[Congressional Record Volume 162, Number 174 (Monday, December 5, 2016)]
[Senate]
[Pages S6714-S6716]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 5136. Mr. LEAHY (for himself, Mr. Grassley, Ms. Klobuchar, and Mr.
Lee) submitted an amendment intended to be proposed by him to the bill
H.R. 34, to authorize and strengthen the tsunami detection, forecast,
warning, research, and mitigation program of the National Oceanic and
Atmospheric Administration, and for other purposes; which was ordered
to lie on the table; as follows:
At the end of title III of division A, add the following:
Subtitle K--CREATES Act
SEC. 3201. SHORT TITLE.
This subtitle may be cited as the ``Creating and Restoring
Equal Access to Equivalent Samples Act of 2016'' or the
``CREATES Act of 2016''.
SEC. 3202. FINDINGS.
Congress finds the following:
(1) It is the policy of the United States to promote
competition in the market for drugs and biological products
by facilitating the timely entry of low-cost generic and
biosimilar versions of those drugs and biological products.
(2) Since their enactment in 1984 and 2010, respectively,
the Drug Price Competition and Patent Term Restoration Act of
1984 (Public Law 98-417; 98 Stat. 1585) and the Biologics
Price Competition and Innovation Act of 2009 (Subtitle A of
title VII of Public Law 111-148; 124 Stat. 804), have
provided pathways for making lower-cost versions of
previously approved drugs and previously licensed biological
products available to the people of the United States in a
timely manner, thereby lowering overall prescription drug
costs for patients and taxpayers by billions of dollars each
year.
(3) In order for these pathways to function as intended,
developers of generic drugs and biosimilar biological
products (referred to in this section as ``generic product
developers'') must be able to obtain quantities of the
reference listed drug or biological product with which the
generic drug or biosimilar biological product is intended to
compete (referred to in this section as a ``covered
product'') for purposes of supporting an application for
approval by the Food and Drug Administration, including for
testing to show that--
(A) a prospective generic drug is bioequivalent to the
covered product in accordance with subsection (j) of section
505 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C.
355), or meets the requirements for approval of an
application submitted under subsection (b)(2) of that
section; or
(B) a prospective biosimilar biological product is
biosimilar to or interchangeable with its reference
biological product under section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)), as applicable.
(4) For drugs and biological products that are subject to a
risk evaluation and mitigation strategy, another essential
component in the creation of low-cost generic and biosimilar
versions of covered products is the ability of generic
product developers to join the manufacturer of the covered
product (referred to in this section as the ``license
holder'') in a single, shared system of elements to assure
safe use and supporting agreements, or secure a variance
therefrom, as required by section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1).
(5) Contrary to the policy of the United States to promote
competition in the market for drugs and biological products
by facilitating the timely entry of lower-cost generic and
biosimilar versions of those drugs and biological products,
certain license holders are preventing generic product
developers from obtaining quantities of the covered product
necessary for the generic product developer to support an
application for approval by the Food and Drug Administration,
including testing to show bioequivalence, biosimilarity, or
interchangeability to the covered product, in some instances
based on the justification that the covered product is
subject to a risk evaluation and mitigation strategy with
elements to assure safe use under section 505-1 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1).
(6) The Director of the Center for Drug Evaluation and
Research at the Food and Drug Administration has testified
that some manufacturers of covered products have used REMS
and distribution restrictions adopted by the manufacturer on
their own behalf as reasons to not sell quantities of a
covered product to generic product developers, causing
barriers and delays in getting generic products on the
market. The Food and Drug
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Administration has reported receiving significant numbers of
inquiries from generic product developers who were unable to
obtain samples of covered products to conduct necessary
testing and otherwise meet requirements for approval of
generic drugs.
(7) The Chairwoman of the Federal Trade Commission has
testified that the Federal Trade Commission continues to be
very concerned about potential abuses by manufacturers of
brand drugs of REMS or other closed distribution systems to
impede generic competition.
(8) Also contrary to the policy of the United States to
promote competition in the market for drugs and biological
products by facilitating the timely entry of lower-cost
generic and biosimilar versions of those drugs and biological
products, certain license holders are impeding the prompt
negotiation and development on commercially reasonable terms
of a single, shared system of elements to assure safe use,
which may be necessary for the generic product developer to
gain approval for its drug or licensing for its biological
product.
(9) While the antitrust laws may address the refusal by
some license holders to provide quantities of a covered
product to a generic product developer, a more tailored legal
pathway would help ensure that generic product developers can
obtain necessary quantities of a covered product in a timely
way for purposes of developing a generic drug or biosimilar
biological product, facilitating competition in the
marketplace for drugs and biological products.
(10) The antitrust laws may address actions by license
holders who impede the prompt negotiation and development of
a single, shared system of elements to assure safe use, and
the Food and Drug Administration has some authority to waive
the requirement of a single, shared system. Clearer
regulatory authority to approve different systems that meet
the statutory requirements to ensure patient safety, however,
would limit the effectiveness of bad faith negotiations over
single, shared systems to delay generic approval. At the same
time, clearer regulatory authority would ensure all systems
protect patient safety.
SEC. 3203. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR
BIOLOGICAL PRODUCTS.
(a) Definitions.--In this section--
(1) the term ``covered product''--
(A) means--
(i) any drug approved under subsection (b) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or biological product licensed under subsection
(a) or (k) of section 351 of the Public Health Service Act
(42 U.S.C. 262);
(ii) any combination of a drug or biological product
described in clause (i); or
(iii) when reasonably necessary to demonstrate sameness,
biosimilarity, or interchangeability for purposes of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), or section 351 of the Public Health Service Act (42
U.S.C. 262), as applicable, any product, including any
device, that is marketed or intended for use with such drug
or biological product; and
(B) does not include any drug or biological product that
the Secretary has determined to be currently in shortage and
that appears on the drug shortage list in effect under
section 506E of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356e), unless the shortage will not be promptly
resolved--
(i) as demonstrated by the fact that the drug or biological
product has been in shortage for more than 6 months; or
(ii) as otherwise determined by the Secretary;
(2) the term ``device'' has the meaning given the term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321);
(3) the term ``eligible product developer'' means a person
that seeks to develop a product for approval pursuant to an
application for approval under subsection (b)(2) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or for licensing pursuant to an application under
section 351(k) of the Public Health Service Act (42 U.S.C.
262(k));
(4) the term ``license holder'' means the holder of an
application approved under subsection (c) or (j) of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) or the holder of a license under subsection (a) or (k)
of section 351 of the Public Health Service Act (42 U.S.C.
262) for a covered product;
(5) the term ``REMS'' means a risk evaluation and
mitigation strategy under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1);
(6) the term ``REMS with ETASU'' means a REMS that contains
elements to assure safe use under section 505-1 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1);
(7) the term ``Secretary'' means the Secretary of Health
and Human Services;
(8) the term ``single, shared system of elements to assure
safe use'' means a single, shared system of elements to
assure safe use under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1); and
(9) the term ``sufficient quantities'' means an amount of a
covered product that allows the eligible product developer
to--
(A) conduct testing to support an application--
(i) for approval under subsection (b)(2) or (j) of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355); or
(ii) for licensing under section 351(k) of the Public
Health Service Act (42 U.S.C. 262(k)); and
(B) fulfill any regulatory requirements relating to such an
application for approval or licensing.
(b) Civil Action for Failure to Provide Sufficient
Quantities of a Covered Product.--
(1) In general.--An eligible product developer may bring a
civil action against the license holder for a covered product
seeking relief under this subsection in an appropriate
district court of the United States alleging that the license
holder has declined to provide sufficient quantities of the
covered product to the eligible product developer on
commercially reasonable, market-based terms.
(2) Elements.--
(A) In general.--To prevail in a civil action brought under
paragraph (1), an eligible product developer shall prove, by
a preponderance of the evidence--
(i) that--
(I) the covered product is not subject to a REMS with
ETASU; or
(II) if the covered product is subject to a REMS with
ETASU--
(aa) the eligible product developer has obtained a covered
product authorization from the Secretary in accordance with
subparagraph (B); and
(bb) the eligible product developer has provided a copy of
the covered product authorization to the license holder;
(ii) that, as of the date on which the civil action is
filed, the product developer has not obtained sufficient
quantities of the covered product on commercially reasonable,
market-based terms;
(iii) that the eligible product developer has requested to
purchase sufficient quantities of the covered product from
the license holder; and
(iv) that the license holder has not delivered to the
eligible product developer sufficient quantities of the
covered product on commercially reasonable, market-based
terms--
(I) for a covered product that is not subject to a REMS
with ETASU, by the date that is 31 days after the date on
which the license holder received the request for the covered
product; and
(II) for a covered product that is subject to a REMS with
ETASU, by 31 days after the later of--
(aa) the date on which the license holder received the
request for the covered product; or
(bb) the date on which the license holder received a copy
of the covered product authorization issued by the Secretary
in accordance with subparagraph (B).
(B) Authorization for covered product subject to a rems
with etasu.--
(i) Request.--An eligible product developer may submit to
the Secretary a written request for the eligible product
developer to be authorized to obtain sufficient quantities of
an individual covered product subject to a REMS with ETASU.
(ii) Authorization.--Not later than 90 days after the date
on which a request under clause (i) is received, the
Secretary shall, by written notice, authorize the eligible
product developer to obtain sufficient quantities of an
individual covered product subject to a REMS with ETASU for
purposes of--
(I) development and testing that does not involve human
clinical trials, if the eligible product developer has agreed
to comply with any conditions the Secretary determines
necessary; or
(II) development and testing that involves human clinical
trials, if the eligible product developer has--
(aa)(AA) submitted protocols, informed consent documents,
and informational materials for testing that include
protections that provide safety protections comparable to
those provided by the REMS for the covered product; or
(BB) otherwise satisfied the Secretary that such
protections will be provided; and
(bb) met any other requirements the Secretary may
establish.
(iii) Notice.--A covered product authorization issued under
this subparagraph shall state that the provision of the
covered product by the license holder under the terms of the
authorization will not be a violation of the REMS for the
covered product.
(3) Affirmative defense.--In a civil action brought under
paragraph (1), it shall be an affirmative defense, on which
the defendant has the burden of persuasion by a preponderance
of the evidence--
(A) that, on the date on which the eligible product
developer requested to purchase sufficient quantities of the
covered product from the license holder--
(i) neither the license holder nor any of its agents,
wholesalers, or distributors was engaged in the manufacturing
or commercial marketing of the covered product; and
(ii) neither the license holder nor any of its agents,
wholesalers, or distributors otherwise had access to
inventory of the covered product to supply to the eligible
product developer on commercially reasonable, market-based
terms; or
(B) that--
(i) the license holder sells the covered product through
agents, distributors, or wholesalers;
(ii) the license holder has placed no restrictions,
explicit or implicit, on its agents, distributors, or
wholesalers to sell covered products to eligible product
developers; and
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(iii) the covered product can be purchased by the eligible
product developer in sufficient quantities on commercially
reasonable, market-based terms from the agents, distributors,
or wholesalers of the license holder.
(4) Remedies.--
(A) In general.--If an eligible product developer prevails
in a civil action brought under paragraph (1), the court
shall--
(i) order the license holder to provide to the eligible
product developer without delay sufficient quantities of the
covered product on commercially reasonable, market-based
terms;
(ii) award to the eligible product developer reasonable
attorney fees and costs of the civil action; and
(iii) award to the eligible product developer a monetary
amount sufficient to deter the license holder from failing to
provide other eligible product developers with sufficient
quantities of a covered product on commercially reasonable,
market-based terms, if the court finds, by a preponderance of
the evidence--
(I) that the license holder delayed providing sufficient
quantities of the covered product to the eligible product
developer without a legitimate business justification; or
(II) that the license holder failed to comply with an order
issued under clause (i).
(B) Maximum monetary amount.--A monetary amount awarded
under subparagraph (A)(iii) shall not be greater than the
revenue that the license holder earned on the covered product
during the period--
(i) beginning on--
(I) for a covered product that is not subject to a REMS
with ETASU, the date that is 31 days after the date on which
the license holder received the request; or
(II) for a covered product that is subject to a REMS with
ETASU, the date that is 31 days after the later of--
(aa) the date on which the license holder received the
request; or
(bb) the date on which the license holder received a copy
of the covered product authorization issued by the Secretary
in accordance with paragraph (2)(B); and
(ii) ending on the date on which the eligible product
developer received sufficient quantities of the covered
product.
(C) Avoidance of delay.--The court may issue an order under
subparagraph (A)(i) before conducting further proceedings
that may be necessary to determine whether the eligible
product developer is entitled to an award under clause (ii)
or (iii) of subparagraph (A), or the amount of any such
award.
(c) Limitation of Liability.--A license holder for a
covered product shall not be liable for any claim arising out
of the failure of an eligible product developer to follow
adequate safeguards to assure safe use of the covered product
during development or testing activities described in this
section, including transportation, handling, use, or disposal
of the covered product by the eligible product developer.
(d) Rule of Construction.--
(1) Definition.--In this subsection, the term ``antitrust
laws''--
(A) has the meaning given the term in subsection (a) of the
first section of the Clayton Act (15 U.S.C. 12); and
(B) includes section 5 of the Federal Trade Commission Act
(15 U.S.C. 45) to the extent that such section applies to
unfair methods of competition.
(2) Antitrust laws.--Nothing in this section shall be
construed to limit the operation of any provision of the
antitrust laws.
SEC. 3204. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.
Section 505-1 of the Federal Food Drug and Cosmetic Act (21
U.S.C. 355-1) is amended--
(1) in subsection (g)(4)(B)--
(A) in clause (i) by striking ``or'' after the semicolon;
(B) in clause (ii) by striking the period at the end and
inserting ``; or''; and
(C) by adding at the end the following:
``(iii) accommodate different approved risk evaluation and
mitigation strategies for a reference drug product and a drug
that is the subject of an abbreviated new drug
application.''; and
(2) in subsection (i)(1), by striking subparagraph (B) and
inserting the following:
``(B) Elements to assure safe use, if required under
subsection (f) for the listed drug.
``(i) Subject to clause (ii), a drug that is the subject of
an abbreviated new drug application may use--
``(I) a single, shared system with the listed drug under
subsection (f); or
``(II) a different, comparable aspect of the elements to
assure safe use under subsection (f).
``(ii) The Secretary may require a drug that is the subject
of an abbreviated new drug application and the listed drug to
use a single, shared system under subsection (f), if the
Secretary determines that no different, comparable aspect of
the elements to assure safe use could satisfy the
requirements of subsection (f).''.
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