SEC. 2. FINDINGS. 
The 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)(2) 
or 505(j) of the Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(2) and 355(j)) and under section 
351(k) of the Public Health Service Act (42 U.S.C. 
262(k)). These restrictions are deterring and delay-
ing development of drugs, generic drugs, and 
biosimilars by extending lawful patent-based monop-
olies beyond their lawful 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 
drugs, generic drugs, and biosimilars. 
(3) There is not a regulatory structure in place 
that is sufficient to deter or remedy the anti-com-
petitive harm that results when— 
(A) access to reference products is re-
stricted to sponsors developing drugs, generic 
drugs, or biosimilars in accordance with section 
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505(b)(2) or 505(j) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(2) or 
355(j)), and section 351(k) of the Public 
Health Service Act (42 U.S.C. 262(k)), respec-
tively; or 
(B) license holders impede the prompt ne-
gotiation and development of a single, shared 
system of elements to assure safe use and sup-
porting 
agreements 
under 
section 
505– 
1(i)(1)(B) of such Act (21 U.S.C. 355– 
1(i)(1)(B)), on commercially reasonable terms. 
(4) Requiring license holders to comply with re-
quirements for competitive access to their products, 
and for the negotiation and development of single, 
shared systems of elements to assure safe use under 
section 505–1(i)(1)(B) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355–1(i)(1)(B)), and 
subjecting license holders to 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 Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
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ed 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 PROD-
UCTS FOR DEVELOPMENT PURPOSES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) COVERED PRODUCT.—The term ‘covered 
product’— 
‘‘(A) means— 
‘‘(i) any drug approved under section 
505 or biological product licensed under 
section 351 of the Public Health Service 
Act; 
‘‘(ii) any combination thereof; or 
‘‘(iii) when reasonably necessary to 
demonstrate sameness, biosimilarity, or 
interchangeability for purposes of this sec-
tion, 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; and 
‘‘(B) excludes any drug or biological prod-
uct which the Secretary has determined to be 
currently in shortage and that appears on the 
drug shortage list in effect under section 506E, 
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unless the shortage will not be promptly re-
solved— 
‘‘(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) ELIGIBLE
PRODUCT
DEVELOPER.—The 
term ‘eligible product developer’ means a person that 
seeks to develop a product for approval pursuant to 
an application under section 505(b)(2) or 505(j) or 
for licensing pursuant to an application under sec-
tion 351(k) 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) of this Act or 
under section 351 of the Public Health Service Act 
for a covered product (including the holder’s agents, 
wholesalers, distributors, assigns, corporate affili-
ates, and contractors). 
‘‘(4) REMS.—The term ‘REMS’ means a risk 
evaluation and mitigation strategy under section 
505–1. 
‘‘(5) REMS 
PRODUCT.—The term ‘REMS 
product’ means a covered product that— 
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‘‘(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. 
‘‘(6) REMS IMPACTING
PRODUCT
DISTRIBU-
TION.—The term ‘REMS impacting product dis-
tribution’ means a REMS that contains elements to 
assure safe use that impact the distribution of the 
product subject to the REMS. 
‘‘(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 construe or apply 
any condition or restriction relating to the sale, resale, or 
distribution of the covered product, including any condi-
tion or restriction adopted, imposed, or enforced as an as-
pect of a risk evaluation and mitigation strategy, in a way 
that restricts or has the effect of restricting the supply 
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of such covered product to an eligible product developer 
for development or testing purposes. 
‘‘(c) COMPETITIVE ACCESS FOR DEVELOPMENT PUR-
POSES TO PRODUCTS WITH REMS IMPACTING PRODUCT 
DISTRIBUTION.—With respect to a product subject to a 
REMS impacting product distribution, no aspect of such 
a REMS shall be construed or applied by the REMS prod-
uct’s license holder in a way that prohibits or restricts the 
supply, at commercially reasonable, market-based prices, 
of such REMS product from the REMS product’s license 
holder to an eligible product developer with an applicable 
individual covered product authorization obtained pursu-
ant to subsection (e) for development and testing pur-
poses. 
‘‘(d) SINGLE, SHARED SYSTEM OF ELEMENTS TO 
ASSURE SAFE USE.—Where an eligible product developer 
seeks approval of an application under 505(j) referencing 
a REMS product whose REMS includes elements to as-
sure safe use— 
‘‘(1) no license holder shall take any step that 
impedes— 
‘‘(A) the prompt development on commer-
cially reasonable terms of a single, shared sys-
tem of elements to assure safe use under sec-
tion 505–1; or 
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‘‘(B) the prompt entry on commercially 
reasonable terms of an eligible product devel-
oper into a previously approved system of ele-
ments to assure safe use; and 
‘‘(2) license holders shall negotiate in good faith 
towards the prompt development of (or entry into) 
a single, shared system of elements to assure safe 
use under section 505–1(i) on commercially reason-
able terms. 
‘‘(e) PROCEDURES FOR OBTAINING ACCESS TO COV-
ERED PRODUCTS.— 
‘‘(1) COMPETITIVE ACCESS TO PRODUCTS NOT 
SUBJECT TO REMS IMPACTING PRODUCT DISTRIBU-
TION.—Notwithstanding any other provision of law, 
a license holder that receives a request from an eligi-
ble product developer or its agent for sufficient sup-
plies of a covered product (that is not subject to a 
REMS impacting product distribution) to conduct 
testing necessary to support an application under 
section 505(b)(2) or 505(j) or under section 351(k) 
of the Public Health Service Act (or otherwise meet 
the requirements for approval of such an applica-
tion) shall provide to the eligible product developer 
or its agent the quantity requested within 30 days 
of receipt of the request at a nondiscriminatory, 
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commercially reasonable, market-based price for 
which such covered product has been previously sold 
by the license holder to third parties in the open 
market. 
‘‘(2) COMPETITIVE ACCESS TO PRODUCTS SUB-
JECT TO REMS IMPACTING PRODUCT DISTRIBUTION: 
INDIVIDUAL COVERED PRODUCT AUTHORIZATION.— 
Any eligible product developer may seek an author-
ization to obtain an individual covered product sub-
ject to a REMS impacting product distribution for 
development and testing purposes by making a writ-
ten request to the Secretary. Within 120 days of re-
ceiving such a request, the Secretary shall, by writ-
ten 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 nec-
essary; or 
‘‘(B) development and testing that involves 
human clinical trials if the eligible product de-
veloper has— 
‘‘(i) submitted a protocol for testing 
that includes protections that will provide 
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an assurance of safety comparable to the 
assurance of safety provided by any dis-
tribution restrictions governing the ap-
proval or licensure of the covered product; 
or 
‘‘(ii) otherwise satisfied the Secretary 
that such protections will be provided. 
‘‘(3)(A) PROCESS
FOR
OBTAINING
PRODUCT 
PURSUANT TO AN AUTHORIZATION.— 
‘‘(i) An eligible product developer shall be 
entitled to obtain, from the license holder of a 
covered product subject to a REMS impacting 
distribution, sufficient quantities of the covered 
product for purposes of development and test-
ing necessary to support an application under 
section 505(b)(2) or 505(j) or under section 
351(k) of the Public Health Service Act, or oth-
erwise meet the requirements for approval of 
such application, if the eligible product devel-
oper has obtained an applicable authorization 
under paragraph (2). 
‘‘(ii) Each license holder shall publicly des-
ignate at least one wholesaler or specialty dis-
tributor to receive and fulfill requests for cov-
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ered products submitted pursuant to paragraph 
(1) or clause (i) of this paragraph. 
‘‘(iii) An eligible product developer shall 
initiate its acquisition of a covered product 
under clause (i) by providing or having its 
agent provide a written request for specific 
quantities of such covered product to the license 
holder. 
‘‘(B) REQUEST CONTENTS AND RESPONSE.—A 
request under subparagraph (A)(iii) shall include a 
statement regarding the quantity of covered product 
sought for development or testing purposes, and 
state that the eligible product developer has an au-
thorization under paragraph (2) to obtain the spe-
cific covered product. Within 30 days of receiving 
such a request, the wholesaler or specialty dis-
tributor shall provide the requested quantity of the 
covered product at a nondiscriminatory, commer-
cially reasonable, market-based price for which such 
covered product has been previously sold by the li-
cense holder to third parties in the open market. 
‘‘(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 
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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— 
‘‘(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) 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) ENFORCEMENT.— 
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