I 

116TH CONGRESS 

1ST SESSION H. R. 985 

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 

FEBRUARY 5, 2019 

Mr. WELCH (for himself, Mr. MCKINLEY, and Mr. CICILLINE) 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Fair Access for Safe 

5 and Timely Generics Act of 2019’’ or the ‘‘FAST Generics 

6 Act of 2019’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

3 (1) Reference product license or approval hold4 ers are restricting competitive access to reference 

5 products by sponsors seeking to develop drugs, ge6 neric drugs, and biosimilars under section 505(b)(2) 

7 or 505(j) of the Food, Drug, and Cosmetic Act (21 

8 U.S.C. 355(b)(2) and 355(j)) and under section 

9 351(k) of the Public Health Service Act (42 U.S.C. 

10 262(k)). These restrictions are deterring and delay11 ing development of drugs, generic drugs, and 

12 biosimilars by extending lawful patent-based monop13 olies beyond their lawful patent life. 

14 (2) The enforcement provisions set forth in sec15 tion 505–1(f)(8) of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 355–1(f)(8)) have not been 

17 sufficient to prevent anti-competitive practices that 

18 interfere with access to reference products which is 

19 necessary for the timely development of affordable 

20 drugs, generic drugs, and biosimilars. 

21 (3) There is not a regulatory structure in place 

22 that is sufficient to deter or remedy the anti-com23 petitive harm that results when— 

24 (A) access to reference products is re25 stricted to sponsors developing drugs, generic 

26 drugs, or biosimilars in accordance with section 


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1 505(b)(2) or 505(j) of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 355(b)(2) or 

3 355(j)), and section 351(k) of the Public 

4 Health Service Act (42 U.S.C. 262(k)), respec5 tively; or 

6 (B) license holders impede the prompt ne7 gotiation and development of a single, shared 

8 system of elements to assure safe use and sup9 porting agreements under section 505– 

10 1(i)(1)(B) of such Act (21 U.S.C. 355– 

11 1(i)(1)(B)), on commercially reasonable terms. 

12 (4) Requiring license holders to comply with re13 quirements for competitive access to their products, 

14 and for the negotiation and development of single, 

15 shared systems of elements to assure safe use under 

16 section 505–1(i)(1)(B) of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 355–1(i)(1)(B)), and 

18 subjecting license holders to liability for failing to do 

19 so, will not impose obligations on the courts that 

20 they cannot adequately and reasonably adjudicate. 

21 SEC. 3. COMPETITIVE ACCESS TO COVERED PRODUCTS 

22 FOR DEVELOPMENT PURPOSES. 

23 (a) IN GENERAL.—Chapter V of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amendVerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985

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1 ed by inserting after section 505–1 of such Act (21 U.S.C. 

2 355–1) the following new section: 

3 ‘‘SEC. 505–2. COMPETITIVE ACCESS TO COVERED PROD4 UCTS FOR DEVELOPMENT PURPOSES. 

5 ‘‘(a) DEFINITIONS.—In this section: 

6 ‘‘(1) COVERED PRODUCT.—The term ‘covered 

7 product’— 

8 ‘‘(A) means— 

9 ‘‘(i) any drug approved under section 

10 505 or biological product licensed under 

11 section 351 of the Public Health Service 

12 Act; 

13 ‘‘(ii) any combination thereof; or 

14 ‘‘(iii) when reasonably necessary to 

15 demonstrate sameness, biosimilarity, or 

16 interchangeability for purposes of this sec17 tion, section 505, or section 351 of the 

18 Public Health Service Act (as applicable), 

19 any product, including any device, that is 

20 marketed or intended for use with such 

21 drug or biological product; and 

22 ‘‘(B) excludes any drug or biological prod23 uct which the Secretary has determined to be 

24 currently in shortage and that appears on the 

25 drug shortage list in effect under section 506E, 


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1 unless the shortage will not be promptly re2 solved— 

3 ‘‘(i) as demonstrated by the fact that 

4 the drug or biological product has been in 

5 shortage for more than 6 months; or 

6 ‘‘(ii) as otherwise determined by the 

7 Secretary. 

8 ‘‘(2) ELIGIBLE PRODUCT DEVELOPER.—The 

9 term ‘eligible product developer’ means a person that 

10 seeks to develop a product for approval pursuant to 

11 an application under section 505(b)(2) or 505(j) or 

12 for licensing pursuant to an application under sec13 tion 351(k) of the Public Health Service Act. 

14 ‘‘(3) LICENSE HOLDER.—The term ‘license 

15 holder’ means the holder of an application approved 

16 under section 505(b) or section 505(j) of this Act or 

17 under section 351 of the Public Health Service Act 

18 for a covered product (including the holder’s agents, 

19 wholesalers, distributors, assigns, corporate affili20 ates, and contractors). 

21 ‘‘(4) REMS.—The term ‘REMS’ means a risk 

22 evaluation and mitigation strategy under section 

23 505–1. 

24 ‘‘(5) REMS PRODUCT.—The term ‘REMS 

25 product’ means a covered product that— 


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1 ‘‘(A) is subject to a risk evaluation and 

2 mitigation strategy under section 505–1; or 

3 ‘‘(B) is deemed under section 909(b) of the 

4 Food and Drug Administration Amendments 

5 Act of 2007 to have in effect an approved risk 

6 evaluation and mitigation strategy under sec7 tion 505–1. 

8 ‘‘(6) REMS IMPACTING PRODUCT DISTRIBU9 TION.—The term ‘REMS impacting product dis10 tribution’ means a REMS that contains elements to 

11 assure safe use that impact the distribution of the 

12 product subject to the REMS. 

13 ‘‘(b) COMPETITIVE ACCESS TO COVERED PRODUCTS

14 AS A CONDITION ON APPROVAL OR LICENSING.—As a 

15 condition of approval or licensure, or continuation or re16 newal of approval or licensure, of a covered product under 

17 section 505 of this Act or section 351 of the Public Health 

18 Service Act, respectively, the Secretary shall require that 

19 the covered product’s license holder not construe or apply 

20 any condition or restriction relating to the sale, resale, or 

21 distribution of the covered product, including any condi22 tion or restriction adopted, imposed, or enforced as an as23 pect of a risk evaluation and mitigation strategy, in a way 

24 that restricts or has the effect of restricting the supply 


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1 of such covered product to an eligible product developer 

2 for development or testing purposes. 

3 ‘‘(c) COMPETITIVE ACCESS FOR DEVELOPMENT PUR4 POSES TO PRODUCTS WITH REMS IMPACTING PRODUCT

5 DISTRIBUTION.—With respect to a product subject to a 

6 REMS impacting product distribution, no aspect of such 

7 a REMS shall be construed or applied by the REMS prod8 uct’s license holder in a way that prohibits or restricts the 

9 supply, at commercially reasonable, market-based prices, 

10 of such REMS product from the REMS product’s license 

11 holder to an eligible product developer with an applicable 

12 individual covered product authorization obtained pursu13 ant to subsection (e) for development and testing pur14 poses. 

15 ‘‘(d) SINGLE, SHARED SYSTEM OF ELEMENTS TO

16 ASSURE SAFE USE.—Where an eligible product developer 

17 seeks approval of an application under 505(j) referencing 

18 a REMS product whose REMS includes elements to as19 sure safe use— 

20 ‘‘(1) no license holder shall take any step that 

21 impedes— 

22 ‘‘(A) the prompt development on commer23 cially reasonable terms of a single, shared sys24 tem of elements to assure safe use under sec25 tion 505–1; or 


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1 ‘‘(B) the prompt entry on commercially 

2 reasonable terms of an eligible product devel3 oper into a previously approved system of ele4 ments to assure safe use; and 

5 ‘‘(2) license holders shall negotiate in good faith 

6 towards the prompt development of (or entry into) 

7 a single, shared system of elements to assure safe 

8 use under section 505–1(i) on commercially reason9 able terms. 

10 ‘‘(e) PROCEDURES FOR OBTAINING ACCESS TO COV11 ERED PRODUCTS.— 

12 ‘‘(1) COMPETITIVE ACCESS TO PRODUCTS NOT

13 SUBJECT TO REMS IMPACTING PRODUCT DISTRIBU14 TION.—Notwithstanding any other provision of law, 

15 a license holder that receives a request from an eligi16 ble product developer or its agent for sufficient sup17 plies of a covered product (that is not subject to a 

18 REMS impacting product distribution) to conduct 

19 testing necessary to support an application under 

20 section 505(b)(2) or 505(j) or under section 351(k) 

21 of the Public Health Service Act (or otherwise meet 

22 the requirements for approval of such an applica23 tion) shall provide to the eligible product developer 

24 or its agent the quantity requested within 30 days 

25 of receipt of the request at a nondiscriminatory, 


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1 commercially reasonable, market-based price for 

2 which such covered product has been previously sold 

3 by the license holder to third parties in the open 

4 market. 

5 ‘‘(2) COMPETITIVE ACCESS TO PRODUCTS SUB6 JECT TO REMS IMPACTING PRODUCT DISTRIBUTION: 

7 INDIVIDUAL COVERED PRODUCT AUTHORIZATION.— 

8 Any eligible product developer may seek an author9 ization to obtain an individual covered product sub10 ject to a REMS impacting product distribution for 

11 development and testing purposes by making a writ12 ten request to the Secretary. Within 120 days of re13 ceiving such a request, the Secretary shall, by writ14 ten notice, issue such authorization for purposes 

15 of— 

16 ‘‘(A) development and testing that does 

17 not involve human clinical trials, if the eligible 

18 product developer has agreed to comply with 

19 any conditions the Secretary determines nec20 essary; or 

21 ‘‘(B) development and testing that involves 

22 human clinical trials if the eligible product de23 veloper has— 

24 ‘‘(i) submitted a protocol for testing 

25 that includes protections that will provide 


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1 an assurance of safety comparable to the 

2 assurance of safety provided by any dis3 tribution restrictions governing the ap4 proval or licensure of the covered product; 

5 or 

6 ‘‘(ii) otherwise satisfied the Secretary 

7 that such protections will be provided. 

8 ‘‘(3)(A) PROCESS FOR OBTAINING PRODUCT

9 PURSUANT TO AN AUTHORIZATION.— 

10 ‘‘(i) An eligible product developer shall be 

11 entitled to obtain, from the license holder of a 

12 covered product subject to a REMS impacting 

13 distribution, sufficient quantities of the covered 

14 product for purposes of development and test15 ing necessary to support an application under 

16 section 505(b)(2) or 505(j) or under section 

17 351(k) of the Public Health Service Act, or oth18 erwise meet the requirements for approval of 

19 such application, if the eligible product devel20 oper has obtained an applicable authorization 

21 under paragraph (2). 

22 ‘‘(ii) Each license holder shall publicly des23 ignate at least one wholesaler or specialty dis24 tributor to receive and fulfill requests for covVerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985

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1 ered products submitted pursuant to paragraph 

2 (1) or clause (i) of this paragraph. 

3 ‘‘(iii) An eligible product developer shall 

4 initiate its acquisition of a covered product 

5 under clause (i) by providing or having its 

6 agent provide a written request for specific 

7 quantities of such covered product to the license 

8 holder. 

9 ‘‘(B) REQUEST CONTENTS AND RESPONSE.—A 

10 request under subparagraph (A)(iii) shall include a 

11 statement regarding the quantity of covered product 

12 sought for development or testing purposes, and 

13 state that the eligible product developer has an au14 thorization under paragraph (2) to obtain the spe15 cific covered product. Within 30 days of receiving 

16 such a request, the wholesaler or specialty dis17 tributor shall provide the requested quantity of the 

18 covered product at a nondiscriminatory, commer19 cially reasonable, market-based price for which such 

20 covered product has been previously sold by the li21 cense holder to third parties in the open market. 

22 ‘‘(C) DISCLOSURE OF INFORMATION BY

23 WHOLESALERS AND SPECIALTY DISTRIBUTORS.—In 

24 the event that a request is made to a wholesaler or 

25 specialty distributor under this paragraph, the 


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1 wholesaler or specialty distributor shall not disclose 

2 to the license holder of the covered product involved 

3 the identity of the eligible product developer, but 

4 may disclose to such license holder— 

5 ‘‘(i) the fact that a request has been made; 

6 ‘‘(ii) the dates on which the request was 

7 made and fulfilled; 

8 ‘‘(iii) the commercial terms on which the 

9 request was fulfilled; and 

10 ‘‘(iv) the quantity of the covered product 

11 furnished by the wholesaler or specialty dis12 tributor in compliance with the request. 

13 ‘‘(D) IMMINENT HAZARD.—At any time, the 

14 Secretary may prohibit, limit, or otherwise suspend 

15 a transfer of a covered product to an eligible product 

16 developer if the Secretary determines that the trans17 fer of such product to the eligible product developer 

18 would present an imminent hazard to the public 

19 health. In such cases, the Secretary shall specify the 

20 basis for the determination, including the specific in21 formation available to the Secretary which served as 

22 the basis for such determination, and confirm such 

23 determination in writing. 

24 ‘‘(f) ENFORCEMENT.— 


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1 ‘‘(1) REMEDIES.—An eligible product developer 

2 that is aggrieved by a violation of subsection (b), (c), 

3 (d), (e)(1) or (e)(3) by a license holder may sue such 

4 license holder in a court of competent jurisdiction 

5 for injunctive relief and treble damages (including 

6 costs and interest of the kind described in section 

7 4(a) of the Clayton Act (15 U.S.C. 15(a))). 

8 ‘‘(2) RULE OF CONSTRUCTION.— 

9 ‘‘(A) PRESERVATION OF ANTITRUST

10 LAWS.—Nothing in this Act, or the amend11 ments made by this Act, shall be construed to 

12 modify, supersede, or impair the operation of 

13 the antitrust laws. 

14 ‘‘(B) DEFINITION.—For purposes of para15 graph (1), the term ‘antitrust laws’ shall have 

16 the meaning given such term in subsection (a) 

17 of the 1st section of the Clayton Act (15 U.S.C. 

18 12), except that such term shall include section 

19 5 of the Federal Trade Commission Act (15 

20 U.S.C. 45) to the extent that such subsection 

21 applies to unfair methods of competition. 

22 ‘‘(g) LIMITATION OF LIABILITY.—The holder of an 

23 approved application or license for a covered product shall 

24 not be liable for any claim arising out of an eligible prod25 uct developer’s failure to follow adequate safeguards to asVerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985

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1 sure safe use of the covered product during development 

2 or testing activities conducted under this section.’’. 

3 (b) WAIVER OF SINGLE, SHARED SYSTEM REQUIRE4 MENT.—Section 505–1(i)(1)(C) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 355–1(i)(1)(C)) is 

6 amended— 

7 (1) in clause (i), by striking ‘‘or’’ at the end; 

8 (2) in clause (ii), by striking the period at the 

9 end and inserting ‘‘; or’’; and 

10 (3) by inserting after clause (ii) the following: 

11 ‘‘(iii) the applicant for an abbreviated 

12 new drug application certifies that it at13 tempted in good faith to create or nego14 tiate entry into a single, shared system, 

15 but was unable to finalize commercially 

16 reasonable terms with the holder of the 

17 listed drug within 120 days, and such cer18 tification includes a description of the ef19 forts made by the applicant for the abbre20 viated new drug application to create or 

21 negotiate entry into a single, shared sys22 tem.’’. 

23 (c) EFFECTIVE DATE.—This section and the amend24 ments made by this section shall take effect upon enact25 ment, and shall apply to all approved applications or liVerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985

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1 censes for a covered product (as defined in section 505– 

2 2(a) of the Federal Food, Drug, and Cosmetic Act, as 

3 added by this section) regardless of whether those applica4 tions or licenses were approved before, on, or after the 

5 date of enactment of this Act. 

Æ 


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