ORANGE BOOK TRANSPARENCY ACT OF 2019; Congressional Record Vol. 165, No. 76
(House of Representatives - May 08, 2019)

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[Pages H3486-H3488]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  ORANGE BOOK TRANSPARENCY ACT OF 2019

  Ms. ESHOO. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 1503) to amend the Federal Food, Drug, and Cosmetic Act regarding 
the list under section 505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1503

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Orange Book Transparency Act 
     of 2019''.

     SEC. 2. ORANGE BOOK.

       (a) Submission of Patent Information for Brand Name 
     Drugs.--Paragraph (1) of section 505(b) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended to read 
     as follows:
       ``(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 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;
       ``(G) any assessments required under section 505B; and
       ``(H) patent information, with respect to each patent for 
     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, and consistent with 
     the following requirements:
       ``(i) The applicant shall file with the application the 
     patent number and the expiration date of--
       ``(I) any patent which claims the drug for which the 
     applicant submitted the application and is a drug substance 
     (including active ingredient) patent or a drug product 
     (including formulation and composition) patent; and

[[Page H3487]]

       ``(II) any patent which claims the method of using such 
     drug.
       ``(ii) If an application is filed under this subsection for 
     a drug and a patent of the type described in clause (i) 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 such 
     patent information.

     Upon approval of the application, the Secretary shall publish 
     the information submitted under subparagraph (H). 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 subparagraph (A).''.
       (b) Conforming Changes to Requirements for Subsequent 
     Submission of Patent Information.--Section 505(c)(2) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is 
     amended--
       (1) by inserting after ``the patent number and the 
     expiration date of any patent which'' the following: 
     ``fulfills the criteria in subsection (b) and'';
       (2) by inserting after the first sentence the following: 
     ``Patent information that is not the type of patent 
     information required by subsection (b) shall not be 
     submitted.''; and
       (3) by inserting after ``could not file patent information 
     under subsection (b) because no patent'' the following: ``of 
     the type required to be submitted in subsection (b)''.
       (c) Listing of Exclusivities.--Subparagraph (A) of section 
     505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355(j)(7)) is amended by adding at the end the 
     following:
       ``(iv) For each drug included on the list, the Secretary 
     shall specify each exclusivity period that is applicable and 
     has not concluded under--
       ``(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) 
     of this section;
       ``(II) clause (iv) or (v) of paragraph (5)(B) of this 
     subsection;
       ``(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of 
     this subsection;
       ``(IV) section 505A;
       ``(V) section 505E; or
       ``(VI) section 527(a).''.
       (d) Removal of Invalid Patents.--
       (1) In general.--Section 505(j)(7) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by 
     adding at the end the following:
       ``(D)(i) The holder of an application approved under 
     subsection (c) for a drug on the list shall notify within 14 
     days the Secretary in writing if either of the following 
     occurs:
       ``(I) The Patent Trial and Appeals Board issues a decision 
     from which no appeal has been or can be taken that a patent 
     for such drug is invalid.
       ``(II) A court issues a decision from which no appeal has 
     been or can be taken that a patent for such drug is invalid.
       ``(ii) The holder of an approved application shall include 
     in any notification under clause (i) a copy of the decision 
     described in subclause (I) or (II) of clause (i).
       ``(iii) The Secretary shall remove from the list any patent 
     that is determined to be invalid in a decision described in 
     subclause (I) or (II) of clause (i)--
       ``(I) promptly; but
       ``(II) not before the expiration of any 180-day exclusivity 
     period under paragraph (5)(B)(iv) that relies on a 
     certification described in paragraph (2)(A)(vii)(IV) that 
     such patent was invalid.''.
       (2) Applicability.--Subparagraph (D) of section 505(j)(7) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(j)(7)), as added by paragraph (1), applies only with 
     respect to a decision described in such subparagraph that is 
     issued on or after the date of enactment of this Act.
       (e) Review and Report.--Not later than one year after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services, acting through the Commissioner of Food and 
     Drugs, shall--
       (1) solicit public comment regarding the types of patent 
     information that should be included on the list under section 
     507(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355(j)(7)); and
       (2) transmit to the Congress an evaluation of such 
     comments, including any recommendations about the types of 
     patent information that should be included on or removed from 
     such list.

     SEC. 3. GAO REPORT TO CONGRESS.

       (a) In General.--Not later than one year after the date of 
     enactment of this Act, the Comptroller General of the United 
     States (referred to in this section as the ``Comptroller 
     General'') shall submit to the Committee on Energy and 
     Commerce of the House of Representatives a report on the 
     patents included in the list published under section 
     505(j)(7) of the Federal Food, Drug and Cosmetic Act (21 
     U.S.C. 355(j)(7)), including an analysis and evaluation of 
     the types of patents included in such list and the claims 
     such patents make about the products they claim.
       (b) Contents.--The Comptroller General shall include in the 
     report under subsection (a)--
       (1) data on the number of--
       (A) patents included in the list published under paragraph 
     (7) of section 505(j) of the Federal Food, Drug and Cosmetic 
     Act (21 U.S.C. 355(j)), that claim the active ingredient or 
     formulation of a drug in combination with a device that is 
     used for delivery of the drug, together comprising the 
     finished dosage form of the drug; and
       (B) claims in each patent that claim a device that is used 
     for the delivery of the drug, but do not claim such device in 
     combination with an active ingredient or formulation of a 
     drug;
       (2) data on the date of inclusion in the list under 
     paragraph (7) of such section 505(j) for all patents under 
     such list, as compared to patents that claim a method of 
     using the drug in combination with a device;
       (3) an analysis regarding the impact of including on the 
     list under paragraph (7) of such section 505(j) certain types 
     of patent information for drug product applicants and 
     approved application holders, including an analysis of 
     whether--
       (A) the listing of the patents described in paragraph 
     (1)(A) delayed the market entry of one or more drugs approved 
     under such section 505(j); and
       (B) not listing the patents described in paragraph (1)(A) 
     would delay the market entry of one or more such drugs; and
       (4) recommendations about which kinds of patents relating 
     to devices described in paragraph (1)(A) should be submitted 
     to the Secretary of Health and Human Services for inclusion 
     on the list under paragraph (7) of such section 505(j) and 
     which patents should not be required to be so submitted.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
California (Ms. Eshoo) and the gentleman from Texas (Mr. Burgess) each 
will control 20 minutes.
  The Chair recognizes the gentlewoman from California.


                             General Leave

  Ms. ESHOO. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
include extraneous material on H.R. 1503.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from California?
  There was no objection.
  Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 1503. This is a different 
color book. It is the Orange Book Transparency Act of 2019, sponsored 
by the gentlewoman from Illinois, Congresswoman Robin Kelly. Her 
bipartisan legislation makes important updates to the Food and Drug 
Administration's Orange Book to ensure that this resource is accurate 
and up-to-date to promote the development of generic drugs that save so 
many Americans so much money.
  When it passed in 1984, the Drug Price Competition and Patent Term 
Restoration Act, also referred to as Hatch-Waxman, created the Orange 
Book as a resource for drug manufacturers to reference when deciding 
when and how to seek approval for new drug products. The so-called 
``Orange Book'' contains valuable information, is regularly referenced 
by manufacturers, and is published in a user-friendly way on FDA's 
website.
  But this resource has not been updated since it was created in 1994. 
That is a long time ago. It is over 3 decades ago. And the Orange Book 
Transparency Act of 2019 makes important updates to the resource to 
adapt to the changes in drug development since Hatch-Waxman became law.
  Generic drug manufacturers rely heavily on the Orange Book, and it is 
imperative that this resource is accurate and up-to-date so drug 
manufacturers can invest in products that promote competition and lower 
drug prices for the American people.
  The Orange Book Transparency Act of 2019 passed the Energy and 
Commerce Committee by voice vote last month, and I was proud to support 
it. I urge my colleagues to support the Orange Book Transparency Act of 
2019 today.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today in support of H.R. 1503, the Orange Book 
Transparency Act of 2019. This is a bipartisan product that moved 
through the Energy and Commerce Committee, and I would like to thank 
Representative Robin Kelly for introducing this legislation.
  The publication of the Approved Drug Products with Therapeutic 
Equivalence Evaluations, known as the Orange Book, lists drug products 
that have been approved by the Food and Drug Administration on the 
basis of safety and effectiveness. Importantly, the Orange Book lists 
therapeutic equivalence evaluations for approved multisource 
prescription drug products in addition to relevant patent and 
exclusivity information.
  This publication provides information to State health agencies, 
prescribers, and to others to inform decisionmaking, and allow for the 
containment of healthcare costs, as well as educate the public.

[[Page H3488]]

  


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  A preliminary version of the Orange Book was produced in 1979. It was 
not until 1984, with the enactment of the Drug Price Competition and 
Patent Term Restoration Act of 1984, more commonly known as the Hatch-
Waxman Act, that Congress codified the Orange Book.
  This bill amends existing statute to make the Orange Book more 
useful, particularly for manufacturers of generic drugs. Enactment of 
this bill will allow these manufacturers to know which branded products 
face competition and when those products will no longer be protected by 
patents. Insurance companies, doctors, and patients will be able to 
determine when a generic alternative is available for a more expensive 
branded product.
  The Food and Drug Administration is already performing the practices 
contained in this bill, but the legislation would codify current 
practices and ensure that certain patents are listed in the Orange 
Book. Additionally, patents that are found invalid would have to be 
removed following the conclusion of any appeals process.
  Mr. Speaker, I reserve the balance of my time.
  Ms. ESHOO. Mr. Speaker, I yield 4 minutes to the gentlewoman from 
Illinois (Ms. Kelly), the author of H.R. 1503 and a wonderful member of 
the Health Subcommittee.
  Ms. KELLY of Illinois. Mr. Speaker, I am pleased today to speak on my 
bill, H.R. 1503, the Orange Book Transparency Act, and the critical 
issue of transparency in the drug and medical device development space.
  Should my colleagues vote in favor of this significant bill, the 
Orange Book Transparency Act will more efficiently achieve lowered 
costs and higher quality life-saving medicines for consumers. It will 
enhance market competition by getting generic drugs to market more 
rapidly. As much data show us, enhancing the market for generic drugs 
is one of the quickest ways to lower the costs that consumers pay at 
the pharmacy.
  Two things matter to me with respect to healthcare costs. One, we 
must be proactive in enhancing transparency with regard to the 
information made available to generic drug developers. Most 
importantly, we must improve efficiency in the market for prescription 
drugs in order to ultimately lower costs to patients, their families, 
and their caregivers.
  The Orange Book Transparency Act addresses both of these points by 
ensuring clarity in patent and exclusivity information maintained by 
FDA. It also requires that the Government Accountability Office study 
the effects of listing drug delivery patents in the Orange Book.
  To be very clear, I support intellectual property protections for 
those researching and developing innovative treatments, but we have the 
responsibility to close loopholes that allow drugmakers to prevent 
timely access to information that would lead to new generic drug 
development, increasing patient access and affordability.
  Today, I present a strong and straightforward piece of legislation in 
order to get lower-cost drugs to Americans in my district and across 
the country. I am ecstatic that this bill is not only straightforward 
but also bipartisan.
  Mr. Speaker, I thank my colleague from Kentucky, Mr. Guthrie, for his 
work on this bill and key stakeholders for their feedback throughout 
the process.
  The Orange Book Transparency Act moves us in the right direction 
toward transparency and lower drug costs.
  Mr. Speaker, I urge all my colleagues to vote in support of H.R. 1503 
today.
  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Kentucky (Mr. Guthrie), the Republican ranking member of the Oversight 
and Investigations Subcommittee of the Energy and Commerce Committee.
  Mr. GUTHRIE. Mr. Speaker, I rise today in support of H.R. 1503, the 
Orange Book Transparency Act of 2019.
  The Food and Drug Administration's list of approved brand name 
therapeutic drug products, known as the Orange Book, plays an important 
role in drug development. H.R. 1503 will ensure the Orange Book 
continues to be effective and accurate by requiring drug companies to 
provide up-to-date information on patents that are relevant to each 
individual drug. It also directs the Government Accountability Office 
to study the impact of the patents being listed in the Orange Book.
  Mr. Speaker, I thank Congresswoman Kelly from Illinois for her 
commitment to maintaining the value of the Orange Book to drug 
manufacturers, payers, providers, and patients. I appreciate her 
willingness to work together in a bipartisan manner, and I urge my 
colleagues to support H.R. 1503.
  Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.
  H.R. 1503 would support the work that the Food and Drug 
Administration is already conducting and facilitate competition in the 
marketplace. Therefore, I urge my fellow Members to support this 
important legislation.
  Mr. Speaker, I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, I urge all Members of the House to support 
this bipartisan legislation that is going to move us closer to our 
overall goal of lowering the cost of prescription drugs for the 
American people.
  Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentlewoman from California (Ms. Eshoo) that the House suspend the 
rules and pass the bill, H.R. 1503, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Ms. ESHOO. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

                          ____________________