Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS).
Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development.
Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug.
Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially.
Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health.
Eliminates license holder liability for claims arising from a product developer's testing of an approved drug.
Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act.
Allows the Secretary to waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the developer of the drug is unable to finalize terms for a shared system with the license holder of the approved drug.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5657 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 5657
To amend the Federal Food, Drug, and Cosmetic Act to ensure that
eligible product developers have competitive access to approved drugs
and licensed biological products, so as to enable eligible product
developers to develop and test new products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 18, 2014
Mr. Stivers (for himself and Mr. Welch) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to ensure that
eligible product developers have competitive access to approved drugs
and licensed biological products, so as to enable eligible product
developers to develop and test new products, and for other purposes.
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 ``Fair Access for Safe and Timely
Generics Act of 2014'' or the ``FAST Generics Act of 2014''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Reference product license or approval holders are
restricting competitive access to reference products by
sponsors seeking to develop drugs, generic drugs, and
biosimilars under section 505(b) or 505(j) of the Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)(2) and 355(j)) and under
section 351 of the Public Health Service Act (42 U.S.C. 262).
These restrictions are deterring and delaying development of
generic drugs and biosimilars by extending lawful patent-based
monopolies beyond their lawful patent life.
(2) The enforcement provisions set forth in section 505-
1(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355-1(f)(8)) have not been sufficient to prevent anti-
competitive practices that interfere with access to reference
products which is necessary for the timely development of
affordable generic drugs and biosimilars.
(3) The opinion in Verizon Communications Inc. v. Law
Offices of Curtis V. Trinko, LLP, 540 U.S. 398 (2004) should
not be construed to impair or bar the application of the
antitrust laws consistent with the provisions of this Act.
(4) There is not a regulatory structure in place that is
sufficient to deter or remedy the anti-competitive harm that
results when access to reference brand products is restricted
to sponsors developing drugs, generic drugs, and biosimilars in
accordance with section 505(b) or 505(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)(2) and 355(j)), and
section 351 of the Public Health Service Act (42 U.S.C. 262),
respectively.
(5) Requiring license holders to comply with requirements
for competitive access to their products, and subjecting
license holders to antitrust liability for failing to do so,
will not impose obligations on the courts that they cannot
adequately and reasonably adjudicate.
SEC. 3. COMPETITIVE ACCESS TO COVERED PRODUCTS FOR DEVELOPMENT
PURPOSES.
(a) In General.--Chapter V of the Food Drug and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 505-1 of such
Act (21 U.S.C. 355-1) the following new section:
``SEC. 505-2. COMPETITIVE ACCESS TO COVERED PRODUCTS FOR DEVELOPMENT
PURPOSES.
``(a) Definitions.--In this section:
``(1) Covered product.--The term `covered product' means
any drug approved under section 505 or any biological product
that is licensed under section 351 of the Public Health Service
Act, including--
``(A) any combination thereof; and
``(B) when reasonably necessary to demonstrate
sameness, biosimilarity, or interchangeability for
purposes of this section, section 505, or section 351
of the Public Health Service Act (as applicable), any
product, including any device, that is marketed or
intended for use with such drug or biological product.
``(2) Eligible product developer.--The term `eligible
product developer' means a person that seeks to develop an
application for the approval of a drug under section 505(b) or
505(j) or the licensing of a biological product under section
351 of the Public Health Service Act.
``(3) License holder.--The term `license holder' means the
holder of an application approved under section 505(b) or
section 505(j) or a license under section 351 of the Public
Health Service Act for a covered product (including the
holder's agents, wholesalers, distributors, assigns, and
corporate affiliates).
``(4) REMS product.--The term `REMS product' means a
covered product that--
``(A) is subject to a risk evaluation and
mitigation strategy under section 505-1; or
``(B) is deemed under section 909(b) of the Food
and Drug Administration Amendments Act of 2007 to have
in effect an approved risk evaluation and mitigation
strategy under section 505-1.
``(b) Competitive Access to Covered Products as a Condition on
Approval or Licensing.--As a condition of approval or licensure, or
continuation or renewal of approval or licensure, of a covered product
under section 505 of this Act or section 351 of the Public Health
Service Act, respectively, the Secretary shall require that the covered
product's license holder not adopt, impose, or enforce any condition
relating to the sale, resale, or distribution of the covered product,
including any condition adopted, imposed, or enforced as an aspect of a
risk evaluation and mitigation strategy approved by the Secretary, that
restricts or has the effect of restricting the supply of such covered
product to an eligible product developer for development or testing
purposes.
``(c) Competitive Access to Covered Products Other Than REMS
Products for Development Purposes.--No license holder shall adopt,
impose, or enforce any condition relating to the sale, resale, or
distribution of a covered product that interferes with or restricts
access to reasonable quantities of a covered product by an eligible
product developer for development and testing purposes, at commercially
reasonable, market-based prices, from the license holder or from any
wholesaler or specialty distributor authorized by the license holder to
commercially distribute or sell the covered product unless the license
holder generally adopts, imposes, or enforces lawful conditions
relating to the sale, resale, or distribution of a covered product,
with respect to other buyers of the covered product.
``(d) Competitive Access to REMS Products for Development
Purposes.--
``(1) Prohibited use of rems to restrict access.--With
respect to a REMS product, no aspect of a risk evaluation and
mitigation strategy under section 505-1 shall prohibit or
restrict, or be construed or applied to prohibit or restrict,
the supply of such REMS product to an eligible product
developer for development and testing purposes, at commercially
reasonable, market-based prices, from the REMS product's
license holder or from any wholesaler or specialty distributor
authorized by the license holder to commercially distribute or
sell the REMS product.
``(2) Single, shared system of elements to assure safe
use.--With respect to a REMS product, no license holder shall
take any step that impedes--
``(A) the prompt development of a single, shared
system of elements to assure safe use under section
505-1; or
``(B) the entry on commercially reasonable terms of
an eligible product developer into a previously
approved system of elements to assure safe use.
``(e) Procedures for Obtaining Access to Covered Products.--
``(1) Competitive access.--Notwithstanding any other
provision of law, in the case of an eligible product developer
that has an authorization to obtain a covered product in effect
under paragraph (2) or (3), no license holder shall adopt,
impose, or enforce any other condition relating to the sale,
resale, or distribution of such covered product that interferes
with or restricts access to reasonable quantities of the
covered product by the eligible product developer for
development and testing purposes, at commercially reasonable,
market-based prices, from the license holder or from any
wholesaler or specialty distributor authorized by the license
holder to commercially distribute or sell the covered product,
unless the license holder generally adopts, imposes, or
enforces lawful conditions relating to the sale, resale, or
distribution of a covered product, with respect to other buyers
of the covered product.
``(2) General covered products authorization.--Any eligible
product developer may seek a general covered products
authorization, authorizing the eligible product developer to
obtain any covered product for the purposes of development and
testing, by making a written request to the Secretary. Within
60 days after receiving such a request, the Secretary shall, by
written notice, issue such authorization if--
``(A) the eligible product developer holds one or
more approved applications or licenses for a covered
product or, in the absence of such approvals or
licensures, otherwise establishes that the eligible
product developer can comply with the requirements of
this Act and other applicable law for the development
and testing of covered products; and
``(B) the Secretary does not find that the eligible
product developer has materially failed to comply with
the requirements of this Act or other applicable law
for the development and testing of covered products.
``(3) Individual covered product authorization.--Any
eligible product developer may seek an authorization to obtain
an individual covered product for development and testing
purposes by making a written request to the Secretary. Within
60 days of receiving such a request, the Secretary shall, by
written notice, issue such authorization for purposes of--
``(A) 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
``(B) testing that involves human clinical trials
if the eligible product developer has submitted a
protocol for testing that includes protections that
will provide an assurance of safety comparable to the
assurance of safety provided by any distribution
restrictions governing the approval or licensure of the
covered product or the license holder's distribution of
the covered product.
``(4) Failure by secretary to take final action.--If the
60-day period referred to in paragraph (2) or (3) expires
without the Secretary having taken final action on the request
for authorization, the Secretary shall be deemed to have
issued, by written notice, the requested authorization.
``(5)(A) Process for obtaining product pursuant to an
authorization.--If an eligible product developer is unable, for
purposes of development and testing, to obtain reasonable
quantities of a covered product commercially, either from the
license holder or from any wholesaler or specialty distributor
authorized by the license holder to commercially distribute or
sell the covered product, any eligible product developer that
has obtained authorization to do so, in accordance with
paragraph (2) or (3), shall be entitled to obtain such
reasonable quantities of such covered product at the same
commercially reasonable, market based price on which such
reasonable quantities of such covered product have been
previously sold by the license holder to third parties in the
open market. Such eligible product developer shall initiate its
acquisition of such covered product by providing a written
request for specific quantities of such covered product
either--
``(i) to any wholesaler or specialty distributor
authorized by the license holder to commercially
distribute or sell the covered product; or
``(ii) in the event no such wholesaler or specialty
distributor has been designated for such purpose by the
license holder, to the Secretary.
``(B) Request contents.--Such request shall include a
statement regarding the quantity of covered product sought for
development or testing purposes, and state that either--
``(i) the eligible product developer has, or is
deemed to have, a general covered products
authorization under paragraph (2); or
``(ii) the eligible product developer has, or is
deemed to have, an authorization under paragraph (3) to
obtain the specific covered product.
``(C) Disclosure of information by wholesalers and
specialty distributors.--In the event that a request is made to
a wholesaler or specialty distributor under this paragraph, the
wholesaler or specialty distributor shall not disclose to the
license holder of the covered product involved the identity of
the eligible product developer, but may disclose to such
license holder, only if required to do so by the holder--
``(i) the fact that a request has been made;
``(ii) the dates on which the request was made and
fulfilled;
``(iii) the commercial terms on which the request
was fulfilled; and
``(iv) the quantity of the covered product
furnished by the wholesaler or specialty distributor in
compliance with the request.
``(D) Disclosure pursuant to means specified by
secretary.--In the event that a request is made to the
Secretary under this subsection, then the Secretary shall,
within 5 business days of receipt of the request, notify the
license holder that a request for such covered product has been
made, and the quantity of the covered product requested, and
such license holder shall, within 30 days after receiving
notice from the Secretary, provide the quantity of the
requested covered product, through means specified by the
Secretary, at a non-discriminatory, commercially reasonable,
market-based price for which such covered product has been
previously sold by the license holder (or any wholesaler or
specialty distributor authorized by the license holder to
commercially distribute or sell the covered product) to third
parties in the open market. The means established by the
Secretary under this clause shall not disclose to the license
holder the identity of the eligible product developer that has
requested quantities of the covered product for development and
testing purposes.
``(E) Imminent hazard.--At any time, the Secretary may
prohibit, limit, or otherwise suspend a transfer of a covered
product to an eligible product developer if the Secretary
determines that the transfer of such product to the eligible
product developer would present an imminent hazard to the
public health. In such cases, the Secretary shall specify the
basis for the determination, including the specific information
available to the Secretary which served as the basis for such
determination, and confirm such determination in writing.
``(f) Public and Private Enforcement.--
``(1) Application of certain provisions.--For purposes of
this Act and the Public Health Service Act, a violation of a
requirement or prohibition in subsection (b), (c), (d)(1),
(d)(2), or (e)(1) shall be treated in the case of a REMS
product, as a violation of the product's risk evaluation and
mitigation strategy.
``(2) Remedies.--An eligible product developer that has
authorization for access to a covered product from the
Secretary under subsection (e) and that is aggrieved by a
violation of subsection (b), (c), (d)(1), (d)(2), or (e)(1) by
a license holder or any wholesaler or specialty distributor
authorized by the license holder to commercially distribute or
sell the covered product may sue such license holder for
injunctive relief and treble damages (including costs and
interest of the kind described in section 4(a) of the Clayton
Act (15 U.S.C. 15(a))).
``(g) Limitation of Liability.--The holder of an approved
application or license for a covered product shall not be liable for
any claim arising out of an eligible product developer's development or
testing activities conducted under this section, including a claim
arising out of a failure of the eligible drug developer to follow
adequate safeguards to assure safe use of the covered product.
``(h) Reports.--
``(1) Report by fda.--Not later than 180 days after the
enactment of the Fair Access for Safe and Timely Generics Act
of 2014, and annually thereafter, the Secretary, acting through
the Commissioner of Food and Drugs, shall submit to Congress a
report that--
``(A) identifies each instance of noncompliance by
any license holder with a requirement or prohibition in
subsection (b), (c), (d)(1), (d)(2), or (e)(1); and
``(B) describes the actions taken by the Secretary
to remedy such noncompliance and to enforce such
requirements and prohibitions, whether by assessment of
a penalty or otherwise.
``(2) Report by ftc.--Not later than 270 days after the
enactment of the Fair Access for Safe and Timely Generics Act
of 2014, and annually thereafter, the Federal Trade Commission
shall submit to Congress a report that--
``(A) describes the complaints received by the
Commission pertaining to the withholding of competitive
access to covered products, the actions taken by the
Commission with respect to each such complaint, and the
result of each such Commission action; and
``(B) examines the impact on the market entry of
competing drug products, and the pricing and
availability of such products, in the United States
resulting from noncompliance by license holders with a
requirement or prohibition in subsection (b), (c),
(d)(1), (d)(2), or (e)(1).''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(ddd) Any violation by the license holder of a covered product
(as such terms are defined in section 505-2(a) (including its
contractors, assigns, or corporate affiliates)) of a requirement or
prohibition in subsection (b), (c), (d)(1), (d)(2), or (e)(1) of
section 505-2 (relative to competitive access to covered products for
development purposes).''.
(c) Waiver of Single, Shared System Requirement.--Section 505-
1(i)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
1(i)(1)(B)) is amended--
(1) in clause (i), by striking ``or'' at the end;
(2) in clause (ii), by striking the period at the end and
inserting ``; or''; and
(3) by adding at the end the following:
``(iii) the applicant for an abbreviated
new drug application certifies that it
attempted in good faith to create or negotiate
entry into a single, shared system, but was
unable to finalize commercially reasonable
terms with the holder of the listed drug within
120 days, and such certification includes a
description of the efforts made by the
applicant for the abbreviated new drug
application to create or negotiate entry into a
single, shared system.''.
(d) Effective Date.--This section and the amendments made by this
section shall take effect upon enactment, and shall apply to all
approved applications or licenses for a covered product (as defined in
section 505-2(a) of the Federal Food, Drug, and Cosmetic Act, as added
by this section) regardless of whether those applications or licenses
were approved before, on, or after the date of enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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