[Congressional Record Volume 165, Number 76 (Wednesday, May 8, 2019)]
[House]
[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.
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