SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Reference product license or approval hold-
ers are restricting competitive access to reference 
products by sponsors seeking to develop drugs, ge-
neric 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 devel-
opment of generic drugs and biosimilars by extend-
ing lawful patent-based monopolies beyond their law-
ful patent life. 
(2) The enforcement provisions set forth in sec-
tion 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 con-
sistent with the provisions of this Act. 
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(4) There is not a regulatory structure in place 
that is sufficient to deter or remedy the anti-com-
petitive 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 Serv-
ice Act (42 U.S.C. 262), respectively. 
(5) Requiring license holders to comply with re-
quirements 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 reason-
ably 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 in-
serting after section 505–1 of such Act (21 U.S.C. 355– 
1) the following new section: 
‘‘SEC. 505–2. COMPETITIVE ACCESS TO COVERED PROD-
UCTS FOR DEVELOPMENT PURPOSES. 
‘‘(a) DEFINITIONS.—In this section: 
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‘‘(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, includ-
ing— 
‘‘(A) any combination thereof; and 
‘‘(B) when reasonably necessary to dem-
onstrate sameness, biosimilarity, or inter-
changeability for purposes of this section, sec-
tion 505, or section 351 of the Public Health 
Service Act (as applicable), any product, includ-
ing 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 licens-
ing 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, 
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wholesalers, distributors, assigns, and corporate af-
filiates). 
‘‘(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 sec-
tion 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 re-
newal 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 dis-
tribution of the covered product, including any condition 
adopted, imposed, or enforced as an aspect of a risk eval-
uation 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. 
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‘‘(c) COMPETITIVE ACCESS TO COVERED PRODUCTS 
OTHER THAN REMS PRODUCTS
FOR DEVELOPMENT 
PURPOSES.—No license holder shall adopt, impose, or en-
force any condition relating to the sale, resale, or distribu-
tion 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 distribu-
tion 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 as-
pect 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 sup-
ply of such REMS product to an eligible product de-
veloper for development and testing purposes, at 
commercially reasonable, market-based prices, from 
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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 as-
sure safe use. 
‘‘(e) PROCEDURES FOR OBTAINING ACCESS TO COV-
ERED PRODUCTS.— 
‘‘(1) COMPETITIVE
ACCESS.—Notwithstanding 
any other provision of law, in the case of an eligible 
product developer that has an authorization to ob-
tain a covered product in effect under paragraph (2) 
or (3), no license holder shall adopt, impose, or en-
force any other condition relating to the sale, resale, 
or distribution of such covered product that inter-
feres with or restricts access to reasonable quantities 
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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 dis-
tributor in compliance with the request. 
‘‘(D) DISCLOSURE PURSUANT TO MEANS SPECI-
FIED 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 re-
quest for such covered product has been made, and 
the quantity of the covered product requested, and 
such license holder shall, within 30 days after receiv-
ing notice from the Secretary, provide the quantity 
of the requested covered product, through means 
specified by the Secretary, at a non-discriminatory, 
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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 com-
mercially distribute or sell the covered product) to 
third parties in the open market. The means estab-
lished by the Secretary under this clause shall not 
disclose to the license holder the identity of the eligi-
ble 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 trans-
fer 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 in-
formation 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 
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Service Act, a violation of a requirement or prohibi-
tion 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 miti-
gation strategy. 
‘‘(2) REMEDIES.—An eligible product developer 
that has authorization for access to a covered prod-
uct 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 in-
junctive 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 prod-
uct developer’s development or testing activities conducted 
under this section, including a claim arising out of a fail-
ure of the eligible drug developer to follow adequate safe-
guards to assure safe use of the covered product. 
‘‘(h) REPORTS.— 
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‘‘(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 Com-
missioner of Food and Drugs, shall submit to Con-
gress a report that— 
‘‘(A) identifies each instance of noncompli-
ance 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 other-
wise. 
‘‘(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 sub-
mit 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 
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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 pric-
ing and availability of such products, in the 
United States resulting from noncompliance by 
license holders with a requirement or prohibi-
tion 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 amend-
ed by adding at the end the following: 
‘‘(ddd) Any violation by the license holder of a cov-
ered product (as such terms are defined in section 505– 
2(a) (including its contractors, assigns, or corporate affili-
ates)) 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 REQUIRE-
MENT.—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; 
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(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 at-
tempted in good faith to create or nego-
tiate 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 cer-
tification includes a description of the ef-
forts made by the applicant for the abbre-
viated new drug application to create or 
negotiate entry into a single, shared sys-
tem.’’. 
(d) EFFECTIVE DATE.—This section and the amend-
ments made by this section shall take effect upon enact-
ment, and shall apply to all approved applications or li-
censes 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 applica-
tions or licenses were approved before, on, or after the 
date of enactment of this Act. 
Æ 
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