not more than 20 years or 
     fined not more than $1,000,000, or both.''.

     SEC. 714. ENHANCED CRIMINAL PENALTY FOR COUNTERFEITING DRUGS.

       (a) FFDCA.--Section 303(b) (21 U.S.C. 333(b)), as amended 
     by section 713, is further amended by adding at the end the 
     following:
       ``(8) Notwithstanding subsection (a)(2), any person who 
     knowingly and intentionally violates section 301(i) shall be 
     imprisoned for not more than 20 years or fined not more than 
     $4,000,000 or both.''.
       (b) Title 18.--Section 2320(b) of title 18, United States 
     Code, is amended--
       (1) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (2) by inserting after paragraph (1) the following:
       ``(2) Counterfeit drugs.--
       ``(A) In general.--Whoever commits an offense under 
     subsection (a) with respect to a drug (as defined in section 
     201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321)) shall--
       ``(i) if an individual, be fined not more than $4,000,000, 
     imprisoned not more than 20 years, or both; and
       ``(ii) if a person other than an individual, be fined not 
     more than $10,000,000.
       ``(B) Multiple offenses.--In the case of an offense by a 
     person under this paragraph that occurs after that person is 
     convicted of another offense under this paragraph, the person 
     convicted--
       ``(i) if an individual, shall be fined not more than 
     $8,000,000, imprisoned not more than 20 years, or both; and
       ``(ii) if other than an individual, shall be fined not more 
     than $20,000,000.''.
       (c) Sentencing.--
       (1) Directive to sentencing commission.--Pursuant to its 
     authority under section 994(p) of title 28, United States 
     Code, and in accordance with this section, the United States 
     Sentencing Commission shall review and amend, if appropriate, 
     its guidelines and its policy statements applicable to 
     persons convicted of an offense described in section 
     2320(b)(2) of title 18, United States Code, as amended by 
     subsection (b), in order to reflect the intent of Congress 
     that such penalties be increased in comparison to those 
     currently provided by the guidelines and policy statements.
       (2) Requirements.--In carrying out this subsection, the 
     Commission shall--
       (A) ensure that the sentencing guidelines and policy 
     statements reflect the intent of Congress that the guidelines 
     and policy statements reflect the serious nature of the 
     offenses described in paragraph (1) and the need for an 
     effective deterrent and appropriate punishment to prevent 
     such offenses;
       (B) consider the extent to which the guidelines may or may 
     not appropriately account for the potential and actual harm 
     to the public resulting from the offense;
       (C) assure reasonable consistency with other relevant 
     directives and with other sentencing guidelines;
       (D) account for any additional aggravating or mitigating 
     circumstances that might justify exceptions to the generally 
     applicable sentencing ranges;
       (E) make any necessary conforming changes to the sentencing 
     guidelines; and
       (F) assure that the guidelines adequately meet the purposes 
     of sentencing as set forth in section 3553(a)(2) of title 18, 
     United States Code.

     SEC. 715. EXTRATERRITORIAL JURISDICTION.

       Chapter III (21 U.S.C. 331 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 311. EXTRATERRITORIAL JURISDICTION.

       ``There is extraterritorial jurisdiction over any violation 
     of this Act relating to any article regulated under this Act 
     if such article was intended for import into the United 
     States or if any act in furtherance of the violation was 
     committed in the United States.''.

     SEC. 716. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.

       Nothing in this title (or an amendment made by this title) 
     shall be construed in a manner inconsistent with the 
     obligations of the United States under the Agreement 
     Establishing the World Trade Organization, or any other 
     treaty or international agreement to which the United States 
     is a party.

           Subtitle B--Pharmaceutical Distribution Integrity

     SEC. 721. SHORT TITLE.

       This subtitle may be referred to as the ``Securing 
     Pharmaceutical Distribution Integrity to Protect the Public 
     Health Act of 2012'' or the ``Securing Pharmaceutical 
     Distribution Integrity Act of 2012''.

     SEC. 722. SECURING THE PHARMACEUTICAL DISTRIBUTION SUPPLY 
                   CHAIN.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by adding at the end the following:

         ``Subchapter H--Pharmaceutical Distribution Integrity

     ``SEC. 581. DEFINITIONS.

       ``In this subchapter:
       ``(1) Data carrier.--The term `data carrier' means a 
     machine-readable graphic that is intended to be affixed to, 
     or imprinted upon, an individual saleable unit and a 
     homogeneous case of product. The data carrier shall comply 
     with a form and format developed by a widely recognized 
     international standards development organization to ensure 
     interoperability among distribution chain participants.
       ``(2) Individual saleable unit.--The term `individual 
     saleable unit' means the smallest container of product put 
     into interstate commerce by the manufacturer that is intended 
     by the manufacturer for individual sale to a pharmacy or 
     other dispenser of such product.
       ``(3) Product.--The term `product' means a finished drug 
     subject to section 503(b)(1).
       ``(4) Product tracing.--The term `product tracing' means--
       ``(A) identifying the immediate previous source and 
     immediate subsequent recipient of a product in wholesale 
     distribution at the lot level where a change of ownership of 
     such product has occurred between non-affiliated entities, 
     except as otherwise described in this subchapter;
       ``(B) identifying the immediate subsequent recipient of the 
     product at the lot level when a manufacturer or repackager 
     introduces such product into interstate commerce;
       ``(C) identifying that manufacturer and dispenser of a 
     product at the lot level when a manufacturer ships a product 
     at the lot level, without regard to the change in ownership 
     involving the wholesale distributor; and
       ``(D) identifying the immediate previous source of a 
     product at the lot level for dispensers.
       ``(5) Rxtec.--The term `RxTEC' means a data carrier that 
     includes the standardized numerical identifier (SNI), the lot 
     number, and the expiration date of a product. The standard 
     data carrier RxTEC shall be a 2D data matrix barcode affixed 
     to each individual saleable unit of a product and a linear or 
     2D data matrix barcode on a homogenous case of a product. 
     Such information shall be both machine readable and human 
     readable.
       ``(6) Suspect product.--The term `suspect product' means a 
     product that, based on credible evidence--
       ``(A) is potentially counterfeit, diverted, or stolen;
       ``(B) is reasonably likely to be intentionally adulterated 
     such that the product would result in serious adverse health 
     consequences or death to humans; or
       ``(C) appears otherwise unfit for distribution such that 
     the product would result in serious adverse health 
     consequence or death to humans.
       ``(7) Verification.--The term `verification' means the 
     process of determining whether a product has the standardized 
     numerical identifier or lot number, consistent with section 
     582, and expiration date assigned by the manufacturer, or the 
     repackager as applicable, and identifying whether a product 
     has the appearance of being a counterfeit, diverted, or 
     stolen product, or a product otherwise unfit for 
     distribution. Verification of the RxTEC data may occur by 
     using either a human-readable, machine-readable, or other 
     method such as through purchase records or invoices.

     ``SEC. 582. ENSURING THE SAFETY OF THE PHARMACEUTICAL 
                   DISTRIBUTION SUPPLY CHAIN THROUGH THE 
                   ESTABLISHMENT OF AN RXTEC SYSTEM.

       ``(a) Manufacturer Requirements.--
       ``(1) Product tracing.--A manufacturer, not later than 4\1/
     2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) apply RxTEC to the individual saleable units and 
     homogeneous case of all products intended to be introduced 
     into interstate commerce;
       ``(B) maintain change of ownership and transaction 
     information, including RxTEC data that associate unit and lot 
     level data for each individual saleable unit of product and 
     homogenous case introduced in interstate commerce; and
       ``(C) maintain, where a change of ownership has occurred 
     between non-affiliated entities or, in the case of a return 
     from the immediate previous source, change of ownership and 
     transaction information relating to a product, including--
       ``(i) RxTEC data;
       ``(ii) the business name and address of the immediate 
     previous source, if applicable, and the immediate subsequent 
     recipient of the product;
       ``(iii) the proprietary or established name or names of the 
     product;
       ``(iv) the National Drug Code number of the product;
       ``(v) container size;
       ``(vi) number of containers;
       ``(vii) the lot number or numbers of the product; and
       ``(viii) the date of the transaction;
       ``(D) provide the following change of ownership and trans 
     action information to the

[[Page S3592]]

     immediate subsequent recipient of such product--
       ``(i) the proprietary or established name or names of the 
     product;
       ``(ii) the National Drug Code number of the product;
       ``(iii) container size;
       ``(iv) number of containers;
       ``(v) the lot number or numbers of the product; and
       ``(vi) a signed statement that the manufacturer did not 
     knowingly and intentionally adulterate or knowingly and 
     intentionally counterfeit such product; and
       ``(E) upon request by the Secretary, other appropriate 
     Federal official, or State official, in the event of a recall 
     or as determined necessary by the Secretary, or such other 
     Federal or State official, to investigate a suspect product, 
     provide in a reasonable time and in a reasonable manner--
       ``(i) RxTEC data by lot; and
       ``(ii) change of ownership and transaction information 
     pursuant to subparagraphs (C) and (D) necessary to identify 
     the immediate previous source or immediate subsequent 
     recipient of such product, as applicable.
       ``(2) Verification requirements.--A manufacturer, not later 
     than 4\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) utilize RxTEC data at the lot level, as part of 
     ongoing activities to significantly minimize or prevent the 
     incidences of a suspect product in the pharmaceutical 
     distribution supply chain, as applicable and appropriate, 
     which--
       ``(i) may include responding to an alert regarding a 
     suspect product from a trading partner or the Secretary, 
     routine monitoring of a suspect product at the lot level 
     while such product is in the possession of the manufacturer, 
     and checking inventory for a suspect product at the request 
     of a trading partner or the Secretary in case of returns; and
       ``(ii) shall take into consideration--

       ``(I) the likelihood that a particular product has a high 
     potential risk with respect to pharmaceutical distribution 
     supply chain security;
       ``(II) the history and severity of incidences of 
     counterfeit, diversion, and theft of such product;
       ``(III) the point in the pharmaceutical distribution supply 
     chain where counterfeit, diversion, or theft has occurred or 
     is most likely to occur;
       ``(IV) the likelihood that such activities will reduce the 
     possibility of the counterfeit, diversion, and theft of such 
     product;
       ``(V) whether the product could mitigate or prevent a drug 
     shortage as defined in section 506C; and
       ``(VI) any guidance the Secretary issues regarding high-
     risk scenarios that could increase the risk of a suspect 
     product entering the pharmaceutical distribution supply 
     chain; and

       ``(B) conduct unit level verification upon the request of a 
     licensed or registered repackager, wholesale distributor, 
     dispenser, or the Secretary, regarding such product.
       ``(3) Notification of product removal.--
       ``(A) In general.--Not later than 4\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     manufacturer, upon confirming that a product does not have 
     the standardized numerical identifier or lot number, 
     consistent with this section, and expiration date assigned by 
     the manufacturer, or has the appearance of being a 
     counterfeit, diverted, or stolen product, or a product 
     otherwise unfit for distribution such that the product would 
     result in serious adverse health consequences or death to 
     humans, shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this subsection may not be redistributed 
     as a saleable product unless the manufacturer, in 
     consultation with the Secretary, determines such product may 
     reenter the pharmaceutical distribution supply chain.
       ``(4) Limitation.--Nothing in this section shall require a 
     manufacturer to aggregate unit level data to cases or 
     pallets.
       ``(b) Repackager Requirements.--
       ``(1) Product tracing.--A repackager, not later than 5\1/2\ 
     years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) apply RxTEC to the individual saleable unit and the 
     homogenous case of all product intended to be introduced into 
     interstate commerce;
       ``(B) maintain change of ownership and transaction 
     information, including RxTEC data, that associate unit and 
     lot level data for each individual saleable unit of product 
     and each homogenous case of product introduced in interstate 
     commerce, including RxTEC data received for such products and 
     for which a repackager applies a new RxTEC;
       ``(C) receive only products encoded with RxTEC data from a 
     licensed or registered manufacturer or wholesaler;
       ``(D) maintain, where a change of ownership has occurred 
     between non-affiliated entities in wholesale distribution, 
     change of ownership and transaction information relating to a 
     product, including--
       ``(i) RxTEC data;
       ``(ii) the business name and address of the immediate 
     previous source and the immediate subsequent recipient of the 
     product;
       ``(iii) the proprietary or established name or names of the 
     product;
       ``(iv) the National Drug Code number of the product;
       ``(v) container size;
       ``(vi) number of containers;
       ``(vii) the lot number or numbers of the product; and
       ``(viii) the date of the transaction;
       ``(E) provide the following change of ownership and 
     transaction information to the immediate subsequent recipient 
     of such product--
       ``(i) the proprietary or established name or names of the 
     product;
       ``(ii) the National Drug Code number of the product;
       ``(iii) container size;
       ``(iv) number of containers;
       ``(v) the lot number or numbers of the product; and
       ``(vi) a signed statement that the repackager--

       ``(I) is licensed or registered;
       ``(II) received the product from a manufacturer that is 
     licensed or registered;
       ``(III) received a signed statement from the manufacturer 
     of such product consistent with subsection (a)(1)(D)(vi); and
       ``(IV) did not knowingly and intentionally adulterate or 
     knowingly and intentionally counterfeit such product; and

       ``(F) upon request by the Secretary, other appropriate 
     Federal official, or State official, in the event of a 
     recall, or as determined necessary by the Secretary or such 
     other Federal or State official to investigate a suspect 
     product, provide in a reasonable time and in a reasonable 
     manner--
       ``(i) RxTEC data by lot; and
       ``(ii) change of ownership and transaction information 
     pursuant to subparagraph (C) or (E) necessary to identify the 
     immediate previous source or the immediate subsequent 
     recipient of such product, as applicable.
       ``(2) Verification requirements.--A repackager, not later 
     than 5\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) utilize RxTEC data at the lot level, as part of 
     ongoing activities to significantly minimize or prevent the 
     incidences of suspect product in the pharmaceutical 
     distribution supply chain, as applicable and appropriate, 
     which--
       ``(i) may include--

       ``(I) responding to alerts regarding a suspect product from 
     a trading partner or the Secretary, routine monitoring of a 
     suspect product at the lot level while such product is in the 
     possession of the repackager; and
       ``(II) checking inventory for a suspect product at the 
     request of a trading partner or the Secretary in the case of 
     returns; and

       ``(ii) shall take into consideration--

       ``(I) the likelihood that a particular product has a high 
     potential risk with respect to pharmaceutical distribution 
     supply chain security;
       ``(II) the history and severity of incidences of 
     counterfeit, diversion, and theft of such product;
       ``(III) the point in the pharmaceutical distribution supply 
     chain where counterfeit, diversion, and theft has occurred or 
     is most likely to occur;
       ``(IV) the likelihood that such activities will reduce the 
     possibility of counterfeit, diversion, and theft of such 
     product;
       ``(V) whether the product could mitigate or prevent a drug 
     shortage as defined in section 506C; and
       ``(VI) any guidance the Secretary issues regarding high-
     risk scenarios that could increase the risk of a suspect 
     product entering the pharmaceutical distribution supply 
     chain; and

       ``(B) conduct unit level verification upon the request of a 
     licensed or registered manufacturer, wholesale distributor, 
     dispenser, or the Secretary, regarding such product.
       ``(3) Notification and product removal.--
       ``(A) In general.--Not later than 5\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     repackager, upon confirming that a product does not have the 
     standardized numerical identifier or lot number, consistent 
     with this section, and expiration date assigned by the 
     manufacturer, or has the appearance of being a counterfeit, 
     diverted, or stolen product, or a product otherwise unfit for 
     distribution such that it would result in serious adverse 
     health consequences or death to humans, shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this subsection may not be redistributed 
     as a saleable product unless the repackager, in consultation 
     with the Secretary, and manufacturer as applicable, 
     determines such product may reenter the pharmaceutical 
     distribution supply chain.
       ``(4) Limitation.--Nothing in this section shall require a 
     repackager to aggregate unit level data to cases or pallets.
       ``(c) Wholesale Distributor Requirements.--
       ``(1) Product tracing requirements.--A wholesale 
     distributor engaged in wholesale distribution, not later than 
     6\1/2\ years after

[[Page S3593]]

     the date of enactment of the Securing Pharmaceutical 
     Distribution Integrity Act of 2012 and in accordance with 
     this section, shall--
       ``(A) receive only products encoded with RxTEC from a 
     licensed or registered manufacturer, wholesaler, or 
     repackager;
       ``(B) maintain, in wholesale distribution where a change of 
     ownership has occurred between non-affiliated entities, 
     change of ownership and transaction information, including--
       ``(i) RxTEC data by lot;
       ``(ii) the business name and address of the immediate 
     previous source and the immediate subsequent recipient of the 
     product;
       ``(iii) the proprietary or established name or names of the 
     product;
       ``(iv) the National Drug Code number of the product;
       ``(v) container size;
       ``(vi) number of containers;
       ``(vii) the lot number or numbers of the product; and
       ``(viii) the date of the transaction;
       ``(C) provide the following change of ownership and 
     transaction information to the immediate subsequent recipient 
     of such product--
       ``(i) the proprietary or established name or names of the 
     product;
       ``(ii) the National Drug Code number of the product;
       ``(iii) container size;
       ``(iv) number of containers;
       ``(v) the lot number or numbers of the product;
       ``(vi) the date of the transaction; and
       ``(vii) a signed statement that the wholesale distributor--

       ``(I) is licensed or registered;
       ``(II) received the product from a registered or licensed 
     manufacturer, repackager, or wholesale distributor, as 
     applicable;
       ``(III) received a signed statement from the immediate 
     subsequent recipient of such product that such trading 
     partner did not knowingly and intentionally adulterate or 
     knowingly and intentionally counterfeit such product; and
       ``(IV) did not knowingly and intentionally adulterate or 
     knowingly and intentionally counterfeit such product; and

       ``(D) upon request by the Secretary, other appropriate 
     Federal official, or State official, in the event of a 
     recall, return, or as determined necessary by the Secretary, 
     or such other Federal or State official, to investigate a 
     suspect product, provide in a reasonable time and in a 
     reasonable manner--
       ``(i) RxTEC data by lot; and
       ``(ii) change of ownership and transaction information 
     pursuant to subparagraphs (B) and (C), as necessary to 
     identify the immediate previous source or the immediate 
     subsequent recipient of such product.
       ``(2) Verification requirements.--
       ``(A) In general.--A wholesale distributor engaged in 
     wholesale distribution, not later than 6\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, 
     shall--
       ``(i) utilize RxTEC data at the lot level, as part of 
     ongoing activities to significantly minimize or prevent the 
     incidence of suspect product in the pharmaceutical 
     distribution supply chain, as applicable and appropriate, 
     which--

       ``(I) may include responding to an alert regarding a 
     suspect product from a trading partner or the Secretary, 
     routine monitoring of a suspect product at the lot level 
     while such product is in the possession of the wholesale 
     distributor, and checking inventory for a suspect product at 
     the request of a trading partner or the Secretary; and
       ``(II) shall take into consideration--

       ``(aa) the likelihood that a particular product has a high 
     potential risk with respect to pharmaceutical distribution 
     supply chain security;
       ``(bb) the history and severity of incidences of 
     counterfeit, diversion, and theft of such product;
       ``(cc) the point in the pharmaceutical distribution supply 
     chain where counterfeit, diversion, and theft has occurred or 
     is most likely to occur;
       ``(dd) the likelihood that such activities will reduce the 
     possibility of counterfeit, diversion, and theft of such 
     product;
       ``(ee) whether the product could mitigate or prevent a drug 
     shortage as defined in section 506C; and
       ``(ff) any guidance the Secretary issues regarding high-
     risk scenarios that could increase the risk of suspect 
     product entering the pharmaceutical distribution supply 
     chain;
       ``(ii) conduct lot-level verification in the event of a 
     recall, including upon the request of a licensed or 
     registered manufacturer, repackager, dispenser, or the 
     Secretary, regarding such product and recall;
       ``(iii) conduct verification of a returned product to 
     validate the return at the lot level for a sealed homogenous 
     case of such product or at the individual saleable unit of 
     such product if the unit is not in a sealed homogenous case; 
     and
       ``(iv) conduct unit level verification of a suspect 
     product--

       ``(I) upon the request of a licensed or registered 
     manufacturer, repackager, wholesaler, dispenser, or the 
     Secretary, regarding such product; or
       ``(II) upon the determination that a product is a suspect 
     product.

       ``(B) Limitation.--Nothing in this paragraph shall require 
     a wholesale distributor to verify product at the unit level 
     except as required under clauses (iii) and (iv) of 
     subparagraph (A).
       ``(3) Notification and product removal.--
       ``(A) In general.--Not later than 6\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     wholesale distributor, upon confirming that a product does 
     not have the standardized numerical identifier or lot number, 
     consistent with this section, and expiration date assigned by 
     the manufacturer, or has the appearance of being a 
     counterfeit, diverted, or stolen product, or a product 
     otherwise unfit for distribution such that the product would 
     result in serious adverse health consequences or death to 
     humans, shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this subsection may not be redistributed 
     as a saleable product unless the wholesaler, in consultation 
     with the Secretary, and manufacturer or repackager as 
     applicable, determines such product may reenter the 
     pharmaceutical distribution supply chain.
       ``(C) Confidential data.--A wholesale distributor may 
     confidentially maintain RxTEC data for a direct trading 
     partner and provide access to such information to such 
     trading partner in lieu of data transmission, if mutually 
     agreed upon by such trading partners.
       ``(d) Dispenser Requirements.--
       ``(1) Product tracing requirements.--A dispenser, not later 
     than 7\1/2\ years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, shall--
       ``(A) receive product only from a licensed or registered 
     manufacturer, repackager, or wholesale distributor;
       ``(B) receive only products encoded with RxTEC lot level 
     data from a manufacturer, repackager, or wholesale 
     distributor selling the drug product to the dispenser;
       ``(C) maintain RxTEC lot level data or allow the wholesale 
     distributor to confidentially maintain and store the RxTEC 
     lot level data sufficient to identify the product provided to 
     the dispenser from the immediate previous source where a 
     change of ownership has occurred between non-affiliated 
     entities (if such arrangement is mutually agreed upon by the 
     dispenser and the wholesale distributor);
       ``(D) use the RxTEC lot level data maintained by the 
     dispenser or maintained by the wholesale distributor on 
     behalf of the dispenser (if such arrangement is mutually 
     agreed upon by the dispenser and the wholesale distributor), 
     as necessary to respond to a request from the Secretary in 
     the event of a suspect product or recall;
       ``(E) maintain lot level data upon change of ownership 
     between non-affiliated entities and for recalled product; and
       ``(F) for investigation purposes only, and upon request by 
     the Secretary, other appropriate Federal official, or State 
     official, for the purpose of investigating a suspect or 
     recalled product, provide the RxTEC data by lot and the 
     immediate previous source or immediate subsequent receipt of 
     the suspect or recalled product, as applicable.
       ``(2) Verification requirements.--Not later than 7\1/2\ 
     years after the date of enactment of the Securing 
     Pharmaceutical Distribution Integrity Act of 2012 and in 
     accordance with this section, a dispenser shall be required 
     to conduct lot level verification of suspect product only.
       ``(3) Notification and product removal.--
       ``(A) In general.--Not later than 7\1/2\ years after the 
     date of enactment of the Securing Pharmaceutical Distribution 
     Integrity Act of 2012 and in accordance with this section, a 
     dispenser, upon confirming that a product is a suspect 
     product or a product otherwise unfit for distribution, 
     shall--
       ``(i) promptly notify the Secretary and impacted trading 
     partners, as applicable and appropriate; and
       ``(ii) take steps to remove such product from the 
     pharmaceutical distribution supply chain.
       ``(B) Redistribution.--Any product subject to a 
     notification under this paragraph may not be redistributed as 
     a saleable product unless the dispenser, in consultation with 
     the Secretary, and manufacturer, repackager, or wholesaler as 
     applicable, determines such product may reenter the 
     pharmaceutical distribution supply chain.
       ``(C) Limitations.--Nothing in this section shall--
       ``(i) require a dispenser to verify product at the unit 
     level; or
       ``(ii) require a dispenser to adopt specific technologies 
     or business systems for compliance with this section.
       ``(e) Ensuring Flexibility.--The requirements under this 
     section shall--
       ``(1) require the maintenance and transmission only of 
     information that is reasonably available and appropriate;
       ``(2) be based on current scientific and technological 
     capabilities and shall neither require nor restrict the use 
     of additional data carrier technologies;
       ``(3) not prescribe or proscribe specific technologies or 
     systems for the maintenance and transmission of data other 
     than the standard data carrier for RxTEC or specific methods 
     of verification;

[[Page S3594]]

       ``(4) not require a record of the complete previous 
     distribution history of the drug from the point of origin of 
     such drug;
       ``(5) take into consideration whether the public health 
     benefits of imposing any additional regulations outweigh the 
     cost of compliance with such requirements;
       ``(6) be scale-appropriate and practicable for entities of 
     varying sizes and capabilities;
       ``(7) with respect to cost and recordkeeping burdens, not 
     require the creation and maintenance of duplicative records 
     where the information is contained in other company records 
     kept in the normal course of business;
       ``(8) to the extent practicable, not require specific 
     business systems for compliance with such requirements;
       ``(9) include a process by which the Secretary may issue a 
     waiver of such regulations for an individual entity if the 
     Secretary determines that such requirements would result in 
     an economic hardship or for emergency medical reasons, 
     including a public health emergency declaration pursuant to 
     section 319 of the Public Health Service Act; and
       ``(10) include a process by which the Secretary may 
     determine exceptions to the standard data carrier RxTEC 
     requirement if a drug is packaged in a container too small or 
     otherwise unable to accommodate a label with sufficient space 
     to bear the information required for compliance with this 
     section.
       ``(f) Regulations and Guidance.--
       ``(1) In general.--The Secretary may issue guidance 
     consistent with this section regarding the circumstances 
     surrounding suspect product and verification practices.
       ``(2) Procedure.--The Secretary, in promulgating any 
     regulation pursuant to this section, shall--
       ``(A) issue a notice of proposed rulemaking that includes a 
     copy of the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2).
       ``(g) Standards.--The Secretary shall, in consultation with 
     other appropriate Federal officials, manufacturers, 
     repackagers, wholesale distributors, dispensers, and other 
     supply chain stakeholders, prioritize and develop standards 
     for the interoperable exchange of ownership and transaction 
     information for tracking and tracing prescription drugs.''.
       (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as 
     amended by section 712, is further amended by inserting at 
     the end the following:
       ``(bbb) The violation of any requirement under section 
     582.''.
       (c) Small Entity Compliance Guide.--Not later than 180 days 
     after enactment of this Act, the Secretary of Health and 
     Human Services (referred to in this title as the 
     ``Secretary'') shall issue a compliance guide setting forth 
     in plain language the requirements under section 582 of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (a), in order to assist small entities in complying with such 
     section.
       (d) Limitations.--
       (1) Savings clause.--Nothing in this subtitle or the 
     amendments made by this subtitle shall preempt any State or 
     local law or regulation.
       (2) Effect on california law.--Notwithstanding any other 
     provision of Federal or State law, including any provision of 
     this subtitle or of subchapter H of chapter V of the Federal 
     Food, Drug, and Cosmetic Act, as added by subsection (a), 
     such subchapter H shall not trigger California Business and 
     Professions Code, section 4034.1.
       (3) Effective date.--Subsection (c) and the amendments made 
     by subsections (a) and (b) shall take effect on January 1, 
     2022, or on the date on which Congress enacts a law providing 
     for express preemption of any State law regulating the 
     distribution of drugs, whichever is later.

     SEC. 723. INDEPENDENT ASSESSMENT.

       (a) In General.--The Secretary shall contract with a 
     private, independent consulting firm capable of performing 
     the technical analysis, management assessment, and program 
     evaluation tasks required to conduct a comprehensive 
     assessment of the process for the review of drug applications 
     under subsections (b) and (j) of section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and 
     subsections (a) and (k) of section 351 of the Public Health 
     Service Act (42 U.S.C. 262(a), (k)). The assessment shall 
     address the premarket review process of drugs by the Food and 
     Drug Administration, using an assessment framework that draws 
     from appropriate quality system standards, including 
     management responsibility, documents controls and records 
     management, and corrective and preventive action.
       (b) Participation.--Representatives of the Food and Drug 
     Administration and manufacturers of drugs subject to user 
     fees under part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) 
     shall participate in a comprehensive assessment of the 
     process for the review of drug applications under section 505 
     of the Federal Food, Drug, and Cosmetic Act and section 351 
     of the Public Health Service Act. The assessment shall be 
     conducted in phases.
       (c) First Contract.--The Secretary shall award the contract 
     for the first assessment under this section not later than 
     March 31, 2013. Such contractor shall evaluate the 
     implementation of recommendations and publish a written 
     assessment not later than February 1, 2016.
       (d) Findings and Recommendations.--
       (1) In general.--The Secretary shall publish the findings 
     and recommendations under this section that are likely to 
     have a significant impact on review times not later than 6 
     months after the contract is awarded. Final comprehensive 
     findings and recommendations shall be published not later 
     than 1 year after the contract is awarded.
       (2) Implementation plan.--The Food and Drug Administration 
     shall publish an implementation plan not later than 6 months 
     after the date of receipt of each set of recommendation.
       (e) Scope of Assessment.--The assessment under this section 
     shall include the following:
       (1) Identification of process improvements and best 
     practices for conducting predictable, efficient, and 
     consistent premarket reviews that meet regulatory review 
     standards.
       (2) Analysis of elements of the review process that consume 
     or save time to facilitate a more efficient process. Such 
     analysis shall include--
       (A) consideration of root causes for inefficiencies that 
     may affect review performance and total time to decision;
       (B) recommended actions to correct any failures to meet 
     user fee program goals; and
       (C) consideration of the impact of combination products on 
     the review process.
       (3) Assessment of methods and controls of the Food and Drug 
     Administration for collecting and reporting information on 
     premarket review process resource use and performance.
       (4) Assessment of effectiveness of the reviewer training 
     program of the Food and Drug Administration.
       (5) Recommendations for ongoing periodic assessments and 
     any additional, more detailed or focused assessments.
       (f) Requirements.--The Secretary shall--
       (1) analyze the recommendations for improvement 
     opportunities identified in the assessment, develop and 
     implement a corrective action plan, and ensure it 
     effectiveness;
       (2) incorporate the findings and recommendations of the 
     contractors, as appropriate, into the management of the 
     premarket review program of the Food and Drug Administration; 
     and
       (3) incorporate the results of the assessment in a Good 
     Review Management Practices guidance document, which shall 
     include initial and ongoing training of Food and Drug 
     Administration staff, and periodic audits of compliance with 
     the guidance.

            TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW

     SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

       (a) In General.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 505D the following:

     ``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
                   QUALIFIED INFECTIOUS DISEASE PRODUCTS.

       ``(a) Extension.--If the Secretary approves an application 
     pursuant to section 505 for a drug that has been designated 
     as a qualified infectious disease product under subsection 
     (d), the 4- and 5-year periods described in subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year 
     periods described in clauses (iii) and (iv) of subsection 
     (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) 
     of section 505, or the 7-year period described in section 
     527, as applicable, shall be extended by 5 years.
       ``(b) Relation to Pediatric Exclusivity.--Any extension 
     under subsection (a) of a period shall be in addition to any 
     extension of the period under section 505A with respect to 
     the drug.
       ``(c) Limitations.--Subsection (a) does not apply to the 
     approval of--
       ``(1) a supplement to an application under section 505(b) 
     for any qualified infectious disease product for which an 
     extension described in subsection (a) is in effect or has 
     expired;
       ``(2) a subsequent application filed with respect to a 
     product approved under section 505 for a change that results 
     in a new indication, route of administration, dosing 
     schedule, dosage form, delivery system, delivery device, or 
     strength; or
       ``(3) an application for a product that is not approved for 
     the use for which it received a designation under subsection 
     (d).
       ``(d) Designation.--
       ``(1) In general.--The manufacturer or sponsor of a drug 
     may request the Secretary to designate a drug as a qualified 
     infectious disease product at any time before the submission 
     of an application under section 505(b) for such drug. The 
     Secretary shall, not later than 60 days after the submission 
     of such a request, determine whether the drug is a qualified 
     infectious disease product.
       ``(2) Limitation.--Except as provided in paragraph (3), a 
     designation under this subsection shall not be withdrawn for 
     any reason, including modifications to the list of qualifying 
     pathogens under subsection (f)(2)(C).
       ``(3) Revocation of designation.--The Secretary may revoke 
     a designation of a drug as a qualified infectious disease 
     product if the

[[Page S3595]]

     Secretary finds that the request for such designation 
     contained an untrue statement of material fact.
       ``(e) Regulations.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt final regulations 
     implementing this section.
       ``(2) Procedure.--In promulgating a regulation implementing 
     this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the effective date of the regulation.
       ``(3) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraph (2), except that 
     the Secretary may issue interim guidance for sponsors seeking 
     designation under subsection (d) prior to the promulgation of 
     such regulations.
       ``(4) Designation prior to regulations.--The Secretary may 
     designate drugs as qualified infectious disease products 
     under subsection (d) prior to the promulgation of regulations 
     under this subsection.
       ``(f) Qualifying Pathogen.--
       ``(1) Definition.--In this section, the term `qualifying 
     pathogen' means a pathogen identified and listed by the 
     Secretary under paragraph (2) that has the potential to pose 
     a serious threat to public health, such as--
       ``(A) resistant gram positive pathogens, including 
     methicillin-resistant Staphylococcus aureus, vancomycin-
     resistant Staphylococcus aureus, and vancomycin-resistant 
     enterococcus;
       ``(B) multi-drug resistant gram negative bacteria, 
     including Acinetobacter, Klebsiella, Pseudomonas, and E. coli 
     species;
       ``(C) multi-drug resistant tuberculosis; and
       ``(D) Clostridium difficile.
       ``(2) List of qualifying pathogens.--
       ``(A) In general.--The Secretary shall establish and 
     maintain a list of qualifying pathogens, and shall make 
     public the methodology for developing such list.
       ``(B) Considerations.--In establishing and maintaining the 
     list of pathogens described under this section the Secretary 
     shall--
       ``(i) consider--

       ``(I) the impact on the public health due to drug-resistant 
     organisms in humans;
       ``(II) the rate of growth of drug-resistant organisms in 
     humans;
       ``(III) the increase in resistance rates in humans; and
       ``(IV) the morbidity and mortality in humans; and

       ``(ii) consult with experts in infectious diseases and 
     antibiotic resistance, including the Centers for Disease 
     Control and Prevention, the Food and Drug Administration, 
     medical professionals, and the clinical research community.
       ``(C) Review.--Every 5 years, or more often as needed, the 
     Secretary shall review, provide modifications to, and publish 
     the list of qualifying pathogens under subparagraph (A) and 
     shall by regulation revise the list as necessary, in 
     accordance with subsection (e).
       ``(g) Qualified Infectious Disease Product.--The term 
     `qualified infectious disease product' means an antibacterial 
     or antifungal drug for human use intended to treat serious or 
     life-threatening infections, including those caused by--
       ``(1) an antibacterial or antifungal resistant pathogen, 
     including novel or emerging infectious pathogens; or
       ``(2) qualifying pathogens listed by the Secretary under 
     subsection (f).''.
       (b) Application.--Section 505E of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to a drug that is first approved under section 
     505(c) of such Act (21 U.S.C. 355(c)) on or after the date of 
     the enactment of this Act.

     SEC. 802. PRIORITY REVIEW.

       (a) Amendment.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 524 the following:

     ``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE 
                   PRODUCTS.

       ``If the Secretary designates a drug under section 505E(d) 
     as a qualified infectious disease product, then the Secretary 
     shall give priority review to any application submitted for 
     approval for such drug under section 505(b).''.
       (b) Application.--Section 524A of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to an application that is submitted under 
     section 505(b) of such Act (21 U.S.C. 355(b)) on or after the 
     date of the enactment of this Act.

     SEC. 803. FAST TRACK PRODUCT.

       Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by 
     section 901(b), is amended by inserting ``, or if the 
     Secretary designates the drug as a qualified infectious 
     disease product under section 505E(d)'' before the period at 
     the end of the first sentence.

     SEC. 804. GAO STUDY.

       (a) In General.--The Comptroller General of the United 
     States shall--
       (1) conduct a study--
       (A) on the need for, and public health impact of, 
     incentives to encourage the research, development, and 
     marketing of qualified infectious disease biological products 
     and antifungal products; and
       (B) consistent with trade and confidentiality data 
     protections, assessing, for all antibacterial and antifungal 
     drugs, including biological products, the average or 
     aggregate--
       (i) costs of all clinical trials for each phase;
       (ii) percentage of success or failure at each phase of 
     clinical trials; and
       (iii) public versus private funding levels of the trials 
     for each phase; and
       (2) not later than 1 year after the date of enactment of 
     this Act, submit a report to Congress on the results of such 
     study, including any recommendations of the Comptroller 
     General on appropriate incentives for addressing such need.
       (b) Contents.--The part of the study described in 
     subsection (a)(1)(A) shall include--
       (1) an assessment of any underlying regulatory issues 
     related to qualified infectious disease products, including 
     qualified infectious disease biological products;
       (2) an assessment of the management by the Food and Drug 
     Administration of the review of qualified infectious disease 
     products, including qualified infectious disease biological 
     products and the regulatory certainty of related regulatory 
     pathways for such products;
       (3) a description of any regulatory impediments to the 
     clinical development of new qualified infectious disease 
     products, including qualified infectious disease biological 
     products, and the efforts of the Food and Drug Administration 
     to address such impediments; and
       (4) recommendations with respect to--
       (A) improving the review and predictability of regulatory 
     pathways for such products; and
       (B) overcoming any regulatory impediments identified in 
     paragraph (3).
       (c) Definitions.--In this section:
       (1) The term ``biological product'' has the meaning given 
     to such term in section 351 of the Public Health Service Act 
     (42 U.S.C. 262).
       (2) The term ``qualified infectious disease biological 
     product'' means a biological product intended to treat a 
     serious or life-threatening infection described in section 
     505E(g) of the Federal Food, Drug, and Cosmetic Act, as added 
     by section 801.
       (3) The term ``qualified infectious disease product'' has 
     the meaning given such term in section 505E(g) of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 801.

     SEC. 805. CLINICAL TRIALS.

       (a) Review and Revision of Guidance Documents.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     review and, as appropriate, revise not fewer than 3 guidance 
     documents per year, which shall include--
       (A) reviewing the guidance documents of the Food and Drug 
     Administration for the conduct of clinical trials with 
     respect to antibacterial and antifungal drugs; and
       (B) as appropriate, revising such guidance documents to 
     reflect developments in scientific and medical information 
     and technology and to ensure clarity regarding the procedures 
     and requirements for approval of antibacterial and antifungal 
     drugs under chapter V of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 351 et seq.).
       (2) Issues for review.--At a minimum, the review under 
     paragraph (1) shall address the appropriate animal models of 
     infection, in vitro techniques, valid micro-biological 
     surrogate markers, the use of non-inferiority versus 
     superiority trials, trial enrollment, data requirements, and 
     appropriate delta values for non-inferiority trials.
       (3) Rule of construction.--Except to the extent to which 
     the Secretary makes revisions under paragraph (1)(B), nothing 
     in this section shall be construed to repeal or otherwise 
     effect the guidance documents of the Food and Drug 
     Administration.
       (b) Recommendations for Investigations.--
       (1) Request.--The sponsor of a drug intended to be 
     designated as a qualified infectious disease product may 
     request that the Secretary provide written recommendations 
     for nonclinical and clinical investigations which the 
     Secretary believes may be necessary to be conducted with the 
     drug before such drug may be approved under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for 
     use in treating, detecting, preventing, or identifying a 
     qualifying pathogen, as defined in section 505E of such Act.
       (2) Recommendations.--If the Secretary has reason to 
     believe that a drug for which a request is made under this 
     subsection is a qualified infectious disease product, the 
     Secretary shall provide the person making the request written 
     recommendations for the nonclinical and clinical 
     investigations which the Secretary believes, on the basis of 
     information available to the Secretary at the time of the 
     request, would be necessary for approval under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of 
     such drug for the use described in paragraph (1).
       (c) GAO Study.--Not later than January 1, 2016, the 
     Comptroller General of the United States shall submit to 
     Congress a report--
       (1) regarding the review and revision of the clinical trial 
     guidance documents required under subsection (a) and the 
     impact such review and revision has had on the review and 
     approval of qualified infectious disease products;
       (2) assessing--

[[Page S3596]]

       (A) the effectiveness of the results-oriented metrics 
     managers employ to ensure that reviewers of such products are 
     familiar with, and consistently applying, clinical trial 
     guidance documents; and
       (B) the predictability of related regulatory pathways and 
     review;
       (3) identifying any outstanding regulatory impediments to 
     the clinical development of qualified infectious disease 
     products;
       (4) reporting on the progress the Food and Drug 
     Administration has made in addressing the impediments 
     identified under paragraph (3); and
       (5) containing recommendations regarding how to improve the 
     review of, and regulatory pathway for, such products.
       (d) Qualified Infectious Disease Product.--For purposes of 
     this section, the term ``qualified infectious disease 
     product'' has the meaning given such term in section 505E(g) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 801.

     SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY.

       (a) Initial Strategy and Implementation Plan.--Not later 
     than 1 year after the date of enactment of this Act, the 
     Secretary of Health and Human Services (referred to in this 
     section as the ``Secretary'') shall submit to Congress a 
     strategy and implementation plan with respect to the 
     requirements of this Act. The strategy and implementation 
     plan shall include--
       (1) a description of the regulatory challenges to clinical 
     development, approval, and licensure of qualified infectious 
     disease products;
       (2) the regulatory and scientific priorities of the 
     Secretary with respect to such challenges; and
       (3) the steps the Secretary will take to ensure regulatory 
     certainty and predictability with respect to qualified 
     infectious disease products, including steps the Secretary 
     will take to ensure managers and reviewers are familiar with 
     related regulatory pathways, requirements of the Food and 
     Drug Administration, guidance documents related to such 
     products, and applying such requirements consistently.
       (b) Subsequent Report.--Not later than 3 years after the 
     date of enactment of this Act, the Secretary shall submit to 
     Congress a report on--
       (1) the progress made toward the priorities identified 
     under subsection (a)(2);
       (2) the number of qualified infectious disease products 
     that have been submitted for approval or licensure on or 
     after the date of enactment of this Act;
       (3) a list of qualified infectious disease products with 
     information on the types of exclusivity granted for each 
     product, consistent with the information published under 
     section 505(j)(7)(A)(iii) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii));
       (4) the number of such qualified infectious disease 
     products and that have been approved or licensed on or after 
     the date of enactment of this Act; and
       (5) the number of calendar days it took for the approval or 
     licensure of the qualified infectious disease products 
     approved or licensed on or after the date of enactment of 
     this Act.
       (c) Qualified Infectious Disease Product.--For purposes of 
     this section, the term ``qualified infectious disease 
     product'' has the meaning given such term in section 505E(g) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 801.

               TITLE IX--DRUG APPROVAL AND PATIENT ACCESS

     SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW 
                   MEDICAL TREATMENTS.

       (a) Findings; Sense of Congress.--
       (1) Findings.--Congress finds as follows:
       (A) The Food and Drug Administration (referred to in this 
     section as the ``FDA'') serves a critical role in helping to 
     assure that new medicines are safe and effective. Regulatory 
     innovation is 1 element of the Nation's strategy to address 
     serious and life-threatening diseases or conditions by 
     promoting investment in and development of innovative 
     treatments for unmet medical needs.
       (B) During the 2 decades following the establishment of the 
     accelerated approval mechanism, advances in medical sciences, 
     including genomics, molecular biology, and bioinformatics, 
     have provided an unprecedented understanding of the 
     underlying biological mechanism and pathogenesis of disease. 
     A new generation of modern, targeted medicines is under 
     development to treat serious and life-threatening diseases, 
     some applying drug development strategies based on biomarkers 
     or pharmacogenomics, predictive toxicology, clinical trial 
     enrichment techniques, and novel clinical trial designs, such 
     as adaptive clinical trials.
       (C) As a result of these remarkable scientific and medical 
     advances, the FDA should be encouraged to implement more 
     broadly effective processes for the expedited development and 
     review of innovative new medicines intended to address unmet 
     medical needs for serious or life-threatening diseases or 
     conditions, including those for rare diseases or conditions, 
     using a broad range of surrogate or clinical endpoints and 
     modern scientific tools earlier in the drug development cycle 
     when appropriate. This may result in fewer, smaller, or 
     shorter clinical trials for the intended patient population 
     or targeted subpopulation without compromising or altering 
     the high standards of the FDA for the approval of drugs.
       (D) Patients benefit from expedited access to safe and 
     effective innovative therapies to treat unmet medical needs 
     for serious or life-threatening diseases or conditions.
       (E) For these reasons, the statutory authority in effect on 
     the day before the date of enactment of this Act governing 
     expedited approval of drugs for serious or life-threatening 
     diseases or conditions should be amended in order to enhance 
     the authority of the FDA to consider appropriate scientific 
     data, methods, and tools, and to expedite development and 
     access to novel treatments for patients with a broad range of 
     serious or life-threatening diseases or conditions.
       (2) Sense of congress.--It is the sense of Congress that 
     the Food and Drug Administration should apply the accelerated 
     approval and fast track provisions set forth in section 506 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), 
     as amended by this section, to help expedite the development 
     and availability to patients of treatments for serious or 
     life-threatening diseases or conditions while maintaining 
     safety and effectiveness standards for such treatments.
       (b) Expedited Approval of Drugs for Serious or Life-
     Threatening Diseases or Conditions.--Section 506 (21 U.S.C. 
     356) is amended to read as follows:

     ``SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
                   THREATENING DISEASES OR CONDITIONS.

       ``(a) Designation of Drug as Fast Track Product.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a new drug, facilitate the development and 
     expedite the review of such drug if it is intended, whether 
     alone or in combination with one or more other drugs, for the 
     treatment of a serious or life-threatening disease or 
     condition, and it demonstrates the potential to address unmet 
     medical needs for such a disease or condition. (In this 
     section, such a drug is referred to as a `fast track 
     product'.)
       ``(2) Request for designation.--The sponsor of a new drug 
     may request the Secretary to designate the drug as a fast 
     track product. A request for the designation may be made 
     concurrently with, or at any time after, submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--Within 60 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track product 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such product.
       ``(b) Accelerated Approval of a Drug for a Serious or Life-
     Threatening Disease or Condition, Including a Fast Track 
     Product.--
       ``(1) In general.--
       ``(A) Accelerated approval.--The Secretary may approve an 
     application for approval of a product for a serious or life-
     threatening disease or condition, including a fast track 
     product, under section 505(c) or section 351(a) of the Public 
     Health Service Act upon a determination that the product has 
     an effect on a surrogate endpoint that is reasonably likely 
     to predict clinical benefit, or on a clinical endpoint that 
     can be measured earlier than irreversible morbidity or 
     mortality, that is reasonably likely to predict an effect on 
     irreversible morbidity or mortality or other clinical 
     benefit, taking into account the severity, rarity, or 
     prevalence of the condition and the availability or lack of 
     alternative treatments. The approval described in the 
     preceding sentence is referred to in this section as 
     `accelerated approval'.
       ``(B) Evidence.--The evidence to support that an endpoint 
     is reasonably likely to predict clinical benefit under 
     subparagraph (A) may include epidemiological, 
     pathophysiological, therapeutic, pharmacologic, or other 
     evidence developed using biomarkers, for example, or other 
     scientific methods or tools.
       ``(2) Limitation.--Approval of a product under this 
     subsection may be subject to 1 or both of the following 
     requirements:
       ``(A) That the sponsor conduct appropriate post-approval 
     studies to verify and describe the predicted effect on 
     irreversible morbidity or mortality or other clinical 
     benefit.
       ``(B) That the sponsor submit copies of all promotional 
     materials related to the product during the preapproval 
     review period and, following approval and for such period 
     thereafter as the Secretary determines to be appropriate, at 
     least 30 days prior to dissemination of the materials.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a product approved under accelerated 
     approval using expedited procedures (as prescribed by the 
     Secretary in regulations which shall include an opportunity 
     for an informal hearing) if--
       ``(A) the sponsor fails to conduct any required post-
     approval study of the drug with due diligence;
       ``(B) a study required to verify and describe the predicted 
     effect on irreversible morbidity or mortality or other 
     clinical benefit of the

[[Page S3597]]

     product fails to verify and describe such effect or benefit;
       ``(C) other evidence demonstrates that the product is not 
     safe or effective under the conditions of use; or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the product.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Product.--
       ``(1) In general.--If the Secretary determines, after 
     preliminary evaluation of clinical data submitted by the 
     sponsor, that a fast track product may be effective, the 
     Secretary shall evaluate for filing, and may commence review 
     of portions of, an application for the approval of the 
     product before the sponsor submits a complete application. 
     The Secretary shall commence such review only if the 
     applicant--
       ``(A) provides a schedule for submission of information 
     necessary to make the application complete; and
       ``(B) pays any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a description of the provisions 
     of this section applicable to accelerated approval and fast 
     track products; and
       ``(2) establish a program to encourage the development of 
     surrogate and clinical endpoints, including biomarkers, and 
     other scientific methods and tools that can assist the 
     Secretary in determining whether the evidence submitted in an 
     application is reasonably likely to predict clinical benefit 
     for serious or life-threatening conditions for which 
     significant unmet medical needs exist.
       ``(e) Construction.--
       ``(1) Purpose.--The amendments made by the Food and Drug 
     Administration Safety and Innovation Act to this section are 
     intended to encourage the Secretary to utilize innovative and 
     flexible approaches to the assessment of products under 
     accelerated approval for treatments for patients with serious 
     or life-threatening diseases or conditions and unmet medical 
     needs.
       ``(2) Construction.--Nothing in this section shall be 
     construed to alter the standards of evidence under subsection 
     (c) or (d) of section 505 (including the substantial evidence 
     standard in section 505(d)) of this Act or under section 
     351(a) of the Public Health Service Act. Such sections and 
     standards of evidence apply to the review and approval of 
     products under this section, including whether a product is 
     safe and effective. Nothing in this section alters the 
     ability of the Secretary to rely on evidence that does not 
     come from adequate and well-controlled investigations for the 
     purpose of determining whether an endpoint is reasonably 
     likely to predict clinical benefit as described in subsection 
     (b)(1)(B).''.
       (c) Guidance; Amended Regulations.--
       (1) Draft guidance.--Not later than 1 year after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance to implement the amendments made 
     by this section. In developing such guidance, the Secretary 
     shall specifically consider issues arising under the 
     accelerated approval and fast track processes under section 
     506 of the Federal Food, Drug, and Cosmetic Act, as amended 
     by subsection (b), for drugs designated for a rare disease or 
     condition under section 526 of such Act (21 U.S.C. 360bb) and 
     shall also consider any unique issues associated with very 
     rare diseases.
       (2) Final guidance.--Not later than 1 year after the 
     issuance of draft guidance under paragraph (1), and after an 
     opportunity for public comment, the Secretary shall issue 
     final guidance.
       (3) Conforming changes.--The Secretary shall issue, as 
     necessary, conforming amendments to the applicable 
     regulations under title 21, Code of Federal Regulations, 
     governing accelerated approval.
       (4) No effect of inaction on requests.--If the Secretary 
     fails to issue final guidance or amended regulations as 
     required by this subsection, such failure shall not preclude 
     the review of, or action on, a request for designation or an 
     application for approval submitted pursuant to section 506 of 
     the Federal Food, Drug, and Cosmetic Act, as amended by 
     subsection (b).
       (d) Independent Review.--The Secretary may, in conjunction 
     with other planned reviews, contract with an independent 
     entity with expertise in assessing the quality and efficiency 
     of biopharmaceutical development and regulatory review 
     programs to evaluate the Food and Drug Administration's 
     application of the processes described in section 506 of the 
     Federal Food, Drug, and Cosmetic Act, as amended by 
     subsection (b), and the impact of such processes on the 
     development and timely availability of innovative treatments 
     for patients suffering from serious or life-threatening 
     conditions. Any such evaluation shall include consultation 
     with regulated industries, patient advocacy and disease 
     research foundations, and relevant academic medical centers.

     SEC. 902. BREAKTHROUGH THERAPIES.

       (a) In General.--Section 506 (21 U.S.C. 356), as amended by 
     section 901, is further amended--
       (1) by redesignating subsections (a) through (c) as 
     subsections (b) through (d), respectively;
       (2) by redesignating subsection (d) as subsection (f);
       (3) by inserting before subsection (b), as so redesignated, 
     the following:
       ``(a) Designation of a Drug as a Breakthrough Therapy.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a drug, expedite the development and review of 
     such drug if the drug is intended, alone or in combination 
     with 1 or more other drugs, to treat a serious or life-
     threatening disease or condition and preliminary clinical 
     evidence indicates that the drug may demonstrate substantial 
     improvement over existing therapies on 1 or more clinically 
     significant endpoints, such as substantial treatment effects 
     observed early in clinical development. (In this section, 
     such a drug is referred to as a `breakthrough therapy'.)
       ``(2) Request for designation.--The sponsor of a drug may 
     request the Secretary to designate the drug as a breakthrough 
     therapy. A request for the designation may be made 
     concurrently with, or at any time after, the submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--
       ``(A) In general.--Not later than 60 calendar days after 
     the receipt of a request under paragraph (2), the Secretary 
     shall determine whether the drug that is the subject of the 
     request meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a breakthrough therapy 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such drug.
       ``(B) Actions.--The actions to expedite the development and 
     review of an application under subparagraph (A) may include, 
     as appropriate--
       ``(i) holding meetings with the sponsor and the review team 
     throughout the development of the drug;
       ``(ii) providing timely advice to, and interactive 
     communication with, the sponsor regarding the development of 
     the drug to ensure that the development program to gather the 
     non-clinical and clinical data necessary for approval is as 
     efficient as practicable;
       ``(iii) involving senior managers and experienced review 
     staff, as appropriate, in a collaborative, cross-disciplinary 
     review;
       ``(iv) assigning a cross-disciplinary project lead for the 
     Food and Drug Administration review team to facilitate an 
     efficient review of the development program and to serve as a 
     scientific liaison between the review team and the sponsor; 
     and
       ``(v) taking steps to ensure that the design of the 
     clinical trials is as efficient as practicable, when 
     scientifically appropriate, such as by minimizing the number 
     of patients exposed to a potentially less efficacious 
     treatment.'';
       (4) in subsection (f)(1), as so redesignated, by striking 
     ``applicable to accelerated approval'' and inserting 
     ``applicable to breakthrough therapies, accelerated approval, 
     and''; and
       (5) by adding at the end the following:
       ``(g) Report.--Beginning in fiscal year 2013, the Secretary 
     shall annually prepare and submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, and make publicly available, with respect to 
     this section for the previous fiscal year--
       ``(1) the number of drugs for which a sponsor requested 
     designation as a breakthrough therapy;
       ``(2) the number of products designated as a breakthrough 
     therapy; and
       ``(3) for each product designated as a breakthrough 
     therapy, a summary of the actions taken under subsection 
     (a)(3).''.
       (b) Guidance; Amended Regulations.--
       (1) In general.--
       (A) Guidance.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance on implementing the requirements 
     with respect to breakthrough therapies, as set forth in 
     section 506(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 356(a)), as amended by this section. The Secretary 
     shall issue final guidance not later than 1 year after the 
     close of the comment period for the draft guidance.
       (B) Amended regulations.--
       (i) In general.--If the Secretary determines that it is 
     necessary to amend the regulations under title 21, Code of 
     Federal Regulations in order to implement the amendments made 
     by this section to section 506(a) of the Federal Food, Drug, 
     and Cosmetic Act, the Secretary shall amend such regulations 
     not later than 2 years after the date of enactment of this 
     Act.
       (ii) Procedure.--In amending regulations under clause (i), 
     the Secretary shall--

       (I) issue a notice of proposed rulemaking that includes the 
     proposed regulation;

[[Page S3598]]

       (II) provide a period of not less than 60 days for comments 
     on the proposed regulation; and
       (III) publish the final regulation not less than 30 days 
     before the effective date of the regulation.

       (iii) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     the amendments made by section only as described in clause 
     (ii).
       (2) Requirements.--Guidance issued under this section 
     shall--
       (A) specify the process and criteria by which the Secretary 
     makes a designation under section 506(a)(3) of the Federal 
     Food, Drug, and Cosmetic Act; and
       (B) specify the actions the Secretary shall take to 
     expedite the development and review of a breakthrough therapy 
     pursuant to such designation under such section 506(a)(3), 
     including updating good review management practices to 
     reflect breakthrough therapies.
       (c) Independent Review.--Not later than 3 years after the 
     date of enactment of this Act, the Comptroller General of the 
     United States, in consultation with appropriate experts, 
     shall assess the manner by which the Food and Drug 
     Administration has applied the processes described in section 
     506(a) of the Federal Food, Drug, and Cosmetic Act, as 
     amended by this section, and the impact of such processes on 
     the development and timely availability of innovative 
     treatments for patients affected by serious or life-
     threatening conditions. Such assessment shall be made 
     publicly available upon completion.
       (d) Conforming Amendments.--Section 506B(e) (21 U.S.C. 
     356b) is amended by striking ``section 506(b)(2)(A)'' each 
     place such term appears and inserting ``section 
     506(c)(2)(A)''.

     SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 712, is further amended by adding at the 
     end the following:

     ``SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       ``(a) In General.--For the purpose of promoting the 
     efficiency of and informing the review by the Food and Drug 
     Administration of new drugs and biological products for rare 
     diseases and drugs and biological products that are 
     genetically targeted, the following shall apply:
       ``(1) Consultation with stakeholders.--Consistent with 
     sections X.C and IX.E.4 of the PDUFA Reauthorization 
     Performance Goals and Procedures Fiscal Years 2013 through 
     2017, as referenced in the letters described in section 
     101(b) of the Prescription Drug User Fee Amendments of 2012, 
     the Secretary shall ensure that opportunities exist, at a 
     time the Secretary determines appropriate, for consultations 
     with stakeholders on the topics described in subsection (c).
       ``(2) Consultation with external experts.--The Secretary 
     shall develop and maintain a list of external experts who, 
     because of their special expertise, are qualified to provide 
     advice on rare disease issues, including topics described in 
     subsection (c). The Secretary may, when appropriate to 
     address a specific regulatory question, consult such external 
     experts on issues related to the review of new drugs and 
     biological products for rare diseases and drugs and 
     biological products that are genetically targeted, including 
     the topics described in subsection (c), when such 
     consultation is necessary because the Secretary lacks 
     specific scientific, medical, or technical expertise 
     necessary for the performance of its regulatory 
     responsibilities and the necessary expertise can be provided 
     by the external experts.
       ``(b) External Experts.--For purposes of subsection (a)(2), 
     external experts are those who possess scientific or medical 
     training that the Secretary lacks with respect to one or more 
     rare diseases.
       ``(c) Topics for Consultation.--Topics for consultation 
     pursuant to this section may include--
       ``(1) rare diseases;
       ``(2) the severity of rare diseases;
       ``(3) the unmet medical need associated with rare diseases;
       ``(4) the willingness and ability of individuals with a 
     rare disease to participate in clinical trials;
       ``(5) an assessment of the benefits and risks of therapies 
     to treat rare diseases;
       ``(6) the general design of clinical trials for rare 
     disease populations and subpopulations; and
       ``(7) demographics and the clinical description of patient 
     populations.
       ``(d) Classification as Special Government Employees.--The 
     external experts who are consulted under this section may be 
     considered special government employees, as defined under 
     section 202 of title 18, United States Code.
       ``(e) Protection of Proprietary Information.--Nothing in 
     this section shall be construed to alter the protections 
     offered by laws, regulations, and policies governing 
     disclosure of confidential commercial or trade secret 
     information, and any other information exempt from disclosure 
     pursuant to section 552(b) of title 5, United States Code, as 
     such provisions would be applied to consultation with 
     individuals and organizations prior to the date of enactment 
     of this section.
       ``(f) Other Consultation.--Nothing in this section shall be 
     construed to limit the ability of the Secretary to consult 
     with individuals and organizations as authorized prior to the 
     date of enactment of this section.
       ``(g) No Right or Obligation.--Nothing in this section 
     shall be construed to create a legal right for a consultation 
     on any matter or require the Secretary to meet with any 
     particular expert or stakeholder. Nothing in this section 
     shall be construed to alter agreed upon goals and procedures 
     identified in the letters described in section 101(b) of the 
     Prescription Drug User Fee Amendments of 2012. Nothing in 
     this section is intended to increase the number of review 
     cycles as in effect before the date of enactment of this 
     section.''.

     SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG 
                   CONTAINER LABELS BY VISUALLY-IMPAIRED AND BLIND 
                   CONSUMERS.

       (a) Establishment of Working Group.--
       (1) In general.--The Architectural and Transportation 
     Barriers Compliance Board (referred to in this section as the 
     ``Access Board'') shall convene a stakeholder working group 
     (referred to in this section as the ``working group'') to 
     develop best practices on access to information on 
     prescription drug container labels for individuals who are 
     blind or visually impaired.
       (2) Members.--The working group shall be comprised of 
     representatives of national organizations representing blind 
     and visually-impaired individuals, national organizations 
     representing the elderly, and industry groups representing 
     stakeholders, including retail, mail order, and independent 
     community pharmacies, who would be impacted by such best 
     practices. Representation within the working group shall be 
     divided equally between consumer and industry advocates.
       (3) Best practices.--
       (A) In general.--The working group shall develop, not later 
     than 1 year after the date of the enactment of this Act, best 
     practices for pharmacies to ensure that blind and visually-
     impaired individuals have safe, consistent, reliable, and 
     independent access to the information on prescription drug 
     container labels.
       (B) Public availability.--The best practices developed 
     under subparagraph (A) may be made publicly available, 
     including through the Internet websites of the working group 
     participant organizations, and through other means, in a 
     manner that provides access to interested individuals, 
     including individuals with disabilities.
       (C) Limitations.--The best practices developed under 
     subparagraph (A) shall not be construed as accessibility 
     guidelines or standards of the Access Board, and shall not 
     confer any rights or impose any obligations on working group 
     participants or other persons. Nothing in this section shall 
     be construed to limit or condition any right, obligation, or 
     remedy available under the Americans with Disabilities Act of 
     1990 (42 U.S.C. 12101 et seq.) or any other Federal or State 
     law requiring effective communication, barrier removal, or 
     nondiscrimination on the basis of disability.
       (4) Considerations.--In developing and issuing the best 
     practices under paragraph (3)(A), the working group shall 
     consider--
       (A) the use of--
       (i) Braille;
       (ii) auditory means, such as--

       (I) ``talking bottles'' that provide audible container 
     label information;
       (II) digital voice recorders attached to the prescription 
     drug container; and
       (III) radio frequency identification tags;

       (iii) enhanced visual means, such as--

       (I) large font labels or large font ``duplicate'' labels 
     that are affixed or matched to a prescription drug container;
       (II) high-contrast printing; and
       (III) sans-serf font; and

       (iv) other relevant alternatives as determined by the 
     working group;
       (B) whether there are technical, financial, manpower, or 
     other factors unique to pharmacies with 20 or fewer retail 
     locations which may pose significant challenges to the 
     adoption of the best practices; and
       (C) such other factors as the working group determines to 
     be appropriate.
       (5) Information campaign.--Upon completion of development 
     of the best practices under subsection (a)(3), the National 
     Council on Disability, in consultation with the working 
     group, shall conduct an informational and educational 
     campaign designed to inform individuals with disabilities, 
     pharmacists, and the public about such best practices.
       (6) FACA waiver.--The Federal Advisory Committee Act (5 
     U.S.C. App.) shall not apply to the working group.
       (b) GAO Study.--
       (1) In general.--Beginning 18 months after the completion 
     of the development of best practices under subsection 
     (a)(3)(A), the Comptroller General of the United States shall 
     conduct a review of the extent to which pharmacies are 
     utilizing such best practices, and the extent to which 
     barriers to accessible information on prescription drug 
     container labels for blind and visually-impaired individuals 
     continue.
       (2) Report.--Not later than September 30, 2016, the 
     Comptroller General of the United States shall submit to 
     Congress a report on the review conducted under paragraph 
     (1). Such report shall include recommendations about how best 
     to reduce the barriers experienced by blind and visually-
     impaired individuals to independently accessing information 
     on prescription drug container labels.
       (c) Definitions.--In this section--

[[Page S3599]]

       (1) the term ``pharmacy'' includes a pharmacy that receives 
     prescriptions and dispenses prescription drugs through an 
     Internet website or by mail;
       (2) the term ``prescription drug'' means a drug subject to 
     section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 353(b)(1)); and
       (3) the term ``prescription drug container label'' means 
     the label with the directions for use that is affixed to the 
     prescription drug container by the pharmacist and dispensed 
     to the consumer.

     SEC. 905. RISK-BENEFIT FRAMEWORK.

       Section 505(d) (21 U.S.C. 355(d)) is amended by adding at 
     the end the following: ``The Secretary shall implement a 
     structured risk-benefit assessment framework in the new drug 
     approval process to facilitate the balanced consideration of 
     benefits and risks, a consistent and systematic approach to 
     the discussion and regulatory decisionmaking, and the 
     communication of the benefits and risks of new drugs. Nothing 
     in the preceding sentence shall alter the criteria for 
     evaluating an application for premarket approval of a 
     drug.''.

     SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT 
                   MODEL.

       (a) In General.--The Secretary of Health and Human Services 
     shall enter into an agreement with the National Academies to 
     provide expert consultation and conduct a study that 
     evaluates the feasibility and possible consequences of the 
     use of innovation inducement prizes to reward successful 
     medical innovations. Under the agreement, the National 
     Academies shall submit to the Secretary a report on such 
     study not later than 15 months after the date of enactment of 
     this Act.
       (b) Requirements.--
       (1) In general.--The study conducted under subsection (a) 
     shall model at least 3 separate segments on the medical 
     technologies market as candidate targets for the new 
     incentive system and consider different medical innovation 
     inducement prize design issues, including the challenges 
     presented in the implementation of prizes for end products, 
     open source dividend prizes, and prizes for upstream 
     research.
       (2) Market segments.--The segments on the medical 
     technologies market that shall be considered under paragraph 
     (1) include--
       (A) all pharmaceutical and biologic drugs and vaccines;
       (B) drugs and vaccines used solely for the treatment of 
     HIV/AIDS; and
       (C) antibiotics.
       (c) Elements.--The study conducted under subsection (a) 
     shall include consideration of each of the following:
       (1) Whether a system of large innovation inducement prizes 
     could work as a replacement for the existing product 
     monopoly/patent-based system, as in effect on the date of 
     enactment of this Act.
       (2) How large the innovation prize funds would have to be 
     in order to induce at least as much research and development 
     investment in innovation as is induced under the current 
     system of time-limited market exclusivity, as in effect on 
     the date of enactment of this Act.
       (3) Whether a system of large innovation inducement prizes 
     would be more or less expensive than the current system of 
     time-limited market exclusivity, as in effect on the date of 
     enactment of this Act, calculated over different time 
     periods.
       (4) Whether a system of large innovation inducement prizes 
     would expand access to new products and improve health 
     outcomes.
       (5) The type of information and decisionmaking skills that 
     would be necessary to manage end product prizes.
       (6) Whether there would there be major advantages in 
     rewarding the incremental impact of innovations, as 
     benchmarked against existing products.
       (7) How open-source dividend prizes could be managed, and 
     whether such prizes would increase access to knowledge, 
     materials, data and technologies.
       (8) Whether a system of competitive intermediaries for 
     interim research prizes would provide an acceptable solution 
     to the valuation challenges for interim prizes.

     SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM.

       (a) Reauthorization of Program.--Section 5(c) of the Orphan 
     Drug Act (21 U.S.C. 360ee(c)) is amended by striking ``2008 
     through 2012'' and inserting ``2013 through 2017''.
       (b) Human Clinical Testing.--Section 5(b)(1)(A)(ii)) of the 
     Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is amended by 
     striking ``after the date such drug is designated under 
     section 526 of such Act and''.

     SEC. 908. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN 
                   CLINICAL TRIALS AND DATA ANALYSIS IN 
                   APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES.

       (a) Report.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary, acting through the 
     Commissioner, shall publish on the Internet website of the 
     Food and Drug Administration a report, consistent with the 
     regulations of the Food and Drug Administration pertaining to 
     the protection of sponsors' confidential commercial 
     information as of the date of enactment of this Act, 
     addressing the extent to which clinical trial participation 
     and the inclusion of safety and effectiveness data by 
     demographic subgroups including sex, age, race, and 
     ethnicity, is included in applications submitted to the Food 
     and Drug Administration, and shall provide such publication 
     to Congress.
       (2) Contents of report.--The report described in paragraph 
     (1) shall contain the following:
       (A) A description of existing tools to ensure that data to 
     support demographic analyses are submitted in applications 
     for drugs, biological products, and devices, and that these 
     analyses are conducted by applicants consistent with 
     applicable Food and Drug Administration requirements and 
     Guidance for Industry. The report shall address how the Food 
     and Drug Administration makes available information about 
     differences in safety and effectiveness of medical products 
     according to demographic subgroups, such as sex, age, racial, 
     and ethnic subgroups, to healthcare providers, researchers, 
     and patients.
       (B) An analysis of the extent to which demographic data 
     subset analyses on sex, age, race, and ethnicity is presented 
     in applications for new drug applications for new molecular 
     entities under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), in biologics license 
     applications under section 351 of the Public Health Service 
     Act (42 U.S.C. 262), and in premarket approval applications 
     under section 515 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360e) for products approved or licensed by the 
     Food and Drug Administration, consistent with applicable 
     requirements and Guidance for Industry, and consistent with 
     the regulations of the Food and Drug Administration 
     pertaining to the protection of sponsors' confidential 
     commercial information as of the date of enactment of this 
     Act.
       (C) An analysis of the extent to which demographic 
     subgroups, including sex, age, racial, and ethnic subgroups, 
     are represented in clinical studies to support applications 
     for approved or licensed new molecular entities, biological 
     products, and devices.
       (D) An analysis of the extent to which a summary of product 
     safety and effectiveness data by demographic subgroups 
     including sex, age, race, and ethnicity is readily available 
     to the public in a timely manner by means of the product 
     labeling or the Food and Drug Administration's Internet 
     website.
       (b) Action Plan.--
       (1) In general.--Not later than 1 year after the 
     publication of the report described in subsection (a), the 
     Secretary, acting through the Commissioner, shall publish an 
     action plan on the Internet website of the Food and Drug 
     Administration, and provide such publication to Congress.
       (2) Content of action plan.--The plan described in 
     paragraph (1) shall include--
       (A) recommendations, as appropriate, to improve the 
     completeness and quality of analyses of data on demographic 
     subgroups in summaries of product safety and effectiveness 
     data and in labeling;
       (B) recommendations, as appropriate, on the inclusion of 
     such data, or the lack of availability of such data in 
     labeling;
       (C) recommendations, as appropriate, to otherwise improve 
     the public availability of such data to patients, healthcare 
     providers, and researchers; and
       (D) a determination with respect to each recommendation 
     identified in subparagraphs (A) through (C) that 
     distinguishes between product types referenced in subsection 
     (a)(2)(B) insofar as the applicability of each such 
     recommendation to each type of product.
       (c) Definitions.--In this section:
       (1) The term ``Commissioner'' means the Commissioner of 
     Food and Drugs.
       (2) The term ``device'' has the meaning given such term in 
     section 201(h) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(h)).
       (3) The term ``drug'' has the meaning given such term in 
     section 201(g) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(g)).
       (4) The term ``biological product'' has the meaning given 
     such term in section 351(i) of the Public Health Service Act 
     (42 U.S.C. 262(i)).
       (5) The term ``Secretary'' means the Secretary of Health 
     and Human Services.

                        TITLE X--DRUG SHORTAGES

     SEC. 1001. DRUG SHORTAGES.

       (a) In General.--Section 506C (21 U.S.C. 356c) is amended 
     to read as follows:

     ``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION 
                   OF LIFE-SAVING DRUGS.

       ``(a) In General.--A manufacturer of a drug--
       ``(1) that is--
       ``(A) life-supporting;
       ``(B) life-sustaining;
       ``(C) intended for use in the prevention of a debilitating 
     disease or condition;
       ``(D) a sterile injectable product; or
       ``(E) used in emergency medical care or during surgery; and
       ``(2) that is not a radio pharmaceutical drug product, a 
     human tissue replaced by a recombinant product, a product 
     derived from human plasma protein, or any other product as 
     designated by the Secretary,
     shall notify the Secretary, in accordance with subsection 
     (b), of a permanent discontinuance in the manufacture of the 
     drug or an interruption of the manufacture of the drug that 
     could lead to a meaningful disruption in the supply of that 
     drug in the United States.
       ``(b) Timing.--A notice required under subsection (a) shall 
     be submitted to the Secretary--
       ``(1) at least 6 months prior to the date of the 
     discontinuance or interruption; or

[[Page S3600]]

       ``(2) if compliance with paragraph (1) is not possible, as 
     soon as practicable.
       ``(c) Expedited Inspections and Reviews.--If, based on 
     notifications described in subsection (a) or any other 
     relevant information, the Secretary concludes that there is, 
     or is likely to be, a drug shortage of a drug described in 
     subsection (a), the Secretary may--
       ``(1) expedite the review of a supplement to a new drug 
     application submitted under section 505(b), an abbreviated 
     new drug application submitted under section 505(j), or a 
     supplement to such an application submitted under section 
     505(j) that could help mitigate or prevent such shortage; or
       ``(2) expedite an inspection or reinspection of an 
     establishment that could help mitigate or prevent such drug 
     shortage.
       ``(d) Coordination.--
       ``(1) Task force and strategic plan.--
       ``(A) In general.--
       ``(i) Task force.--As soon as practicable after the date of 
     enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall establish a Task Force to 
     develop and implement a strategic plan for enhancing the 
     Secretary's response to preventing and mitigating drug 
     shortages.
       ``(ii) Strategic plan.--The strategic plan described in 
     clause (i) shall include--

       ``(I) plans for enhanced interagency and intraagency 
     coordination, communication, and decisionmaking;
       ``(II) plans for ensuring that drug shortages are 
     considered when the Secretary initiates a regulatory action 
     that could precipitate a drug shortage or exacerbate an 
     existing drug shortage;
       ``(III) plans for effective communication with outside 
     stakeholders, including who the Secretary should alert about 
     potential or actual drug shortages, how the communication 
     should occur, and what types of information should be shared; 
     and
       ``(IV) plans for considering the impact of drug shortages 
     on research and clinical trials.

       ``(iii) Consultation.--In carrying out this subparagraph, 
     the Task Force shall ensure consultation with the appropriate 
     offices within the Food and Drug Administration, including 
     the Office of the Commissioner, the Center for Drug 
     Evaluation and Research, the Office of Regulatory Affairs, 
     and employees within the Department of Health and Human 
     Services with expertise regarding drug shortages. The 
     Secretary shall engage external stakeholders and experts as 
     appropriate.
       ``(B) Timing.--Not later than 1 year after the date of 
     enactment Food and Drug Administration Safety and Innovation 
     Act, the Task Force shall--
       ``(i) publish the strategic plan described in subparagraph 
     (A); and
       ``(ii) submit such plan to Congress.
       ``(2) Communication.--The Secretary shall ensure that, 
     prior to any enforcement action or issuance of a warning 
     letter that the Secretary determines could reasonably be 
     anticipated to lead to a meaningful disruption in the supply 
     in the United States of a drug described under subsection 
     (a), there is communication with the appropriate office of 
     the Food and Drug Administration with expertise regarding 
     drug shortages regarding whether the action or letter could 
     cause, or exacerbate, a shortage of the drug.
       ``(3) Action.--If the Secretary determines, after the 
     communication described in paragraph (2), that an enforcement 
     action or a warning letter could reasonably cause or 
     exacerbate a shortage of a drug described under subsection 
     (a), then the Secretary shall evaluate the risks associated 
     with the impact of such shortage upon patients and those 
     risks associated with the violation involved before taking 
     such action or issuing such letter, unless there is imminent 
     risk of serious adverse health consequences or death to 
     humans.
       ``(4) Reporting by other entities.--The Secretary shall 
     identify or establish a mechanism by which healthcare 
     providers and other third-party organizations may report to 
     the Secretary evidence of a drug shortage.
       ``(5) Review and construction.--No determination, finding, 
     action, or omission of the Secretary under this subsection 
     shall--
       ``(A) be subject to judicial review; or
       ``(B) be construed to establish a defense to an enforcement 
     action by the Secretary.
       ``(e) Recordkeeping and Reporting.--
       ``(1) Recordkeeping.--The Secretary shall maintain records 
     related to drug shortages, including with respect to each of 
     the following:
       ``(A) The number of manufacturers that submitted a 
     notification to the Secretary under subsection (a) in each 
     calendar year.
       ``(B) The number of drug shortages that occurred in each 
     calendar year and a list of drug names, drug types, and 
     classes that were the subject of such shortages.
       ``(C) A list of the known factors contributing to the drug 
     shortages described in subparagraph (B).
       ``(D)(i) A list of major actions taken by the Secretary to 
     prevent or mitigate the drug shortages described in 
     subparagraph (B).
       ``(ii) The Secretary shall include in the list under clause 
     (i) the following:
       ``(I) The number of applications for which the Secretary 
     expedited review under subsection (c)(1) in each calendar 
     year.
       ``(II) The number of establishment inspections or 
     reinspections that the Secretary expedited under subsection 
     (c)(2) in each calendar year.
       ``(E) The number of notifications submitted to the 
     Secretary under subsection (a) in each calendar year.
       ``(F) The names of manufacturers that the Secretary has 
     learned did not comply with the notification requirement 
     under subsection (a) in each calendar year.
       ``(G) The number of times in each calendar year that the 
     Secretary determined under subsection (d)(3) that an 
     enforcement action or a warning letter could reasonably cause 
     or exacerbate a shortage of a drug described under subsection 
     (a), but did not evaluate the risks associated with the 
     impact of such shortage upon patients and those risks 
     associated with the violation involved before taking such 
     action or issuing such letter on the grounds that there was 
     imminent risk of serious adverse health consequences or death 
     to humans, and a summary of the determinations.
       ``(H) A summary of the communications made and actions 
     taken under subsection (d) in each calendar year.
       ``(I) Any other information the Secretary deems appropriate 
     to better prevent and mitigate drug shortages.
       ``(2) Trend analysis.--The Secretary is authorized to 
     retain a third party to conduct a study, if the Secretary 
     believes such a study would help clarify the causes, trends, 
     or solutions related to drug shortages.
       ``(3) Annual summary.--Not later than 18 months after the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act, and annually thereafter, the Secretary 
     shall submit to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report 
     summarizing, with respect to the 1-year period preceding such 
     report, the information described in paragraph (1). Such 
     report shall not include any information that is exempt from 
     disclosure under subsection (a) of section 552 of title 5, 
     United States Code, by reason of subsection (b)(4) of such 
     section.
       ``(f) Definitions.--For purposes of this section--
       ``(1) the term `drug'--
       ``(A) means a drug (as defined in section 201(g)) that is 
     intended for human use; and
       ``(B) does not include biological products (as defined in 
     section 351 of the Public Health Service Act), unless 
     otherwise provided by the Secretary in the regulations 
     promulgated under subsection (h);
       ``(2) the term `drug shortage' or `shortage', with respect 
     to a drug, means a period of time when the demand or 
     projected demand for the drug within the United States 
     exceeds the supply of the drug; and
       ``(3) the term `meaningful disruption'--
       ``(A) means a change in production that is reasonably 
     likely to lead to a reduction in the supply of a drug by a 
     manufacturer that is more than negligible and impacts the 
     ability of the manufacturer to fill orders or meet expected 
     demand for its product; and
       ``(B) does not include interruptions in manufacturing due 
     to matters such as routine maintenance or insignificant 
     changes in manufacturing so long as the manufacturer expects 
     to resume operations in a short period of time.
       ``(g) Distribution.--To the maximum extent practicable, the 
     Secretary may distribute information on drug shortages and on 
     the permanent discontinuation of the drugs described in this 
     section to appropriate provider and patient organizations, 
     except that any such distribution shall not include any 
     information that is exempt from disclosure under section 552 
     of title 5, United States Code, by reason of subsection 
     (b)(4) of such section.
       ``(h) Regulations.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary shall adopt a final regulation 
     implementing this section.
       ``(2) Inclusion of biological products.--
       ``(A) In general.--The Secretary may by regulation apply 
     this section to biological products (as defined in section 
     351 of the Public Health Service Act) if the Secretary 
     determines such inclusion would benefit the public health.
       ``(B) Rule for vaccines.--If the Secretary applies this 
     section to vaccines pursuant to subparagraph (A), the 
     Secretary shall--
       ``(i) consider whether the notification requirement under 
     subsection (a) may be satisfied by submitting a notification 
     to the Centers for Disease Control and Prevention under the 
     vaccine shortage notification program of such Centers; and
       ``(ii) explain the determination made by the Secretary 
     under clause (i) in the regulation.
       ``(3) Procedure.--In promulgating a regulation implementing 
     this section, the Secretary shall--
       ``(A) issue a notice of proposed rulemaking that includes 
     the proposed regulation;
       ``(B) provide a period of not less than 60 days for 
     comments on the proposed regulation; and
       ``(C) publish the final regulation not less than 30 days 
     before the regulation's effective date.
       ``(4) Restrictions.--Notwithstanding any other provision of 
     Federal law, in implementing this section, the Secretary 
     shall only promulgate regulations as described in paragraph 
     (3).''.
       (b) Effect of Notification.--The submission of a 
     notification to the Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') for 
     purposes of complying with the requirement in section 506C(a) 
     of the Federal Food, Drug, and

[[Page S3601]]

     Cosmetic Act (as amended by subsection (a)) shall not be 
     construed--
       (1) as an admission that any product that is the subject of 
     such notification violates any provision of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
       (2) as evidence of an intention to promote or market the 
     product for an indication or use for which the product has 
     not been approved by the Secretary.
       (c) Internal Review.--Not later than 2 years after the date 
     of enactment of this Act, the Secretary shall--
       (1) analyze and review the regulations promulgated under 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.), the guidances or policies issued under such Act 
     related to drugs intended for human use, and the practices of 
     the Food and Drug Administration regarding enforcing such Act 
     related to manufacturing of such drugs, to identify any such 
     regulations, guidances, policies, or practices that cause, 
     exacerbate, prevent, or mitigate drug shortages (as defined 
     in section 506C of the Federal Food, Drug, and Cosmetic Act 
     (as amended by subsection (a)); and
       (2) determine how regulations, guidances, policies, or 
     practices identified under paragraph (1) should be modified, 
     streamlined, expanded, or discontinued in order to reduce or 
     prevent such drug shortages, taking into consideration the 
     effect of any changes on the public health.
       (d) Study on Market Factors Contributing to Drug Shortages 
     and Stockpiling.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Comptroller General of the United 
     States, in consultation with the Secretary, the Department of 
     Health and Human Services Office of the Inspector General, 
     the Attorney General, and Chairman of the Federal Trade 
     Commission, shall publish a report reviewing any findings 
     that drug shortages (as so defined) have led market 
     participants to stockpile affected drugs or sell them at 
     significantly increased prices, the impact of such activities 
     on Federal revenue, and any economic factors that have 
     exacerbated or created a market for such actions.
       (2) Content.--The report under paragraph (1) shall 
     include--
       (A) an analysis of the incidence of any of the activities 
     described in paragraph (1) and the effect of such activities 
     on the public health;
       (B) an evaluation of whether in such cases there is a 
     correlation between drugs in shortage and--
       (i) the number of manufacturers producing such drugs;
       (ii) the pricing structure, including Federal 
     reimbursements, for such drugs before such drugs were in 
     shortage, and to the extent possible, revenue received by 
     each such manufacturer of such drugs;
       (iii) pricing structure and revenue, to the extent 
     possible, for the same drugs when sold under the conditions 
     described in paragraph (1); and
       (iv) the impact of contracting practices by market 
     participants (including manufacturers, distributors, group 
     purchasing organizations, and providers) on competition, 
     access to drugs, and pricing of drugs;
       (C) whether the activities described in paragraph (1) are 
     consistent with applicable law; and
       (D) recommendations to Congress on what, if any, additional 
     reporting or enforcement actions are necessary.
       (3) Trade secret and confidential information.--Nothing in 
     this subsection alters or amends section 1905 of title 18, 
     United States Code, or section 552(b)(4) of title 5, United 
     States Code.
       (e) Guidance Regarding Repackaging.--Not later than 1 year 
     after the date of enactment of this Act, the Secretary shall 
     issue guidance that clarifies the policy of the Food and Drug 
     Administration regarding hospital pharmacies repackaging and 
     safely transferring repackaged drugs among hospitals within a 
     common health system during a drug shortage, as identified by 
     the Secretary.

                       TITLE XI--OTHER PROVISIONS

                      Subtitle A--Reauthorizations

     SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO 
                   EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 
                   ENANTIOMERS.

       (a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is 
     amended by striking ``2012'' and inserting ``2017''.
       (b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C. 
     355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical'' 
     after ``any''.

     SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-
                   PRIVATE PARTNERSHIPS.

       Section 566(f) (21 U.S.C. 360bbb 5(f)) is amended by 
     striking ``2012'' and inserting ``2017''.

               Subtitle B--Medical Gas Product Regulation

     SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS.

       (a) Regulation.--Chapter V (21 U.S.C. 351 et seq.) is 
     amended by adding at the end the following:

                  ``Subchapter G--Medical Gas Products

     ``SEC. 575. DEFINITIONS.

       ``In this subchapter:
       ``(1) The term `designated medical gas product' means any 
     of the following:
       ``(A) Oxygen, that meets the standards set forth in an 
     official compendium.
       ``(B) Nitrogen, that meets the standards set forth in an 
     official compendium.
       ``(C) Nitrous oxide, that meets the standards set forth in 
     an official compendium.
       ``(D) Carbon dioxide, that meets the standards set forth in 
     an official compendium.
       ``(E) Helium, that meets the standards set forth in an 
     official compendium.
       ``(F) Carbon monoxide, that meets the standards set forth 
     in an official compendium.
       ``(G) Medical air, that meets the standards set forth in an 
     official compendium.
       ``(H) Any other medical gas product deemed appropriate by 
     the Secretary, unless any period of exclusivity under section 
     505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the extension of any 
     such period under section 505A, applicable to such medical 
     gas product has not expired.
       ``(2) The term `medical gas product' means a drug that--
       ``(A) is manufactured or stored in a liquefied, 
     nonliquefied, or cryogenic state; and
       ``(B) is administered as a gas.

     ``SEC. 576. REGULATION OF MEDICAL GAS PRODUCTS.

       ``(a) Certification of Designated Medical Gas Products.--
       ``(1) Submission.--
       ``(A) In general.--Beginning on the date of enactment of 
     this section, any person may file with the Secretary a 
     request for a certification of a designated medical gas 
     product.
       ``(B) Content.--A request under subparagraph (A) shall 
     contain--
       ``(i) a description of the medical gas product;
       ``(ii) the name and address of the sponsor;
       ``(iii) the name and address of the facility or facilities 
     where the gas product is or will be manufactured; and
       ``(iv) any other information deemed appropriate by the 
     Secretary to determine whether the medical gas product is a 
     designated medical gas product.
       ``(2) Grant of certification.--A certification described 
     under paragraph (1)(A) shall be determined to have been 
     granted unless, not later than 60 days after the filing of a 
     request under paragraph (1), the Secretary finds that--
       ``(A) the medical gas product subject to the certification 
     is not a designated medical gas product;
       ``(B) the request does not contain the information required 
     under paragraph (1) or otherwise lacks sufficient information 
     to permit the Secretary to determine that the gas product is 
     a designated medical gas product; or
       ``(C) granting the request would be contrary to public 
     health.
       ``(3) Effect of certification.--
       ``(A) In general.--
       ``(i) Approved uses.--A designated medical gas product for 
     which a certification is granted under paragraph (2) is 
     deemed, alone or in combination with another designated gas 
     product or products as medically appropriate, to have in 
     effect an approved application under section 505 or 512, 
     subject to all applicable postapproval requirements, for the 
     following indications for use:

       ``(I) Oxygen for the treatment or prevention of hypoxemia 
     or hypoxia.
       ``(II) Nitrogen for use in hypoxic challenge testing.
       ``(III) Nitrous oxide for analgesia.
       ``(IV) Carbon dioxide for use in extracorporeal membrane 
     oxygenation therapy or respiratory stimulation.
       ``(V) Helium for the treatment of upper airway obstruction 
     or increased airway resistance.
       ``(VI) Medical air to reduce the risk of hyperoxia.
       ``(VII) Carbon monoxide for use in lung diffusion testing.
       ``(VIII) Any other indication for use for a designated 
     medical gas product or combination of designated medical gas 
     products deemed appropriate by the Secretary, unless any 
     period of exclusivity under clause (iii) or (iv) of section 
     505(c)(3)(E), under clause (iii) or (iv) of section 
     505(j)(5)(F), or under section 527, or the extension of any 
     such period under section 505A, applicable to such indication 
     for use for such gas product or combination of products has 
     not expired.

       ``(ii) Labeling.--The requirements established in sections 
     503(b)(4) and 502(f) shall be deemed to have been met for a 
     designated medical gas product if the labeling on final use 
     containers of such gas product bears the information required 
     by section 503(b)(4) and a warning statement concerning the 
     use of the gas product, as determined by the Secretary by 
     regulation, as well as appropriate directions and warnings 
     concerning storage and handling.
       ``(B) Inapplicability of exclusivity provisions.--
       ``(i) Effect on ineligibility.--No designated medical gas 
     product deemed under paragraph (3)(A)(i) to have in effect an 
     approved application shall be eligible for any periods of 
     exclusivity under sections 505(c), 505(j), or 527, or the 
     extension of any such period under section 505A, on the basis 
     of such deemed approval.
       ``(ii) Effect on certification.--No period of exclusivity 
     under sections 505(c), 505(j), or section 527, or the 
     extension of any such period under section 505A, with respect 
     to an application for a drug shall prohibit, limit, or 
     otherwise affect the submission, grant, or effect of a 
     certification under this section, except as provided in 
     paragraph (3)(A)(i)(VIII).
       ``(4) Withdrawal, suspension, or revocation of approval.--
       ``(A) In general.--Nothing in this subchapter limits the 
     authority of the Secretary

[[Page S3602]]

     to withdraw or suspend approval of a drug, including a 
     designated medical gas product deemed under this section to 
     have in effect an approved application, under section 505 or 
     section 512.
       ``(B) Revocation.--The Secretary may revoke the grant of a 
     certification under this section if the Secretary determines 
     that the request for certification contains any material 
     omission or falsification.
       ``(b) Prescription Requirement.--
       ``(1) In general.--A designated medical gas product shall 
     be subject to section 503(b)(1) unless the Secretary 
     exercises the authority provided in section 503(b)(3) to 
     remove such gas product from the requirements of section 
     503(b)(1) or the use in question is authorized pursuant to 
     another provision of this Act relating to use of medical 
     products in emergencies.
       ``(2) Exception for oxygen.--
       ``(A) In general.--Notwithstanding paragraph (1), oxygen 
     may be provided without a prescription for the following 
     uses:
       ``(i) The use in the event of depressurization or other 
     environmental oxygen deficiency.
       ``(ii) The use in the event of oxygen deficiency or use in 
     emergency resuscitation, when administered by properly 
     trained personnel.
       ``(B) Labeling.--For oxygen provided pursuant to 
     subparagraph (A), the requirements established in section 
     503(b)(4) shall be deemed to have been met if the labeling of 
     the oxygen bears a warning that the medical gas product can 
     be used for emergency use only and for all other medical 
     applications a prescription is required.
       ``(c) Inapplicability of Drugs Fees to Designated Medical 
     Gas Products.--A designated medical gas product deemed under 
     this section to have in effect an approved application shall 
     not be assessed fees under section 736(a) on the basis of 
     such deemed approval.''.

     SEC. 1112. REGULATIONS.

       (a) Review of Regulations.--Not later than 18 months after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services (referred to in this section as the 
     ``Secretary'') shall, after obtaining input from medical gas 
     product manufacturers, and any other interested members of 
     the public, submit a report to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives regarding any changes to the Federal drug 
     regulations in title 21, Code of Federal Regulations that the 
     Secretary determines to be necessary.
       (b) Amended Regulations.--If the Secretary determines that 
     changes to the Federal drug regulations in title 21, Code of 
     Federal Regulations are necessary under subsection (a), the 
     Secretary shall issue final regulations implementing such 
     changes not later than 4 years after the date of enactment of 
     this Act.

     SEC. 1113. APPLICABILITY.

       Nothing in this subtitle or the amendments made by this 
     subtitle shall apply to--
       (1) a drug that is covered by an application under section 
     505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355, 360b) approved prior to May 1, 2012; or
       (2) any of the gases listed in subparagraphs (A) through 
     (G) of section 575(1) of such Act (as added by section 1111), 
     or any mixture of any such gases, for an indication that--
       (A) is not included in, or is different from, those 
     specified in subclauses (I) through (VII) of section 
     576(a)(3)(i) of such Act (as added by section 1111); and
       (B) is approved on or after May 1, 2012, pursuant to an 
     application submitted under section 505 or 512 of such Act.

                  Subtitle C--Miscellaneous Provisions

     SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTEREST.

       Section 712 (21 U.S.C. 379d 1) is amended--
       (1) in subsection (b)--
       (A) by striking paragraph (2); and
       (B) in paragraph (1)--
       (i) by redesignating subparagraph (B) as paragraph (2) and 
     moving such paragraph, as so redesignated, 2 ems to the left;
       (ii) in subparagraph (A), by redesignating clauses (i) 
     through (iii) as subparagraphs (A) through (C), respectively, 
     and moving such subparagraphs, as so redesignated, 2 ems to 
     the left;
       (iii) in subparagraph (A), as so redesignated, by inserting 
     ``, including strategies to increase the number of special 
     Government employees across medical and scientific 
     specialties in areas where the Secretary would benefit from 
     specific scientific, medical, or technical expertise 
     necessary for the performance of its regulatory 
     responsibilities'' before the semicolon at the end;
       (iv) by striking ``(1) Recruitment.--'' and inserting ``(1) 
     Recruitment in general.--The Secretary shall--'';
       (v) by striking ``(A) In general.--The Secretary shall--'';
       (vi) by redesignating clauses (i) through (iii) of 
     paragraph (2) (as so redesignated) as subparagraphs (A) 
     through (C), respectively, and moving such subparagraphs, as 
     so redesignated, 2 ems to the left;
       (vii) in paragraph (2) (as so redesignated), in the matter 
     before subparagraph (A) (as so redesignated), by striking 
     ``subparagraph (A)'' and inserting ``paragraph (1)''; and
       (viii) by adding at the end the following:
       ``(3) Recruitment through referrals.--In carrying out 
     paragraph (1), the Secretary shall, in order to further the 
     goal of including in advisory committees highly qualified and 
     specialized experts in the specific diseases to be considered 
     by such advisory committees, at least every 180 days, request 
     referrals from a variety of stakeholders, such as the 
     Institute of Medicine, the National Institutes of Health, 
     product developers, patient groups, disease advocacy 
     organizations, professional societies, medical societies, 
     including the American Academy of Medical Colleges, and other 
     governmental organizations.'';
       (2) by amending subsection (c)(2)(C) to read as follows:
       ``(C) Consideration by secretary.--The Secretary shall 
     ensure that each determination made under subparagraph (B) 
     considers the type, nature, and magnitude of the financial 
     interests at issue and the public health interest in having 
     the expertise of the member with respect to the particular 
     matter before the advisory committee.'';
       (3) in subsection (e), by inserting ``, and shall make 
     publicly available,'' after ``House of Representatives''; and
       (4) by adding at the end the following:
       ``(g) Guidance on Reported Financial Interest or 
     Involvement.--The Secretary shall issue guidance that 
     describes how the Secretary reviews the financial interests 
     and involvement of advisory committee members that are 
     reported under subsection (c)(1) but that the Secretary 
     determines not to meet the definition of a disqualifying 
     interest under section 208 of title 18, United States Code 
     for the purposes of participating in a particular matter.''.

     SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION 
                   USING THE INTERNET.

       Not later than 2 years after the date of enactment this 
     Act, the Secretary of Health and Human Services shall issue 
     guidance that describes Food and Drug Administration policy 
     regarding the promotion, using the Internet (including social 
     media), of medical products that are regulated by such 
     Administration.

     SEC. 1123. ELECTRONIC SUBMISSION OF APPLICATIONS.

       Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is 
     amended by inserting after section 745 the following:

     ``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.

       ``(a) Drugs and Biologics.--
       ``(1) In general.--Beginning no earlier than 24 months 
     after the issuance of a final guidance issued after public 
     notice and opportunity for comment, submissions under 
     subsection (b), (i), or (j) of section 505 of this Act or 
     subsection (a) or (k) of section 351 of the Public Health 
     Service Act shall be submitted in such electronic format as 
     specified by the Secretary in such guidance.
       ``(2) Guidance contents.--In the guidance under paragraph 
     (1), the Secretary may--
       ``(A) provide a timetable for establishment by the 
     Secretary of further standards for electronic submission as 
     required by such paragraph; and
       ``(B) set forth criteria for waivers of and exemptions from 
     the requirements of this subsection.
       ``(3) Exception.--This subsection shall not apply to 
     submissions described in section 561.
       ``(b) Devices.--
       ``(1) In general.--Beginning after the issuance of final 
     guidance implementing this paragraph, pre-submissions and 
     submissions for devices under section 510(k), 513(f)(2)(A), 
     515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or 
     section 351 of the Public Health Service Act, and any 
     supplements to such pre-submissions or submissions, shall 
     include an electronic copy of such pre-submissions or 
     submissions.
       ``(2) Guidance contents.--In the guidance under paragraph 
     (1), the Secretary may--
       ``(A) provide standards for the electronic copy required 
     under such paragraph; and
       ``(B) set forth criteria for waivers of and exemptions from 
     the requirements of this subsection.''.

     SEC. 1124. COMBATING PRESCRIPTION DRUG ABUSE.

       (a) In General.--To combat the significant rise in 
     prescription drug abuse and the consequences of such abuse, 
     the Secretary of Health and Human Services (referred to in 
     this section as the ``Secretary''), acting through the 
     Commissioner of Food and Drugs (referred to in this section 
     as the ``Commissioner'') and in coordination with other 
     Federal agencies, as appropriate, shall review current 
     Federal initiatives and identify gaps and opportunities with 
     respect to ensuring the safe use and disposal of prescription 
     drugs with the potential for abuse.
       (b) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary shall post a report on 
     the Internet website of the Food and Drug Administration on 
     the findings of the review under subsection (a). Such report 
     shall include findings and recommendations on--
       (1) how best to leverage and build upon existing Federal 
     and federally funded data sources, such as prescription drug 
     monitoring program data and the sentinel initiative of the 
     Food and Drug Administration under section 505(k)(3) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), 
     as it relates to collection of information relevant to 
     adverse events, patient safety, and patient outcomes, to 
     create a centralized data clearinghouse and early warning 
     tool;
       (2) how best to develop and disseminate widely best 
     practices models and suggested standard requirements to 
     States for achieving greater interoperability and 
     effectiveness of prescription drug monitoring programs, 
     especially with respect to provider

[[Page S3603]]

     participation, producing standardized data on adverse events, 
     patient safety, and patient outcomes; and
       (3) how best to develop provider, pharmacist, and patient 
     education tools and a strategy to widely disseminate such 
     tools and assess the efficacy of such tools.
       (c) Guidance on Abuse-deterrent Products.--Not later than 6 
     months after the date of enactment of this Act, the 
     Secretary, acting through the Commissioner, shall promulgate 
     guidance on the development of abuse-deterrent drug products.
       (d) Study and Report on Prescription Drug Abuse.--Not later 
     than 1 year after the date of enactment of this Act, the 
     Secretary shall seek to enter into an agreement with the 
     Institute of Medicine to conduct a study and report on 
     prescription drug abuse. Such report shall evaluate trends in 
     prescription drug abuse, assess opportunities to inform and 
     educate the public, patients, and health care providers on 
     issues related to prescription drug abuse and misuse, and 
     identify potential barriers, if any, to prescription drug 
     monitoring program participation and implementation.

     SEC. 1125. TANNING BED LABELING.

       Not later than 18 months after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     determine whether to amend the warning label requirements for 
     sunlamp products to include specific requirements to more 
     clearly and effectively convey the risks that such products 
     pose for the development of irreversible damage to the eyes 
     and skin, including skin cancer.

     SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 903, is further amended by adding at the 
     end the following:

     ``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.

       ``(a) In General.--The Secretary shall--
       ``(1) work with other regulatory authorities of similar 
     standing, medical research companies, and international 
     organizations to foster and encourage uniform, 
     scientifically-driven clinical trial standards with respect 
     to medical products around the world; and
       ``(2) enhance the commitment to provide consistent parallel 
     scientific advice to manufacturers seeking simultaneous 
     global development of new medical products in order to--
       ``(A) enhance medical product development;
       ``(B) facilitate the use of foreign data; and
       ``(C) minimize the need to conduct duplicative clinical 
     studies, preclinical studies, or non-clinical studies.
       ``(b) Medical Product.--In this section, the term `medical 
     product' means a drug, as defined in subsection (g) of 
     section 201, a device, as defined in subsection (h) of such 
     section, or a biological product, as defined in section 
     351(i) of the Public Health Service Act.
       ``(c) Savings Clause.--Nothing in this section shall alter 
     the criteria for evaluating the safety or effectiveness of a 
     medical product under this Act.

     ``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE 
                   THE UNITED STATES.

       ``(a) In General.--In determining whether to approve, 
     license, or clear a drug or device pursuant to an application 
     submitted under this chapter, the Secretary shall accept data 
     from clinical investigations conducted outside of the United 
     States, including the European Union, if the applicant 
     demonstrates that such data are adequate under applicable 
     standards to support approval, licensure, or clearance of the 
     drug or device in the United States.
       ``(b) Notice to Sponsor.--If the Secretary finds under 
     subsection (a) that the data from clinical investigations 
     conducted outside the United States, including in the 
     European Union, are inadequate for the purpose of making a 
     determination on approval, clearance, or licensure of a drug 
     or device pursuant to an application submitted under this 
     chapter, the Secretary shall provide written notice to the 
     sponsor of the application of such finding and include the 
     rationale for such finding.''.

     SEC. 1127. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC 
                   HEALTH INNOVATION.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall develop a strategy and implementation plan for 
     advancing regulatory science for medical products in order to 
     promote the public health and advance innovation in 
     regulatory decisionmaking.
       (b) Requirements.--The strategy and implementation plan 
     developed under subsection (a) shall be consistent with the 
     user fee performance goals in the Prescription Drug User Fee 
     Agreement commitment letter, the Generic Drug User Fee 
     Agreement commitment letter, and the Biosimilar User Fee 
     Agreement commitment letter transmitted by the Secretary to 
     Congress on January 13, 2012, and the Medical Device User Fee 
     Agreement commitment letter transmitted by the Secretary to 
     Congress on April 20, 2012, and shall--
       (1) identify a clear vision of the fundamental role of 
     efficient, consistent, and predictable, science-based 
     decisions throughout regulatory decisionmaking of the Food 
     and Drug Administration with respect to medical products;
       (2) identify the regulatory science priorities of the Food 
     and Drug Administration directly related to fulfilling the 
     mission of the agency with respect to decisionmaking 
     concerning medical products and allocation of resources 
     towards such regulatory science priorities;
       (3) identify regulatory and scientific gaps that impede the 
     timely development and review of, and regulatory certainty 
     with respect to, the approval, licensure, or clearance of 
     medical products, including with respect to companion 
     products and new technologies, and facilitating the timely 
     introduction and adoption of new technologies and 
     methodologies in a safe and effective manner;
       (4) identify clear, measurable metrics by which progress on 
     the priorities identified under paragraph (2) and gaps 
     identified under paragraph (3) will be measured by the Food 
     and Drug Administration, including metrics specific to the 
     integration and adoption of advances in regulatory science 
     described in paragraph (5) and improving medical product 
     decisionmaking, in a predictable and science-based manner; 
     and
       (5) set forth how the Food and Drug Administration will 
     ensure that advances in regulatory science for medical 
     products are adopted, as appropriate, on an ongoing basis and 
     in an manner integrated across centers, divisions, and 
     branches of the Food and Drug Administration, including by 
     senior managers and reviewers, including through the--
       (A) development, updating, and consistent application of 
     guidance documents that support medical product 
     decisionmaking; and
       (B) the adoption of the tools, methods, and processes under 
     section 566 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb 5).
       (c) Annual Performance Reports.--As part of the annual 
     performance reports submitted to Congress under sections 
     736B(a) (as amended by section 104), 738A(a) (as amended by 
     section 204), 744C(a) (as added by section 303), and 744I(a) 
     (as added by section 403) of the Federal Food, Drug, and 
     Cosmetic Act for each of fiscal years 2013 through 2017, the 
     Secretary shall annually report on the progress made with 
     respect to--
       (1) advancing the regulatory science priorities identified 
     under paragraph (2) of subsection (b) and resolving the gaps 
     identified under paragraph (3) of such subsection, including 
     reporting on specific metrics identified under paragraph (4) 
     of such subsection;
       (2) the integration and adoption of advances in regulatory 
     science as set forth in paragraph (5) of such subsection; and
       (3) the progress made in advancing the regulatory science 
     goals outlined in the Prescription Drug User Fee Agreement 
     commitment letter, the Generic Drug User Fee Agreement 
     commitment letter, and the Biosimilar User Fee Agreement 
     commitment letter transmitted by the Secretary to Congress on 
     January 13, 2012, and the Medical Device User Fee Agreement 
     transmitted by the Secretary to Congress on April 20, 2012.
       (d) Independent Assessment.--Not later than January 1, 
     2016, the Comptroller General of the United States shall 
     submit to Congress a report--
       (1) detailing the progress made by the Food and Drug 
     Administration in meeting the priorities and addressing the 
     gaps identified in subsection (b), including any outstanding 
     gaps; and
       (2) containing recommendations, as appropriate, on how 
     regulatory science initiatives for medical products can be 
     strengthened and improved to promote the public health and 
     advance innovation in regulatory decisionmaking.
       (e) Medical Product.--In this section, the term ``medical 
     product'' means a drug, as defined in subsection (g) of 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321), a device, as defined in subsection (h) of such 
     section, or a biological product, as defined in section 
     351(i) of the Public Health Service Act.

     SEC. 1128. INFORMATION TECHNOLOGY.

       (a) HHS Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall--
       (1) report to Congress on--
       (A) the milestones and a completion date for developing and 
     implementing a comprehensive information technology strategic 
     plan to align the information technology systems 
     modernization projects with the strategic goals of the Food 
     and Drug Administration, including results-oriented goals, 
     strategies, milestones, performance measures;
       (B) efforts to finalize and approve a comprehensive 
     inventory of the information technology systems of the Food 
     and Drug Administration that includes information describing 
     each system, such as costs, system function or purpose, and 
     status information, and incorporate use of the system 
     portfolio into the information investment management process 
     of the Food and Drug Administration;
       (C) the ways in which the Food and Drug Administration uses 
     the plan described in subparagraph (A) to guide and 
     coordinate the modernization projects and activities of the 
     Food and Drug Administration, including the interdependencies 
     among projects and activities; and
       (D) the extent to which the Food and Drug Administration 
     has fulfilled or is implementing recommendations of the 
     Government Accountability Office with respect to the Food and 
     Drug Administration and information technology; and

[[Page S3604]]

       (2) develop--
       (A) a documented enterprise architecture program management 
     plan that includes the tasks, activities, and timeframes 
     associated with developing and using the architecture and 
     addresses how the enterprise architecture program management 
     will be performed in coordination with other management 
     disciplines, such as organizational strategic planning, 
     capital planning and investment control, and performance 
     management; and
       (B) a skills inventory, needs assessment, gap analysis, and 
     initiatives to address skills gaps as part of a strategic 
     approach to information technology human capital planning.
       (b) GAO Report.--Not later than January 1, 2016, the 
     Comptroller General of the United States shall issue a report 
     regarding the strategic plan described in subsection 
     (a)(1)(A) and related actions carried out by the Food and 
     Drug Administration. Such report shall assess the progress 
     the Food and Drug Administration has made on--
       (1) the development and implementation of a comprehensive 
     information technology strategic plan, including the results-
     oriented goals, strategies, milestones, and performance 
     measures identified in subsection (a)(1)(A);
       (2) the effectiveness of the comprehensive information 
     technology strategic plan described in subsection (a)(1)(A), 
     including the results-oriented goals and performance 
     measures; and
       (3) the extent to which the Food and Drug Administration 
     has fulfilled recommendations of the Government 
     Accountability Office with respect to such agency and 
     information technology.

     SEC. 1129. REPORTING REQUIREMENTS.

       Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as 
     amended by section 208, is further amended by adding at the 
     end the following:

     ``SEC. 715. REPORTING REQUIREMENTS.

       ``(a) New Drugs.--Beginning with fiscal year 2013 and 
     ending with fiscal year 2017, not later than 120 days after 
     the end of each fiscal year for which fees are collected 
     under part 2 of subchapter C, the Secretary shall prepare and 
     submit to the Committee on Health Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report concerning, 
     for all applications for approval of a new drug under section 
     505(b) of this Act or a new biological product under section 
     351(a) of the Public Health Service Act filed in the previous 
     fiscal year--
       ``(1) the number of such applications that met the goals 
     identified for purposes of part 2 of subchapter C in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record;
       ``(2) the percentage of such applications that were 
     approved;
       ``(3) the percentage of such applications that were issued 
     complete response letters;
       ``(4) the percentage of such applications that were subject 
     to a refuse-to-file action;
       ``(5) the percentage of such applications that were 
     withdrawn; and
       ``(6) the average total time to decision by the Secretary 
     for all applications for approval of a new drug under section 
     505(b) of this Act or a new biological product under section 
     351(a) of the Public Health Service Act filed in the previous 
     fiscal year, including the number of calendar days spent 
     during the review by the Food and Drug Administration and the 
     number of calendar days spent by the sponsor responding to a 
     complete response letter.''.
       ``(b) Generic Drugs.--Beginning with fiscal year 2013 and 
     ending after fiscal year 2017, not later than 120 days after 
     the end of each fiscal year for which fees are collected 
     under part 7 of subchapter C, the Secretary shall prepare and 
     submit to the Committee on Health Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report concerning, 
     for all applications for approval of a generic drug under 
     section 505(j), amendments to such applications, and prior 
     approval supplements with respect to such applications filed 
     in the previous fiscal year--
       ``(1) the number of such applications that met the goals 
     identified for purposes of part 7 of subchapter C, in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record;
       ``(2) the average total time to decision by the Secretary 
     for applications for approval of a generic drug under section 
     505(j), amendments to such applications, and prior approval 
     supplements with respect to such applications filed in the 
     previous fiscal year, including the number of calendar days 
     spent during the review by the Food and Drug Administration 
     and the number of calendar days spent by the sponsor 
     responding to a complete response letter;
       ``(3) the total number of applications under section 
     505(j), amendments to such applications, and prior approval 
     supplements with respect to such applications that were 
     pending with the Secretary for more than 10 months on the 
     date of enactment of the Food and Drug Administration Safety 
     and Innovation Act; and
       ``(4) the number of applications described in paragraph (3) 
     on which the Food and Drug Administration took final 
     regulatory action in the previous fiscal year.
       ``(c) Biosimilar Biological Products.--
       ``(1) In general.--Beginning with fiscal year 2014, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under part 8 of subchapter C, the 
     Secretary shall prepare and submit to the Committee on Health 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report concerning--
       ``(A) the number of applications for approval filed under 
     section 351(k) of the Public Health Service Act; and
       ``(B) the percentage of applications described in 
     subparagraph (A) that were approved by the Secretary.
       ``(2) Additional information.--As part of the performance 
     report described in paragraph (1), the Secretary shall 
     include an explanation of how the Food and Drug 
     Administration is managing the biological product review 
     program to ensure that the user fees collected under part 2 
     are not used to review an application under section 351(k) of 
     the Public Health Service Act.''.

     SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN.

       (a) Strategic Integrated Management Plan.--Not later than 1 
     year after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this section as 
     the ``Secretary'') shall submit to Congress a strategic 
     integrated management plan for the Center for Drug Evaluation 
     and Research, the Center for Biologics Evaluation and 
     Research, and the Center for Devices and Radiological Health. 
     Such strategic management plan shall--
       (1) identify strategic institutional goals and priorities 
     for the Center for Drug Evaluation and Research, the Center 
     for Biologics Evaluation and Research, and the Center for 
     Devices and Radiological Health;
       (2) describe the actions the Secretary will take to 
     recruit, retain, train, and continue to develop the workforce 
     at the Center for Drug Evaluation and Research, the Center 
     for Biologics Evaluation and Research, and the Center for 
     Devices and Radiological Health to fulfill the public health 
     mission of the Food and Drug Administration; and
       (3) identify results-oriented, outcome-based measures that 
     the Secretary will use to measure the progress of achieving 
     the strategic goals and priorities identified under paragraph 
     (1) and the effectiveness of the actions identified under 
     paragraph (2), including metrics to ensure that managers and 
     reviewers of the Center for Drug Evaluation and Research, the 
     Center for Biologics Evaluation and Research, and the Center 
     for Devices and Radiological Health are familiar with and 
     appropriately and consistently apply the requirements under 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.), including new requirements under parts 2, 3, 7, and 8 
     of subchapter C of title VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379f et seq.).
       (b) Report.--Not later than January 1, 2016, the 
     Comptroller General of the United States shall issue a report 
     regarding the strategic management plan described in 
     subsection (a) and related actions carried out by the Food 
     and Drug Administration. Such report shall--
       (1) assess the effectiveness of the actions described in 
     subsection (a)(2) in recruiting, retaining, training, and 
     developing the workforce at the Center for Drug Evaluation 
     and Research, the Center for Biologics Evaluation and 
     Research, and the Center for Devices and Radiological Health 
     in fulfilling the public health mission of the Food and Drug 
     Administration;
       (2) assess the effectiveness of the measures identified 
     under subsection (a)(3) in gauging progress against the 
     strategic goals and priorities identified under subsection 
     (a)(1);
       (3) assess the extent to which the Center for Drug 
     Evaluation and Research, the Center for Biologics Evaluation 
     and Research, and the Center for Devices and Radiological 
     Health are using the identified results-oriented set of 
     performance measures in tracking their workload by strategic 
     goals and the effectiveness of such measures;
       (4) assess the extent to which performance information is 
     collected, analyzed, and acted on by managers; and
       (5) make recommendations, as appropriate, regarding how the 
     strategic management plan and related actions of the Center 
     for Drug Evaluation and Research, the Center for Biologics 
     Evaluation and Research, and the Center for Devices and 
     Radiological Health could be improved to fulfill the public 
     health mission of the Food and Drug Administration in as 
     efficient and effective manner as possible.

     SEC. 1131. DRUG DEVELOPMENT AND TESTING.

       (a) In General.--Section 505 1 (21 U.S.C. 355 1) is amended 
     by adding at the end the following:
       ``(k) Drug Development and Testing.--
       ``(1) In general.--Notwithstanding any other provision of 
     law, if a drug is a covered drug, no elements to ensure safe 
     use shall prohibit, or be construed or applied to prohibit, 
     supply of such drug to any eligible drug developer for the 
     purpose of conducting testing necessary to support an 
     application under subsection (b)(2) or (j) of section 505 of 
     this Act or section 351(k) of the Public Health Service Act, 
     if the Secretary has issued a written notice described in 
     paragraph (2), and the eligible drug developer has

[[Page S3605]]

     agreed to comply with the terms of the notice.
       ``(2) Written notice.--For purposes of this subsection, the 
     Secretary shall, within a reasonable period of time, consider 
     and respond to a request by an eligible drug developer for a 
     written notice authorizing the supply of a covered drug for 
     purposes of testing as described in paragraph (1), and the 
     Secretary shall issue a written notice to such eligible drug 
     developer and the holder of an application for a covered drug 
     authorizing the supply of such drug to such eligible drug 
     developer for purposes of testing if--
       ``(A) the eligible drug developer has agreed to comply with 
     any conditions the Secretary considers necessary;
       ``(B) in the event the eligible drug developer is 
     conducting bioequivalence or other clinical testing, the 
     eligible drug developer has submitted, and the Secretary has 
     approved, a protocol that includes protections that the 
     Secretary finds will provide assurance of safety comparable 
     to the assurance of safety provided by the elements to ensure 
     safe use in the risk evaluation and mitigation strategy for 
     the covered drug as applicable to such testing; and
       ``(C) the eligible drug developer is in compliance with 
     applicable laws and regulations related to such testing, 
     including any applicable requirements related to 
     Investigational New Drug Applications or informed consent.
       ``(3) Additional required element.--The Secretary shall 
     require as an element of each risk evaluation and mitigation 
     strategy with elements to ensure safe use approved by the 
     Secretary that the holder of an application for a covered 
     drug shall not restrict the resale of the covered drug to an 
     eligible drug developer that receives a written notice from 
     the Secretary under paragraph (2) unless, at any time, the 
     Secretary provides written notice to the holder of the 
     application directing otherwise based on a shortage of such 
     drug for patients, national security concerns related to 
     access to such drug, or such other reason as the Secretary 
     may specify.
       ``(4) Violation and penalties.--For purposes of subsection 
     (f)(8) and sections 301, 303(f)(4), 502(y), and 505(p), it 
     shall be a violation of the risk evaluation and mitigation 
     strategy for the holder of the application for a covered drug 
     to violate the element described in paragraph (3), or in the 
     case of a holder of an application that is a sole distributor 
     or supplier of a covered drug, to prevent the sale thereof 
     after receipt of a written notice by the Secretary issued 
     under paragraph (2). The Secretary shall provide written 
     notice to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives within 30 days of 
     the Secretary becoming aware that a holder of an application 
     of a covered drug has restricted the sale of such a covered 
     drug to any eligible drug developer after receipt of written 
     notice as provided in paragraph (2).
       ``(5) Liability.--Unless the holder of the application for 
     a covered drug and the eligible developer are the same 
     entity, the holder of an application for a covered drug shall 
     not be liable for any claim arising out of the eligible drug 
     developer's testing necessary to support an application under 
     subsection (b)(2) or (j) of section 505 of this Act or 
     section 351(k) of the Public Health Service Act for a drug 
     obtained under this subsection. Nothing in this subsection 
     shall be construed to expand or limit the liability of the 
     eligible drug developer or the holder of an application for a 
     covered drug for any other claim.
       ``(6) Certification.--In any request for supply of a 
     covered drug for purposes of testing as described in 
     paragraph (1), an eligible drug developer shall certify to 
     the Secretary that--
       ``(A) the eligible drug developer will comply with all 
     conditions the Secretary considers necessary, any protocol 
     approved by the Secretary, and all applicable laws and 
     regulations pertaining to such testing; and
       ``(B) the eligible drug developer intends to submit an 
     application under subsection (b)(2) or (j) of section 505 of 
     this Act or section 351(k) of the Public Health Service Act 
     for the drug for which it is requesting written notice 
     pursuant to paragraph (2), and will use the covered drug only 
     for the purpose of conducting testing to support such an 
     application.
       ``(7) Definitions.--
       ``(A) Covered drug.--Notwithstanding subsection (b)(2), for 
     purposes of this subsection, the term `covered drug' means a 
     drug, including a biological product licensed under section 
     351(a) of the Public Health Service Act, that is subject to a 
     risk evaluation and mitigation strategy with elements to 
     ensure safe use under subsection (f), or a drug, including a 
     biological product licensed under section 351(a) of the 
     Public Health Service Act, required to have a risk evaluation 
     and mitigation strategy with elements to ensure safe use 
     under section 909(b) of the Food and Drug Administration 
     Amendments Act of 2007.
       ``(B) Eligible drug developer.--For purposes of this 
     subsection, the term `eligible drug developer' means a 
     sponsor that has submitted, or intends to submit, an 
     application under subsection (b)(2) or (j) of section 505 of 
     this Act or section 351(k) of the Public Health Service Act 
     to market a version of the covered drug in the United States.
       ``(8) Effect on other law.--Notwithstanding the provisions 
     of this subsection, the antitrust statutes enforced by the 
     Federal Trade Commission, including the Federal Trade 
     Commission Act (15 U.S.C. 41 58), the Sherman Act (15 U.S.C. 
     1 7), and any other statute properly under such Commission's 
     jurisdiction, shall apply to the conduct described in this 
     subsection to the same extent as such statutes did on the day 
     before the date of enactment of this subsection.''.
       (b) Technical and Conforming Amendments.--
       (1) Section 505 1(c)(2) (21 U.S.C. 355 1(c)(2)) is amended 
     by striking ``(e) and (f)'' and inserting ``(e), (f), and 
     (k)(3)''.
       (2) Section 502(y) (21 U.S.C. 352(y)) is amended by 
     striking ``''(d), (e), or (f) of section 505 1'' and 
     inserting ``(d), (e), (f), or (k)(3) of section 505 1''.

     SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT 
                   DISCUSSIONS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 1126, is further amended by adding at the 
     end the following:

     ``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT 
                   DISCUSSION.

       ``(a) In General.--The Secretary shall develop and 
     implement strategies to solicit the views of patients during 
     the medical product development process and consider the 
     perspectives of patients during regulatory discussions, 
     including by--
       ``(1) fostering participation of a patient representative 
     who may serve as a special government employee in appropriate 
     agency meetings with medical product sponsors and 
     investigators; and
       ``(2) exploring means to provide for identification of 
     patient representatives who do not have any, or have minimal, 
     financial interests in the medical products industry.
       ``(b) Financial Interest.--In this section, the term 
     `financial interest' means a financial interest under section 
     208(a) of title 18, United States Code.''.

     SEC. 1133. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

       (a) In General.--Chapter X (21 U.S.C. 391 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

       ``(a) In General.--Not later than 180 days after the date 
     of enactment of the Food and Drug Administration Safety and 
     Innovation Act, the Secretary, in consultation as appropriate 
     with the Secretary of Agriculture, shall establish within the 
     Food and Drug Administration a Nanotechnology Regulatory 
     Science Program (referred to in this section as the 
     `program') to enhance scientific knowledge regarding 
     nanomaterials included or intended for inclusion in products 
     regulated under this Act or other statutes administered by 
     the Food and Drug Administration, to address issues relevant 
     to the regulation of those products, including the potential 
     toxicology of such materials, the effects of such materials 
     on biological systems, and interaction of such materials with 
     biological systems.
       ``(b) Program Purposes.--The purposes of the program 
     established under subsection (a) may include--
       ``(1) assessing scientific literature and data on general 
     nanomaterials interactions with biological systems and on 
     specific nanomaterials of concern to the Food and Drug 
     Administration;
       ``(2) in cooperation with other Federal agencies, 
     developing and organizing information using databases and 
     models that will facilitate the identification of generalized 
     principles and characteristics regarding the behavior of 
     classes of nanomaterials with biological systems;
       ``(3) promoting Food and Drug Administration programs and 
     participate in collaborative efforts, to further the 
     understanding of the science of novel properties of 
     nanomaterials that might contribute to toxicity;
       ``(4) promoting and participating in collaborative efforts 
     to further the understanding of measurement and detection 
     methods for nanomaterials;
       ``(5) collecting, synthesizing, interpreting, and 
     disseminating scientific information and data related to the 
     interactions of nanomaterials with biological systems;
       ``(6) building scientific expertise on nanomaterials within 
     the Food and Drug Administration, including field and 
     laboratory expertise, for monitoring the production and 
     presence of nanomaterials in domestic and imported products 
     regulated under this Act;
       ``(7) ensuring ongoing training, as well as dissemination 
     of new information within the centers of the Food and Drug 
     Administration, and more broadly across the Food and Drug 
     Administration, to ensure timely, informed consideration of 
     the most current science pertaining to nanomaterials;
       ``(8) encouraging the Food and Drug Administration to 
     participate in international and national consensus standards 
     activities pertaining to nanomaterials; and
       ``(9) carrying out other activities that the Secretary 
     determines are necessary and consistent with the purposes 
     described in paragraphs (1) through (8).
       ``(c) Program Administration.--
       ``(1) Designated individual.--In carrying out the program 
     under this section, the Secretary, acting through the 
     Commissioner of Food and Drugs, may designate an 
     appropriately qualified individual who shall supervise the 
     planning, management, and coordination of the program.
       ``(2) Duties.--The duties of the individual designated 
     under paragraph (1) may include--
       ``(A) developing a detailed strategic plan for achieving 
     specific short- and long-term technical goals for the 
     program;

[[Page S3606]]

       ``(B) coordinating and integrating the strategic plan with 
     activities by the Food and Drug Administration and other 
     departments and agencies participating in the National 
     Nanotechnology Initiative; and
       ``(C) developing Food and Drug Administration programs, 
     contracts, memoranda of agreement, joint funding agreements, 
     and other cooperative arrangements necessary for meeting the 
     long-term challenges and achieving the specific technical 
     goals of the program.
       ``(d) Report.--Not later than March 15, 2015, the Secretary 
     shall publish on the Internet Web site of the Food and Drug 
     Administration a report on the program carried out under this 
     section. Such report shall include--
       ``(1) a review of the specific short- and long-term goals 
     of the program;
       ``(2) an assessment of current and proposed funding levels 
     for the program, including an assessment of the adequacy of 
     such funding levels to support program activities; and
       ``(3) a review of the coordination of activities under the 
     program with other departments and agencies participating in 
     the National Nanotechnology Initiative.
       ``(e) Effect of Section.--Nothing in this section shall 
     affect the authority of the Secretary under any other 
     provision of this Act or other statutes administered by the 
     Food and Drug Administration.''.
       (b) Effective Date; Sunset.--The Nanotechnology Regulatory 
     Science Program authorized under section 1013 of the Federal 
     Food, Drug, and Cosmetic Act (as added by subsection (a)) 
     shall take effect on October 1, 2012, or the date of the 
     enactment of this Act, whichever is later. Such Program shall 
     cease to be effective October 1, 2017.

     SEC. 1134. ONLINE PHARMACY REPORT TO CONGRESS.

       Not later than 1 year after the date of enactment of this 
     Act, the Comptroller General of the United States shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report that 
     describes any problems posed by pharmacy Internet websites 
     that violate Federal or State law, including--
       (1) the methods by which Internet websites are used to sell 
     prescription drugs in violation of Federal or State law or 
     established industry standards;
       (2) the harmful health effects that patients experience 
     when they consume prescription drugs purchased through such 
     pharmacy Internet websites;
       (3) efforts by the Federal Government and State and local 
     governments to investigate and prosecute the owners or 
     operators of pharmacy Internet websites, to address the 
     threats such websites pose, and to protect patients;
       (4) the level of success that Federal, State, and local 
     governments have experienced in investigating and prosecuting 
     such cases;
       (5) whether the law, as in effect on the date of the 
     report, provides sufficient authorities to Federal, State, 
     and local governments to investigate and prosecute the owners 
     and operators of pharmacy Internet websites;
       (6) additional authorities that could assist Federal, 
     State, and local governments in investigating and prosecuting 
     the owners and operators of pharmacy Internet websites;
       (7) laws, policies, and activities that would educate 
     consumers about how to distinguish pharmacy Internet websites 
     that comply with Federal and State laws and established 
     industry standards from those pharmacy Internet websites that 
     do not comply with such laws and standards; and
       (8) laws, policies, and activities that would encourage 
     private sector actors to take steps to address the prevalence 
     of illegitimate pharmacy Internet websites.

     SEC. 1135. MEDICATION AND DEVICE ERRORS.

       The Secretary of Health and Human Services shall continue 
     and further coordinate activities of the Department of Health 
     and Human Services related to the prevention of medication 
     and device errors, including consideration of medication and 
     device errors that affect the pediatric patient population. 
     In developing initiatives to address medication and device 
     errors, the Secretary shall consider the root causes of 
     medication and device errors, including pediatric medication 
     and device errors, in the clinical setting and consult with 
     relevant stakeholders on effective strategies to reduce and 
     prevent medication and device errors in the clinical setting.

     SEC. 1136. COMPLIANCE PROVISION.

       The budgetary effects of this Act, for the purpose of 
     complying with the Statutory Pay-As-You-Go-Act of 2010, shall 
     be determined by reference to the latest statement titled 
     ``Budgetary Effects of PAYGO Legislation'' for this Act, 
     submitted for printing in the Congressional Record by the 
     Chairman of the Senate Budget Committee, provided that such 
     statement has been submitted prior to the vote on passage.

     SEC. 1137. ENSURING ADEQUATE INFORMATION REGARDING 
                   PHARMACEUTICALS FOR ALL POPULATIONS, 
                   PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS, 
                   INCLUDING RACIAL SUBGROUPS.

       (a) Communication Plan.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     acting through the Commissioner of Food and Drugs, shall 
     review and modify, as necessary, the Food and Drug 
     Administration's communication plan to inform and educate 
     health care providers, patients, and payors on the benefits 
     and risks of medical products, with particular focus on 
     underrepresented subpopulations, including racial subgroups.
       (b) Content.--The communication plan described under 
     subsection (a)--
       (1) shall take into account--
       (A) the goals and principles set forth in the Strategic 
     Action Plan to Reduce Racial and Ethnic Health Disparities 
     issued by the Department of Health and Human Services;
       (B) the nature of the medical product; and
       (C) health and disease information available from other 
     agencies within such Department, as well as any new means of 
     communicating health and safety benefits and risks related to 
     medical products;
       (2) taking into account the nature of the medical product, 
     shall address the best strategy for communicating safety 
     alerts, labeled indications for the medical products, changes 
     to the label or labeling of medical products (including black 
     box warnings, health advisories, health and safety benefits 
     and risks), particular actions to be taken by healthcare 
     professionals and patients, any information identifying 
     particular subpopulations, and any other relevant information 
     as determined appropriate to enhance communication, including 
     varied means of electronic communication; and
       (3) shall include a process for implementation of any 
     improvements or other modifications determined to be 
     necessary.
       (c) Issuance and Posting of Communication Plan.--
       (1) Communication plan.--Not later than 1 year after the 
     date of enactment of this Act, the Secretary, acting through 
     the Commissioner of Food and Drugs, shall issue the 
     communication plan described under this section.
       (2) Posting of communication plan on the office of minority 
     health website.--The Secretary, acting through the 
     Commissioner of Food and Drugs, shall publicly post the 
     communication plan on the Internet website of the Office of 
     Minority Health of the Food and Drug Administration, and 
     provide links to any other appropriate webpage, and seek 
     public comment on the communication plan.

     SEC. 1138. REPORT ON SMALL BUSINESSES.

       Not later than 1 year after the date of enactment of this 
     Act, the Commissioner of Food and Drugs shall submit a report 
     to Congress that includes--
       (1) a listing of and staffing levels of all small business 
     offices at the Food and Drug Administration, including the 
     small business liaison program;
       (2) the status of partnership efforts between the Food and 
     Drug Administration and the Small Business Administration;
       (3) a summary of outreach efforts to small businesses and 
     small business associations, including availability of toll-
     free telephone help lines;
       (4) with respect to the program under the Orphan Drug Act 
     (Public Law 97 414), the number of applications made by small 
     businesses and number of applications approved for research 
     grants, the amount of tax credits issued for clinical 
     research, and the number of companies receiving protocol 
     assistance for the development of drugs for rare diseases and 
     disorders;
       (5) with respect to waivers and reductions for small 
     business under the Prescription Drug User Fee Act, the number 
     of small businesses applying for and receiving waivers and 
     reductions from drug user fees under subchapter C of chapter 
     VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379f et seq.);
       (6) the number of small businesses submitting applications 
     and receiving approval for unsolicited grant applications 
     from the Food and Drug Administration;
       (7) the number of small businesses submitting applications 
     and receiving approval for solicited grant applications from 
     the Food and Drug Administration;
       (8) barriers small businesses encounter in the drug and 
     medical device approval process; and
       (9) recommendations for changes in the user fee structure 
     to help alleviate generic drug shortages.

     SEC. 1139. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE 
                   PUBLIC HEALTH SERVICE ACT.

       (a) In General.--Section 221(a) of the Public Health 
     Service Act (42 U.S.C. 213a(a)) is amended by adding at the 
     end the following:
       ``(18) Section 1034, Protected Communications; Prohibition 
     of Retaliatory Personnel Actions.''.
       (b) Conforming Amendment.--Section 221(b) of the Public 
     Health Service Act (42 U.S.C. 213a(b)) is amended by adding 
     at the end the following: ``For purposes of paragraph (18) of 
     subsection (a), the term `Inspector General' in section 1034 
     of such title 10 shall mean the Inspector General of the 
     Department of Health and Human Services.''.

     SEC. 1140. REGULATIONS ON CLINICAL TRIAL REGISTRATION; GAO 
                   STUDY OF CLINICAL TRIAL REGISTRATION AND 
                   REPORTING REQUIREMENTS.

       (a) Definitions.--In this section--
       (1) the term ``applicable clinical trial'' has the meaning 
     given such term under section 402(j) of the Public Health 
     Service Act (42 U.S.C. 282(j));
       (2) the term ``Director'' means the Director of the 
     National Institutes of Health;
       (3) the term ``responsible party'' has the meaning given 
     such term under such section 402(j); and
       (4) the term ``Secretary'' means the Secretary of Health 
     and Human Services.
       (b) Required Regulations.--
       (1) Proposed rulemaking.--Not later than 180 days after the 
     date of enactment of this

[[Page S3607]]

     Act, the Secretary, acting through the Director, shall issue 
     a notice of proposed rulemaking for a proposed rule on the 
     registration of applicable clinical trials by responsible 
     parties under section 402(j) of the Public Health Service Act 
     (42 U.S.C. 282(j)) (as amended by section 801 of the Food and 
     Drug Administration Amendments Act of 2007).
       (2) Final rule.--Not later than 180 days after the issuance 
     of the notice of proposed rulemaking under paragraph (1), the 
     Secretary, acting through the Director, shall issue the final 
     rule on the registration of applicable clinical trials by 
     responsible parties under such section 402(j).
       (3) Letter to congress.--If the final rule described in 
     paragraph (2) is not issued by the date required under such 
     paragraph, the Secretary shall submit to Congress a letter 
     that describes the reasons why such final rule has not been 
     issued.
       (c) Report by GAO.--
       (1) In general.--Not later than 2 years after the issuance 
     of the final rule under subsection (b), the Comptroller 
     General of the United States shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report on the implementation of the 
     registration and reporting requirements for applicable drug 
     and device clinical trials under section 402(j) the Public 
     Health Service Act (42 U.S.C. 282(j)) (as amended by section 
     801 of the Food and Drug Administration Amendments Act of 
     2007).
       (2) Content.--The report under paragraph (1) shall 
     include--
       (A) information on the rate of compliance and non-
     compliance (by category of sponsor, category of trial (phase 
     II, III, or IV), whether the applicable clinical trial is 
     conducted domestically, in foreign sites, or a combination of 
     sites, and such other categories as the Comptroller General 
     determines useful) with the requirements of--
       (i) registering applicable clinical trials under such 
     section 402(j);
       (ii) reporting the results of such trials under such 
     section; and
       (iii) the completeness of the reporting of the required 
     data under such section; and
       (B) information on the promulgation of regulations for the 
     registration of applicable clinical trials by the responsible 
     parties under such section 402(j).
       (3) Recommendations.--If the Comptroller General finds 
     problems with timely compliance or completeness of the data 
     being reported under such section 402(j), or finds that the 
     implementation of registration and reporting requirements 
     under such section 402(j) for applicable drug and device 
     clinical trials could be improved, the Comptroller General 
     shall, after consulting with the Commissioner of Food and 
     Drugs, applicable stakeholders, and experts in the conduct of 
     clinical trials, make recommendations for administrative or 
     legislative actions to increase the compliance with the 
     requirements of such section 402(j).

     SEC. 1141. HYDROCODONE AMENDMENT.

       The Controlled Substances Act is amended--
       (1) in schedule III(d) in section 202(c) (21 U.S.C. 
     812(c)), by--
       (A) striking paragraphs (3) and (4); and
       (B) redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (3), (4), (5), and (6), respectively; and
       (2) in section 401(b)(1) (21 U.S.C. 841(b)(1)), by adding 
     at the end the following:
       ``(F) In the case of any material, compound, mixture, or 
     preparation containing--
       ``(i) not more than 300 milligrams of dihydrocodeinone per 
     100 milliliters or not more than 15 milligrams per dosage 
     unit, with a fourfold or greater quantity of an isoquinoline 
     alkaloid of opium; or
       ``(ii) not more than 300 milligrams of dihydrocodeinone per 
     100 milliliters or not more than 15 milligrams per dosage 
     unit, with one or more active, nonnarcotic ingredients in 
     recognized therapeutic amounts,
     subparagraph (C) shall not apply and such case shall be 
     subject to subparagraph (E).''.

     SEC. 1142. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN 
                   DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.

       In accordance with the final rule issued by the 
     Commissioner of Food and Drug entitled ``Labeling and 
     Effectiveness Testing; Sunscreen Drug Products for Over-the- 
     Counter Human Use; Delay of Compliance Dates'' (77 Fed. Reg. 
     27591 (May 11, 2012)), a product subject to the final rule 
     issued by the Commissioner entitled ``Labeling and 
     Effectiveness Testing; Sunscreen Drug Products for Over-the-
     Counter Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)), 
     shall comply with such rule not later than--
       (1) December 17, 2013, for products subject to such rule 
     with annual sales of less than $25,000 and
       (2) December 17, 2012, for all other products subject to 
     such rule.

     SEC. 1143. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

       (a) In General.--The Attorney General and the Secretary of 
     Health and Human Services may collaborate to facilitate the 
     development of recommendations on interoperability standards 
     to inform and facilitate the exchange of prescription 
     information across State lines by States receiving grant 
     funds under--
       (1) the Harold Rogers Prescription Drug Monitoring Program 
     established under the Departments of Commerce, Justice, and 
     State, the Judiciary, and Related Agencies Appropriations 
     Act, 2002 (Public Law 107 77; 115 Stat. 748); and
       (2) the Controlled Substance Monitoring Program established 
     under section 399O of the Public Health Service Act (42 
     U.S.C. 280g 3).
       (b) Requirements.--The Attorney General and the Secretary 
     of Health and Human Services shall consider the following in 
     facilitating the development of recommendations on 
     interoperability of prescription drug monitoring programs 
     under subsection (a)--
       (1) open standards that are freely available, without cost 
     and without restriction, in order to promote broad 
     implementation;
       (2) the use of exchange intermediaries, or hubs, as 
     necessary to facilitate interstate interoperability by 
     accommodating State-to-hub and direct State-to-State 
     communication;
       (3) the support of transmissions that are fully secured as 
     required, using industry standard methods of encryption, to 
     ensure that Protected Health Information and Personally 
     Identifiable Information are not compromised at any point 
     during such transmission; and
       (4) access control methodologies to share protected 
     information solely in accordance with State laws and 
     regulations.
       (c) Report.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Attorney General, in consultation 
     with the Secretary of Health and Human Services, shall submit 
     to the Committee on the Judiciary and the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on the Judiciary and the Committee on Energy and 
     Commerce of the House of Representatives a report on 
     enhancing the interoperability of State prescription 
     monitoring programs with other technologies and databases 
     used for detecting and reducing fraud, diversion, and abuse 
     of prescription drugs.
       (2) Contents.--The report required under paragraph (1) 
     shall include--
       (A) an assessment of legal, technical, fiscal, privacy, or 
     security challenges that have an impact on interoperability;
       (B) a discussion of how State prescription monitoring 
     programs could increase the production and distribution of 
     unsolicited reports to prescribers and dispensers of 
     prescription drugs, law enforcement officials, and health 
     professional licensing agencies, including the enhancement of 
     such reporting through interoperability with other States and 
     relevant technology and databases; and
       (C) any recommendations for addressing challenges that 
     impact interoperability of State prescription monitoring 
     programs in order to reduce fraud, diversion, and abuse of 
     prescription drugs.

                      Subtitle D--Synthetic Drugs

     SEC. 1151. SHORT TITLE.

       This subtitle may be cited as the ``Synthetic Drug Abuse 
     Prevention Act of 2012''.

     SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE 
                   CONTROLLED SUBSTANCES ACT.

       (a) Cannabimimetic Agents.--Schedule I, as set forth in 
     section 202(c) of the Controlled Substances Act (21 U.S.C. 
     812(c)) is amended by adding at the end the following:
       ``(d)(1) Unless specifically exempted or unless listed in 
     another schedule, any material, compound, mixture, or 
     preparation which contains any quantity of cannabimimetic 
     agents, or which contains their salts, isomers, and salts of 
     isomers whenever the existence of such salts, isomers, and 
     salts of isomers is possible within the specific chemical 
     designation.
       ``(2) In paragraph (1):
       ``(A) The term `cannabimimetic agents' means any substance 
     that is a cannabinoid receptor type 1 (CB1 receptor) agonist 
     as demonstrated by binding studies and functional assays 
     within any of the following structural classes:
       ``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at 
     the 5-position of the phenolic ring by alkyl or alkenyl, 
     whether or not substituted on the cyclohexyl ring to any 
     extent.
       ``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole 
     by substitution at the nitrogen atom of the indole ring, 
     whether or not further substituted on the indole ring to any 
     extent, whether or not substituted on the naphthoyl or 
     naphthyl ring to any extent.
       ``(iii) 3-(1-naphthoyl)pyrrole by substitution at the 
     nitrogen atom of the pyrrole ring, whether or not further 
     substituted in the pyrrole ring to any extent, whether or not 
     substituted on the naphthoyl ring to any extent.
       ``(iv) 1-(1-naphthylmethylene)indene by substitution of the 
     3-position of the indene ring, whether or not further 
     substituted in the indene ring to any extent, whether or not 
     substituted on the naphthyl ring to any extent.
       ``(v) 3-phenylacetylindole or 3-benzoylindole by 
     substitution at the nitrogen atom of the indole ring, whether 
     or not further substituted in the indole ring to any extent, 
     whether or not substituted on the phenyl ring to any extent.
       ``(B) Such term includes--
       ``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (CP 47,497);
       ``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
     hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP 47,497 
     C8-homolog);
       ``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH 018 and AM678);

[[Page S3608]]

       ``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH 073);
       ``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH 019);
       ``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole 
     (JWH 200);
       ``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH 250);
       ``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH 
     081);
       ``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH 122);
       ``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH 398);
       ``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
       ``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
       ``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR 19 and 
     RCS 4);
       ``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 
     (SR 18 and RCS 8); and
       ``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH 
     203).''.
       (b) Other Drugs.--Schedule I of section 202(c) of the 
     Controlled Substances Act (21 U.S.C. 812(c)) is amended in 
     subsection (c) by adding at the end the following:
       ``(18) 4-methylmethcathinone (Mephedrone).
       ``(19) 3,4-methylenedioxypyrovalerone (MDPV).
       ``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C E).
       ``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C D).
       ``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C C).
       ``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C I).
       ``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C 
     T 2).
       ``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 
     (2C T 4).
       ``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C H).
       ``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C N).
       ``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C 
     P).''.

     SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO 
                   PUBLIC SAFETY EXPANSION.

       Section 201(h)(2) of the Controlled Substances Act (21 
     U.S.C. 811(h)(2)) is amended--
       (1) by striking ``one year'' and inserting ``2 years''; and
       (2) by striking ``six months'' and inserting ``1 year''.

     SEC. 1154. PROHIBITION ON IMPOSING MANDATORY MINIMUM 
                   SENTENCES.

       Section 401(b)(1)(C) of the Controlled Substances Act (21 
     U.S.C. 841(b)(1)(C)) is amended by adding at the end the 
     following: ``Any mandatory minimum term of imprisonment 
     required to be imposed under this subparagraph shall not 
     apply with respect to any controlled substance added to 
     schedule I by the Synthetic Drug Abuse Prevention Act of 
     2012.''.

  Mr. REID. Madam President, I move to reconsider the vote and move to 
lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The majority leader is recognized.
  Mr. REID. Madam President, I know people are very anxious to move on. 
I am, too, but I have to say just a word. I have said in my own caucus 
how much I appreciate the cooperation of Senator Enzi. He is a fine 
Senator. He and Senator Harkin have worked so well together. It is 
exemplary for what the rest of us should do. I appreciate very much the 
work they have done. I repeat, it is how we should get other work done.
  This is an important piece of legislation, and we made it look 
simple; it was not. But because of these two fine Senators, we were 
able to get this done in a very short period of time and get good 
things done for the American people.
  Mr. HARKIN. Madam President, today, with passage of the FDA Safety 
and Innovation Act and the reauthorization of the FDA user fee 
agreements, we have helped both the FDA and the biomedical industry 
ensure that they can get needed medical products to patients quickly 
and safely.
  This legislation will ensure that the FDA can swiftly approve drugs 
and medical devices, save biomedical industry jobs, protect patient 
access to new therapies, and preserve America's global leadership in 
biomedical innovation. It will keep patients safer by modernizing FDA's 
inspection process for foreign manufacturing facilities, while also 
improving access to new and innovative medicines and devices. It will 
reduce drug costs for consumers by speeding the approval of lower cost 
generic drugs and help prevent and address drug shortages. Finally, by 
improving the way FDA does business, increasing accountability and 
transparency, U.S. companies will be better able to innovate and 
compete in the global marketplace.
  By passing the FDA Safety and Innovation Act, we have taken an 
important step to improve American families' access to lifesaving drugs 
and medical devices.
  As I have said throughout this debate, the bipartisan process that 
produced this excellent bill has been quite remarkable. I have worked 
closely with my colleagues on both sides of the aisle, as well as 
industry stakeholders, patient groups, and consumer groups to solicit 
ideas and improvements on the critical provisions in this bill. We have 
a better product thanks to everyone's input.
  I extend a special thank-you to my colleague, Ranking Member Enzi. I 
have been working with Senator Enzi for over a year on this bill. It 
has been a wonderful and cooperative partnership and a trusting 
friendship. I can honestly say we would not have gotten this done 
without his excellent leadership and wise counsel. I thank him for 
that.
  I also thank all of the HELP Committee members, as well as members 
off the committee, who were thoroughly engaged with this process from 
the beginning as part of the bipartisan working groups we established. 
Each of them has contributed significantly to this legislation, and I 
am sincerely grateful for all their contributions.
  Madam President, I will submit for the Record a list of all staff 
members who were part of our bipartisan working groups throughout the 
past year. We all know we could not have achieved this without the 
tireless and diligent work of our loyal staffs. I extend my deep 
appreciation for their hard work and extraordinary efforts.
  I ask unanimous consent that the list of staff members be printed in 
the Record.
   There being no objection, the material was ordered to be printed in 
the Record, as follows:

                          ____________________