I 

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. 

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 2014’’ or the ‘‘FAST Generics 

6 Act of 2014’’. 


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1 SEC. 2. FINDINGS. 

2 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) or 

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

8 U.S.C. 355(b)(2) and 355(j)) and under section 351 

9 of the Public Health Service Act (42 U.S.C. 262). 

10 These restrictions are deterring and delaying devel11 opment of generic drugs and biosimilars by extend12 ing lawful patent-based monopolies beyond their law13 ful 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 generic drugs and biosimilars. 

21 (3) The opinion in Verizon Communications 

22 Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 

23 U.S. 398 (2004) should not be construed to impair 

24 or bar the application of the antitrust laws con25 sistent with the provisions of this Act. 


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1 (4) There is not a regulatory structure in place 

2 that is sufficient to deter or remedy the anti-com3 petitive harm that results when access to reference 

4 brand products is restricted to sponsors developing 

5 drugs, generic drugs, and biosimilars in accordance 

6 with section 505(b) or 505(j) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355(b)(2) and 

8 355(j)), and section 351 of the Public Health Serv9 ice Act (42 U.S.C. 262), respectively. 

10 (5) Requiring license holders to comply with re11 quirements for competitive access to their products, 

12 and subjecting license holders to antitrust liability 

13 for failing to do so, will not impose obligations on 

14 the courts that they cannot adequately and reason15 ably adjudicate. 

16 SEC. 3. COMPETITIVE ACCESS TO COVERED PRODUCTS 

17 FOR DEVELOPMENT PURPOSES. 

18 (a) IN GENERAL.—Chapter V of the Food Drug and 

19 Cosmetic Act (21 U.S.C. 351 et seq.) is amended by in20 serting after section 505–1 of such Act (21 U.S.C. 355– 

21 1) the following new section: 

22 ‘‘SEC. 505–2. COMPETITIVE ACCESS TO COVERED PROD23 UCTS FOR DEVELOPMENT PURPOSES. 

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


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

2 product’ means any drug approved under section 

3 505 or any biological product that is licensed under 

4 section 351 of the Public Health Service Act, includ5 ing— 

6 ‘‘(A) any combination thereof; and 

7 ‘‘(B) when reasonably necessary to dem8 onstrate sameness, biosimilarity, or inter9 changeability for purposes of this section, sec10 tion 505, or section 351 of the Public Health 

11 Service Act (as applicable), any product, includ12 ing any device, that is marketed or intended for 

13 use with such drug or biological product. 

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

15 term ‘eligible product developer’ means a person that 

16 seeks to develop an application for the approval of 

17 a drug under section 505(b) or 505(j) or the licens18 ing of a biological product under section 351 of the 

19 Public Health Service Act. 

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

21 holder’ means the holder of an application approved 

22 under section 505(b) or section 505(j) or a license 

23 under section 351 of the Public Health Service Act 

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


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1 wholesalers, distributors, assigns, and corporate af2 filiates). 

3 ‘‘(4) REMS PRODUCT.—The term ‘REMS 

4 product’ means a covered product that— 

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

6 mitigation strategy under section 505–1; or 

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

8 Food and Drug Administration Amendments 

9 Act of 2007 to have in effect an approved risk 

10 evaluation and mitigation strategy under sec11 tion 505–1. 

12 ‘‘(b) COMPETITIVE ACCESS TO COVERED PRODUCTS

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

14 condition of approval or licensure, or continuation or re15 newal of approval or licensure, of a covered product under 

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

17 Service Act, respectively, the Secretary shall require that 

18 the covered product’s license holder not adopt, impose, or 

19 enforce any condition relating to the sale, resale, or dis20 tribution of the covered product, including any condition 

21 adopted, imposed, or enforced as an aspect of a risk eval22 uation and mitigation strategy approved by the Secretary, 

23 that restricts or has the effect of restricting the supply 

24 of such covered product to an eligible product developer 

25 for development or testing purposes. 


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1 ‘‘(c) COMPETITIVE ACCESS TO COVERED PRODUCTS

2 OTHER THAN REMS PRODUCTS FOR DEVELOPMENT

3 PURPOSES.—No license holder shall adopt, impose, or en4 force any condition relating to the sale, resale, or distribu5 tion of a covered product that interferes with or restricts 

6 access to reasonable quantities of a covered product by 

7 an eligible product developer for development and testing 

8 purposes, at commercially reasonable, market-based 

9 prices, from the license holder or from any wholesaler or 

10 specialty distributor authorized by the license holder to 

11 commercially distribute or sell the covered product unless 

12 the license holder generally adopts, imposes, or enforces 

13 lawful conditions relating to the sale, resale, or distribu14 tion of a covered product, with respect to other buyers of 

15 the covered product. 

16 ‘‘(d) COMPETITIVE ACCESS TO REMS PRODUCTS

17 FOR DEVELOPMENT PURPOSES.— 

18 ‘‘(1) PROHIBITED USE OF REMS TO RESTRICT

19 ACCESS.—With respect to a REMS product, no as20 pect of a risk evaluation and mitigation strategy 

21 under section 505–1 shall prohibit or restrict, or be 

22 construed or applied to prohibit or restrict, the sup23 ply of such REMS product to an eligible product de24 veloper for development and testing purposes, at 

25 commercially reasonable, market-based prices, from 


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1 the REMS product’s license holder or from any 

2 wholesaler or specialty distributor authorized by the 

3 license holder to commercially distribute or sell the 

4 REMS product. 

5 ‘‘(2) SINGLE, SHARED SYSTEM OF ELEMENTS

6 TO ASSURE SAFE USE.—With respect to a REMS 

7 product, no license holder shall take any step that 

8 impedes— 

9 ‘‘(A) the prompt development of a single, 

10 shared system of elements to assure safe use 

11 under section 505–1; or 

12 ‘‘(B) the entry on commercially reasonable 

13 terms of an eligible product developer into a 

14 previously approved system of elements to as15 sure safe use. 

16 ‘‘(e) PROCEDURES FOR OBTAINING ACCESS TO COV17 ERED PRODUCTS.— 

18 ‘‘(1) COMPETITIVE ACCESS.—Notwithstanding 

19 any other provision of law, in the case of an eligible 

20 product developer that has an authorization to ob21 tain a covered product in effect under paragraph (2) 

22 or (3), no license holder shall adopt, impose, or en23 force any other condition relating to the sale, resale, 

24 or distribution of such covered product that inter25 feres with or restricts access to reasonable quantities 


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1 of the covered product by the eligible product devel2 oper for development and testing purposes, at com3 mercially reasonable, market-based prices, from the 

4 license holder or from any wholesaler or specialty 

5 distributor authorized by the license holder to com6 mercially distribute or sell the covered product, un7 less the license holder generally adopts, imposes, or 

8 enforces lawful conditions relating to the sale, resale, 

9 or distribution of a covered product, with respect to 

10 other buyers of the covered product. 

11 ‘‘(2) GENERAL COVERED PRODUCTS AUTHOR12 IZATION.—Any eligible product developer may seek a 

13 general covered products authorization, authorizing 

14 the eligible product developer to obtain any covered 

15 product for the purposes of development and testing, 

16 by making a written request to the Secretary. With17 in 60 days after receiving such a request, the Sec18 retary shall, by written notice, issue such authoriza19 tion if— 

20 ‘‘(A) the eligible product developer holds 

21 one or more approved applications or licenses 

22 for a covered product or, in the absence of such 

23 approvals or licensures, otherwise establishes 

24 that the eligible product developer can comply 

25 with the requirements of this Act and other apVerDate Sep 11 2014 00:50 Oct 04, 2014 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5657.IH H5657

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1 plicable law for the development and testing of 

2 covered products; and 

3 ‘‘(B) the Secretary does not find that the 

4 eligible product developer has materially failed 

5 to comply with the requirements of this Act or 

6 other applicable law for the development and 

7 testing of covered products. 

8 ‘‘(3) INDIVIDUAL COVERED PRODUCT AUTHOR9 IZATION.—Any eligible product developer may seek 

10 an authorization to obtain an individual covered 

11 product for development and testing purposes by 

12 making a written request to the Secretary. Within 

13 60 days of receiving such a request, the Secretary 

14 shall, by written notice, issue such authorization for 

15 purposes 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) testing that involves human clinical 

22 trials if the eligible product developer has sub23 mitted a protocol for testing that includes pro24 tections that will provide an assurance of safety 

25 comparable to the assurance of safety provided 


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1 by any distribution restrictions governing the 

2 approval or licensure of the covered product or 

3 the license holder’s distribution of the covered 

4 product. 

5 ‘‘(4) FAILURE BY SECRETARY TO TAKE FINAL

6 ACTION.—If the 60-day period referred to in para7 graph (2) or (3) expires without the Secretary hav8 ing taken final action on the request for authoriza9 tion, the Secretary shall be deemed to have issued, 

10 by written notice, the requested authorization. 

11 ‘‘(5)(A) PROCESS FOR OBTAINING PRODUCT

12 PURSUANT TO AN AUTHORIZATION.—If an eligible 

13 product developer is unable, for purposes of develop14 ment and testing, to obtain reasonable quantities of 

15 a covered product commercially, either from the li16 cense holder or from any wholesaler or specialty dis17 tributor authorized by the license holder to commer18 cially distribute or sell the covered product, any eli19 gible product developer that has obtained authoriza20 tion to do so, in accordance with paragraph (2) or 

21 (3), shall be entitled to obtain such reasonable quan22 tities of such covered product at the same commer23 cially reasonable, market based price on which such 

24 reasonable quantities of such covered product have 

25 been previously sold by the license holder to third 


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1 parties in the open market. Such eligible product de2 veloper shall initiate its acquisition of such covered 

3 product by providing a written request for specific 

4 quantities of such covered product either— 

5 ‘‘(i) to any wholesaler or specialty dis6 tributor authorized by the license holder to 

7 commercially distribute or sell the covered prod8 uct; or 

9 ‘‘(ii) in the event no such wholesaler or 

10 specialty distributor has been designated for 

11 such purpose by the license holder, to the Sec12 retary. 

13 ‘‘(B) REQUEST CONTENTS.—Such request shall 

14 include a statement regarding the quantity of cov15 ered product sought for development or testing pur16 poses, and state that either— 

17 ‘‘(i) the eligible product developer has, or 

18 is deemed to have, a general covered products 

19 authorization under paragraph (2); or 

20 ‘‘(ii) the eligible product developer has, or 

21 is deemed to have, an authorization under para22 graph (3) to obtain the specific covered product. 

23 ‘‘(C) DISCLOSURE OF INFORMATION BY

24 WHOLESALERS AND SPECIALTY DISTRIBUTORS.—In 

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


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1 specialty distributor under this paragraph, the 

2 wholesaler or specialty distributor shall not disclose 

3 to the license holder of the covered product involved 

4 the identity of the eligible product developer, but 

5 may disclose to such license holder, only if required 

6 to do so by the holder— 

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

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

9 made and fulfilled; 

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

11 request was fulfilled; and 

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

13 furnished by the wholesaler or specialty dis14 tributor in compliance with the request. 

15 ‘‘(D) DISCLOSURE PURSUANT TO MEANS SPECI16 FIED BY SECRETARY.—In the event that a request 

17 is made to the Secretary under this subsection, then 

18 the Secretary shall, within 5 business days of receipt 

19 of the request, notify the license holder that a re20 quest for such covered product has been made, and 

21 the quantity of the covered product requested, and 

22 such license holder shall, within 30 days after receiv23 ing notice from the Secretary, provide the quantity 

24 of the requested covered product, through means 

25 specified by the Secretary, at a non-discriminatory, 


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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 (or any wholesaler or specialty 

4 distributor authorized by the license holder to com5 mercially distribute or sell the covered product) to 

6 third parties in the open market. The means estab7 lished by the Secretary under this clause shall not 

8 disclose to the license holder the identity of the eligi9 ble product developer that has requested quantities 

10 of the covered product for development and testing 

11 purposes. 

12 ‘‘(E) IMMINENT HAZARD.—At any time, the 

13 Secretary may prohibit, limit, or otherwise suspend 

14 a transfer of a covered product to an eligible product 

15 developer if the Secretary determines that the trans16 fer of such product to the eligible product developer 

17 would present an imminent hazard to the public 

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

19 basis for the determination, including the specific in20 formation available to the Secretary which served as 

21 the basis for such determination, and confirm such 

22 determination in writing. 

23 ‘‘(f) PUBLIC AND PRIVATE ENFORCEMENT.— 

24 ‘‘(1) APPLICATION OF CERTAIN PROVISIONS.— 

25 For purposes of this Act and the Public Health 


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1 Service Act, a violation of a requirement or prohibi2 tion in subsection (b), (c), (d)(1), (d)(2), or (e)(1) 

3 shall be treated in the case of a REMS product, as 

4 a violation of the product’s risk evaluation and miti5 gation strategy. 

6 ‘‘(2) REMEDIES.—An eligible product developer 

7 that has authorization for access to a covered prod8 uct from the Secretary under subsection (e) and that 

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

10 (d)(1), (d)(2), or (e)(1) by a license holder or any 

11 wholesaler or specialty distributor authorized by the 

12 license holder to commercially distribute or sell the 

13 covered product may sue such license holder for in14 junctive relief and treble damages (including costs 

15 and interest of the kind described in section 4(a) of 

16 the Clayton Act (15 U.S.C. 15(a))). 

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

18 approved application or license for a covered product shall 

19 not be liable for any claim arising out of an eligible prod20 uct developer’s development or testing activities conducted 

21 under this section, including a claim arising out of a fail22 ure of the eligible drug developer to follow adequate safe23 guards to assure safe use of the covered product. 

24 ‘‘(h) REPORTS.— 


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1 ‘‘(1) REPORT BY FDA.—Not later than 180 

2 days after the enactment of the Fair Access for Safe 

3 and Timely Generics Act of 2014, and annually 

4 thereafter, the Secretary, acting through the Com5 missioner of Food and Drugs, shall submit to Con6 gress a report that— 

7 ‘‘(A) identifies each instance of noncompli8 ance by any license holder with a requirement 

9 or prohibition in subsection (b), (c), (d)(1), 

10 (d)(2), or (e)(1); and 

11 ‘‘(B) describes the actions taken by the 

12 Secretary to remedy such noncompliance and to 

13 enforce such requirements and prohibitions, 

14 whether by assessment of a penalty or other15 wise. 

16 ‘‘(2) REPORT BY FTC.—Not later than 270 

17 days after the enactment of the Fair Access for Safe 

18 and Timely Generics Act of 2014, and annually 

19 thereafter, the Federal Trade Commission shall sub20 mit to Congress a report that— 

21 ‘‘(A) describes the complaints received by 

22 the Commission pertaining to the withholding 

23 of competitive access to covered products, the 

24 actions taken by the Commission with respect 


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1 to each such complaint, and the result of each 

2 such Commission action; and 

3 ‘‘(B) examines the impact on the market 

4 entry of competing drug products, and the pric5 ing and availability of such products, in the 

6 United States resulting from noncompliance by 

7 license holders with a requirement or prohibi8 tion in subsection (b), (c), (d)(1), (d)(2), or 

9 (e)(1).’’. 

10 (b) PROHIBITED ACT.—Section 301 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend12 ed by adding at the end the following: 

13 ‘‘(ddd) Any violation by the license holder of a cov14 ered product (as such terms are defined in section 505– 

15 2(a) (including its contractors, assigns, or corporate affili16 ates)) of a requirement or prohibition in subsection (b), 

17 (c), (d)(1), (d)(2), or (e)(1) of section 505–2 (relative to 

18 competitive access to covered products for development 

19 purposes).’’. 

20 (c) WAIVER OF SINGLE, SHARED SYSTEM REQUIRE21 MENT.—Section 505–1(i)(1)(B) of the Federal Food, 

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

23 amended— 

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


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

2 end and inserting ‘‘; or’’; and 

3 (3) by adding at the end the following: 

4 ‘‘(iii) the applicant for an abbreviated 

5 new drug application certifies that it at6 tempted in good faith to create or nego7 tiate entry into a single, shared system, 

8 but was unable to finalize commercially 

9 reasonable terms with the holder of the 

10 listed drug within 120 days, and such cer11 tification includes a description of the ef12 forts made by the applicant for the abbre13 viated new drug application to create or 

14 negotiate entry into a single, shared sys15 tem.’’. 

16 (d) EFFECTIVE DATE.—This section and the amend17 ments made by this section shall take effect upon enact18 ment, and shall apply to all approved applications or li19 censes for a covered product (as defined in section 505– 

20 2(a) of the Federal Food, Drug, and Cosmetic Act, as 

21 added by this section) regardless of whether those applica22 tions or licenses were approved before, on, or after the 

23 date of enactment of this Act. 

Æ 


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