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116th Congress    }                                  {   Rept. 116-693
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                  {          Part 1

======================================================================



 
       PRESERVE ACCESS TO AFFORDABLE GENERICS AND BIOSIMILARS ACT

                                _______
                                

 December 24, 2020.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

    Mr. Nadler, from the Committee on the Judiciary, submitted the 
                               following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 2375]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on the Judiciary, to whom was referred the 
bill (H.R. 2375) to prohibit prescription drug companies from 
compensating other prescription drug companies to delay the 
entry of a generic drug, biosimilar biological product, or 
interchangeable biological product into the market, having 
considered the same, reports favorably thereon without 
amendment and recommends that the bill do pass.

                           TABLE OF CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for the Legislation..........................     2
Hearings.........................................................     8
Committee Consideration..........................................     8
Committee Votes..................................................     9
Committee Oversight Findings.....................................     9
New Budget Authority and Tax Expenditures........................     9
Congressional Budget Office Cost Estimate........................     9
Duplication of Federal Programs..................................    11
Performance Goals and Objectives.................................    11
Advisory on Earmarks.............................................    11
Section-by-Section Analysis......................................    12
Changes in Existing Law Made by the Bill, as Reported............    14
Additional Views.................................................    79

                          Purpose and Summary

    H.R. 2375, the ``Preserve Access to Affordable Generics and 
Biosimilars Act,'' is designed to address the soaring cost of 
prescription drugs by targeting reverse-payment patent 
settlement agreements (``reverse-payment agreements''), also 
referred to as ``pay-for-delay'' agreements. Reverse-payment 
agreements occur when a pharmaceutical drug company pays a 
competitor to keep a generic (or biosimilar) version of its 
drug off the market as part of a patent settlement agreement. 
These deals delay access to more affordable generic (or 
biosimilar) versions of the drugs, costing consumers and the 
government billions of dollars in higher drug costs. H.R. 2375 
is supported by a coalition of healthcare providers, patient 
groups, and public-interest organizations including AARP, 
Consumer Reports, Public Citizen, Patients for Affordable Drugs 
Now, Premier Inc. Healthcare Alliance, and the American Academy 
of Dermatology Association.

                Background and Need for the Legislation


                               BACKGROUND

    Reverse payment patent settlements arise in the context of 
patent litigation between pharmaceutical drug companies. These 
financial arrangements often take the form of a patent 
litigation settlement agreement in which the branded drug firm 
pays its potential generic competitor to settle patent claims 
and delay entering the market with a lower-cost generic 
product. Notably, such agreements could also occur between 
manufacturers of biologic or biosimilar drugs, or manufacturers 
of competing generic (or biosimilar) products. According to a 
Federal Trade Commission (FTC) report in 2010, pay-for-delay 
agreements were estimated to cost American consumers $3.5 
billion per year--$35 billion over the decade from 2010 to 
2020.\1\
---------------------------------------------------------------------------
    \1\Fed. Trade Comm'n, Pay-for-Delay: How Drug Company Pay-Offs Cost 
Consumers Billions 2 (2010), https://www.ftc.gov/sites/default/files/
documents/reports/pay-delay-how-drug-company-pay-offs-cost-consumers-
billions-federal-trade-commission-staff-study/100112payfordelayrpt.pdf.
---------------------------------------------------------------------------

The Role of Generic and Biosimilar Competition in Lowering Prescription 
        Drug Costs

    Pay-for-delay agreements seek to block or delay price-
reducing generic and biosimilar entry. Because generic 
competition is critical to reducing the high cost of 
prescription drugs this conduct is particularly harmful. 
Generic drugs typically cost 80 to 85% less than their brand-
name alternatives.\2\ Lower-priced generic drugs saved the U.S. 
health care system about $1.7 trillion from 2007 to 2016.\3\ 
Because of the universal recognition that generic competition 
is beneficial for patients and taxpayers, Congress and state 
legislatures have enacted legislation to facilitate the ability 
of drug makers to bring generic and biosimilar prescription 
drug products to market.
---------------------------------------------------------------------------
    \2\Generic Drugs: Questions & Answers, U.S. Food & Drug Admin. 
(2018), https://www.fda.gov/drugs/questions-answers/generic-drugs-
questions-answers.
    \3\Id.
---------------------------------------------------------------------------
    The Federal Food, Drug, and Cosmetic Act (FDCA),\4\ as 
amended by the Drug Price Competition and Patent Term 
Restoration Act of 1984 (Hatch-Waxman Act)\5\ and the Medicare 
Prescription Drug, Improvement, and Modernization Act of 
2003,\6\ has established procedures to facilitate competition 
from lower-priced generic drug manufacturers, while maintaining 
incentives for branded drug manufacturers to invest in 
developing new drugs.
---------------------------------------------------------------------------
    \4\21 U.S.C. Sec. 301 (2019).
    \5\Id. at Sec. 355.
    \6\Id. at Sec. 355(b)(2), (j); 35 U.S.C. Sec. 271(e) (2019).
---------------------------------------------------------------------------
    Biologics are governed by the Biologics Price Competition 
and Innovation Act (BPCIA), rather than the Hatch-Waxman 
Act.\7\ Similar to the Hatch-Waxman Act, the BPCIA establishes 
procedures to facilitate competition from drug manufacturers of 
lower-priced biosimilars (or interchangeables), while 
maintaining incentives for branded drug manufacturers to invest 
in developing new biological drug products.
---------------------------------------------------------------------------
    \7\See Patient Protection and Affordable Care Act (PPACA), Pub. L. 
No. 111-148, 124 Stat. 119,804 (2010) (codified as amended in scattered 
sections of the U.S. Code) (BPCIA was enacted under Title VII of 
PPACA).
---------------------------------------------------------------------------
    The Hatch-Waxman Act has succeeded in facilitating generic 
competition and generating large savings for patients, health 
care plans, and federal and state governments. Among other 
provisions, the Act includes a mechanism for accelerated 
approval of generic drugs through an Abbreviated New Drug 
Application (ANDA) process. Although the BCPIA is relatively 
new, the legislation has facilitated biosimilar competition to 
expensive biologic products, also resulting in savings.
    Due to these significant price advantages and cost savings, 
many third-party payers for prescription drugs--health 
insurance plans and Medicaid programs--have adopted policies to 
encourage the substitution of generic drugs for their branded 
counterparts. In addition, all fifty states and the District of 
Columbia have drug substitution laws that encourage and 
facilitate the substitution of lower-cost generic drugs for 
branded drugs. Consequently, generic drugs typically capture 
over 80% of a branded drug's share of unit and dollar sales 
within six months of market entry.\8\ Meanwhile, according to a 
2016 Journal of the American Medical Association analysis, 72% 
of drug spending comes from just 10% of brand-name 
medications.\9\ Consequently, there is significant money at 
stake in the battle between branded and generic drug 
manufacturers.
---------------------------------------------------------------------------
    \8\Generics Grab 80% Share of US Market and Fill 78% of 
Prescriptions, Generics and Biosimilars Initiative (May 13, 2011), 
http://gabionline.net/Reports/Generics-grab-80-share-of-US-market-and-
fill-78-of-prescriptions. (citing a report published by IMS Health in 
April 2011); see also U.S. Dep't of Health and Human Servs., ``Some 
Observations Related to the Generic Drug Market 4 (2015), https://
aspe.hhs.gov/system/files/pdf/139331/ib_GenericMarket.pdf (on average 
the generic product captures 90% of the market within one year of 
entry).
    \9\Aaron S. Kesselheim et al., The High Cost of Prescription Drugs 
in the United States: Origins and Prospects for Reform, 316 J. A. Med. 
Ass'n 858, 860 (2016), https://phhp-bahealthscience-
new.sites.medinfo.ufl.edu/files/2016/09/jsc1600151.pdf.
---------------------------------------------------------------------------

The Statutory Framework in Which Pay-for-Delay Agreements Arise

    The patent litigation that gives rise to these types of 
agreements usually occurs within the framework that the Hatch-
Waxman Act established for generic entry.\10\ Under Hatch-
Waxman, a generic competitor may seek entry before the 
expiration of a brand-name drug's patents. To seek Food and 
Drug Administration (FDA) approval for entry before the patents 
expire, a generic must declare that its product does not 
infringe the relevant patents or that the patents are 
invalid.\11\ Branded drug companies often challenge the 
generic's declaration, resulting in litigation between the 
brand-name and generic drug makers to determine whether the 
patents at issue are valid or infringed. This is often referred 
to as ANDA litigation because it arises under the FDA's 
Abbreviated New Drug Application (ANDA) process. Hatch-Waxman 
incentivizes generics to challenge the branded company's 
patents, and risk ANDA litigation, because the Act provides 
that the first generic to file its application can obtain a 
180-day period of market exclusivity--during which it is the 
only generic on the market.\12\ For the brand-name company to 
win the ANDA litigation and block generic entry, it must defend 
the validity of its patents and show that the generic's product 
would infringe those patents.
---------------------------------------------------------------------------
    \10\The Drug Price Competition and Patent Term Restoration Act of 
1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 
21 U.S.C. Sec.  355 (2019)) (governing how generics may enter the 
marketplace to compete with brand-name pharmaceuticals).
    \11\21 U.S.C. Sec.  355(j)(2)(A)(vii)(IV) (2019).
    \12\Id. at Sec.  355(j)(5)(B)(iv).
---------------------------------------------------------------------------
    Because of the expense and uncertain outcome of patent 
litigation, brand-name and generic pharmaceutical companies 
sometimes settle the litigation before a court reaches a final 
decision. In the absence of compensation to the generic for 
delaying its entry, it is unlikely that these settlement 
agreements would raise antitrust issues.\13\
---------------------------------------------------------------------------
    \13\See Fed. Trade Comm'n v. Actavis, Inc., 570 U.S. 136, 158 
(2013) (``[T]he fact that a large, unjustified reverse payment risks 
antitrust liability does not prevent litigating parties from settling 
their lawsuit. They may, as in other industries, settle in other ways, 
for example, by allowing the generic manufacturer to enter the 
patentee's market prior to the patent's expiration, without the 
patentee paying the challenger to stay out prior to that point.'').
---------------------------------------------------------------------------
    Due to the significant loss of market share and profits 
that branded manufacturers experience upon entry of generic 
competitors, however, some of these settlement agreements are 
anti-competitive, involving brand-name drug companies 
committing to pay the generic manufacturer a fee to delay the 
marketing of its generic version of the drug for a given period 
of time. Markus Meier, who leads the FTC's health care division 
and previously served as Acting Director of the FTC's Bureau of 
Competition, testified last Congress that ``[b]randed 
manufacturers have used such agreement [sic] to buy more 
protection from competition than their patent rights provide, 
at the expense to competition and consumers.''\14\ A recent FTC 
opinion explained why these pay-for-delay agreements are also 
referred to as ``reverse payment'' settlements:
---------------------------------------------------------------------------
    \14\Antitrust Concerns and the FDA Approval Process: Hearing Before 
the Subcomm. on Regulatory Reform, Commercial, and Antitrust Law of the 
H. Comm. on the Judiciary, 115th Cong. (2017) (written testimony of 
Markus Meier, Acting Director, Bureau of Competition, Fed. Trade 
Comm'n, at 15), https://republicans-judiciary.house.gov/wp-content/
uploads/2017/07/Meier-FTC-Testimony.pdf.

          In a reverse payment settlement, the branded drug 
        maker--the plaintiff in the patent infringement 
        action--pays the patent challenger and alleged 
        infringer--the defendant--to refrain from offering its 
        generic drug for a period of time as part of a 
        settlement of patent litigation. The value in the 
        settlement flows in the opposite direction of what one 
        would ordinarily expect, where the defendant and 
        alleged infringer might pay the plaintiff intellectual 
        property (IP) rights holder for allegedly violating 
        those rights.\15\
---------------------------------------------------------------------------
    \15\In re Impax Labs., Inc., No. 9373, at 2 (F.T.C. Mar. 28, 2019).

    Since 2001, the FTC has filed a number of successful 
lawsuits to stop pay-for-delay settlements due to these 
significant anti-competitive effects. Its efforts resulted in 
the Supreme Court's 2013 landmark decision in FTC v. Actavis, 
which held that these settlements are subject to antitrust 
scrutiny.\16\ Following this decision, the number of these 
potentially anti-competitive deals has fallen, but a 
significant number have continued to occur. The total number of 
such settlements filed with the FTC has dropped to 21 in FY 
2014 from 29 in FY 2013, and 40 in FY 2012 prior to the Actavis 
ruling.\17\ In the FTC's 2017 report assessing final Hatch-
Waxman patent settlements--the most recent report available--
the agency identified 20 final settlements that contained 
explicit compensation to the generic company and a restriction 
on selling a generic product for a period of time.\18\
---------------------------------------------------------------------------
    \16\Fed. Trade Comm'n v. Actavis, Inc., 570 U.S. 136, 158 (2013) 
(holding that a ``reverse payment'' settlement agreement, ``where large 
and unjustified, can bring with it the risk of significant 
anticompetitive effects'').
    \17\See Press Release, Fed. Trade Comm'n, FTC Report on Drug Patent 
Settlements Shows Potential Pay-for-Delay Deals Decreased Substantially 
in the First Year Since Supreme Court's Actavis Decision (Jan. 13, 
2016), https://www.ftc.gov/news-events/press-releases/2016/01/ftc-
report-drug-patent-settlements-shows-potential-pay-delay.
    \18\See Press Release, Fed. Trade Comm'n, FTC Staff Issues FY 2017 
Report on Branded Drug Firms' Patent Settlements with Generic 
Competitors (Dec. 3, 2020), https://www.ftc.gov/news-events/press-
releases/2020/12/ftc-staff-issues-fy-2017-report-branded-drug-firms-
patent?utm_source=govdelivery.
---------------------------------------------------------------------------

                        NEED FOR THE LEGISLATION

    H.R. 2375 is necessary to put an end to pay-for-delay 
settlements. These agreements cause significant consumer harm 
by imposing increased costs for prescription drugs on patients 
and taxpayers. Despite the FTC's landmark victory in 2013 at 
the Supreme Court in Actavis, pharmaceutical companies continue 
to engage in pay-for-delay agreements. In the years since 
Actavis, lawsuits challenging pay-for-delay agreements 
continued to take up a large amount of the FTC's time and 
resources.\19\ Furthermore, given that judges in some post-
Actavis cases appear to have misinterpreted or ignored key 
aspects of the Supreme Court's decision,\20\ the ``Preserve 
Access to Affordable Generics and Biosimilars Act,'' is a vital 
piece of legislation to prevent backsliding by the courts that 
may result in uncertainty, enforcement difficulties, or result 
in a less competitive landscape altogether.
---------------------------------------------------------------------------
    \19\See Diagnosing the Problem: Exploring the Effects of 
Consolidation and Anticompetitive Conduct in Health Care Markets: 
Hearing Before the Subcomm. on Antitrust, Commercial, and Admin. Law of 
the H. Comm. on the Judiciary, 116th Cong. (2019) (written testimony of 
Michael Kades, Director of Markets and Competition, at 2), https://
docs.house.gov/meetings/JU/JU05/20190307/109024/HHRG-116-JU05-Bio-
KadesM-20190307.pdf.
    \20\Id.; Michael A. Carrier, The Curious Case of Wellbutrin: How 
the Third Circuit Mistook Itself for the Supreme Court, 103 Cornell L. 
Rev. Online 137, 145 (2018) (stating that the Third Circuit's ruling in 
Wellbutrin ``cannot be reconciled'' with the Supreme Court's holding in 
Actavis).
---------------------------------------------------------------------------

Pay-for-Delay Agreements Result in Higher Prescription Drug Costs and 
        Significant Harm to Patients

    When pharmaceutical companies delay entry of generic or 
biosimilar drugs through pay-for-delay agreements, they deprive 
consumers of the lower prices that generic and biosimilar 
competition brings to the market. For some consumers, these 
delays could mean the difference between life and death. As a 
result of soaring prices, many patients skip doses, take less 
than the prescribed amount of medicine, or do not fill their 
prescriptions.\21\ According to a study by Kaiser Health News, 
``[h]undreds of thousands of cancer patients are delaying care, 
cutting their pills in half or skipping drug treatment 
entirely.''\22\
---------------------------------------------------------------------------
    \21\Liz Szabo, Sticker Shock Forces Thousands of Cancer Patients To 
Skip Drugs, Skimp On Treatment, Kaiser Health News (Mar. 15, 2017), 
https://khn.org/news/sticker-shock-forces-thousands-of-cancer-patients-
to-skip-drugs-skimp-on-treatment.
    \22\Id.
---------------------------------------------------------------------------
    As several leading experts have noted, these delay tactics 
can be enormously profitable for drug manufacturers.\23\ 
Michael Kades, the Director of Markets and Competition Policy 
at the Washington Center for Equitable Growth, testified this 
Congress that ``delaying competition on a blockbuster drug for 
just a year can mean hundreds of million[s], if not billions of 
dollars in additional profit.''\24\ Furthermore, in the absence 
of a strong deterrent, ``many companies will see antitrust 
liability simply as a cost of doing business.''\25\
---------------------------------------------------------------------------
    \23\See, e.g., Diagnosing the Problem: Exploring the Effects of 
Consolidation and Anticompetitive Conduct in Health Care Markets: 
Hearing Before the Subcomm. on Antitrust, Commercial, and Admin. Law of 
the H. Comm. on the Judiciary, 116th Cong. (2019).
    \24\Id. (testimony of Michael Kades, Director of Markets and 
Competition Policy, Washington Center for Equitable Growth), available 
at http://www.cq.com/doc/congressionaltranscripts-5482270?2; see also 
In re Impax Labs., Inc., No. 9373, at 7 (F.T.C. Mar. 28, 2019) (``Endo 
forecast that, if Impax launched its generic at risk, Endo would lose 
85 percent of its branded Opana ER sales within three months, and $100 
million in sales revenue within six months.'').
    \25\Diagnosing the Problem: Exploring the Effects of Consolidation 
and Anticompetitive Conduct in Health Care Markets, Hearing Before the 
Subcomm. on Antitrust, Commercial, and Admin. Law of the H. Comm. on 
the Judiciary, 116th Cong. (2019) (written testimony of Michael Kades, 
Director of Markets and Competition Policy, Washington Center for 
Equitable Growth, at 1), https://docs.house.gov/meetings/JU/JU05/
20190307/109024/HHRG-116-JU05-Bio-KadesM-20190307.pdf.
---------------------------------------------------------------------------

The Supreme Court's Actavis Decision Did Not Solve the Problem

    Although there has been significant progress toward 
eliminating reverse payment agreements in the wake of the 
Supreme Court's decision in Actavis, this ruling did not 
entirely resolve the problem. As Dr. Aaron Kesselheim of 
Harvard Medical School testified before the Subcommittee last 
Congress:

          [T]he Actavis case was really about . . . settlements 
        that included extremely large monetary transfers like 
        handing over of suitcases full of cash. But since then, 
        pay-for-delay settlements have continued. Many of them 
        also still involve monetary settlements. But many of 
        them also now involve more complex co-marketing 
        arrangements or other kinds of business deals . . . and 
        these kinds of agreements persist.\26\
---------------------------------------------------------------------------
    \26\Antitrust Concerns and the FDA Approval Process: Hearing Before 
the Subcomm. on Regulatory Reform, Commercial, and Antitrust Law of the 
H. Comm. on the Judiciary, 115th Cong. 32-34 (2017) (testimony of Aaron 
S. Kesselheim, M.D., M.P.H., Associate Professor of Medicine, Harvard 
Medical School), https://republicans-judiciary.house.gov/wp-content/
uploads/2017/07/115-27.pdf.

    Lawsuits challenging pay-for-delay agreements continue to 
take up a large amount of time and resources. For example, last 
year marked the ten-year anniversary of when the FTC filed its 
original complaint in Actavis.\27\ After over a decade, 
however, the FTC announced that it reached a settlement with 
the last remaining defendant.\28\ As Mr. Kades of the 
Washington Center for Equitable Growth testified:
---------------------------------------------------------------------------
    \27\Complaint, Fed. Trade Comm'n v. Watson Pharm., Inc., No. 09-
00598 (C.D. Cal. Jan. 29, 2009), https://www.ftc.gov/sites/default/
files/documents/cases/2009/02/090202androgelcmpt_0.pdf.
    \28\See Press Release, Fed. Trade Comm'n, Last Remaining Defendant 
Settles FTC Suit that Led to Landmark Supreme Court Ruling on Drug 
Company ``Reverse Payments'' (Feb. 28, 2019), https://www.ftc.gov/news-
events/press-releases/2019/02/last-remaining-defendant-settles-ftc-
suit-led-landmark-supreme.

          Despite the U.S. Supreme Court's clear signal in the 
        Actavis case that pay-for-delay can be anticompetitive, 
        the FTC continues to spend substantial resources and 
        time challenging clear violations. Tougher laws, such 
        as the Preserve Access to Affordable Generics Act, 
        would deter such conduct and free up limited resources 
        to attack other anticompetitive conduct.\29\
---------------------------------------------------------------------------
    \29\Diagnosing the Problem: Exploring the Effects of Consolidation 
and Anticompetitive Conduct in Health Care Markets, Hearing Before the 
Subcomm. on Antitrust, Commercial, and Admin. Law of the H. Comm. on 
the Judiciary, 116th Cong. (2019) (written testimony of Michael Kades, 
Director of Markets and Competition Policy, Washington Center for 
Equitable Growth, at 2), https://docs.house.gov/meetings/JU/JU05/
20190307/109024/HHRG-116-JU05-Bio-KadesM-20190307.pdf.

    Additionally, judges in some post-Actavis cases appear to 
have misinterpreted or ignored key aspects of the Supreme 
Court's decision. For example, a number of commentators have 
pointed out that in In re Wellbutrin XL Antitrust 
Litigation,\30\ the Third Circuit departed from the Supreme 
Court's reasoning in Actavis as it upheld the lower court's 
dismissal of an antitrust claim based on a reverse payment 
settlement.\31\ In reaching its decision, the Third Circuit 
stated that it was persuaded by a defense\32\ specifically 
rejected by the Supreme Court in Actavis, namely that ``risk 
aversion'' could justify a branded drug company's settlement 
payment to a potential generic competitor.\33\ Accordingly, the 
Wellbutrin decision may invite defendants in pay-for-delay 
cases to hide behind a defense the Supreme Court has already 
rejected--that a large reverse payment may be justified on the 
basis of the brand-name company's aversion to risk. Such 
backsliding is inconsistent with the principle of stare 
decisis, raises hurdles to effective enforcement, and creates 
uncertainty for litigants. The ``Preserve Access to Affordable 
Generics and Biosimilars Act'' is necessary to prevent courts 
from backsliding. H.R. 2375 makes clear that the defenses that 
the Supreme Court rejected in Actavis, including the avoidance 
of risk and desire for certainty, are not available to 
defendants as a justification for an otherwise illegal reverse-
payment agreement.
---------------------------------------------------------------------------
    \30\868 F.3d 132 (3d Cir. 2017).
    \31\See, e.g., Michael A. Carrier, The Curious Case of Wellbutrin: 
How the Third Circuit Mistook Itself for the Supreme Court, 103 Cornell 
L. Rev. Online 137, 145 (2018) (stating that the Third Circuit's ruling 
in Wellbutrin ``cannot be reconciled'' with the Supreme Court's holding 
in Actavis); Br. for the Nat'l Ass'n of Chain Drug Stores, Inc. as 
Amicus Curiae Supporting Appellants at 2, In re Wellbutrin XL Antitrust 
Litig., 868 F.3d 132 (3d Cir. 2017) (``[T]he Panel's opinion 
resuscitated the risk aversion explanation for reverse payments that 
Actavis definitively rejected.'').
    \32\In re Wellbutrin XL Antitrust Litig., 868 F.3d 132, 168 (3d 
Cir. 2017).
    \33\See Michael A. Carrier, The Curious Case of Wellbutrin: How the 
Third Circuit Mistook Itself for the Supreme Court, 103 Cornell L. Rev. 
Online 137, 145 (2018) (explaining that the Wellbutrin court 
``resuscitated the defense based on risk aversion that the Supreme 
Court had rejected'').
---------------------------------------------------------------------------

H.R. 2375 Is an Effective Solution to Anti-Competitive Pay-for-Delay 
        Agreements

    The ``Preserve Access to Affordable Generics and 
Biosimilars Act'' strengthens the FTC's ability to challenge 
anti-competitive pay-for-delay agreements in court. By 
establishing that pay-for-delay agreements that keep lower-
priced generics from entering the market are presumptively 
illegal under antitrust law, H.R. 2375 will result in lower 
drug prices for consumers. This bill strikes the right balance 
by deterring drug companies from reaching anti-competitive 
settlements while allowing them to pursue agreements that do 
not harm competition.

                                Hearings

    In the 116th Congress, the Subcommittee on Antitrust, 
Commercial, and Administrative Law held a hearing on 
``Diagnosing the Problem: Exploring the Effects of 
Consolidation and Anticompetitive Conduct in Health Care 
Markets.''\34\ At this hearing, several witnesses testified 
about competition issues in health care markets, including Dr. 
Fiona Scott Morton, Professor of Economics at Yale School of 
Management; Dr. Martin Gaynor, Professor of Economics and 
Health Policy at Carnegie Mellon University; Michael Kades, 
Director of Markets and Competition Policy at Washington Center 
for Equitable Growth; and Dr. Craig Garthwaite, Herman R. Smith 
Research Professor at Northwestern University's Kellogg School 
of Management. At this hearing, both Dr. Scott Morton\35\ and 
Mr. Kades\36\ identified pay-for-delay settlements as an 
ongoing problem, and each testified about the need for 
congressional action in this area. This hearing satisfies the 
requirement of H. Res. 6, sec. 103(i).
---------------------------------------------------------------------------
    \34\Id.
    \35\Id. (written testimony of Fiona Scott Morton, Professor of 
Economics, Yale School of Management, at 3), https://docs.house.gov/
meetings/JU/JU05/20190307/109024/HHRG-116-JU05-Wstate-MortonF-
20190307.pdf.
    \36\Id. (written testimony of Michael Kades, Director of Markets 
and Competition, Washington Center for Equitable Growth, at 2), https:/
/docs.house.gov/meetings/JU/JU05/20190307/109024/HHRG-116-JU05-Bio-
KadesM-20190307.pdf.
---------------------------------------------------------------------------
    Last Congress, the Subcommittee held a hearing on 
``Antitrust Concerns and the FDA Approval Process.''\37\ On the 
first panel, the Subcommittee heard testimony from Dr. Scott 
Gottlieb, Commissioner of the FDA, and Mr. Markus Meier, Acting 
Director, Bureau of Competition. On the second panel, the 
Subcommittee heard testimony from Professor David Olson, Boston 
College Law School; Professor Erika Lietzan, University of 
Missouri School of Law; Mr. Alden Abbott, Deputy Director and 
Senior Legal Fellow, the Heritage Foundation; and Professor 
Aaron Kesselheim, M.D. M.P.H., Harvard Medical School. During 
the hearing, Acting Director Meier\38\ and Professor 
Kesselheim\39\ each testified that pay-for-delay agreements 
inhibit competition in health care markets and remain an 
ongoing problem.
---------------------------------------------------------------------------
    \37\Antitrust Concerns and the FDA Approval Process: Hearing Before 
the Subcomm. on Regulatory Reform, Commercial, and Antitrust Law of the 
H. Comm. on the Judiciary, 115th Cong. (2017), https://republicans-
judiciary.house.gov/wp-content/uploads/2017/07/115-27.pdf.
    \38\Id. at 10-11 (testimony of Markus Meier, Acting Director, 
Bureau of Competition, Federal Trade Commission).
    \39\Id. at 32-34 (testimony of Aaron S. Kesselheim, Associate 
Professor of Medicine, Harvard Medical School).
---------------------------------------------------------------------------

                        Committee Consideration

    On April 30, 2019, the Committee met in open session and 
ordered the bill, H.R. 2375, favorably reported by unanimous 
voice vote, a quorum being present.

                            Committee Votes

    In compliance with clause 3(b) of rule XIII of the Rules of 
the House of Representatives, the Committee advises that no 
rollcall votes occurred during the Committee's consideration of 
H.R. 2375.

                      Committee Oversight Findings

    In compliance with clause 3(c)(1) of rule XIII of the Rules 
of the House of Representatives, the Committee advises that the 
findings and recommendations of the Committee, based on 
oversight activities under clause 2(b)(1) of rule X of the 
Rules of the House of Representatives, are incorporated in the 
descriptive portions of this report.

               New Budget Authority and Tax Expenditures

    Clause 3(c)(2) of rule XIII of the Rules of the House of 
Representatives is inapplicable because this legislation does 
not provide new budgetary authority or increased tax 
expenditures.

               Congressional Budget Office Cost Estimate

    In compliance with clause 3(c)(3) of rule XIII of the Rules 
of the House of Representatives, the Committee sets forth, with 
respect to the bill, H.R. 2375, the following estimate and 
comparison prepared by the Director of the Congressional Budget 
Office under section 402 of the Congressional Budget Act of 
1974:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    H.R. 2375 would make certain agreements--used to settle 
claims of patent infringement between sponsors of brand-name, 
generic, or biosimilar drugs and relating to the sale of a drug 
or biological product--presumptively illegal under antitrust 
law. The bill would require particular types of agreements 
arising from proceedings conducted by the Patent Trial and 
Appeal Board (PTAB) to be reported to Federal Trade Commission 
(FTC) and the Department of Justice (DOJ). H.R. 2375 also would 
establish the authority to impose civil penalties when a party 
to a settlement is found to have violated the bill's 
requirements.
    CBO expects that the bill would accelerate the availability 
of lower-priced generic or biosimilar drugs that would have 
been affected by agreements targeted by the bill and reduce the 
average price of drugs paid by federal health programs that 
purchase drugs or provide health insurance that covers drugs. 
In total, CBO estimates that enacting H.R. 2375 would decrease 
the deficit by $613 million over the 2019-2029 period. That 
amount includes a $520 million reduction in direct spending and 
a $93 million increase in revenues.
    CBO also estimates that implementing H.R. 2375 would 
decrease spending subject to appropriation by $24 million over 
the 2019-2024 period, assuming appropriation actions consistent 
with the bill. That decrease would result primarily because 
lower estimated drug prices would reduce costs for 
discretionary health programs.
    Details of the estimated budgetary effect of H.R 2375 are 
shown in Table 1. Those effects fall primarily within budget 
functions 370 (commerce and housing credit), 550 (health), and 
570 (Medicare).

                                                   TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 2375
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                By fiscal year, millions of dollars--
                                           -------------------------------------------------------------------------------------------------------------
                                             2019    2020    2021    2022    2023    2024    2025    2026    2027    2028    2029   2019-2024  2019-2029
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Decreases in Direct Spending
 
Estimated Budget Authority................       0       0     -21     -53     -63     -56     -58     -61     -65     -74     -69      -193       -520
Estimated Outlays.........................       0       0     -21     -53     -63     -56     -58     -61     -65     -74     -69      -193       -520
    On-Budget.............................       0       0     -21     -53     -63     -56     -58     -61     -65     -74     -69      -192       -518
    Off-Budgeta...........................       0       0       *       *       *       *       *       *       *       *       *        -1         -2
                                                                  Increases in Revenues
 
Estimated Revenues........................       0       0       3       9      11      11      10      11      12      12      13        34         93
    On-Budget.............................       0       0       3       6       8       8       7       8       9       9      10        25         69
    Off-Budget............................       0       0       1       2       3       3       3       3       3       3       3         9         24
                                                               Net Decrease in the Deficit
                                                      From Changes in Direct Spending and Revenues
 
Effect on the Deficit.....................       0       0     -24     -62     -74     -67     -68     -72     -77     -86     -82      -227       -613
    On-Budget.............................       0       0     -23     -59     -71     -64     -66     -69     -74     -83     -78      -217       -587
    Off-Budget............................       0       0      -1      -3      -3      -3      -3      -3      -3      -3      -4       -10        -26
                                           -------------------------------------------------------------------------------------------------------------
                                             Increases or Decreases (-) in Spending Subject to Appropriation
Estimated Authorization...................       0       *      -3      -6      -8      -7    n.e.    n.e.    n.e.    n.e.    n.e.       -24       n.e.
Estimated Outlays.........................       0       *      -3      -6      -8      -7    n.e.    n.e.    n.e.    n.e.    n.e.       -24      n.e.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Components may not sum to totals because of rounding; n.e. = not estimated; * = between -$500,000 and zero.
aIncludes off-budget effects on the operating costs of the U.S. Postal Service.

    By enhancing FTC authority to restrict certain agreements 
between sponsors of brand-name, generic, or biosimilar drugs, 
H.R. 2375 would impose a private-sector mandate as defined in 
the Unfunded Mandates Reform Act (UMRA). The bill also would 
impose a private-sector mandate by requiring those 
manufacturers to notify the FTC of agreements that resolve PTAB 
proceedings. CBO estimates the cost of the mandate, 
particularly in the form of lost revenues, would exceed the 
threshold for private-sector mandates established in UMRA ($164 
million in 2019, adjusted annually for inflation) in at least 
two of the first five years the mandate is in effect.
    On April 26, 2019, CBO transmitted an estimate for H.R. 
1499, the Protecting Consumer Access to Generic Drugs Act of 
2019, as ordered reported by the House Committee on Energy and 
Commerce on April 3, 2019. CBO's estimates of the effect on the 
deficit through 2029 for the two bills are the same. In 
different ways, both H.R. 2375 and H.R. 1499 would modify the 
conduct of enforcement actions by FTC against parties to 
certain agreements to settle a claim of patent infringement and 
would impose significant restrictions on the terms of 
compensation in affected agreements. H.R. 2375 also would 
require particular types of agreements relating to PTAB 
proceedings to be filed with FTC and the DOJ; H.R. 1499 does 
not contain a comparable provision. CBO expects that both bills 
would accelerate, on average, the availability of lower-priced 
generic and biosimilar drugs to a similar extent and would 
generate an equivalent amount of budgetary savings from 2020 
through 2029.
    The CBO staff contact for this estimate is Julia 
Christensen. The estimate was reviewed by Leo Lex, Deputy 
Assistant Director for Budget Analysis.

                    Duplication of Federal Programs

    No provision of H.R. 2375 establishes or reauthorizes a 
program of the Federal government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                    Performance Goals and Objectives

    The Committee states that pursuant to clause 3(c)(4) of 
rule XIII of the Rules of the House of Representatives, H.R. 
2375 would lower drug prices by ending abusive pay-for-delay 
settlements. By establishing that pay-for-delay agreements are 
presumptively illegal under antitrust law, the ``Preserve 
Access to Affordable Generics and Biosimilars Act'' will lower 
drug prices for consumers.

                          Advisory on Earmarks

    In accordance with clause 9 of rule XXI of the Rules of the 
House of Representatives, H.R. 2375 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                      Section-by-Section Analysis

    The following discussion describes the bill as reported by 
the Committee.
    Section 1. Short Title. Section 1 sets forth the title of 
the legislation as the ``Preserve Access to Affordable Generics 
and Biosimilars Act.''
    Section 2. Declaration of Purposes. Section 2 sets forth 
the purposes of the Act as: (1) to enhance competition in the 
pharmaceutical market by stopping anti-competitive agreements 
between brand name and generic drug or biosimilar manufacturers 
(and also among generic or biosimilar manufacturers) that 
limit, delay, or otherwise prevent competition; and (2) to 
support the purpose and intent of antitrust law by prohibiting 
anti-competitive practices in the pharmaceutical industry that 
harm consumers.
    Section 3. Unlawful Compensation for Delay. Subsection (a) 
of Section 3 amends the Federal Trade Commission (FTC) Act by 
adding a new Section 27 to the FTC Act after Section 26 (15 
U.S.C. Sec.  57c-2).
    New subsection (a) authorizes the FTC to initiate 
enforcement proceedings against the parties to an agreement 
resolving or settling, on a final or interim basis, a patent 
claim in connection with the sale of a drug product or 
biological product. In such an action, an agreement shall be 
presumed to have anti-competitive effects and be in violation 
of the section if: (1) the agreement provides anything of value 
to the ANDA or biosimilar biological product application filer; 
and (2) the agreement includes a limitation on research, 
development, manufacturing, marketing, or sales of a product 
for any period of time; unless the parties can demonstrate by 
clear and convincing evidence that the compensation is solely 
for other goods or services the filer has promised to provide, 
or the pro-competitive benefits of the agreement outweigh the 
anti-competitive effects of the agreement.
    New subsection (b) provides that when determining if the 
parties have met the burden of the exception under subsection 
(a), the fact-finder shall not presume (1) that the entry of a 
product into the market would not have occurred until the 
relevant patent or statutory exclusivity expires; or (2) that 
the agreement for entry of a product prior to the expiration of 
the relevant patent or statutory exclusivity means that the 
agreement is pro-competitive.
    New subsection (c) provides that nothing in this section 
shall prohibit a resolution or settlement of a patent 
infringement claim where the thing of value received by the 
filer includes only one or more of the following: (1) the right 
to market and secure final regulatory approval for a product in 
the U.S. prior to the expiration of any patent that is the 
basis for the patent infringement claim; or any patent right or 
other statutory exclusivity that would prevent the marketing of 
such ANDA product or biosimilar biological product (including 
certain acceleration clauses that allow for early generic entry 
and waivers of regulatory and statutory exclusivities that may 
otherwise block generic entry); (2) any payment for reasonable 
litigation expenses not to exceed $7,500,000 in 2019, adjusted 
each year thereafter to reflect any increases in the Producer 
Price Index for Legal Services; or (3) a covenant not to sue on 
any claim that the ANDA product or biosimilar biological 
product infringes a United States patent.
    New subsection (d) provides that a violation of this 
section shall be treated as an unfair method of competition 
under Section 5(a)(1) of the FTC Act. A party has 30 days to 
file a petition for review of the Commission's decision to a 
United States Court of Appeals, but the findings of the 
Commission as to the facts, if supported by evidence, shall be 
conclusive.
    New subsection (e) provides that nothing in this Section 
shall modify, impair, limit, or supersede the antitrust laws or 
the right to assert claims under the antitrust laws of any 
filer of an application to approve a generic drug or a 
biosimilar product.
    New subsection (f) provides for penalties. A civil penalty 
shall not be greater than three times the value received or 
given by the parties that is reasonably attributable to 
violation of this section. The Commission may recover the 
penalty through a civil action in district court. In such 
actions, the courts may grant mandatory injunctions and such 
other and further equitable relief as the courts deem 
appropriate. If the FTC issues a cease and desist order against 
a party, the FTC may commence an action under this section at 
any time before the expiration of one year after such order 
becomes final. When determining the civil penalty amount, the 
court shall take into account: (1) the nature, circumstances, 
gravity, and extent of the violation; (2) the degree of 
culpability, any history of violations, the ability to pay, any 
effect on the ability to continue doing business, profits 
earned by the parties to the agreement, compensation received 
by the generic or biosimilar biological product application 
filer; (3) the amount of commerce affected by the violation; 
and (4) other matters that justice requires.
    New subsection (g) sets forth various definitions.
    Subsection (b) of Section 3 sets the effective date of the 
new Section 27. That section applies to all agreements 
described in section 27(a)(1) entered into on or after the date 
of enactment of this Act.
    Section 4. Notice and Certification of Agreements. Section 
4 amends the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 by extending the definition of 
``Brand Name Drug Company'' to include the owners of patents 
that could be the subject of patent infringement claims arising 
from the marketing of a biological product in the U.S.; and (2) 
adding that an official from the company must file a 
certification regarding the completeness of the materials filed 
with the Assistant Attorney General and the FTC within 30 days 
after the filing of any settlement agreement required to be 
filed under the statute.
    Section 5. Notification of Agreements. Section 5 amends the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003 by clarifying that the requirement to file certain 
agreements with the FTC extends to agreements resolving or 
settling a Patent Trial and Appeal Board proceeding.
    Section 6. Forfeiture of 180-Day Exclusivity Period. 
Section 6 amends the Federal Food, Drug, and Cosmetic Act to 
eliminate the 180-day exclusivity period for the first-to-file 
generic drug on the market if the generic drug's manufacturer 
is found to have violated new section 27 of the Federal Trade 
Commission Act.
    Section 7. Commission Litigation Authority. Section 7 
provides the FTC exclusive authority to commence and supervise 
litigation of any action or appeal under the Act, unless the 
FTC authorizes the Department of Justice to do so.
    Section 8. Report on Additional Exclusion. Section 8 
requires the FTC to provide a recommendation to the Committee 
on the Judiciary of the House of Representatives and the 
Committee on the Judiciary of the Senate within one year of 
enactment regarding a potential amendment to add to section 
27(c) of the FTC Act an additional exclusion for consideration 
granted by a branded drug company to a generic drug or 
biosimilar manufacturer in the form of a release, waiver, or 
limitation of a claim for damages or other monetary relief.
    Section 9. Statute of Limitations. Section 9 requires the 
FTC to commence an action under new section 27 of the Federal 
Trade Commission Act, except for an action described in new 
section 27(f)(2), no later than six years after receiving 
notice of the settlement agreement under section 1112(d) of the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003.
    Section 10. Severability. Section 10 provides that if a 
provision of this Act is held unconstitutional the remainder of 
this Act will not be affected.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                      FEDERAL TRADE COMMISSION ACT




           *       *       *       *       *       *       *
  Sec. 16. (a)(1) Except as otherwise provided in paragraph (2) 
or (3), if--
          (A) before commencing, defending, or intervening in, 
        any civil action involving this Act (including an 
        action to collect a civil penalty) which the 
        Commission, or the Attorney General on behalf of the 
        Commission, is authorized to commence, defend, or 
        intervene in, the Commission gives written notification 
        and undertakes to consult with the Attorney General 
        with respect to such action; and
          (B) the Attorney General fails within 45 days after 
        receipt of such notification to commence, defend, or 
        intervene in, such action;
the Commission may commence, defend, or intervene in, and 
supervise the litigation of, such action and any appeal of such 
action in its own name by any of its attorneys designated by it 
for such purpose.
  (2) Except as otherwise provided in paragraph (3), in any 
civil action--
          (A) under section 13 of this Act (relating to 
        injunctive relief);
          (B) under section 19 of this Act (relating to 
        consumer redress);
          (C) to obtain judicial review of a rule prescribed by 
        the Commission, or a cease and desist order issued 
        under section 5 of this Act;
          (D) under the second paragraph of section 9 of this 
        Act (relating to enforcement of a subpena) and under 
        the fourth paragraph of such section (relating to 
        compliance with section 6 of this Act); [or]
          (E) under section 21A of this Act; or
          (F) under section 27;
the Commission shall have exclusive authority to commence or 
defend, and supervise the litigation of, such action and any 
appeal of such action in its own name by any of its attorneys 
designated by it for such purpose, unless the Commission 
authorizes the Attorney General to do so. The Commission shall 
inform the Attorney General of the exercise of such authority 
and such exercise shall not preclude the Attorney General from 
intervening on behalf of the United States in such action and 
any appeal of such action as may be otherwise provided by law.
  (3)(A) If the Commission makes a written request to the 
Attorney General, within the 10-day period which begins on the 
date of the entry of the judgment in any civil action in which 
the Commission represented itself pursuant to paragraph (1) or 
(2), to represent itself through any of its attorneys 
designated by it for such purpose before the Supreme Court in 
such action, it may do so, if--
          (i) the Attorney General concurs with such request; 
        or
          (ii) the Attorney General, within the 60-day period 
        which begins on the date of the entry of such 
        judgment--
                  (a) refuses to appeal or file a petition for 
                writ of certiorari with respect to such civil 
                action, in which case he shall give written 
                notification to the Commission of the reasons 
                for such refusal within such 60-day period; or
                  (b) the Attorney General fails to take any 
                action with respect to the Commission's 
                request.
                          
  (B) In any case where the Attorney General represents the 
Commission before the Supreme Court in any civil action in 
which the Commission represented itself pursuant to paragraph 
(1) or (2), the Attorney General may not agree to any 
settlement, compromise, or dismissal of such action, or confess 
error in the Supreme Court with respect to such action, unless 
the Commission concurs.
  (C) For purposes of this paragraph (with respect to 
representation before the Supreme Court), the term ``Attorney 
General'' includes the Solicitor General.
  (4) If, prior to the expiration of the 45-day period 
specified in paragraph (1) of this section or a 60-day period 
specified in paragraph (3), any right of the Commission to 
commence, defend, or intervene in, any such action or appeal 
may be extinguished due to any procedural requirement of any 
court with respect to the time in which any pleadings, notice 
of appeal, or other acts pertaining to such action or appeal 
may be taken, the Attorney General shall have one-half of the 
time required to comply with any such procedural requirement of 
the court (including any extension of such time granted by the 
court) for the purpose of commencing, defending, or intervening 
in the civil action pursuant to paragraph (1) or for the 
purpose of refusing to appeal or file a petition for writ of 
certiorari and the written notification or failing to take any 
action pursuant to paragraph 3(A)(ii).
  (5) The provisions of this subsection shall apply 
notwithstanding chapter 31 of title 28, United States Code, or 
any other provision of law.
  (b) Whenever the Commission has reason to believe that any 
person, partnership, or corporation is liable for a criminal 
penalty under this Act, the Commission shall certify the facts 
to the Attorney General, whose duty it shall be to cause 
appropriate criminal proceedings to be brought.
  (c) Foreign Litigation.--
          (1) Commission attorneys.--With the concurrence of 
        the Attorney General, the Commission may designate 
        Commission attorneys to assist the Attorney General in 
        connection with litigation in foreign courts on 
        particular matters in which the Commission has an 
        interest.
          (2) Reimbursement for foreign counsel.--The 
        Commission is authorized to expend appropriated funds, 
        upon agreement with the Attorney General, to reimburse 
        the Attorney General for the retention of foreign 
        counsel for litigation in foreign courts and for 
        expenses related to litigation in foreign courts in 
        which the Commission has an interest.
          (3) Limitation on use of funds.--Nothing in this 
        subsection authorizes the payment of claims or 
        judgments from any source other than the permanent and 
        indefinite appropriation authorized by section 1304 of 
        title 31, United States Code.
          (4) Other authority.--The authority provided by this 
        subsection is in addition to any other authority of the 
        Commission or the Attorney General.

           *       *       *       *       *       *       *


SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS AND BIOSIMILARS.

  (a) In General.--
          (1) Enforcement proceeding.--The Commission may 
        initiate a proceeding to enforce the provisions of this 
        section against the parties to any agreement resolving 
        or settling, on a final or interim basis, a patent 
        claim, in connection with the sale of a drug product or 
        biological product.
          (2) Presumption and violation.--
                  (A) In general.--Subject to subparagraph (B), 
                in such a proceeding, an agreement shall be 
                presumed to have anticompetitive effects and 
                shall be a violation of this section if--
                          (i) an ANDA filer or a biosimilar 
                        biological product application filer 
                        receives anything of value, including 
                        an exclusive license; and
                          (ii) the ANDA filer or biosimilar 
                        biological product application filer 
                        agrees to limit or forgo research, 
                        development, manufacturing, marketing, 
                        or sales of the ANDA product or 
                        biosimilar biological product, as 
                        applicable, for any period of time.
                  (B) Exception.--Subparagraph (A) shall not 
                apply if the parties to such agreement 
                demonstrate by clear and convincing evidence 
                that--
                          (i) the value described in 
                        subparagraph (A)(i) is compensation 
                        solely for other goods or services that 
                        the ANDA filer or biosimilar biological 
                        product application filer has promised 
                        to provide; or
                          (ii) the procompetitive benefits of 
                        the agreement outweigh the 
                        anticompetitive effects of the 
                        agreement.
  (b) Limitations.--In determining whether the settling parties 
have met their burden under subsection (a)(2)(B), the fact 
finder shall not presume--
          (1) that entry would not have occurred until the 
        expiration of the relevant patent or statutory 
        exclusivity; or
          (2) that the agreement's provision for entry of the 
        ANDA product or biosimilar biological product prior to 
        the expiration of the relevant patent or statutory 
        exclusivity means that the agreement is procompetitive.
  (c) Exclusions.--Nothing in this section shall prohibit a 
resolution or settlement of a patent infringement claim in 
which the consideration that the ANDA filer or biosimilar 
biological product application filer receives as part of the 
resolution or settlement includes only one or more of the 
following:
          (1) The right to market and secure final regulatory 
        approval for the ANDA product or biosimilar biological 
        product at a date, whether certain or contingent, in 
        the United States prior to the expiration of--
                  (A) any patent that is the basis for the 
                patent infringement claim; or
                  (B) any patent right or other statutory 
                exclusivity that would prevent the marketing of 
                such ANDA product or biosimilar biological 
                product.
          (2) A payment for reasonable litigation expenses not 
        to exceed--
                  (A) for calendar year 2019, $7,500,000; and
                  (B) for calendar year 2020 and each calendar 
                year thereafter, the amount determined for the 
                preceding calendar year adjusted to reflect the 
                percentage increase (if any) in the Producer 
                Price Index for Legal Services published by the 
                Bureau of Labor Statistics of the Department of 
                Labor for the then most recent 12-month period 
                ending December 31.
          (3) A covenant not to sue on any claim that the ANDA 
        product or biosimilar biological product infringes a 
        United States patent.
  (d) Enforcement.--
          (1) Enforcement.--A violation of this section shall 
        be treated as an unfair method of competition under 
        section 5(a)(1) of the Federal Trade Commission Act (15 
        U.S.C. 45(a)(1)).
          (2) Judicial review.--
                  (A) In general.--Any party that is subject to 
                a final order of the Commission, issued in an 
                administrative adjudicative proceeding under 
                the authority of subsection (a)(1), may, within 
                30 days of the issuance of such order, petition 
                for review of such order in--
                          (i) the United States Court of 
                        Appeals for the District of Columbia 
                        Circuit;
                          (ii) the United States Court of 
                        Appeals for the circuit in which the 
                        ultimate parent entity, as defined in 
                        section 801.1(a)(3) of title 16, Code 
                        of Federal Regulations, or any 
                        successor thereto, of the NDA holder or 
                        biological product license holder is 
                        incorporated as of the date that the 
                        NDA or biological product license 
                        application, as applicable, is filed 
                        with the Commissioner of Food and 
                        Drugs; or
                          (iii) the United States Court of 
                        Appeals for the circuit in which the 
                        ultimate parent entity of the ANDA 
                        filer or biosimilar biological product 
                        application filer is incorporated as of 
                        the date that the ANDA or biosimilar 
                        biological product application is filed 
                        with the Commissioner of Food and 
                        Drugs.
                  (B) Treatment of findings.--In a proceeding 
                for judicial review of a final order of the 
                Commission, the findings of the Commission as 
                to the facts, if supported by evidence, shall 
                be conclusive.
  (e) Antitrust Laws.--Nothing in this section shall modify, 
impair, limit, or supersede the applicability of the antitrust 
laws as defined in subsection (a) of the first section of the 
Clayton Act (15 U.S.C. 12(a)), and of section 5 of this Act to 
the extent that section 5 applies to unfair methods of 
competition. Nothing in this section shall modify, impair, 
limit, or supersede the right of an ANDA filer or biosimilar 
biological product application filer to assert claims or 
counterclaims against any person, under the antitrust laws or 
other laws relating to unfair competition.
  (f) Penalties.--
          (1) Forfeiture.--Each party that violates or assists 
        in the violation of this section shall forfeit and pay 
        to the United States a civil penalty sufficient to 
        deter violations of this section, but in no event 
        greater than 3 times the value received by the party 
        that is reasonably attributable to the violation of 
        this section. If no such value has been received by the 
        NDA holder, biological product license holder, the ANDA 
        filer, or biosimilar biological product application 
        filer the penalty to the NDA holder, biological product 
        license holder, the ANDA filer, or biosimilar 
        biological product application filer shall be 
        sufficient to deter violations, but in no event greater 
        than 3 times the value given to an ANDA filer or 
        biosimilar biological product application filer 
        reasonably attributable to the violation of this 
        section. Such penalty shall accrue to the United States 
        and may be recovered in a civil action brought by the 
        Commission, in its own name by any of its attorneys 
        designated by it for such purpose, in a district court 
        of the United States against any party that violates 
        this section. In such actions, the United States 
        district courts are empowered to grant mandatory 
        injunctions and such other and further equitable relief 
        as they deem appropriate.
          (2) Cease and desist.--
                  (A) In general.--If the Commission has issued 
                a cease and desist order with respect to a 
                party in an administrative adjudicative 
                proceeding under the authority of subsection 
                (a)(1), an action brought pursuant to paragraph 
                (1) may be commenced against such party at any 
                time before the expiration of 1 year after such 
                order becomes final pursuant to section 5(g).
                  (B) Exception.--In an action under 
                subparagraph (A), the findings of the 
                Commission as to the material facts in the 
                administrative adjudicative proceeding with 
                respect to the violation of this section by a 
                party shall be conclusive unless--
                          (i) the terms of such cease and 
                        desist order expressly provide that the 
                        Commission's findings shall not be 
                        conclusive; or
                          (ii) the order became final by reason 
                        of section 5(g)(1), in which case such 
                        finding shall be conclusive if 
                        supported by evidence.
          (3) Civil penalty.--In determining the amount of the 
        civil penalty described in this section, the court 
        shall take into account--
                  (A) the nature, circumstances, extent, and 
                gravity of the violation;
                  (B) with respect to the violator, the degree 
                of culpability, any history of violations, the 
                ability to pay, any effect on the ability to 
                continue doing business, profits earned by the 
                NDA holder, biological product license holder, 
                the ANDA filer, or biosimilar biological 
                product application filer, compensation 
                received by the ANDA filer or biosimilar 
                biological product application filer, and the 
                amount of commerce affected; and
                  (C) other matters that justice requires.
          (4) Remedies in addition.--Remedies provided in this 
        subsection are in addition to, and not in lieu of, any 
        other remedy provided by Federal law. Nothing in this 
        paragraph shall be construed to affect any authority of 
        the Commission under any other provision of law.
  (g) Definitions.--In this section:
          (1) Agreement.--The term ``agreement'' means anything 
        that would constitute an agreement under section 1 of 
        the Sherman Act (15 U.S.C. 1) or section 5 of this Act.
          (2) Agreement resolving or settling a patent 
        infringement claim.--The term ``agreement resolving or 
        settling a patent infringement claim'' includes any 
        agreement that is entered into within 30 days of the 
        resolution or the settlement of the claim, or any other 
        agreement that is contingent upon, provides a 
        contingent condition for, or is otherwise related to 
        the resolution or settlement of the claim.
          (3) ANDA.--The term ``ANDA'' means an abbreviated new 
        drug application filed under section 505(j) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        or a new drug application filed under section 505(b)(2) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(b)(2)).
          (4) ANDA filer.--The term ``ANDA filer'' means a 
        party that owns or controls an ANDA filed with the Food 
        and Drug Administration or has the exclusive rights 
        under such ANDA to distribute the ANDA product.
          (5) ANDA product.--The term ``ANDA product'' means 
        the product to be manufactured under the ANDA that is 
        the subject of the patent infringement claim.
          (6) Biological product.--The term ``biological 
        product'' has the meaning given such term in section 
        351(i)(1) of the Public Health Service Act (42 U.S.C. 
        262(i)(1)).
          (7) Biological product license application.--The term 
        ``biological product license application'' means an 
        application under section 351(a) of the Public Health 
        Service Act (42 U.S.C. 262(a)).
          (8) Biological product license holder.--The term 
        ``biological product license holder'' means--
                  (A) the holder of an approved biological 
                product license application for a biological 
                product;
                  (B) a person owning or controlling 
                enforcement of any patents that claim the 
                biological product that is the subject of such 
                approved application; or
                  (C) the predecessors, subsidiaries, 
                divisions, groups, and affiliates controlled 
                by, controlling, or under common control with 
                any of the entities described in subparagraphs 
                (A) and (B) (such control to be presumed by 
                direct or indirect share ownership of 50 
                percent or greater), as well as the licensees, 
                licensors, successors, and assigns of each of 
                the entities.
          (9) Biosimilar biological product.--The term 
        ``biosimilar biological product'' means the product to 
        be manufactured under the biosimilar biological product 
        application that is the subject of the patent 
        infringement claim.
          (10) Biosimilar biological product application.--The 
        term ``biosimilar biological product application'' 
        means an application under section 351(k) of the Public 
        Health Service Act (42 U.S.C. 262(k)) for licensure of 
        a biological product as biosimilar to, or 
        interchangeable with, a reference product.
          (11) Biosimilar biological product application 
        filer.--The term ``biosimilar biological product 
        application filer'' means a party that owns or controls 
        a biosimilar biological product application filed with 
        the Food and Drug Administration or has the exclusive 
        rights under such application to distribute the 
        biosimilar biological product.
          (12) Drug product.--The term ``drug product'' has the 
        meaning given such term in section 314.3(b) of title 
        21, Code of Federal Regulations (or any successor 
        regulation).
          (13) Market.--The term ``market'' means the promote, 
        offer for sale, sell, or distribute a drug product.
          (14) NDA.--The term ``NDA'' means a new drug 
        application filed under section 505(b) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).
          (15) NDA holder.--The term ``NDA holder'' means--
                  (A) the holder of an approved NDA application 
                for a drug product;
                  (B) a person owning or controlling 
                enforcement of the patent listed in the 
                Approved Drug Products With Therapeutic 
                Equivalence Evaluations (commonly known as the 
                ``FDA Orange Book'') in connection with the 
                NDA; or
                  (C) the predecessors, subsidiaries, 
                divisions, groups, and affiliates controlled 
                by, controlling, or under common control with 
                any of the entities described in subparagraphs 
                (A) and (B) (such control to be presumed by 
                direct or indirect share ownership of 50 
                percent or greater), as well as the licensees, 
                licensors, successors, and assigns of each of 
                the entities.
          (16) Party.--The term ``party'' means any person, 
        partnership, corporation, or other legal entity.
          (17) Patent infringement.--The term ``patent 
        infringement'' means infringement of any patent or of 
        any filed patent application, including any extension, 
        reissue, renewal, division, continuation, continuation 
        in part, reexamination, patent term restoration, 
        patents of addition, and extensions thereof.
          (18) Patent infringement claim.--The term ``patent 
        infringement claim'' means any allegation made to an 
        ANDA filer or biosimilar biological product application 
        filer, whether or not included in a complaint filed 
        with a court of law, that its ANDA or ANDA product, or 
        biological product license application or biological 
        product, may infringe any patent held by, or 
        exclusively licensed to, the NDA holder or biological 
        product license holder, biological product license 
        holder, the ANDA filer, or biosimilar biological 
        product application filer of the drug product or 
        biological product, as applicable.
          (19) Statutory exclusivity.--The term ``statutory 
        exclusivity'' means those prohibitions on the approval 
        of drug applications under clauses (ii) through (iv) of 
        section 505(c)(3)(E) (5- and 3-year data exclusivity), 
        section 527 (orphan drug exclusivity), or section 505A 
        (pediatric exclusivity) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(c)(3)(E), 360cc, 355a), or 
        on the licensing of biological product applications 
        under section 351(k)(7) (12-year exclusivity) or 
        paragraph (2) or (3) of section 351(m) (pediatric 
        exclusivity) of the Public Health Service Act (42 
        U.S.C. 262) or under section 527 of the Federal Food, 
        Drug, and Cosmetic Act (orphan drug exclusivity).

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 MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION ACT OF 2003



           *       *       *       *       *       *       *
TITLE XI--ACCESS TO AFFORDABLE PHARMACEUTICALS

           *       *       *       *       *       *       *


              Subtitle B--Federal Trade Commission Review

SEC. 1111. DEFINITIONS.

   In this subtitle:
          (1) ANDA.--The term ``ANDA'' means an abbreviated 
        drug application, as defined under section 201(aa) of 
        the Federal Food, Drug, and Cosmetic Act.
          (2) Assistant attorney general.--The term ``Assistant 
        Attorney General'' means the Assistant Attorney General 
        in charge of the Antitrust Division of the Department 
        of Justice.
          (3) Biosimilar biological product.--The term 
        ``biosimilar biological product'' means a biological 
        product for which a biosimilar biological product 
        application under section 351(k) of the Public Health 
        Service Act is approved.
          (4) Biosimilar biological product applicant.--The 
        term ``biosimilar biological product applicant'' means 
        a person who has filed or received approval for a 
        biosimilar biological product application under section 
        351(k) of the Public Health Service Act.
          (5) Biosimilar biological product application.--The 
        term ``biosimilar biological product application'' 
        means an application under section 351(k) of the Public 
        Health Service Act for licensure of a biological 
        product as biosimilar to, or interchangeable with, a 
        reference product.
          (6) Brand name drug.--The term ``brand name drug'' 
        means a drug for which an application is approved under 
        section 505(c) of the Federal Food, Drug, and Cosmetic 
        Act, including an application referred to in section 
        505(b)(2) of such Act, or a biological product for 
        which an application is approved under section 351(a) 
        of the Public Health Service Act.
          (7) Brand name drug company.--The term ``brand name 
        drug company'' means the party that holds the approved 
        application referred to in paragraph (6) for a brand 
        name drug that is a listed drug in an ANDA or a 
        reference product in a biosimilar biological product 
        application, or a party that is the owner of a patent 
        for which information is submitted for such drug under 
        subsection (b) or (c) of section 505 of the Federal 
        Food, Drug, and Cosmetic Act or the owner, or exclusive 
        licensee, of a patent included in a list provided under 
        section 351(l)(3) of the Public Health Service Act or 
        the owner of a patent for which a claim of infringement 
        could reasonably be asserted against any person for 
        making, using, offering to sell, selling, or importing 
        into the United States a biological product that is the 
        subject of a biosimilar biological product application.
          (8) Commission.--The term ``Commission'' means the 
        Federal Trade Commission.
          (9) Generic drug.--The term ``generic drug'' means a 
        drug for which an application under section 505(j) of 
        the Federal Food, Drug, and Cosmetic Act is approved.
          (10) Generic drug applicant.--The term ``generic drug 
        applicant'' means a person who has filed or received 
        approval for an ANDA under section 505(j) of the 
        Federal Food, Drug, and Cosmetic Act.
          (11) Listed drug.--The term ``listed drug'' means a 
        brand name drug that is listed under section 505(j)(7) 
        of the Federal Food, Drug, and Cosmetic Act.
          (12) Reference product.--The term ``reference 
        product''has the meaning given such term in section 
        351(i) of the Public Health Service Act.

SEC. 1112. NOTIFICATION OF AGREEMENTS.

  (a) Agreement With Brand Name Drug Company.--
          (1) Requirement.--A generic drug applicant that has 
        submitted an ANDA containing a certification under 
        section 505(j)(2)(A)(vii)(IV) of the Federal Food, 
        Drug, and Cosmetic Act or a biosimilar biological 
        product applicant who has submitted a biosimilar 
        biological product application and a brand name drug 
        company that enter into an agreement described in 
        paragraph (2) shall each file the agreement in 
        accordance with subsection (c). The agreement shall be 
        filed prior to the date of the first commercial 
        marketing of the generic drug that is the subject of 
        the ANDA or the biosimilar biological product that is 
        the subject of the biosimilar biological product 
        application, as applicable.
          (2) Subject matter of agreement.--An agreement 
        described in this paragraph between a generic drug 
        applicant or a biosimilar biological product applicant 
        and a brand name drug company is an agreement 
        regarding--
                  (A) the manufacture, marketing, or sale of 
                the brand name drug that is the listed drug in 
                the ANDA or the reference product in the 
                biosimilar biological product application 
                involved;
                  (B) the manufacture, marketing, or sale of 
                the generic drug for which the ANDA was 
                submitted or of the biosimilar biological 
                product for which the biosimilar biological 
                product application was submitted; or
                  (C) as applicable--
                          (i) the 180-day period referred to in 
                        section 505(j)(5)(B)(iv) of the Federal 
                        Food, Drug, and Cosmetic Act as it 
                        applies to such ANDA or to any other 
                        ANDA based on the same listed drug; or
                          (ii) any of the time periods referred 
                        to in section 351(k)(6) of the Public 
                        Health Service Act as such period 
                        applies to such biosimilar biological 
                        product application or to any other 
                        biosimilar biological product 
                        application based on the same reference 
                        product.
  (b) Agreement With Another Generic Drug Applicant Or 
Biosimilar Biological Product Applicant.--
          (1) Requirement.--
                  (A) Generic drugs.--A generic drug applicant 
                that has submitted an ANDA containing a 
                certification under section 
                505(j)(2)(A)(vii)(IV) of the Federal Food, 
                Drug, and Cosmetic Act with respect to a listed 
                drug and another generic drug applicant that 
                has submitted an ANDA containing such a 
                certification for the same listed drug shall 
                each file the agreement in accordance with 
                subsection (c). The agreement shall be filed 
                prior to the date of the first commercial 
                marketing of either of the generic drugs for 
                which such ANDAs were submitted.
                  (B) Biosimilar biological products.--A 
                biosimilar biological product applicant that 
                has submitted a biosimilar biological product 
                application that references a reference product 
                and another biosimilar biological product 
                applicant that has submitted a biosimilar 
                biological product application that references 
                the same reference product shall each file the 
                agreement in accordance with subsection (c). 
                The agreement shall be filed prior to the date 
                of the first commercial marketing of either of 
                the biosimilar biological products for which 
                such biosimilar biological product applications 
                were submitted.
          (2) Subject matter of agreement.--An agreement 
        described in this paragraph is, as applicable, an 
        agreement between 2 or more generic drug applicants 
        regarding the 180-day period referred to in section 
        505(j)(5)(B)(iv) of the Federal Food, Drug, and 
        Cosmetic Act as it applies to the ANDAs with which the 
        agreement is concerned,, an agreement between 2 or more 
        biosimilar biological product applicants regarding a 
        time period referred to in section 351(k)(6) of the 
        Public Health Service Act as it applies to the 
        biosimilar biological product, or an agreement between 
        2 or more biosimilar biological product applicants 
        regarding the manufacture, marketing, or sale of a 
        biosimilar biological product.
  (c) Filing.--
          (1) Agreement.--The parties that are required in 
        subsection (a) or (b) to file an agreement in 
        accordance with this subsection shall file with the 
        Assistant Attorney General and the Commission the text 
        of any such agreement, except that such parties are not 
        required to file an agreement that solely concerns--
                  (A) purchase orders for raw material 
                supplies;
                  (B) equipment and facility contracts;
                  (C) employment or consulting contracts; or
                  (D) packaging and labeling contracts.
          (2) Other agreements.--The parties that are required 
        in subsection (a) or (b) to file an agreement in 
        accordance with this subsection shall file with the 
        Assistant Attorney General and the Commission the text 
        of any agreements between the parties that are not 
        described in such subsections and are contingent upon, 
        provide a contingent condition for, were entered into 
        within 30 days of, or are otherwise related to an 
        agreement that is required in subsection (a) or (b) to 
        be filed in accordance with this subsection.
          (3) Description.--In the event that any agreement 
        required in subsection (a) or (b) to be filed in 
        accordance with this subsection has not been reduced to 
        text, each of the parties involved shall file written 
        descriptions of such agreement that are sufficient to 
        disclose all the terms and conditions of the agreement.
  (d) Certification.--The Chief Executive Officer or the 
company official responsible for negotiating any agreement 
under subsection (a) or (b) that is required to be filed under 
subsection (c), within 30 days after such filing, shall execute 
and file with the Assistant Attorney General and the Commission 
a certification as follows: ``I declare that the following is 
true, correct, and complete to the best of my knowledge: The 
materials filed with the Federal Trade Commission and the 
Department of Justice under section 1112 of subtitle B of title 
XI of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, with respect to the agreement 
referenced in this certification--
          ``(1) represent the complete, final, and exclusive 
        agreement between the parties;
          ``(2) include any ancillary agreements that are 
        contingent upon, provide a contingent condition for, or 
        are otherwise related to, the referenced agreement; and
          ``(3) include written descriptions of any oral 
        agreements, representations, commitments, or promises 
        between the parties that are responsive to subsection 
        (a) or (b) of such section 1112 and have not been 
        reduced to writing.''.
          (4) Rule of construction.--
                  (A) An agreement that is required in 
                subsection (a) or (b) shall include agreements 
                resolving any outstanding disputes, including 
                agreements resolving or settling a Patent Trial 
                and Appeal Board proceeding.
                  (B) For purposes of subparagraph (A), the 
                term ``Patent Trial and Appeal Board 
                proceeding'' means a proceeding conducted by 
                the United States Patent and Trademark Office 
                Patent Trial and Appeal Board, including but 
                not limited to inter parties review, post-grant 
                review, the transitional program for covered 
                business method patents, and derivation 
                proceedings.

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                              ----------                              


                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


                               new drugs

  Sec. 505. (a) No person shall introduce or deliver for 
introduction into interstate commerce any new drug, unless an 
approval of an application filed pursuant to subsection (b) or 
(j) is effective with respect to such drug.
  (b)(1) Any person may file with the Secretary an application 
with respect to any drug subject to the provisions of 
subsection (a). Such persons shall submit to the Secretary as a 
part of the application (A) full reports of investigations 
which have been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; (B) a full 
list of the articles used as components of such drug; (C) a 
full statement of the composition of such drug; (D) a full 
description of the methods used in, and the facilities and 
controls used for, the manufacture, processing, and packing of 
such drug; (E) such samples of such drug and of the articles 
used as components thereof as the Secretary may require; (F) 
specimens of the labeling proposed to be used for such drug, 
and (G) any assessments required under section 505B. The 
applicant shall file with the application the patent number and 
the expiration date of any patent which claims the drug for 
which the applicant submitted the application or which claims a 
method of using such drug and with respect to which a claim of 
patent infringement could reasonably be asserted if a person 
not licensed by the owner engaged in the manufacture use, or 
sale of the drug. If a application is filed under this 
subsection for a drug and a patent which claims such drug or a 
method of using such drug is issued after the filing date but 
before approval of the application, the applicant shall amend 
the application to include the information required by the 
preceding sentence. Upon approval of the application, the 
Secretary shall publish information submitted under the two 
preceding sentences. The Secretary shall, in consultation with 
the Director of the National Institutes of Health and with 
representatives of the drug manufacturing industry, review and 
develop guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by clause (A).
  (2) An application submitted under paragraph (1) for a drug 
for which the investigations described in clause (A) of such 
paragraph and relied upon by the applicant for approval of the 
application were not conducted by or for the applicant and for 
which the applicant has not obtained a right of reference or 
use from the person by or for whom the investigations were 
conducted shall also include--
          (A) a certification, in the opinion of the applicant 
        and to the best of his knowledge, with respect to each 
        patent which claims the drug for which such 
        investigations were conducted or which claims a use for 
        such drug for which the applicant is seeking approval 
        under this subsection and for which information is 
        required to be filed under paragraph (1) or subsection 
        (c)--
                  (i) that such patent information has not been 
                filed,
                  (ii) that such patent has expired,
                  (iii) of the date on which such patent will 
                expire, or
                  (iv) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (B) if with respect to the drug for which 
        investigations described in paragraph (1)(A) were 
        conducted information was filed under paragraph (1) or 
        subsection (c) for a method of use patent which does 
        not claim a use for which the applicant is seeking 
        approval under this subsection, a statement that the 
        method of use patent does not claim such a use.
  (3) Notice of opinion that patent is invalid or will not be 
infringed.--
          (A) Agreement to give notice.--An applicant that 
        makes a certification described in paragraph (2)(A)(iv) 
        shall include in the application a statement that the 
        applicant will give notice as required by this 
        paragraph.
          (B) Timing of notice.--An applicant that makes a 
        certification described in paragraph (2)(A)(iv) shall 
        give notice as required under this paragraph--
                  (i) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (ii) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (C) Recipients of notice.--An applicant required 
        under this paragraph to give notice shall give notice 
        to--
                  (i) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (ii) the holder of the approved application 
                under this subsection for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (D) Contents of notice.--A notice required under this 
        paragraph shall--
                  (i) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (ii) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (4)(A) An applicant may not amend or supplement an 
application referred to in paragraph (2) to seek approval of a 
drug that is a different drug than the drug identified in the 
application as submitted to the Secretary.
  (B) With respect to the drug for which such an application is 
submitted, nothing in this subsection or subsection (c)(3) 
prohibits an applicant from amending or supplementing the 
application to seek approval of a different strength.
  (5)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1) or under 
section 351 of the Public Health Service Act, which shall 
relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service Act 
if the sponsor or applicant makes a reasonable written request 
for a meeting for the purpose of reaching agreement on the 
design and size--
          (i)(I) of clinical trials intended to form the 
        primary basis of an effectiveness claim; or
          (II) in the case where human efficacy studies are not 
        ethical or feasible, of animal and any associated 
        clinical trials which, in combination, are intended to 
        form the primary basis of an effectiveness claim; or
          (ii) with respect to an application for approval of a 
        biological product under section 351(k) of the Public 
        Health Service Act, of any necessary clinical study or 
        studies.
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of the 
clinical trials. Minutes of any such meeting shall be prepared 
by the Secretary and made available to the sponsor or applicant 
upon request.
  (C) Any agreement regarding the parameters of the design and 
size of clinical trials of a new drug under this paragraph that 
is reached between the Secretary and a sponsor or applicant 
shall be reduced to writing and made part of the administrative 
record by the Secretary. Such agreement shall not be changed 
after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance division personnel unless such field or 
compliance division personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection or section 351 of the 
Public Health Service Act (including all scientific and medical 
matters, chemistry, manufacturing, and controls).
          (6) An application submitted under this subsection 
        shall be accompanied by the certification required 
        under section 402(j)(5)(B) of the Public Health Service 
        Act. Such certification shall not be considered an 
        element of such application.
  (c)(1) Within one hundred and eighty days after the filing of 
an application under subsection (b), or such additional period 
as may be agreed upon by the Secretary and the applicant, the 
Secretary shall either--
          (A) approve the application if he then finds that 
        none of the grounds for denying approval specified in 
        subsection (d) applies, or
          (B) give the applicant notice of an opportunity for a 
        hearing before the Secretary under subsection (d) on 
        the question whether such application is approvable. If 
        the applicant elects to accept the opportunity for 
        hearing by written request within thirty days after 
        such notice, such hearing shall commence not more than 
        ninety days after the expiration of such thirty days 
        unless the Secretary and the applicant otherwise agree. 
        Any such hearing shall thereafter be conducted on an 
        expedited basis and the Secretary's order thereon shall 
        be issued within ninety days after the date fixed by 
        the Secretary for filing final briefs.
  (2) If the patent information described in subsection (b) 
could not be filed with the submission of an application under 
subsection (b) because the application was filed before the 
patent information was required under subsection (b) or a 
patent was issued after the application was approved under such 
subsection, the holder of an approved application shall file 
with the Secretary, the patent number and the expiration date 
of any patent which claims the drug for which the application 
was submitted or which claims a method of using such drug and 
with respect to which a claim of patent infringement could 
reasonably be asserted if a person not licensed by the owner 
engaged in the manufacture, use, or sale of the drug. If the 
holder of an approved application could not file patent 
information under subsection (b) because it was not required at 
the time the application was approved, the holder shall file 
such information under this subsection not later than thirty 
days after the date of the enactment of this sentence, and if 
the holder of an approved application could not file patent 
information under subsection (b) because no patent had been 
issued when an application was filed or approved, the holder 
shall file such information under this subsection not later 
than thirty days after after the date the patent involved is 
issued. Upon the submission of patent information under this 
subsection, the Secretary shall publish it.
  (3) The approval of an application filed under subsection (b) 
which contains a certification required by paragraph (2) of 
such subsection shall be made effective on the last applicable 
date determined by applying the following to each certification 
made under subsection (b)(2)(A):
          (A) If the applicant only made a certification 
        described in clause (i) or (ii) of subsection (b)(2)(A) 
        or in both such clauses, the approval may be made 
        effective immediately.
          (B) If the applicant made a certification described 
        in clause (iii) of subsection (b)(2)(A), the approval 
        may be made effective on the date certified under 
        clause (iii).
          (C) If the applicant made a certification described 
        in clause (iv) of subsection (b)(2)(A), the approval 
        shall be made effective immediately unless, before the 
        expiration of 45 days after the date on which the 
        notice described in subsection (b)(3) is received, an 
        action is brought for infringement of the patent that 
        is the subject of the certification and for which 
        information was submitted to the Secretary under 
        paragraph (2) or subsection (b)(1) before the date on 
        which the application (excluding an amendment or 
        supplement to the application) was submitted. If such 
        an action is brought before the expiration of such 
        days, the approval may be made effective upon the 
        expiration of the thirty-month period beginning on the 
        date of the receipt of the notice provided under 
        subsection (b)(3) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (i) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (I) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (II) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (ii) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (I) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (aa) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (bb) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (II) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (iii) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in clause (i); or
                  (iv) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in clause (ii).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (D) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        referred to in subsection (b)(2) for a 
                        declaratory judgment with respect to a 
                        patent which is the subject of the 
                        certification referred to in 
                        subparagraph (C) unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant referred to in subsection 
                        (b)(2) for the purpose of determining 
                        whether an action referred to in 
                        subparagraph (C) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under subsection 
                        (b)(2)(A)(iv) and for no other purpose, 
                        and may not disclose information of no 
                        relevance to any issue of patent 
                        infringement to any person other than a 
                        person provided an offer of 
                        confidential access. Further, the 
                        application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or this subsection 
                        on the ground that the patent does not 
                        claim either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (E)(i) If an application (other than an abbreviated 
        new drug application) submitted under subsection (b) 
        for a drug, no active ingredient (including any ester 
        or salt of the active ingredient) of which has been 
        approved in any other application under subsection (b), 
        was approved during the period beginning January 1, 
        1982, and ending on the date of the enactment of this 
        subsection, the Secretary may not make the approval of 
        another application for a drug for which the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and for which the applicant has not obtained 
        a right of reference or use from the person by or for 
        whom the investigations were conducted effective before 
        the expiration of ten years from the date of the 
        approval of the application previously approved under 
        subsection (b).
          (ii) If an application submitted under subsection (b) 
        for a drug, no active ingredient (including any ester 
        or salt of the active ingredient) of which has been 
        approved in any other application under subsection (b), 
        is approved after the date of the enactment of this 
        clause, no application which refers to the drug for 
        which the subsection (b) application was submitted and 
        for which the investigations described in clause (A) of 
        subsection (b)(1) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted may be 
        submitted under subsection (b) before the expiration of 
        five years from the date of the approval of the 
        application under subsection (b), except that such an 
        application may be submitted under subsection (b) after 
        the expiration of four years from the date of the 
        approval of the subsection (b) application if it 
        contains a certification of patent invalidity or 
        noninfringement described in clause (iv) of subsection 
        (b)(2)(A). The approval of such an application shall be 
        made effective in accordance with this paragraph except 
        that, if an action for patent infringement is commenced 
        during the one-year period beginning forty-eight months 
        after the date of the approval of the subsection (b) 
        application, the thirty-month period referred to in 
        subparagraph (C) shall be extended by such amount of 
        time (if any) which is required for seven and one-half 
        years to have elapsed from the date of approval of the 
        subsection (b) application.
          (iii) If an application submitted under subsection 
        (b) for a drug, which includes an active ingredient 
        (including any ester or salt of the active ingredient) 
        that has been approved in another application approved 
        under subsection (b), is approved after the date of the 
        enactment of this clause and if such application 
        contains reports of new clinical investigations (other 
        than bioavailability studies) essential to the approval 
        of the application and conducted or sponsored by the 
        applicant, the Secretary may not make the approval of 
        an application submitted under subsection (b) for the 
        conditions of approval of such drug in the approved 
        subsection (b) application effective before the 
        expiration of three years from the date of the approval 
        of the application under subsection (b) if the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and if the applicant has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations were conducted.
          (iv) If a supplement to an application approved under 
        subsection (b) is approved after the date of enactment 
        of this clause and the supplement contains reports of 
        new clinical investigations (other than bioavailabilty 
        studies) essential to the approval of the supplement 
        and conducted or sponsored by the person submitting the 
        supplement, the Secretary may not make the approval of 
        an application submitted under subsection (b) for a 
        change approved in the supplement effective before the 
        expiration of three years from the date of the approval 
        of the supplement under subsection (b) if the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and if the applicant has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations were conducted.
          (v) If an application (or supplement to an 
        application) submitted under subsection (b) for a drug, 
        which includes an active ingredient (including any 
        ester or salt of the active ingredient) that has been 
        approved in another application under subsection (b), 
        was approved during the period beginning January 1, 
        1982, and ending on the date of the enactment of this 
        clause, the Secretary may not make the approval of an 
        application submitted under this subsection and for 
        which the investigations described in clause (A) of 
        subsection (b)(1) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted and which 
        refers to the drug for which the subsection (b) 
        application was submitted effective before the 
        expiration of two years from the date of enactment of 
        this clause.
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is 
necessary to ensure the safety or effectiveness of the drug.
  (5)(A) The Secretary may rely upon qualified data summaries 
to support the approval of a supplemental application, with 
respect to a qualified indication for a drug, submitted under 
subsection (b), if such supplemental application complies with 
subparagraph (B).
  (B) A supplemental application is eligible for review as 
described in subparagraph (A) only if--
          (i) there is existing data available and acceptable 
        to the Secretary demonstrating the safety of the drug; 
        and
          (ii) all data used to develop the qualified data 
        summaries are submitted to the Secretary as part of the 
        supplemental application.
  (C) The Secretary shall post on the Internet website of the 
Food and Drug Administration and update annually--
          (i) the number of applications reviewed solely under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act;
          (ii) the average time for completion of review under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act;
          (iii) the average time for review of supplemental 
        applications where the Secretary did not use review 
        flexibility under subparagraph (A) or section 
        351(a)(2)(E) of the Public Health Service Act; and
          (iv) the number of applications reviewed under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act for which the Secretary made use of 
        full data sets in addition to the qualified data 
        summary.
  (D) In this paragraph--
          (i) the term ``qualified indication'' means an 
        indication for a drug that the Secretary determines to 
        be appropriate for summary level review under this 
        paragraph; and
          (ii) the term ``qualified data summary'' means a 
        summary of clinical data that demonstrates the safety 
        and effectiveness of a drug with respect to a qualified 
        indication.
  (d) If the Secretary finds, after due notice to the applicant 
in accordance with subsection (c) and giving him an opportunity 
for a hearing, in accordance with said subsection, that (1) the 
investigations, reports of which are required to be submitted 
to the Secretary pursuant to subsection (b), do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug is safe for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling 
thereof; (2) the results of such tests show that such drug is 
unsafe for use under such conditions or do not show that such 
drug is safe for use under such conditions; (3) the methods 
used in, and the facilities and controls used for, the 
manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and 
purity; (4) upon the basis of the information submitted to him 
as part of the application, or upon the basis of any other 
information before him with respect to such drug, he has 
insufficient information to determine whether such drug is safe 
for use under such conditions; or (5) evaluated on the basis of 
the information submitted to him as part of the application and 
any other information before him with respect to such drug, 
there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
proposed labeling thereof; or (6) the application failed to 
contain the patent information prescribed by subsection (b); or 
(7) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; he shall 
issue an order refusing to approve the application. If, after 
such notice and opportunity for hearing, the Secretary finds 
that clauses (1) through (6) do not apply, he shall issue an 
order approving the application. As used in this subsection and 
subsection (e), the term ``substantial evidence'' means 
evidence consisting of adequate and well-controlled 
investigations, including clinical investigations, by experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it 
could fairly and responsibly be concluded by such experts that 
the drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or 
suggested in the labeling or proposed labeling thereof. If the 
Secretary determines, based on relevant science, that data from 
one adequate and well-controlled clinical investigation and 
confirmatory evidence (obtained prior to or after such 
investigation) are sufficient to establish effectiveness, the 
Secretary may consider such data and evidence to constitute 
substantial evidence for purposes of the preceding sentence. 
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 marketing approval of a drug.
  (e) The Secretary shall, after due notice and opportunity for 
hearing to the applicant, withdraw approval of an application 
with respect to any drug under this section if the Secretary 
finds (1) that clinical or other experience, tests, or other 
scientific data show that such drug is unsafe for use under the 
conditions of use upon the basis of which the application was 
approved; (2) that new evidence of clinical experience, not 
contained in such application or not available to the Secretary 
until after such application was approved, or tests by new 
methods, or tests by methods not deemed reasonably applicable 
when such application was approved, evaluated together with the 
evidence available to the Secretary when the application was 
approved, shows that such drug is not shown to be safe for use 
under the conditions of use upon the basis of which the 
application was approved; or (3) on the basis of new 
information before him with respect to such drug, evaluated 
together with the evidence available to him when the 
application was approved, that there is a lack of substantial 
evidence that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling thereof; or (4) the 
patent information prescribed by subsection (c) was not filed 
within thirty days after the receipt of written notice from the 
Secretary specifying the failure to file such information; or 
(5) that the application contains any untrue statement of a 
material fact: Provided, That if the Secretary (or in his 
absence the officer acting as Secretary) finds that there is an 
imminent hazard to the public health, he may suspend the 
approval of such application immediately, and give the 
applicant prompt notice of his action and afford the applicant 
the opportunity for an expedited hearing under this subsection; 
but the authority conferred by this proviso to suspend the 
approval of an application shall not be delegated. The 
Secretary may also, after due notice and opportunity for 
hearing to the applicant, withdraw the approval of an 
application submitted under subsection (b) or (j) with respect 
to any drug under this section if the Secretary finds (1) that 
the applicant has failed to establish a system for maintaining 
required records, or has repeatedly or deliberately failed to 
maintain such records or to make required reports, in 
accordance with a regulation or order under subsection (k) or 
to comply with the notice requirements of section 510(k)(2), or 
the applicant has refused to permit access to, or copying or 
verification of, such records as required by paragraph (2) of 
such subsection; or (2) that on the basis of new information 
before him, evaluated together with the evidence before him 
when the application was approved, the methods used in, or the 
facilities and controls used for, the manufacture, processing, 
and packing of such drug are inadequate to assure and preserve 
its identity, strength, quality, and purity and were not made 
adequate within a reasonable time after receipt of written 
notice from the Secretary specifying the matter complained of; 
or (3) that on the basis of new information before him, 
evaluated together with the evidence before him when the 
application was approved, the labeling of such drug, based on a 
fair evaluation of all material facts, is false or misleading 
in any particular and was not corrected within a reasonable 
time after receipt of written notice from the Secretary 
specifying the matter complained of. Any order under this 
subsection shall state the findings upon which it is based. The 
Secretary may withdraw the approval of an application submitted 
under this section, or suspend the approval of such an 
application, as provided under this subsection, without first 
ordering the applicant to submit an assessment of the approved 
risk evaluation and mitigation strategy for the drug under 
section 505-1(g)(2)(D).
  (f) Whenever the Secretary finds that the facts so require, 
he shall revoke any previous order under subsection (d) or (e) 
refusing, withdrawing, or suspending approval of an application 
and shall approve such application or reinstate such approval, 
as may be appropriate.
  (g) Orders of the Secretary issued under this section shall 
be served (1) in person by any officer or employee of the 
Department designated by the Secretary or (2) by mailing the 
order by registered mail or by certified mail addressed to the 
applicant or respondent at his last-known address in the 
records of the Secretary.
  (h) An appeal may be taken by the applicant from an order of 
the Secretary refusing or withdrawing approval of an 
application under this section. Such appeal shall be taken by 
filing in the United States court of appeals for the circuit 
wherein such applicant resides or has his principal place of 
business, or in the United States Court of Appeals for the 
District of Columbia Circuit, within sixty days after the entry 
of such order, a written petition praying that the order of the 
Secretary be set aside. A copy of such petition shall be 
forthwith transmitted by the clerk of the court to the 
Secretary, or any officer designated by him for that purpose, 
and thereupon the Secretary shall certify and file in the court 
the record upon which the order complained of was entered, as 
provided in section 2112 of title 28, United States Code. Upon 
the filing of such petition such court shall have exclusive 
jurisdiction to affirm or set aside such order, except that 
until the filing of the record the Secretary may modify or set 
aside his order. No objection to the order of the Secretary 
shall be considered by the court unless such objection shall 
have been urged before the Secretary or unless there were 
reasonable grounds for failure so to do. The finding of the 
Secretary as to the facts, if supported by substantial 
evidence, shall be conclusive. If any person shall apply to the 
court for leave to adduce additional evidence, and shall show 
to the satisfaction of the court that such additional evidence 
is material and that there were reasonable grounds for failure 
to adduce such evidence in the proceeding before the Secretary, 
the court may order such additional evidence to be taken before 
the Secretary and to be adduced upon the hearing in such manner 
and upon such terms and conditions as to the court may seem 
proper. The Secretary may modify his findings as to the facts 
by reason of the additional evidence so taken, and he shall 
file with the court such modified findings which, if supported 
by substantial evidence, shall be conclusive, and his 
recommendation, if any, for the setting aside of the original 
order. The judgment of the court affirming or setting aside any 
such order of the Secretary shall be final, subject to review 
by the Supreme Court of the United States upon certiorari or 
certification as provided in section 1254 of title 28 of the 
United States Code. The commencement of proceedings under this 
subsection shall not, unless specifically ordered by the court 
to the contrary, operate as a stay of the Secretary's order.
  (i)(1) The Secretary shall promulgate regulations for 
exempting from the operation of the foregoing subsections of 
this section drugs intended solely for investigational use by 
experts qualified by scientific training and experience to 
investigate the safety and effectiveness of drugs. Such 
regulations may, within the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon--
          (A) the submission to the Secretary, before any 
        clinical testing of a new drug is undertaken, of 
        reports, by the manufacturer or the sponsor of the 
        investigation of such drug, or preclinical tests 
        (including tests on animals) of such drug adequate to 
        justify the proposed clinical testing;
          (B) the manufacturer or the sponsor of the 
        investigation of a new drug proposed to be distributed 
        to investigators for clinical testing obtaining a 
        signed agreement from each of such investigators that 
        patients to whom the drug is administered will be under 
        his personal supervision, or under the supervision of 
        investigators responsible to him, and that he will not 
        supply such drug to any other investigator, or to 
        clinics, for administration to human beings;
          (C) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application pursuant to 
        subsection (b); and
                  (D) the submission to the Secretary by the 
                manufacturer or the sponsor of the 
                investigation of a new drug of a statement of 
                intent regarding whether the manufacturer or 
                sponsor has plans for assessing pediatric 
                safety and efficacy.
  (2) Subject to paragraph (3), a clinical investigation of a 
new drug may begin 30 days after the Secretary has received 
from the manufacturer or sponsor of the investigation a 
submission containing such information about the drug and the 
clinical investigation, including--
          (A) information on design of the investigation and 
        adequate reports of basic information, certified by the 
        applicant to be accurate reports, necessary to assess 
        the safety of the drug for use in clinical 
        investigation; and
          (B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the 
        drug, and primary data tabulations from animal or human 
        studies.
  (3)(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 that--
          (i) the drug 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 drug, the design of the clinical 
        investigation, the condition for which the drug 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 (including reasons established by regulation 
        before the date of the enactment of the Food and Drug 
        Administration Modernization Act of 1997).
  (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.
  (4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the 
sponsor of the investigation, requiring that experts using such 
drugs for investigational purposes certify to such manufacturer 
or sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except 
where it is not feasible, it is contrary to the best interests 
of such human beings, or the proposed clinical testing poses no 
more than minimal risk to such human beings and includes 
appropriate safeguards as prescribed to protect the rights, 
safety, and welfare of such human beings. Nothing in this 
subsection shall be construed to require any clinical 
investigator to submit directly to the Secretary reports on the 
investigational use of drugs. The Secretary shall update such 
regulations to require inclusion in the informed consent 
documents and process a statement that clinical trial 
information for such clinical investigation has been or will be 
submitted for inclusion in the registry data bank pursuant to 
subsection (j) of section 402 of the Public Health Service Act.
  (j)(1) Any person may file with the Secretary an abbreviated 
application for the approval of a new drug.
  (2)(A) An abbreviated application for a new drug shall 
contain--
          (i) information to show that the conditions of use 
        prescribed, recommended, or suggested in the labeling 
        proposed for the new drug have been previously approved 
        for a drug listed under paragraph (7) (hereinafter in 
        this subsection referred to as a ``listed drug'');
          (ii)(I) if the listed drug referred to in clause (i) 
        has only one active ingredient, information to show 
        that the active ingredient of the new drug is the same 
        as that of the listed drug;
          (II) if the listed drug referred to in clause (i) has 
        more than one active ingredient, information to show 
        that the active ingredients of the new drug are the 
        same as those of the listed drug, or
          (III) if the listed drug referred to in clause (i) 
        has more than one active ingredient and if one of the 
        active ingredients of the new drug is different and the 
        application is filed pursuant to the approval of a 
        petition filed under subparagraph (C), information to 
        show that the other active ingredients of the new drug 
        are the same as the active ingredients of the listed 
        drug, information to show that the different active 
        ingredient is an active ingredient of a listed drug or 
        of a drug which does not meet the requirements of 
        section 201(p), and such other information respecting 
        the different active ingredient with respect to which 
        the petition was filed as the Secretary may require;
          (iii) information to show that the route of 
        administration, the dosage form, and the strength of 
        the new drug are the same as those of the listed drug 
        referred to in clause (i) or, if the route of 
        administration, the dosage form, or the strength of the 
        new drug is different and the application is filed 
        pursuant to the approval of a petition filed under 
        subparagraph (C), such information respecting the route 
        of administration, dosage form, or strength with 
        respect to which the petition was filed as the 
        Secretary may require;
          (iv) information to show that the new drug is 
        bioequivalent to the listed drug referred to in clause 
        (i), except that if the application is filed pursuant 
        to the approval of a petition filed under subparagraph 
        (C), information to show that the active ingredients of 
        the new drug are of the same pharmacological or 
        therapeutic class as those of the listed drug referred 
        to in clause (i) and the new drug can be expected to 
        have the same therapeutic effect as the listed drug 
        when administered to patients for a condition of use 
        referred to in clause (i);
          (v) information to show that the labeling proposed 
        for the new drug is the same as the labeling approved 
        for the listed drug referred to in clause (i) except 
        for changes required because of differences approved 
        under a petition filed under subparagraph (C) or 
        because the new drug and the listed drug are produced 
        or distributed by different manufacturers;
          (vi) the items specified in clauses (B) through (F) 
        of subsection (b)(1);
          (vii) a certification, in the opinion of the 
        applicant and to the best of his knowledge, with 
        respect to each patent which claims the listed drug 
        referred to in clause (i) or which claims a use for 
        such listed drug for which the applicant is seeking 
        approval under this subsection and for which 
        information is required to be filed under subsection 
        (b) or (c)--
                  (I) that such patent information has not been 
                filed,
                  (II) that such patent has expired,
                  (III) of the date on which such patent will 
                expire, or
                  (IV) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (viii) if with respect to the listed drug referred to 
        in clause (i) information was filed under subsection 
        (b) or (c) for a method of use patent which does not 
        claim a use for which the applicant is seeking approval 
        under this subsection, a statement that the method of 
        use patent does not claim such a use.
The Secretary may not require that an abbreviated application 
contain information in addition to that required by clauses (i) 
through (viii).
  (B) Notice of opinion that patent is invalid or will not be 
infringed.--
          (i) Agreement to give notice.--An applicant that 
        makes a certification described in subparagraph 
        (A)(vii)(IV) shall include in the application a 
        statement that the applicant will give notice as 
        required by this subparagraph.
          (ii) Timing of notice.--An applicant that makes a 
        certification described in subparagraph (A)(vii)(IV) 
        shall give notice as required under this subparagraph--
                  (I) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (II) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (iii) Recipients of notice.--An applicant required 
        under this subparagraph to give notice shall give 
        notice to--
                  (I) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (II) the holder of the approved application 
                under subsection (b) for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (iv) Contents of notice.--A notice required under 
        this subparagraph shall--
                  (I) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (II) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (C) If a person wants to submit an abbreviated application 
for a new drug which has a different active ingredient or whose 
route of administration, dosage form, or strength differ from 
that of a listed drug, such person shall submit a petition to 
the Secretary seeking permission to file such an application. 
The Secretary shall approve or disapprove a petition submitted 
under this subparagraph within ninety days of the date the 
petition is submitted. The Secretary shall approve such a 
petition unless the Secretary finds--
          (i) that investigations must be conducted to show the 
        safety and effectiveness of the drug or of any of its 
        active ingredients, the route of administration, the 
        dosage form, or strength which differ from the listed 
        drug; or
          (ii) that any drug with a different active ingredient 
        may not be adequately evaluated for approval as safe 
        and effective on the basis of the information required 
        to be submitted in an abbreviated application.
  (D)(i) An applicant may not amend or supplement an 
application to seek approval of a drug referring to a different 
listed drug from the listed drug identified in the application 
as submitted to the Secretary.
  (ii) With respect to the drug for which an application is 
submitted, nothing in this subsection prohibits an applicant 
from amending or supplementing the application to seek approval 
of a different strength.
  (iii) Within 60 days after the date of the enactment of the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, the Secretary shall issue guidance defining the term 
``listed drug'' for purposes of this subparagraph.
  (3)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1), which 
shall relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection if the sponsor or applicant makes a reasonable 
written request for a meeting for the purpose of reaching 
agreement on the design and size of bioavailability and 
bioequivalence studies needed for approval of such application. 
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of such 
studies. Minutes of any such meeting shall be prepared by the 
Secretary and made available to the sponsor or applicant.
  (C) Any agreement regarding the parameters of design and size 
of bioavailability and bioequivalence studies of a drug under 
this paragraph that is reached between the Secretary and a 
sponsor or applicant shall be reduced to writing and made part 
of the administrative record by the Secretary. Such agreement 
shall not be changed after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance office personnel unless such field or 
compliance office personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection (including scientific 
matters, chemistry, manufacturing, and controls).
  (4) Subject to paragraph (5), the Secretary shall approve an 
application for a drug unless the Secretary finds--
          (A) the methods used in, or the facilities and 
        controls used for, the manufacture, processing, and 
        packing of the drug are inadequate to assure and 
        preserve its identity, strength, quality, and purity;
          (B) information submitted with the application is 
        insufficient show that each of the proposed conditions 
        of use have been previously approved for the listed 
        drug referred to in the application;
          (C)(i) if the listed drug has only one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredient is 
        the same as that of the listed drug;
          (ii) if the listed drug has more than one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredients are 
        the same as the active ingredients of the listed drug, 
        or
          (iii) if the listed drug has more than one active 
        ingredient and if the application is for a drug which 
        has an active ingredient different from the listed 
        drug, information submitted with the application is 
        insufficient to show--
                  (I) that the other active ingredients are the 
                same as the active ingredients of the listed 
                drug, or
                  (II) that the different active ingredient is 
                an active ingredient of a listed drug or a drug 
                which does not meet the requirements of section 
                201(p),
        or no petition to file an application for the drug with 
        the different ingredient was approved under paragraph 
        (2)(C);
          (D)(i) if the application is for a drug whose route 
        of administration, dosage form, or strength of the drug 
        is the same as the route of administration, dosage 
        form, or strength of the listed drug referred to in the 
        application, information submitted in the application 
        is insufficient to show that the route of 
        administration, dosage form, or strength is the same as 
        that of the listed drug, or
          (ii) if the application is for a drug whose route of 
        administration, dosage form, or strength of the drug is 
        different from that of the listed drug referred to in 
        the application, no petition to file an application for 
        the drug with the different route of administration, 
        dosage form, or strength was approved under paragraph 
        (2)(C);
          (E) if the application was filed pursuant to the 
        approval of a petition under paragraph (2)(C), the 
        application did not contain the information required by 
        the Secretary respecting the active ingredient, route 
        of administration, dosage form, or strength which is 
        not the same;
          (F) information submitted in the application is 
        insufficient to show that the drug is bioequivalent to 
        the listed drug referred to in the application or, if 
        the application was filed pursuant to a petition 
        approved under paragraph (2)(C), information submitted 
        in the application is insufficient to show that the 
        active ingredients of the new drug are of the same 
        pharmacological or therapeutic class as those of the 
        listed drug referred to in paragraph (2)(A)(i) and that 
        the new drug can be expected to have the same 
        therapeutic effect as the listed drug when administered 
        to patients for a condition of use referred to in such 
        paragraph;
          (G) information submitted in the application is 
        insufficient to show that the labeling proposed for the 
        drug is the same as the labeling approved for the 
        listed drug referred to in the application except for 
        changes required because of differences approved under 
        a petition filed under paragraph (2)(C) or because the 
        drug and the listed drug are produced or distributed by 
        different manufacturers;
          (H) information submitted in the application or any 
        other information available to the Secretary shows that 
        (i) the inactive ingredients of the drug are unsafe for 
        use under the conditions prescribed, recommended, or 
        suggested in the labeling proposed for the drug, or 
        (ii) the composition of the drug is unsafe under such 
        conditions because of the type or quantity of inactive 
        ingredients included or the manner in which the 
        inactive ingredients are included;
          (I) the approval under subsection (c) of the listed 
        drug referred to in the application under this 
        subsection has been withdrawn or suspended for grounds 
        described in the first sentence of subsection (e), the 
        Secretary has published a notice of opportunity for 
        hearing to withdraw approval of the listed drug under 
        subsection (c) for grounds described in the first 
        sentence of subsection (e), the approval under this 
        subsection of the listed drug referred to in the 
        application under this subsection has been withdrawn or 
        suspended under paragraph (6), or the Secretary has 
        determined that the listed drug has been withdrawn from 
        sale for safety or effectiveness reasons;
          (J) the application does not meet any other 
        requirement of paragraph (2)(A); or
          (K) the application contains an untrue statement of 
        material fact.
  (5)(A) Within one hundred and eighty days of the initial 
receipt of an application under paragraph (2) or within such 
additional period as may be agreed upon by the Secretary and 
the applicant, the Secretary shall approve or disapprove the 
application.
  (B) The approval of an application submitted under paragraph 
(2) shall be made effective on the last applicable date 
determined by applying the following to each certification made 
under paragraph (2)(A)(vii):
          (i) If the applicant only made a certification 
        described in subclause (I) or (II) of paragraph 
        (2)(A)(vii) or in both such subclauses, the approval 
        may be made effective immediately.
          (ii) If the applicant made a certification described 
        in subclause (III) of paragraph (2)(A)(vii), the 
        approval may be made effective on the date certified 
        under subclause (III).
          (iii) If the applicant made a certification described 
        in subclause (IV) of paragraph (2)(A)(vii), the 
        approval shall be made effective immediately unless, 
        before the expiration of 45 days after the date on 
        which the notice described in paragraph (2)(B) is 
        received, an action is brought for infringement of the 
        patent that is the subject of the certification and for 
        which information was submitted to the Secretary under 
        subsection (b)(1) or (c)(2) before the date on which 
        the application (excluding an amendment or supplement 
        to the application), which the Secretary later 
        determines to be substantially complete, was submitted. 
        If such an action is brought before the expiration of 
        such days, the approval shall be made effective upon 
        the expiration of the thirty-month period beginning on 
        the date of the receipt of the notice provided under 
        paragraph (2)(B)(i) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (I) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (aa) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (bb) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (II) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (aa) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (AA) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (BB) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (bb) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (III) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in subclause (I); or
                  (IV) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in subclause (II).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (iv)  180-day exclusivity period.--
                  (I) Effectiveness of application.--Subject to 
                subparagraph (D), if the application contains a 
                certification described in paragraph 
                (2)(A)(vii)(IV) and is for a drug for which a 
                first applicant has submitted an application 
                containing such a certification, the 
                application shall be made effective on the date 
                that is 180 days after the date of the first 
                commercial marketing of the drug (including the 
                commercial marketing of the listed drug) by any 
                first applicant.
                  (II) Definitions.--In this paragraph:
                          (aa)  180-day exclusivity period.--
                        The term ``180-day exclusivity period'' 
                        means the 180-day period ending on the 
                        day before the date on which an 
                        application submitted by an applicant 
                        other than a first applicant could 
                        become effective under this clause.
                          (bb) First applicant.--As used in 
                        this subsection, the term ``first 
                        applicant'' means an applicant that, on 
                        the first day on which a substantially 
                        complete application containing a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) is submitted for 
                        approval of a drug, submits a 
                        substantially complete application that 
                        contains and lawfully maintains a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) for the drug.
                          (cc) Substantially complete 
                        application.--As used in this 
                        subsection, the term ``substantially 
                        complete application'' means an 
                        application under this subsection that 
                        on its face is sufficiently complete to 
                        permit a substantive review and 
                        contains all the information required 
                        by paragraph (2)(A).
                          (dd) Tentative approval.--
                                  (AA) In general.--The term 
                                ``tentative approval'' means 
                                notification to an applicant by 
                                the Secretary that an 
                                application under this 
                                subsection meets the 
                                requirements of paragraph 
                                (2)(A), but cannot receive 
                                effective approval because the 
                                application does not meet the 
                                requirements of this 
                                subparagraph, there is a period 
                                of exclusivity for the listed 
                                drug under subparagraph (F) or 
                                section 505A, or there is a 7-
                                year period of exclusivity for 
                                the listed drug under section 
                                527.
                                  (BB) Limitation.--A drug that 
                                is granted tentative approval 
                                by the Secretary is not an 
                                approved drug and shall not 
                                have an effective approval 
                                until the Secretary issues an 
                                approval after any necessary 
                                additional review of the 
                                application.
          (v)  180-day exclusivity period for competitive 
        generic therapies.--
                  (I) Effectiveness of application.--Subject to 
                subparagraph (D)(iv), if the application is for 
                a drug that is the same as a competitive 
                generic therapy for which any first approved 
                applicant has commenced commercial marketing, 
                the application shall be made effective on the 
                date that is 180 days after the date of the 
                first commercial marketing of the competitive 
                generic therapy (including the commercial 
                marketing of the listed drug) by any first 
                approved applicant.
                  (II) Limitation.--The exclusivity period 
                under subclause (I) shall not apply with 
                respect to a competitive generic therapy that 
                has previously received an exclusivity period 
                under subclause (I).
                  (III) Definitions.--In this clause and 
                subparagraph (D)(iv):
                          (aa) The term ``competitive generic 
                        therapy'' means a drug--
                                  (AA) that is designated as a 
                                competitive generic therapy 
                                under section 506H; and
                                  (BB) for which there are no 
                                unexpired patents or 
                                exclusivities on the list of 
                                products described in section 
                                505(j)(7)(A) at the time of 
                                submission.
                          (bb) The term ``first approved 
                        applicant'' means any applicant that 
                        has submitted an application that--
                                  (AA) is for a competitive 
                                generic therapy that is 
                                approved on the first day on 
                                which any application for such 
                                competitive generic therapy is 
                                approved;
                                  (BB) is not eligible for a 
                                180-day exclusivity period 
                                under clause (iv) for the drug 
                                that is the subject of the 
                                application for the competitive 
                                generic therapy; and
                                  (CC) is not for a drug for 
                                which all drug versions have 
                                forfeited eligibility for a 
                                180-day exclusivity period 
                                under clause (iv) pursuant to 
                                subparagraph (D).
          (C) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        under paragraph (2) for a declaratory 
                        judgment with respect to a patent which 
                        is the subject of the certification 
                        referred to in subparagraph (B)(iii) 
                        unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant under paragraph (2) for 
                        the purpose of determining whether an 
                        action referred to in subparagraph 
                        (B)(iii) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV) and for no other 
                        purpose, and may not disclose 
                        information of no relevance to any 
                        issue of patent infringement to any 
                        person other than a person provided an 
                        offer of confidential access. Further, 
                        the application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or (c) on the 
                        ground that the patent does not claim 
                        either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (D) Forfeiture of 180-day exclusivity period.--
                  (i) Definition of forfeiture event.--In this 
                subparagraph, the term ``forfeiture event'', 
                with respect to an application under this 
                subsection, means the occurrence of any of the 
                following:
                          (I) Failure to market.--The first 
                        applicant fails to market the drug by 
                        the later of--
                                  (aa) the earlier of the date 
                                that is--
                                          (AA) 75 days after 
                                        the date on which the 
                                        approval of the 
                                        application of the 
                                        first applicant is made 
                                        effective under 
                                        subparagraph (B)(iii); 
                                        or
                                          (BB) 30 months after 
                                        the date of submission 
                                        of the application of 
                                        the first applicant; or
                                  (bb) with respect to the 
                                first applicant or any other 
                                applicant (which other 
                                applicant has received 
                                tentative approval), the date 
                                that is 75 days after the date 
                                as of which, as to each of the 
                                patents with respect to which 
                                the first applicant submitted 
                                and lawfully maintained a 
                                certification qualifying the 
                                first applicant for the 180-day 
                                exclusivity period under 
                                subparagraph (B)(iv), at least 
                                1 of the following has 
                                occurred:
                                          (AA) In an 
                                        infringement action 
                                        brought against that 
                                        applicant with respect 
                                        to the patent or in a 
                                        declaratory judgment 
                                        action brought by that 
                                        applicant with respect 
                                        to the patent, a court 
                                        enters a final decision 
                                        from which no appeal 
                                        (other than a petition 
                                        to the Supreme Court 
                                        for a writ of 
                                        certiorari) has been or 
                                        can be taken that the 
                                        patent is invalid or 
                                        not infringed.
                                          (BB) In an 
                                        infringement action or 
                                        a declaratory judgment 
                                        action described in 
                                        subitem (AA), a court 
                                        signs a settlement 
                                        order or consent decree 
                                        that enters a final 
                                        judgment that includes 
                                        a finding that the 
                                        patent is invalid or 
                                        not infringed.
                                          (CC) The patent 
                                        information submitted 
                                        under subsection (b) or 
                                        (c) is withdrawn by the 
                                        holder of the 
                                        application approved 
                                        under subsection (b).
                          (II) Withdrawal of application.--The 
                        first applicant withdraws the 
                        application or the Secretary considers 
                        the application to have been withdrawn 
                        as a result of a determination by the 
                        Secretary that the application does not 
                        meet the requirements for approval 
                        under paragraph (4).
                          (III) Amendment of certification.--
                        The first applicant amends or withdraws 
                        the certification for all of the 
                        patents with respect to which that 
                        applicant submitted a certification 
                        qualifying the applicant for the 180-
                        day exclusivity period.
                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within 30 months after the 
                        date on which the application is filed, 
                        unless the failure is caused by a 
                        change in or a review of the 
                        requirements for approval of the 
                        application imposed after the date on 
                        which the application is filed.
                          (V) Agreement with another applicant, 
                        the listed drug application holder, or 
                        a patent owner.--The first applicant 
                        enters into an agreement with another 
                        applicant under this subsection for the 
                        drug, the holder of the application for 
                        the listed drug, or an owner of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV), the Federal Trade 
                        Commission or the Attorney General 
                        files a complaint, and there is a final 
                        decision of the Federal Trade 
                        Commission or the court with regard to 
                        the complaint from which no appeal 
                        (other than a petition to the Supreme 
                        Court for a writ of certiorari) has 
                        been or can be taken that the agreement 
                        has violated section 27 of the Federal 
                        Trade Commission Act or the antitrust 
                        laws (as defined in section 1 of the 
                        Clayton Act (15 U.S.C. 12), except that 
                        the term includes section 5 of the 
                        Federal Trade Commission Act (15 U.S.C. 
                        45) to the extent that that section 
                        applies to unfair methods of 
                        competition).
                          (VI) Expiration of all patents.--All 
                        of the patents as to which the 
                        applicant submitted a certification 
                        qualifying it for the 180-day 
                        exclusivity period have expired.
                  (ii) Forfeiture.--The 180-day exclusivity 
                period described in subparagraph (B)(iv) shall 
                be forfeited by a first applicant if a 
                forfeiture event occurs with respect to that 
                first applicant.
                  (iii) Subsequent applicant.--If all first 
                applicants forfeit the 180-day exclusivity 
                period under clause (ii)--
                          (I) approval of any application 
                        containing a certification described in 
                        paragraph (2)(A)(vii)(IV) shall be made 
                        effective in accordance with 
                        subparagraph (B)(iii); and
                          (II) no applicant shall be eligible 
                        for a 180-day exclusivity period.
                  (iv) Special forfeiture rule for competitive 
                generic therapy.--The 180-day exclusivity 
                period described in subparagraph (B)(v) shall 
                be forfeited by a first approved applicant if 
                the applicant fails to market the competitive 
                generic therapy within 75 days after the date 
                on which the approval of the first approved 
                applicant's application for the competitive 
                generic therapy is made effective.
  (E) If the Secretary decides to disapprove an application, 
the Secretary shall give the applicant notice of an opportunity 
for a hearing before the Secretary on the question of whether 
such application is approvable. If the applicant elects to 
accept the opportunity for hearing by written request within 
thirty days after such notice, such hearing shall commence not 
more than ninety days after the expiration of such thirty days 
unless the Secretary and the applicant otherwise agree. Any 
such hearing shall thereafter be conducted on an expedited 
basis and the Secretary's order thereon shall be issued within 
ninety days after the date fixed by the Secretary for filing 
final briefs.
  (F)(i) If an application (other than an abbreviated new drug 
application) submitted under subsection (b) for a drug, no 
active ingredient (including any ester or salt of the active 
ingredient) of which has been approved in any other application 
under subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted 
effective before the expiration of ten years from the date of 
the approval of the application under subsection (b).
  (ii) If an application submitted under subsection (b) for a 
drug, no active ingredient (including any ester or salt of the 
active ingredient) of which has been approved in any other 
application under subsection (b), is approved after the date of 
the enactment of this subsection, no application may be 
submitted under this subsection which refers to the drug for 
which the subsection (b) application was submitted before the 
expiration of five years from the date of the approval of the 
application under subsection (b), except that such an 
application may be submitted under this subsection after the 
expiration of four years from the date of the approval of the 
subsection (b) application if it contains a certification of 
patent invalidity or noninfringement described in subclause 
(IV) of paragraph (2)(A)(vii). The approval of such an 
application shall be made effective in accordance with 
subparagraph (B) except that, if an action for patent 
infringement is commenced during the one-year period beginning 
forty-eight months after the date of the approval of the 
subsection (b) application, the thirty-month period referred to 
in subparagraph (B)(iii) shall be extended by such amount of 
time (if any) which is required for seven and one-half years to 
have elapsed from the date of approval of the subsection (b) 
application.
  (iii) If an application submitted under subsection (b) for a 
drug, which includes an active ingredient (including any ester 
or salt of the active ingredient) that has been approved in 
another application approved under subsection (b), is approved 
after the date of enactment of this subsection and if such 
application contains reports of new clinical investigations 
(other than bioavailability studies) essential to the approval 
of the application and conducted or sponsored by the applicant, 
the Secretary may not make the approval of an application 
submitted under this subsection for the conditions of approval 
of such drug in the subsection (b) application effective before 
the expiration of three years from the date of the approval of 
the application under subsection (b) for such drug.
  (iv) If a supplement to an application approved under 
subsection (b) is approved after the date of enactment of this 
subsection and the supplement contains reports of new clinical 
investigations (other than bioavailability studies) essential 
to the approval of the supplement and conducted or sponsored by 
the person submitting the supplement, the Secretary may not 
make the approval of an application submitted under this 
subsection for a change approved in the supplement effective 
before the expiration of three years from the date of the 
approval of the supplement under subsection (b).
  (v) If an application (or supplement to an application) 
submitted under subsection (b) for a drug, which includes an 
active ingredient (including any ester or salt of the active 
ingredient) that has been approved in another application under 
subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted or 
which refers to a change approved in a supplement to the 
subsection (b) application effective before the expiration of 
two years from the date of enactment of this subsection.
  (6) If a drug approved under this subsection refers in its 
approved application to a drug the approval of which was 
withdrawn or suspended for grounds described in the first 
sentence of subsection (e) or was withdrawn or suspended under 
this paragraph or which, as determined by the Secretary, has 
been withdrawn from sale for safety or effectiveness reasons, 
the approval of the drug under this subsection shall be 
withdrawn or suspended--
          (A) for the same period as the withdrawal or 
        suspension under subsection (e) or this paragraph, or
          (B) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
  (7)(A)(i) Within sixty days of the date of the enactment of 
this subsection, the Secretary shall publish and make available 
to the public--
          (I) a list in alphabetical order of the official and 
        proprietary name of each drug which has been approved 
        for safety and effectiveness under subsection (c) 
        before the date of the enactment of this subsection;
          (II) the date of approval if the drug is approved 
        after 1981 and the number of the application which was 
        approved; and
          (III) whether in vitro or in vivo bioequivalence 
        studies, or both such studies, are required for 
        applications filed under this subsection which will 
        refer to the drug published.
  (ii) Every thirty days after the publication of the first 
list under clause (i) the Secretary shall revise the list to 
include each drug which has been approved for safety and 
effectiveness under subsection (c) or approved under this 
subsection during the thirty-day period.
  (iii) When patent information submitted under subsection (b) 
or (c) respecting a drug included on the list is to be 
published by the Secretary, the Secretary shall, in revisions 
made under clause (ii), include such information for such drug.
  (B) A drug approved for safety and effectiveness under 
subsection (c) or approved under this subsection shall, for 
purposes of this subsection, be considered to have been 
published under subparagraph (A) on the date of its approval or 
the date of enactment, whichever is later.
  (C) If the approval of a drug was withdrawn or suspended for 
grounds described in the first sentence of subsection (e) or 
was withdrawn or suspended under paragraph (6) or if the 
Secretary determines that a drug has been withdrawn from sale 
for safety or effectiveness reasons, it may not be published in 
the list under subparagraph (A) or, if the withdrawal or 
suspension occurred after its publication in such list, it 
shall be immediately removed from such list--
          (i) for the same period as the withdrawal or 
        suspension under subsection (e) or paragraph (6), or
          (ii) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
A notice of the removal shall be published in the Federal 
Register.
  (8) For purposes of this subsection:
          (A)(i) The term ``bioavailability'' means the rate 
        and extent to which the active ingredient or 
        therapeutic ingredient is absorbed from a drug and 
        becomes available at the site of drug action.
          (ii) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may assess 
        bioavailability by scientifically valid measurements 
        intended to reflect the rate and extent to which the 
        active ingredient or therapeutic ingredient becomes 
        available at the site of drug action.
          (B) A drug shall be considered to be bioequivalent to 
        a listed drug if--
                  (i) the rate and extent of absorption of the 
                drug do not show a significant difference from 
                the rate and extent of absorption of the listed 
                drug when administered at the same molar dose 
                of the therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses; or
                  (ii) the extent of absorption of the drug 
                does not show a significant difference from the 
                extent of absorption of the listed drug when 
                administered at the same molar dose of the 
                therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses and the difference from the 
                listed drug in the rate of absorption of the 
                drug is intentional, is reflected in its 
                proposed labeling, is not essential to the 
                attainment of effective body drug 
                concentrations on chronic use, and is 
                considered medically insignificant for the 
                drug.
          (C) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may establish 
        alternative, scientifically valid methods to show 
        bioequivalence if the alternative methods are expected 
        to detect a significant difference between the drug and 
        the listed drug in safety and therapeutic effect.
  (9) The Secretary shall, with respect to each application 
submitted under this subsection, maintain a record of--
          (A) the name of the applicant,
          (B) the name of the drug covered by the application,
          (C) the name of each person to whom the review of the 
        chemistry of the application was assigned and the date 
        of such assignment, and
          (D) the name of each person to whom the 
        bioequivalence review for such application was assigned 
        and the date of such assignment.
The information the Secretary is required to maintain under 
this paragraph with respect to an application submitted under 
this subsection shall be made available to the public after the 
approval of such application.
  (10)(A) If the proposed labeling of a drug that is the 
subject of an application under this subsection differs from 
the listed drug due to a labeling revision described under 
clause (i), the drug that is the subject of such application 
shall, notwithstanding any other provision of this Act, be 
eligible for approval and shall not be considered misbranded 
under section 502 if--
          (i) the application is otherwise eligible for 
        approval under this subsection but for expiration of 
        patent, an exclusivity period, or of a delay in 
        approval described in paragraph (5)(B)(iii), and a 
        revision to the labeling of the listed drug has been 
        approved by the Secretary within 60 days of such 
        expiration;
          (ii) the labeling revision described under clause (i) 
        does not include a change to the ``Warnings'' section 
        of the labeling;
          (iii) the sponsor of the application under this 
        subsection agrees to submit revised labeling of the 
        drug that is the subject of such application not later 
        than 60 days after the notification of any changes to 
        such labeling required by the Secretary; and
          (iv) such application otherwise meets the applicable 
        requirements for approval under this subsection.
  (B) If, after a labeling revision described in subparagraph 
(A)(i), the Secretary determines that the continued presence in 
interstate commerce of the labeling of the listed drug (as in 
effect before the revision described in subparagraph (A)(i)) 
adversely impacts the safe use of the drug, no application 
under this subsection shall be eligible for approval with such 
labeling.
  (11)(A) Subject to subparagraph (B), the Secretary shall 
prioritize the review of, and act within 8 months of the date 
of the submission of, an original abbreviated new drug 
application submitted for review under this subsection that is 
for a drug--
          (i) for which there are not more than 3 approved drug 
        products listed under paragraph (7) and for which there 
        are no blocking patents and exclusivities; or
          (ii) that has been included on the list under section 
        506E.
  (B) To qualify for priority review under this paragraph, not 
later than 60 days prior to the submission of an application 
described in subparagraph (A) or that the Secretary may 
prioritize pursuant to subparagraph (D), the applicant shall 
provide complete, accurate information regarding facilities 
involved in manufacturing processes and testing of the drug 
that is the subject of the application, including facilities in 
corresponding Type II active pharmaceutical ingredients drug 
master files referenced in an application and sites or 
organizations involved in bioequivalence and clinical studies 
used to support the application, to enable the Secretary to 
make a determination regarding whether an inspection of a 
facility is necessary. Such information shall include the 
relevant (as determined by the Secretary) sections of such 
application, which shall be unchanged relative to the date of 
the submission of such application, except to the extent that a 
change is made to such information to exclude a facility that 
was not used to generate data to meet any application 
requirements for such submission and that is not the only 
facility intended to conduct one or more unit operations in 
commercial production. Information provided by an applicant 
under this subparagraph shall not be considered the submission 
of an application under this subsection.
  (C) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to 
manufacture a drug described in subparagraph (A).
  (D) Nothing in this paragraph shall prevent the Secretary 
from prioritizing the review of other applications as the 
Secretary determines appropriate.
  (12) The Secretary shall publish on the internet website of 
the Food and Drug Administration, and update at least once 
every 6 months, a list of all drugs approved under subsection 
(c) for which all patents and periods of exclusivity under this 
Act have expired and for which no application has been approved 
under this subsection.
  (13) Upon the request of an applicant regarding one or more 
specified pending applications under this subsection, the 
Secretary shall, as appropriate, provide review status updates 
indicating the categorical status of the applications by each 
relevant review discipline.
  (k)(1) In the case of any drug for which an approval of an 
application filed under subsection (b) or (j) is in effect, the 
applicant shall establish and maintain such records, and make 
such reports to the Secretary, of data relating to clinical 
experience and other data or information, received or otherwise 
obtained by such applicant with respect to such drug, as the 
Secretary may by general regulation, or by order with respect 
to such application, prescribe on the basis of a finding that 
such records and reports are necessary in order to enable the 
Secretary to determine, or facilitate a determination, whether 
there is or may be ground for invoking subsection (e) of this 
section. Regulations and orders issued under this subsection 
and under subsection (i) shall have due regard for the 
professional ethics of the medical profession and the interests 
of patients and shall provide, where the Secretary deems it to 
be appropriate, for the examination, upon request, by the 
persons to whom such regulations or orders are applicable, of 
similar information received or otherwise obtained by the 
Secretary.
  (2) Every person required under this section to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
          (3) Active postmarket risk identification.--
                  (A) Definition.--In this paragraph, the term 
                ``data'' refers to information with respect to 
                a drug approved under this section or under 
                section 351 of the Public Health Service Act, 
                including claims data, patient survey data, 
                standardized analytic files that allow for the 
                pooling and analysis of data from disparate 
                data environments, and any other data deemed 
                appropriate by the Secretary.
                  (B) Development of postmarket risk 
                identification and analysis methods.--The 
                Secretary shall, not later than 2 years after 
                the date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007, in 
                collaboration with public, academic, and 
                private entities--
                          (i) develop methods to obtain access 
                        to disparate data sources including the 
                        data sources specified in subparagraph 
                        (C);
                          (ii) develop validated methods for 
                        the establishment of a postmarket risk 
                        identification and analysis system to 
                        link and analyze safety data from 
                        multiple sources, with the goals of 
                        including, in aggregate--
                                  (I) at least 25,000,000 
                                patients by July 1, 2010; and
                                  (II) at least 100,000,000 
                                patients by July 1, 2012; and
                          (iii) convene a committee of experts, 
                        including individuals who are 
                        recognized in the field of protecting 
                        data privacy and security, to make 
                        recommendations to the Secretary on the 
                        development of tools and methods for 
                        the ethical and scientific uses for, 
                        and communication of, postmarketing 
                        data specified under subparagraph (C), 
                        including recommendations on the 
                        development of effective research 
                        methods for the study of drug safety 
                        questions.
                  (C) Establishment of the postmarket risk 
                identification and analysis system.--
                          (i) In general.--The Secretary shall, 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), establish and maintain 
                        procedures--
                                  (I) for risk identification 
                                and analysis based on 
                                electronic health data, in 
                                compliance with the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996, and in a manner 
                                that does not disclose 
                                individually identifiable 
                                health information in violation 
                                of paragraph (4)(B);
                                  (II) for the reporting (in a 
                                standardized form) of data on 
                                all serious adverse drug 
                                experiences (as defined in 
                                section 505-1(b)) submitted to 
                                the Secretary under paragraph 
                                (1), and those adverse events 
                                submitted by patients, 
                                providers, and drug sponsors, 
                                when appropriate;
                                  (III) to provide for active 
                                adverse event surveillance 
                                using the following data 
                                sources, as available:
                                          (aa) Federal health-
                                        related electronic data 
                                        (such as data from the 
                                        Medicare program and 
                                        the health systems of 
                                        the Department of 
                                        Veterans Affairs);
                                          (bb) private sector 
                                        health-related 
                                        electronic data (such 
                                        as pharmaceutical 
                                        purchase data and 
                                        health insurance claims 
                                        data); and
                                          (cc) other data as 
                                        the Secretary deems 
                                        necessary to create a 
                                        robust system to 
                                        identify adverse events 
                                        and potential drug 
                                        safety signals;
                                  (IV) to identify certain 
                                trends and patterns with 
                                respect to data accessed by the 
                                system;
                                  (V) to provide regular 
                                reports to the Secretary 
                                concerning adverse event 
                                trends, adverse event patterns, 
                                incidence and prevalence of 
                                adverse events, and other 
                                information the Secretary 
                                determines appropriate, which 
                                may include data on comparative 
                                national adverse event trends; 
                                and
                                  (VI) to enable the program to 
                                export data in a form 
                                appropriate for further 
                                aggregation, statistical 
                                analysis, and reporting.
                          (ii) Timeliness of reporting.--The 
                        procedures established under clause (i) 
                        shall ensure that such data are 
                        accessed, analyzed, and reported in a 
                        timely, routine, and systematic manner, 
                        taking into consideration the need for 
                        data completeness, coding, cleansing, 
                        and standardized analysis and 
                        transmission.
                          (iii) Private sector resources.--To 
                        ensure the establishment of the active 
                        postmarket risk identification and 
                        analysis system under this subsection 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), as required under clause (i), the 
                        Secretary may, on a temporary or 
                        permanent basis, implement systems or 
                        products developed by private entities.
                          (iv) Complementary approaches.--To 
                        the extent the active postmarket risk 
                        identification and analysis system 
                        under this subsection is not sufficient 
                        to gather data and information relevant 
                        to a priority drug safety question, the 
                        Secretary shall develop, support, and 
                        participate in complementary approaches 
                        to gather and analyze such data and 
                        information, including--
                                  (I) approaches that are 
                                complementary with respect to 
                                assessing the safety of use of 
                                a drug in domestic populations 
                                not included, or 
                                underrepresented, in the trials 
                                used to approve the drug (such 
                                as older people, people with 
                                comorbidities, pregnant women, 
                                or children); and
                                  (II) existing approaches such 
                                as the Vaccine Adverse Event 
                                Reporting System and the 
                                Vaccine Safety Datalink or 
                                successor databases.
                          (v) Authority for contracts.--The 
                        Secretary may enter into contracts with 
                        public and private entities to fulfill 
                        the requirements of this subparagraph.
          (4) Advanced analysis of drug safety data.--
                  (A) Purpose.--The Secretary shall establish 
                collaborations with public, academic, and 
                private entities, which may include the Centers 
                for Education and Research on Therapeutics 
                under section 912 of the Public Health Service 
                Act, to provide for advanced analysis of drug 
                safety data described in paragraph (3)(C) and 
                other information that is publicly available or 
                is provided by the Secretary, in order to--
                          (i) improve the quality and 
                        efficiency of postmarket drug safety 
                        risk-benefit analysis;
                          (ii) provide the Secretary with 
                        routine access to outside expertise to 
                        study advanced drug safety questions; 
                        and
                          (iii) enhance the ability of the 
                        Secretary to make timely assessments 
                        based on drug safety data.
                  (B) Privacy.--Such analysis shall not 
                disclose individually identifiable health 
                information when presenting such drug safety 
                signals and trends or when responding to 
                inquiries regarding such drug safety signals 
                and trends.
                  (C) Public process for priority questions.--
                At least biannually, the Secretary shall seek 
                recommendations from the Drug Safety and Risk 
                Management Advisory Committee (or any successor 
                committee) and from other advisory committees, 
                as appropriate, to the Food and Drug 
                Administration on--
                          (i) priority drug safety questions; 
                        and
                          (ii) mechanisms for answering such 
                        questions, including through--
                                  (I) active risk 
                                identification under paragraph 
                                (3); and
                                  (II) when such risk 
                                identification is not 
                                sufficient, postapproval 
                                studies and clinical trials 
                                under subsection (o)(3).
                  (D) Procedures for the development of drug 
                safety collaborations.--
                          (i) In general.--Not later than 180 
                        days after the date of the 
                        establishment of the active postmarket 
                        risk identification and analysis system 
                        under this subsection, the Secretary 
                        shall establish and implement 
                        procedures under which the Secretary 
                        may routinely contract with one or more 
                        qualified entities to--
                                  (I) classify, analyze, or 
                                aggregate data described in 
                                paragraph (3)(C) and 
                                information that is publicly 
                                available or is provided by the 
                                Secretary;
                                  (II) allow for prompt 
                                investigation of priority drug 
                                safety questions, including--
                                          (aa) unresolved 
                                        safety questions for 
                                        drugs or classes of 
                                        drugs; and
                                          (bb) for a newly-
                                        approved drugs, safety 
                                        signals from clinical 
                                        trials used to approve 
                                        the drug and other 
                                        preapproval trials; 
                                        rare, serious drug side 
                                        effects; and the safety 
                                        of use in domestic 
                                        populations not 
                                        included, or 
                                        underrepresented, in 
                                        the trials used to 
                                        approve the drug (such 
                                        as older people, people 
                                        with comorbidities, 
                                        pregnant women, or 
                                        children);
                                  (III) perform advanced 
                                research and analysis on 
                                identified drug safety risks;
                                  (IV) focus postapproval 
                                studies and clinical trials 
                                under subsection (o)(3) more 
                                effectively on cases for which 
                                reports under paragraph (1) and 
                                other safety signal detection 
                                is not sufficient to resolve 
                                whether there is an elevated 
                                risk of a serious adverse event 
                                associated with the use of a 
                                drug; and
                                  (V) carry out other 
                                activities as the Secretary 
                                deems necessary to carry out 
                                the purposes of this paragraph.
                          (ii) Request for specific 
                        methodology.--The procedures described 
                        in clause (i) shall permit the 
                        Secretary to request that a specific 
                        methodology be used by the qualified 
                        entity. The qualified entity shall work 
                        with the Secretary to finalize the 
                        methodology to be used.
                  (E) Use of analyses.--The Secretary shall 
                provide the analyses described in this 
                paragraph, including the methods and results of 
                such analyses, about a drug to the sponsor or 
                sponsors of such drug.
                  (F) Qualified entities.--
                          (i) In general.--The Secretary shall 
                        enter into contracts with a sufficient 
                        number of qualified entities to develop 
                        and provide information to the 
                        Secretary in a timely manner.
                          (ii) Qualification.--The Secretary 
                        shall enter into a contract with an 
                        entity under clause (i) only if the 
                        Secretary determines that the entity 
                        has a significant presence in the 
                        United States and has one or more of 
                        the following qualifications:
                                  (I) The research, 
                                statistical, epidemiologic, or 
                                clinical capability and 
                                expertise to conduct and 
                                complete the activities under 
                                this paragraph, including the 
                                capability and expertise to 
                                provide the Secretary de-
                                identified data consistent with 
                                the requirements of this 
                                subsection.
                                  (II) An information 
                                technology infrastructure in 
                                place to support electronic 
                                data and operational standards 
                                to provide security for such 
                                data.
                                  (III) Experience with, and 
                                expertise on, the development 
                                of drug safety and 
                                effectiveness research using 
                                electronic population data.
                                  (IV) An understanding of drug 
                                development or risk/benefit 
                                balancing in a clinical 
                                setting.
                                  (V) Other expertise which the 
                                Secretary deems necessary to 
                                fulfill the activities under 
                                this paragraph.
                  (G) Contract requirements.--Each contract 
                with a qualified entity under subparagraph 
                (F)(i) shall contain the following 
                requirements:
                          (i) Ensuring privacy.--The qualified 
                        entity shall ensure that the entity 
                        will not use data under this subsection 
                        in a manner that--
                                  (I) violates the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996;
                                  (II) violates sections 552 or 
                                552a of title 5, United States 
                                Code, with regard to the 
                                privacy of individually-
                                identifiable beneficiary health 
                                information; or
                                  (III) discloses individually 
                                identifiable health information 
                                when presenting drug safety 
                                signals and trends or when 
                                responding to inquiries 
                                regarding drug safety signals 
                                and trends.
                        Nothing in this clause prohibits lawful 
                        disclosure for other purposes.
                          (ii) Component of another 
                        organization.--If a qualified entity is 
                        a component of another organization--
                                  (I) the qualified entity 
                                shall establish appropriate 
                                security measures to maintain 
                                the confidentiality and privacy 
                                of such data; and
                                  (II) the entity shall not 
                                make an unauthorized disclosure 
                                of such data to the other 
                                components of the organization 
                                in breach of such 
                                confidentiality and privacy 
                                requirement.
                          (iii) Termination or nonrenewal.--If 
                        a contract with a qualified entity 
                        under this subparagraph is terminated 
                        or not renewed, the following 
                        requirements shall apply:
                                  (I) Confidentiality and 
                                privacy protections.--The 
                                entity shall continue to comply 
                                with the confidentiality and 
                                privacy requirements under this 
                                paragraph with respect to all 
                                data disclosed to the entity.
                                  (II) Disposition of data.--
                                The entity shall return any 
                                data disclosed to such entity 
                                under this subsection to which 
                                it would not otherwise have 
                                access or, if returning the 
                                data is not practicable, 
                                destroy the data.
                  (H) Competitive procedures.--The Secretary 
                shall use competitive procedures (as defined in 
                section 4(5) of the Federal Procurement Policy 
                Act) to enter into contracts under subparagraph 
                (G).
                  (I) Review of contract in the event of a 
                merger or acquisition.--The Secretary shall 
                review the contract with a qualified entity 
                under this paragraph in the event of a merger 
                or acquisition of the entity in order to ensure 
                that the requirements under this paragraph will 
                continue to be met.
                  (J) Coordination.--In carrying out this 
                paragraph, the Secretary shall provide for 
                appropriate communications to the public, 
                scientific, public health, and medical 
                communities, and other key stakeholders, and to 
                the extent practicable shall coordinate with 
                the activities of private entities, 
                professional associations, or other entities 
                that may have sources of drug safety data.
          (5) The Secretary shall--
                  (A) conduct regular screenings of the Adverse 
                Event Reporting System database and post a 
                quarterly report on the Adverse Event Reporting 
                System Web site of any new safety information 
                or potential signal of a serious risk 
                identified by Adverse Event Reporting System 
                within the last quarter; and
                  (B) on an annual basis, review the entire 
                backlog of postmarket safety commitments to 
                determine which commitments require revision or 
                should be eliminated, report to the Congress on 
                these determinations, and assign start dates 
                and estimated completion dates for such 
                commitments; and
          (C) make available on the Internet website of the 
        Food and Drug Administration--
                  (i) guidelines, developed with input from 
                experts qualified by scientific training and 
                experience to evaluate the safety and 
                effectiveness of drugs, that detail best 
                practices for drug safety surveillance using 
                the Adverse Event Reporting System; and
                  (ii) criteria for public posting of adverse 
                event signals.
  (l)(1) Safety and effectiveness data and information which 
has been submitted in an application under subsection (b) for a 
drug and which has not previously been disclosed to the public 
shall be made available to the public, upon request, unless 
extraordinary circumstances are shown--
          (A) if no work is being or will be undertaken to have 
        the application approved,
          (B) if the Secretary has determined that the 
        application is not approvable and all legal appeals 
        have been exhausted,
          (C) if approval of the application under subsection 
        (c) is withdrawn and all legal appeals have been 
        exhausted,
          (D) if the Secretary has determined that such drug is 
        not a new drug, or
          (E) upon the effective date of the approval of the 
        first application under subsection (j) which refers to 
        such drug or upon the date upon which the approval of 
        an application under subsection (j) which refers to 
        such drug could be made effective if such an 
        application had been submitted.
  (2) Action Package for Approval.--
          (A) Action package.--The Secretary shall publish the 
        action package for approval of an application under 
        subsection (b) or section 351 of the Public Health 
        Service Act on the Internet Web site of the Food and 
        Drug Administration--
                  (i) not later than 30 days after the date of 
                approval of such application for a drug no 
                active ingredient (including any ester or salt 
                of the active ingredient) of which has been 
                approved in any other application under this 
                section or section 351 of the Public Health 
                Service Act; and
                  (ii) not later than 30 days after the third 
                request for such action package for approval 
                received under section 552 of title 5, United 
                States Code, for any other drug.
          (B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall 
        publish, on the Internet Web site of the Food and Drug 
        Administration, the materials described in subparagraph 
        (C)(iv) not later than 48 hours after the date of 
        approval of the drug, except where such materials 
        require redaction by the Secretary.
          (C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and 
        shall include the following:
                  (i) Documents generated by the Food and Drug 
                Administration related to review of the 
                application.
                  (ii) Documents pertaining to the format and 
                content of the application generated during 
                drug development.
                  (iii) Labeling submitted by the applicant.
                  (iv) A summary review that documents 
                conclusions from all reviewing disciplines 
                about the drug, noting any critical issues and 
                disagreements with the applicant and within the 
                review team and how they were resolved, 
                recommendations for action, and an explanation 
                of any nonconcurrence with review conclusions.
                  (v) The Division Director and Office 
                Director's decision document which includes--
                          (I) a brief statement of concurrence 
                        with the summary review;
                          (II) a separate review or addendum to 
                        the review if disagreeing with the 
                        summary review; and
                          (III) a separate review or addendum 
                        to the review to add further analysis.
                  (vi) Identification by name of each officer 
                or employee of the Food and Drug Administration 
                who--
                          (I) participated in the decision to 
                        approve the application; and
                          (II) consents to have his or her name 
                        included in the package.
          (D) Review.--A scientific review of an application is 
        considered the work of the reviewer and shall not be 
        altered by management or the reviewer once final.
          (E) Confidential information.--This paragraph does 
        not authorize the disclosure of any trade secret, 
        confidential commercial or financial information, or 
        other matter listed in section 552(b) of title 5, 
        United States Code.
  (m) For purposes of this section, the term ``patent'' means a 
patent issued by the United States Patent and Trademark Office.
  (n)(1) For the purpose of providing expert scientific advice 
and recommendations to the Secretary regarding a clinical 
investigation of a drug or the approval for marketing of a drug 
under section 505 or section 351 of the Public Health Service 
Act, the Secretary shall establish panels of experts or use 
panels of experts established before the date of enactment of 
the Food and Drug Administration Modernization Act of 1997, or 
both.
  (2) The Secretary may delegate the appointment and oversight 
authority granted under section 1004 to a director of a center 
or successor entity within the Food and Drug Administration.
  (3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall 
consist of--
          (A) members who are qualified by training and 
        experience to evaluate the safety and effectiveness of 
        the drugs to be referred to the panel and who, to the 
        extent feasible, possess skill and experience in the 
        development, manufacture, or utilization of such drugs;
          (B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, 
        pharmacology, pharmacoeconomics, biological and 
        physical sciences, and other related professions;
          (C) a representative of consumer interests, and a 
        representative of interests of the drug manufacturing 
        industry not directly affected by the matter to be 
        brought before the panel; and
          (D) two or more members who are specialists or have 
        other expertise in the particular disease or condition 
        for which the drug under review is proposed to be 
        indicated.
Scientific, trade, and consumer organizations shall be afforded 
an opportunity to nominate individuals for appointment to the 
panels. No individual who is in the regular full-time employ of 
the United States and engaged in the administration of this Act 
may be a voting member of any panel. The Secretary shall 
designate one of the members of each panel to serve as chairman 
thereof.
  (4) The Secretary shall, as appropriate, provide education 
and training to each new panel member before such member 
participates in a panel's activities, including education 
regarding requirements under this Act and related regulations 
of the Secretary, and the administrative processes and 
procedures related to panel meetings.
  (5) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation for each day so engaged, including 
traveltime, at rates to be fixed by the Secretary, but not to 
exceed the daily equivalent of the rate in effect for positions 
classified above grade GS-15 of the General Schedule. While 
serving away from their homes or regular places of business, 
panel members may be allowed travel expenses (including per 
diem in lieu of subsistence) as authorized by section 5703 of 
title 5, United States Code, for persons in the Government 
service employed intermittently.
  (6) The Secretary shall ensure that scientific advisory 
panels meet regularly and at appropriate intervals so that any 
matter to be reviewed by such a panel can be presented to the 
panel not more than 60 days after the matter is ready for such 
review. Meetings of the panel may be held using electronic 
communication to convene the meetings.
  (7) Within 90 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and 
Drug Administration official responsible for the matter shall 
review the conclusions and recommendations of the panel, and 
notify the affected persons of the final decision on the 
matter, or of the reasons that no such decision has been 
reached. Each such final decision shall be documented including 
the rationale for the decision.
  (o) Postmarket Studies and Clinical Trials; Labeling.--
          (1) In general.--A responsible person may not 
        introduce or deliver for introduction into interstate 
        commerce the new drug involved if the person is in 
        violation of a requirement established under paragraph 
        (3) or (4) with respect to the drug.
          (2) Definitions.--For purposes of this subsection:
                  (A) Responsible person.--The term 
                ``responsible person'' means a person who--
                          (i) has submitted to the Secretary a 
                        covered application that is pending; or
                          (ii) is the holder of an approved 
                        covered application.
                  (B) Covered application.--The term ``covered 
                application'' means--
                          (i) an application under subsection 
                        (b) for a drug that is subject to 
                        section 503(b); and
                          (ii) an application under section 351 
                        of the Public Health Service Act.
                  (C) New safety information; serious risk.--
                The terms ``new safety information'', ``serious 
                risk'', and ``signal of a serious risk'' have 
                the meanings given such terms in section 505-
                1(b).
          (3) Studies and clinical trials.--
                  (A) In general.--For any or all of the 
                purposes specified in subparagraph (B), the 
                Secretary may, subject to subparagraph (D), 
                require a responsible person for a drug to 
                conduct a postapproval study or studies of the 
                drug, or a postapproval clinical trial or 
                trials of the drug, on the basis of scientific 
                data deemed appropriate by the Secretary, 
                including information regarding chemically-
                related or pharmacologically-related drugs.
                  (B) Purposes of study or clinical trial.--The 
                purposes referred to in this subparagraph with 
                respect to a postapproval study or postapproval 
                clinical trial are the following:
                          (i) To assess a known serious risk 
                        related to the use of the drug 
                        involved.
                          (ii) To assess signals of serious 
                        risk related to the use of the drug.
                          (iii) To identify an unexpected 
                        serious risk when available data 
                        indicates the potential for a serious 
                        risk.
                  (C) Establishment of requirement after 
                approval of covered application.--The Secretary 
                may require a postapproval study or studies or 
                postapproval clinical trial or trials for a 
                drug for which an approved covered application 
                is in effect as of the date on which the 
                Secretary seeks to establish such requirement 
                only if the Secretary becomes aware of new 
                safety information.
                  (D) Determination by secretary.--
                          (i) Postapproval studies.--The 
                        Secretary may not require the 
                        responsible person to conduct a study 
                        under this paragraph, unless the 
                        Secretary makes a determination that 
                        the reports under subsection (k)(1) and 
                        the active postmarket risk 
                        identification and analysis system as 
                        available under subsection (k)(3) will 
                        not be sufficient to meet the purposes 
                        set forth in subparagraph (B).
                          (ii) Postapproval clinical trials.--
                        The Secretary may not require the 
                        responsible person to conduct a 
                        clinical trial under this paragraph, 
                        unless the Secretary makes a 
                        determination that a postapproval study 
                        or studies will not be sufficient to 
                        meet the purposes set forth in 
                        subparagraph (B).
                  (E) Notification; timetables; periodic 
                reports.--
                          (i) Notification.--The Secretary 
                        shall notify the responsible person 
                        regarding a requirement under this 
                        paragraph to conduct a postapproval 
                        study or clinical trial by the target 
                        dates for communication of feedback 
                        from the review team to the responsible 
                        person regarding proposed labeling and 
                        postmarketing study commitments as set 
                        forth in the letters described in 
                        section 101(c) of the Food and Drug 
                        Administration Amendments Act of 2007.
                          (ii) Timetable; periodic reports.--
                        For each study or clinical trial 
                        required to be conducted under this 
                        paragraph, the Secretary shall require 
                        that the responsible person submit a 
                        timetable for completion of the study 
                        or clinical trial. With respect to each 
                        study required to be conducted under 
                        this paragraph or otherwise undertaken 
                        by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such study 
                        including whether any difficulties in 
                        completing the study have been 
                        encountered. With respect to each 
                        clinical trial required to be conducted 
                        under this paragraph or otherwise 
                        undertaken by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such 
                        clinical trial including whether 
                        enrollment has begun, the number of 
                        participants enrolled, the expected 
                        completion date, whether any 
                        difficulties completing the clinical 
                        trial have been encountered, and 
                        registration information with respect 
                        to the requirements under section 
                        402(j) of the Public Health Service 
                        Act. If the responsible person fails to 
                        comply with such timetable or violates 
                        any other requirement of this 
                        subparagraph, the responsible person 
                        shall be considered in violation of 
                        this subsection, unless the responsible 
                        person demonstrates good cause for such 
                        noncompliance or such other violation. 
                        The Secretary shall determine what 
                        constitutes good cause under the 
                        preceding sentence.
                  (F) Dispute resolution.--The responsible 
                person may appeal a requirement to conduct a 
                study or clinical trial under this paragraph 
                using dispute resolution procedures established 
                by the Secretary in regulation and guidance.
          (4) Safety labeling changes requested by secretary.--
                  (A) New safety or new effectiveness 
                information.--If the Secretary becomes aware of 
                new information, including any new safety 
                information or information related to reduced 
                effectiveness, that the Secretary determines 
                should be included in the labeling of the drug, 
                the Secretary shall promptly notify the 
                responsible person or, if the same drug 
                approved under section 505(b) is not currently 
                marketed, the holder of an approved application 
                under 505(j).
                  (B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person or the holder of the 
                approved application under section 505(j) shall 
                within 30 days--
                          (i) submit a supplement proposing 
                        changes to the approved labeling to 
                        reflect the new safety information, 
                        including changes to boxed warnings, 
                        contraindications, warnings, 
                        precautions, or adverse reactions, or 
                        new effectiveness information; or
                          (ii) notify the Secretary that the 
                        responsible person or the holder of the 
                        approved application under section 
                        505(j) does not believe a labeling 
                        change is warranted and submit a 
                        statement detailing the reasons why 
                        such a change is not warranted.
                  (C) Review.--Upon receipt of such supplement, 
                the Secretary shall promptly review and act 
                upon such supplement. If the Secretary 
                disagrees with the proposed changes in the 
                supplement or with the statement setting forth 
                the reasons why no labeling change is 
                necessary, the Secretary shall initiate 
                discussions to reach agreement on whether the 
                labeling for the drug should be modified to 
                reflect the new safety or new effectiveness 
                information, and if so, the contents of such 
                labeling changes.
                  (D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response 
                to the notification under subparagraph (B), 
                unless the Secretary determines an extension of 
                such discussion period is warranted.
                  (E) Order.--Within 15 days of the conclusion 
                of the discussions under subparagraph (D), the 
                Secretary may issue an order directing the 
                responsible person or the holder of the 
                approved application under section 505(j) to 
                make such a labeling change as the Secretary 
                deems appropriate to address the new safety or 
                new effectiveness information. Within 15 days 
                of such an order, the responsible person or the 
                holder of the approved application under 
                section 505(j) shall submit a supplement 
                containing the labeling change.
                  (F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person or the holder of the 
                approved application under section 505(j) may 
                appeal using dispute resolution procedures 
                established by the Secretary in regulation and 
                guidance.
                  (G) Violation.--If the responsible person or 
                the holder of the approved application under 
                section 505(j) has not submitted a supplement 
                within 15 days of the date of such order under 
                subparagraph (E), and there is no appeal or 
                dispute resolution proceeding pending, the 
                responsible person or holder shall be 
                considered to be in violation of this 
                subsection. If at the conclusion of any dispute 
                resolution procedures the Secretary determines 
                that a supplement must be submitted and such a 
                supplement is not submitted within 15 days of 
                the date of that determination, the responsible 
                person or holder shall be in violation of this 
                subsection.
                  (H) Public health threat.--Notwithstanding 
                subparagraphs (A) through (F), if the Secretary 
                concludes that such a labeling change is 
                necessary to protect the public health, the 
                Secretary may accelerate the timelines in such 
                subparagraphs.
                  (I) Rule of construction.--This paragraph 
                shall not be construed to affect the 
                responsibility of the responsible person or the 
                holder of the approved application under 
                section 505(j) to maintain its label in 
                accordance with existing requirements, 
                including subpart B of part 201 and sections 
                314.70 and 601.12 of title 21, Code of Federal 
                Regulations (or any successor regulations).
          (5) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by 
        individuals at or above the level of individuals 
        empowered to approve a drug (such as division directors 
        within the Center for Drug Evaluation and Research).
  (p) Risk Evaluation and Mitigation Strategy.--
          (1) In general.--A person may not introduce or 
        deliver for introduction into interstate commerce a new 
        drug if--
                  (A)(i) the application for such drug is 
                approved under subsection (b) or (j) and is 
                subject to section 503(b); or
                  (ii) the application for such drug is 
                approved under section 351 of the Public Health 
                Service Act; and
                  (B) a risk evaluation and mitigation strategy 
                is required under section 505-1 with respect to 
                the drug and the person fails to maintain 
                compliance with the requirements of the 
                approved strategy or with other requirements 
                under section 505-1, including requirements 
                regarding assessments of approved strategies.
          (2) Certain postmarket studies.--The failure to 
        conduct a postmarket study under section 506, subpart H 
        of part 314, or subpart E of part 601 of title 21, Code 
        of Federal Regulations (or any successor regulations), 
        is deemed to be a violation of paragraph (1).
  (q) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
          (1) In general.--
                  (A) Determination.--The Secretary shall not 
                delay approval of a pending application 
                submitted under subsection (b)(2) or (j) of 
                this section or section 351(k) of the Public 
                Health Service Act because of any request to 
                take any form of action relating to the 
                application, either before or during 
                consideration of the request, unless--
                          (i) the request is in writing and is 
                        a petition submitted to the Secretary 
                        pursuant to section 10.30 or 10.35 of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulations); and
                          (ii) the Secretary determines, upon 
                        reviewing the petition, that a delay is 
                        necessary to protect the public health.
                Consideration of the petition shall be separate 
                and apart from review and approval of any 
                application.
                  (B) Notification.--If the Secretary 
                determines under subparagraph (A) that a delay 
                is necessary with respect to an application, 
                the Secretary shall provide to the applicant, 
                not later than 30 days after making such 
                determination, the following information:
                          (i) Notification of the fact that a 
                        determination under subparagraph (A) 
                        has been made.
                          (ii) If applicable, any clarification 
                        or additional data that the applicant 
                        should submit to the docket on the 
                        petition to allow the Secretary to 
                        review the petition promptly.
                          (iii) A brief summary of the specific 
                        substantive issues raised in the 
                        petition which form the basis of the 
                        determination.
                  (C) Format.--The information described in 
                subparagraph (B) shall be conveyed via either, 
                at the discretion of the Secretary--
                          (i) a document; or
                          (ii) a meeting with the applicant 
                        involved.
                  (D) Public disclosure.--Any information 
                conveyed by the Secretary under subparagraph 
                (C) shall be considered part of the application 
                and shall be subject to the disclosure 
                requirements applicable to information in such 
                application.
                  (E) Denial based on intent to delay.--If the 
                Secretary determines that a petition or a 
                supplement to the petition was submitted with 
                the primary purpose of delaying the approval of 
                an application and the petition does not on its 
                face raise valid scientific or regulatory 
                issues, the Secretary may deny the petition at 
                any point based on such determination. The 
                Secretary may issue guidance to describe the 
                factors that will be used to determine under 
                this subparagraph whether a petition is 
                submitted with the primary purpose of delaying 
                the approval of an application.
                  (F) Final agency action.--The Secretary shall 
                take final agency action on a petition not 
                later than 150 days after the date on which the 
                petition is submitted. The Secretary shall not 
                extend such period for any reason, including--
                          (i) any determination made under 
                        subparagraph (A);
                          (ii) the submission of comments 
                        relating to the petition or 
                        supplemental information supplied by 
                        the petitioner; or
                          (iii) the consent of the petitioner.
                  (G) Extension of 30-month period.--If the 
                filing of an application resulted in first-
                applicant status under subsection 
                (j)(5)(D)(i)(IV) and approval of the 
                application was delayed because of a petition, 
                the 30-month period under such subsection is 
                deemed to be extended by a period of time equal 
                to the period beginning on the date on which 
                the Secretary received the petition and ending 
                on the date of final agency action on the 
                petition (inclusive of such beginning and 
                ending dates), without regard to whether the 
                Secretary grants, in whole or in part, or 
                denies, in whole or in part, the petition.
                  (H) Certification.--The Secretary shall not 
                consider a petition for review unless the party 
                submitting such petition does so in written 
                form and the subject document is signed and 
                contains the following certification: ``I 
                certify that, to my best knowledge and belief: 
                (a) this petition includes all information and 
                views upon which the petition relies; (b) this 
                petition includes representative data and/or 
                information known to the petitioner which are 
                unfavorable to the petition; and (c) I have 
                taken reasonable steps to ensure that any 
                representative data and/or information which 
                are unfavorable to the petition were disclosed 
                to me. I further certify that the information 
                upon which I have based the action requested 
                herein first became known to the party on whose 
                behalf this petition is submitted on or about 
                the following date: __________. If I received 
                or expect to receive payments, including cash 
                and other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: 
                _____________. I verify under penalty of 
                perjury that the foregoing is true and correct 
                as of the date of the submission of this 
                petition.'', with the date on which such 
                information first became known to such party 
                and the names of such persons or organizations 
                inserted in the first and second blank space, 
                respectively.
                  (I) Verification.--The Secretary shall not 
                accept for review any supplemental information 
                or comments on a petition unless the party 
                submitting such information or comments does so 
                in written form and the subject document is 
                signed and contains the following verification: 
                ``I certify that, to my best knowledge and 
                belief: (a) I have not intentionally delayed 
                submission of this document or its contents; 
                and (b) the information upon which I have based 
                the action requested herein first became known 
                to me on or about __________. If I received or 
                expect to receive payments, including cash and 
                other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: _____. I 
                verify under penalty of perjury that the 
                foregoing is true and correct as of the date of 
                the submission of this petition.'', with the 
                date on which such information first became 
                known to the party and the names of such 
                persons or organizations inserted in the first 
                and second blank space, respectively.
          (2) Exhaustion of administrative remedies.--
                  (A) Final agency action within 150 days.--The 
                Secretary shall be considered to have taken 
                final agency action on a petition if--
                          (i) during the 150-day period 
                        referred to in paragraph (1)(F), the 
                        Secretary makes a final decision within 
                        the meaning of section 10.45(d) of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulation); or
                          (ii) such period expires without the 
                        Secretary having made such a final 
                        decision.
                  (B) Dismissal of certain civil actions.--If a 
                civil action is filed against the Secretary 
                with respect to any issue raised in the 
                petition before the Secretary has taken final 
                agency action on the petition within the 
                meaning of subparagraph (A), the court shall 
                dismiss without prejudice the action for 
                failure to exhaust administrative remedies.
                  (C) Administrative record.--For purposes of 
                judicial review related to the approval of an 
                application for which a petition under 
                paragraph (1) was submitted, the administrative 
                record regarding any issue raised by the 
                petition shall include--
                          (i) the petition filed under 
                        paragraph (1) and any supplements and 
                        comments thereto;
                          (ii) the Secretary's response to such 
                        petition, if issued; and
                          (iii) other information, as 
                        designated by the Secretary, related to 
                        the Secretary's determinations 
                        regarding the issues raised in such 
                        petition, as long as the information 
                        was considered by the agency no later 
                        than the date of final agency action as 
                        defined under subparagraph (2)(A), and 
                        regardless of whether the Secretary 
                        responded to the petition at or before 
                        the approval of the application at 
                        issue in the petition.
          (3) Annual report on delays in approvals per 
        petitions.--The Secretary shall annually submit to the 
        Congress a report that specifies--
                  (A) the number of applications that were 
                approved during the preceding 12-month period;
                  (B) the number of such applications whose 
                effective dates were delayed by petitions 
                referred to in paragraph (1) during such 
                period;
                  (C) the number of days by which such 
                applications were so delayed; and
                  (D) the number of such petitions that were 
                submitted during such period.
          (4) Exceptions.--
                  (A) This subsection does not apply to--
                          (i) a petition that relates solely to 
                        the timing of the approval of an 
                        application pursuant to subsection 
                        (j)(5)(B)(iv); or
                          (ii) a petition that is made by the 
                        sponsor of an application and that 
                        seeks only to have the Secretary take 
                        or refrain from taking any form of 
                        action with respect to that 
                        application.
                  (B) Paragraph (2) does not apply to a 
                petition addressing issues concerning an 
                application submitted pursuant to section 
                351(k) of the Public Health Service Act.
          (5) Definitions.--
                  (A) Application.--For purposes of this 
                subsection, the term ``application'' means an 
                application submitted under subsection (b)(2) 
                or (j) of this section or section 351(k) of the 
                Public Health Service Act.
                  (B) Petition.--For purposes of this 
                subsection, other than paragraph (1)(A)(i), the 
                term ``petition'' means a request described in 
                paragraph (1)(A)(i).
  (r) Postmarket Drug Safety Information for Patients and 
Providers.--
          (1) Establishment.--Not later than 1 year after the 
        date of the enactment of the Food and Drug 
        Administration Amendments Act of 2007, the Secretary 
        shall improve the transparency of information about 
        drugs and allow patients and health care providers 
        better access to information about drugs by developing 
        and maintaining an Internet Web site that--
                  (A) provides links to drug safety information 
                listed in paragraph (2) for prescription drugs 
                that are approved under this section or 
                licensed under section 351 of the Public Health 
                Service Act; and
                  (B) improves communication of drug safety 
                information to patients and providers.
          (2) Internet web site.--The Secretary shall carry out 
        paragraph (1) by--
                  (A) developing and maintaining an accessible, 
                consolidated Internet Web site with easily 
                searchable drug safety information, including 
                the information found on United States 
                Government Internet Web sites, such as the 
                United States National Library of Medicine's 
                Daily Med and Medline Plus Web sites, in 
                addition to other such Web sites maintained by 
                the Secretary;
                  (B) ensuring that the information provided on 
                the Internet Web site is comprehensive and 
                includes, when available and appropriate--
                          (i) patient labeling and patient 
                        packaging inserts;
                          (ii) a link to a list of each drug, 
                        whether approved under this section or 
                        licensed under such section 351, for 
                        which a Medication Guide, as provided 
                        for under part 208 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations), is required;
                          (iii) a link to the registry and 
                        results data bank provided for under 
                        subsections (i) and (j) of section 402 
                        of the Public Health Service Act;
                          (iv) the most recent safety 
                        information and alerts issued by the 
                        Food and Drug Administration for drugs 
                        approved by the Secretary under this 
                        section, such as product recalls, 
                        warning letters, and import alerts;
                          (v) publicly available information 
                        about implemented RiskMAPs and risk 
                        evaluation and mitigation strategies 
                        under subsection (o);
                          (vi) guidance documents and 
                        regulations related to drug safety; and
                          (vii) other material determined 
                        appropriate by the Secretary;
                  (C) providing access to summaries of the 
                assessed and aggregated data collected from the 
                active surveillance infrastructure under 
                subsection (k)(3) to provide information of 
                known and serious side-effects for drugs 
                approved under this section or licensed under 
                such section 351;
                  (D) preparing and making publicly available 
                on the Internet website established under 
                paragraph (1) best practices for drug safety 
                surveillance activities for drugs approved 
                under this section or section 351 of the Public 
                Health Service Act;
                  (E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports 
                through the Internet Web site;
                  (F) providing educational materials for 
                patients and providers about the appropriate 
                means of disposing of expired, damaged, or 
                unusable medications; and
                  (G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes 
                of the Internet Web site.
          (3) Posting of drug labeling.--The Secretary shall 
        post on the Internet Web site established under 
        paragraph (1) the approved professional labeling and 
        any required patient labeling of a drug approved under 
        this section or licensed under such section 351 not 
        later than 21 days after the date the drug is approved 
        or licensed, including in a supplemental application 
        with respect to a labeling change.
          (4) Private sector resources.--To ensure development 
        of the Internet Web site by the date described in 
        paragraph (1), the Secretary may, on a temporary or 
        permanent basis, implement systems or products 
        developed by private entities.
          (5) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to 
        fulfill the requirements of this subsection.
          (6) Review.--The Advisory Committee on Risk 
        Communication under section 567 shall, on a regular 
        basis, perform a comprehensive review and evaluation of 
        the types of risk communication information provided on 
        the Internet Web site established under paragraph (1) 
        and, through other means, shall identify, clarify, and 
        define the purposes and types of information available 
        to facilitate the efficient flow of information to 
        patients and providers, and shall recommend ways for 
        the Food and Drug Administration to work with outside 
        entities to help facilitate the dispensing of risk 
        communication information to patients and providers.
  (s) Referral to Advisory Committee.--Prior to the approval of 
a drug no active ingredient (including any ester or salt of the 
active ingredient) of which has been approved in any other 
application under this section or section 351 of the Public 
Health Service Act, the Secretary shall--
          (1) refer such drug to a Food and Drug Administration 
        advisory committee for review at a meeting of such 
        advisory committee; or
          (2) if the Secretary does not refer such a drug to a 
        Food and Drug Administration advisory committee prior 
        to the approval of the drug, provide in the action 
        letter on the application for the drug a summary of the 
        reasons why the Secretary did not refer the drug to an 
        advisory committee prior to approval.
  (t) Database for Authorized Generic Drugs.--
          (1) In general.--
                  (A) Publication.--The Commissioner shall--
                          (i) not later than 9 months after the 
                        date of the enactment of the Food and 
                        Drug Administration Amendments Act of 
                        2007, publish a complete list on the 
                        Internet Web site of the Food and Drug 
                        Administration of all authorized 
                        generic drugs (including drug trade 
                        name, brand company manufacturer, and 
                        the date the authorized generic drug 
                        entered the market); and
                          (ii) update the list quarterly to 
                        include each authorized generic drug 
                        included in an annual report submitted 
                        to the Secretary by the sponsor of a 
                        listed drug during the preceding 3-
                        month period.
                  (B) Notification.--The Commissioner shall 
                notify relevant Federal agencies, including the 
                Centers for Medicare & Medicaid Services and 
                the Federal Trade Commission, when the 
                Commissioner first publishes the information 
                described in subparagraph (A) that the 
                information has been published and that the 
                information will be updated quarterly.
          (2) Inclusion.--The Commissioner shall include in the 
        list described in paragraph (1) each authorized generic 
        drug included in an annual report submitted to the 
        Secretary by the sponsor of a listed drug after January 
        1, 1999.
          (3) Authorized generic drug.--In this section, the 
        term ``authorized generic drug'' means a listed drug 
        (as that term is used in subsection (j)) that--
                  (A) has been approved under subsection (c); 
                and
                  (B) is marketed, sold, or distributed 
                directly or indirectly to retail class of trade 
                under a different labeling, packaging (other 
                than repackaging as the listed drug in blister 
                packs, unit doses, or similar packaging for use 
                in institutions), product code, labeler code, 
                trade name, or trade mark than the listed drug.
  (u) Certain Drugs Containing Single Enantiomers.--
          (1) In general.--For purposes of subsections 
        (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
        submitted under subsection (b) for a non-racemic drug 
        containing as an active ingredient (including any ester 
        or salt of the active ingredient) a single enantiomer 
        that is contained in a racemic drug approved in another 
        application under subsection (b), the applicant may, in 
        the application for such non-racemic drug, elect to 
        have the single enantiomer not be considered the same 
        active ingredient as that contained in the approved 
        racemic drug, if--
                  (A)(i) the single enantiomer has not been 
                previously approved except in the approved 
                racemic drug; and
                  (ii) the application submitted under 
                subsection (b) for such non-racemic drug--
                          (I) includes full reports of new 
                        clinical investigations (other than 
                        bioavailability studies)--
                                  (aa) necessary for the 
                                approval of the application 
                                under subsections (c) and (d); 
                                and
                                  (bb) conducted or sponsored 
                                by the applicant; and
                          (II) does not rely on any clinical 
                        investigations that are part of an 
                        application submitted under subsection 
                        (b) for approval of the approved 
                        racemic drug; and
                  (B) the application submitted under 
                subsection (b) for such non-racemic drug is not 
                submitted for approval of a condition of use--
                          (i) in a therapeutic category in 
                        which the approved racemic drug has 
                        been approved; or
                          (ii) for which any other enantiomer 
                        of the racemic drug has been approved.
          (2) Limitation.--
                  (A) No approval in certain therapeutic 
                categories.--Until the date that is 10 years 
                after the date of approval of a non-racemic 
                drug described in paragraph (1) and with 
                respect to which the applicant has made the 
                election provided for by such paragraph, the 
                Secretary shall not approve such non-racemic 
                drug for any condition of use in the 
                therapeutic category in which the racemic drug 
                has been approved.
                  (B) Labeling.--If applicable, the labeling of 
                a non-racemic drug described in paragraph (1) 
                and with respect to which the applicant has 
                made the election provided for by such 
                paragraph shall include a statement that the 
                non-racemic drug is not approved, and has not 
                been shown to be safe and effective, for any 
                condition of use of the racemic drug.
          (3) Definition.--
                  (A) In general.--For purposes of this 
                subsection, the term ``therapeutic category'' 
                means a therapeutic category identified in the 
                list developed by the United States 
                Pharmacopeia pursuant to section 1860D-
                4(b)(3)(C)(ii) of the Social Security Act and 
                as in effect on the date of the enactment of 
                this subsection.
                  (B) Publication by secretary.--The Secretary 
                shall publish the list described in 
                subparagraph (A) and may amend such list by 
                regulation.
          (4) Availability.--The election referred to in 
        paragraph (1) may be made only in an application that 
        is submitted to the Secretary after the date of the 
        enactment of this subsection and before October 1, 
        2022.
  (v) Antibiotic Drugs Submitted Before November 21, 1997.--
          (1) Antibiotic drugs approved before november 21, 
        1997.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) shall be eligible for, with 
                respect to the drug, the 3-year exclusivity 
                period referred to under clauses (iii) and (iv) 
                of subsection (c)(3)(E) and under clauses (iii) 
                and (iv) of subsection (j)(5)(F), subject to 
                the requirements of such clauses, as 
                applicable.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        an application approved by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997).
          (2) Antibiotic drugs submitted before november 21, 
        1997, but not approved.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) may elect to be eligible 
                for, with respect to the drug--
                          (i)(I) the 3-year exclusivity period 
                        referred to under clauses (iii) and 
                        (iv) of subsection (c)(3)(E) and under 
                        clauses (iii) and (iv) of subsection 
                        (j)(5)(F), subject to the requirements 
                        of such clauses, as applicable; and
                          (II) the 5-year exclusivity period 
                        referred to under clause (ii) of 
                        subsection (c)(3)(E) and under clause 
                        (ii) of subsection (j)(5)(F), subject 
                        to the requirements of such clauses, as 
                        applicable; or
                          (ii) a patent term extension under 
                        section 156 of title 35, United States 
                        Code, subject to the requirements of 
                        such section.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        1 or more applications received by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997), none of which was approved by 
                        the Secretary under such section.
          (3) Limitations.--
                  (A) Exclusivities and extensions.--Paragraphs 
                (1)(A) and (2)(A) shall not be construed to 
                entitle a drug that is the subject of an 
                approved application described in subparagraphs 
                (1)(B)(i) or (2)(B)(i), as applicable, to any 
                market exclusivities or patent extensions other 
                than those exclusivities or extensions 
                described in paragraph (1)(A) or (2)(A).
                  (B) Conditions of use.--Paragraphs (1)(A) and 
                (2)(A)(i) shall not apply to any condition of 
                use for which the drug referred to in 
                subparagraph (1)(B)(i) or (2)(B)(i), as 
                applicable, was approved before the date of the 
                enactment of this subsection.
          (4) Application of certain provisions.--
        Notwithstanding section 125, or any other provision, of 
        the Food and Drug Administration Modernization Act of 
        1997, or any other provision of law, and subject to the 
        limitations in paragraphs (1), (2), and (3), the 
        provisions of the Drug Price Competition and Patent 
        Term Restoration Act of 1984 shall apply to any drug 
        subject to paragraph (1) or any drug with respect to 
        which an election is made under paragraph (2)(A).
  (w) Deadline for Determination on Certain Petitions.--The 
Secretary shall issue a final, substantive determination on a 
petition submitted pursuant to subsection (b) of section 
314.161 of title 21, Code of Federal Regulations (or any 
successor regulations), no later than 270 days after the date 
the petition is submitted.
  (x) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the 
        Secretary provides notice to the sponsor that the 
        Secretary intends to issue a scientific and medical 
        evaluation and recommend controls under the Controlled 
        Substances Act, approval of such application shall not 
        take effect until the interim final rule controlling 
        the drug is issued in accordance with section 201(j) of 
        the Controlled Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), the term ``date of approval'' shall mean the later 
        of--
                  (A) the date an application under subsection 
                (b) is approved under subsection (c); or
                  (B) the date of issuance of the interim final 
                rule controlling the drug.
  (y) Contrast Agents Intended for Use With Applicable Medical 
Imaging Devices.--
          (1) In general.--The sponsor of a contrast agent for 
        which an application has been approved under this 
        section may submit a supplement to the application 
        seeking approval for a new use following the 
        authorization of a premarket submission for an 
        applicable medical imaging device for that use with the 
        contrast agent pursuant to section 520(p)(1).
          (2) Review of supplement.--In reviewing a supplement 
        submitted under this subsection, the agency center 
        charged with the premarket review of drugs may--
                  (A) consult with the center charged with the 
                premarket review of devices; and
                  (B) review information and data submitted to 
                the Secretary by the sponsor of an applicable 
                medical imaging device pursuant to section 515, 
                510(k), or 513(f)(2) so long as the sponsor of 
                such applicable medical imaging device has 
                provided to the sponsor of the contrast agent a 
                right of reference.
          (3) Definitions.--For purposes of this subsection--
                  (A) the term ``new use'' means a use of a 
                contrast agent that is described in the 
                approved labeling of an applicable medical 
                imaging device described in section 520(p), but 
                that is not described in the approved labeling 
                of the contrast agent; and
                  (B) the terms ``applicable medical imaging 
                device'' and ``contrast agent'' have the 
                meanings given such terms in section 520(p).

           *       *       *       *       *       *       *


                            Additional Views

    During the Committee's consideration of this bill, concerns 
arose about the bill's approach and possible unintended 
consequences of enacting it as drafted. This legislation 
accordingly warranted further deliberation by this Committee 
before any additional legislative action.
                                   Guy Reschenthaler,
                                           Member.

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