FAST Generics Act of 2019

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 li- censed 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 prod- ucts, so as to enable eligible product developers to de- velop and test new products, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Fair Access for Safe 4 and Timely Generics Act of 2019’’ or the ‘‘FAST Generics 5 Act of 2019’’. 6 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 2 •HR 985 IH SEC. 2. FINDINGS. 1 The Congress finds the following: 2 (1) Reference product license or approval hold- 3 ers are restricting competitive access to reference 4 products by sponsors seeking to develop drugs, ge- 5 neric drugs, and biosimilars under section 505(b)(2) 6 or 505(j) of the Food, Drug, and Cosmetic Act (21 7 U.S.C. 355(b)(2) and 355(j)) and under section 8 351(k) of the Public Health Service Act (42 U.S.C. 9 262(k)). These restrictions are deterring and delay- 10 ing development of drugs, generic drugs, and 11 biosimilars by extending lawful patent-based monop- 12 olies beyond their lawful patent life. 13 (2) The enforcement provisions set forth in sec- 14 tion 505–1(f)(8) of the Federal Food, Drug, and 15 Cosmetic Act (21 U.S.C. 355–1(f)(8)) have not been 16 sufficient to prevent anti-competitive practices that 17 interfere with access to reference products which is 18 necessary for the timely development of affordable 19 drugs, generic drugs, and biosimilars. 20 (3) There is not a regulatory structure in place 21 that is sufficient to deter or remedy the anti-com- 22 petitive harm that results when— 23 (A) access to reference products is re- 24 stricted to sponsors developing drugs, generic 25 drugs, or biosimilars in accordance with section 26 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 3 •HR 985 IH 505(b)(2) or 505(j) of the Federal Food, Drug, 1 and Cosmetic Act (21 U.S.C. 355(b)(2) or 2 355(j)), and section 351(k) of the Public 3 Health Service Act (42 U.S.C. 262(k)), respec- 4 tively; or 5 (B) license holders impede the prompt ne- 6 gotiation and development of a single, shared 7 system of elements to assure safe use and sup- 8 porting agreements under section 505– 9 1(i)(1)(B) of such Act (21 U.S.C. 355– 10 1(i)(1)(B)), on commercially reasonable terms. 11 (4) Requiring license holders to comply with re- 12 quirements for competitive access to their products, 13 and for the negotiation and development of single, 14 shared systems of elements to assure safe use under 15 section 505–1(i)(1)(B) of the Federal Food, Drug, 16 and Cosmetic Act (21 U.S.C. 355–1(i)(1)(B)), and 17 subjecting license holders to liability for failing to do 18 so, will not impose obligations on the courts that 19 they cannot adequately and reasonably adjudicate. 20 SEC. 3. COMPETITIVE ACCESS TO COVERED PRODUCTS 21 FOR DEVELOPMENT PURPOSES. 22 (a) IN GENERAL.—Chapter V of the Federal Food, 23 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend- 24 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 4 •HR 985 IH ed by inserting after section 505–1 of such Act (21 U.S.C. 1 355–1) the following new section: 2 ‘‘SEC. 505–2. COMPETITIVE ACCESS TO COVERED PROD- 3 UCTS FOR DEVELOPMENT PURPOSES. 4 ‘‘(a) DEFINITIONS.—In this section: 5 ‘‘(1) COVERED PRODUCT.—The term ‘covered 6 product’— 7 ‘‘(A) means— 8 ‘‘(i) any drug approved under section 9 505 or biological product licensed under 10 section 351 of the Public Health Service 11 Act; 12 ‘‘(ii) any combination thereof; or 13 ‘‘(iii) when reasonably necessary to 14 demonstrate sameness, biosimilarity, or 15 interchangeability for purposes of this sec- 16 tion, section 505, or section 351 of the 17 Public Health Service Act (as applicable), 18 any product, including any device, that is 19 marketed or intended for use with such 20 drug or biological product; and 21 ‘‘(B) excludes any drug or biological prod- 22 uct which the Secretary has determined to be 23 currently in shortage and that appears on the 24 drug shortage list in effect under section 506E, 25 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 5 •HR 985 IH unless the shortage will not be promptly re- 1 solved— 2 ‘‘(i) as demonstrated by the fact that 3 the drug or biological product has been in 4 shortage for more than 6 months; or 5 ‘‘(ii) as otherwise determined by the 6 Secretary. 7 ‘‘(2) ELIGIBLE PRODUCT DEVELOPER.—The 8 term ‘eligible product developer’ means a person that 9 seeks to develop a product for approval pursuant to 10 an application under section 505(b)(2) or 505(j) or 11 for licensing pursuant to an application under sec- 12 tion 351(k) of the Public Health Service Act. 13 ‘‘(3) LICENSE HOLDER.—The term ‘license 14 holder’ means the holder of an application approved 15 under section 505(b) or section 505(j) of this Act or 16 under section 351 of the Public Health Service Act 17 for a covered product (including the holder’s agents, 18 wholesalers, distributors, assigns, corporate affili- 19 ates, and contractors). 20 ‘‘(4) REMS.—The term ‘REMS’ means a risk 21 evaluation and mitigation strategy under section 22 505–1. 23 ‘‘(5) REMS PRODUCT.—The term ‘REMS 24 product’ means a covered product that— 25 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 6 •HR 985 IH ‘‘(A) is subject to a risk evaluation and 1 mitigation strategy under section 505–1; or 2 ‘‘(B) is deemed under section 909(b) of the 3 Food and Drug Administration Amendments 4 Act of 2007 to have in effect an approved risk 5 evaluation and mitigation strategy under sec- 6 tion 505–1. 7 ‘‘(6) REMS IMPACTING PRODUCT DISTRIBU- 8 TION.—The term ‘REMS impacting product dis- 9 tribution’ means a REMS that contains elements to 10 assure safe use that impact the distribution of the 11 product subject to the REMS. 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 re- 15 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 construe or apply 19 any condition or restriction relating to the sale, resale, or 20 distribution of the covered product, including any condi- 21 tion or restriction adopted, imposed, or enforced as an as- 22 pect of a risk evaluation and mitigation strategy, in a way 23 that restricts or has the effect of restricting the supply 24 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 7 •HR 985 IH of such covered product to an eligible product developer 1 for development or testing purposes. 2 ‘‘(c) COMPETITIVE ACCESS FOR DEVELOPMENT PUR- 3 POSES TO PRODUCTS WITH REMS IMPACTING PRODUCT 4 DISTRIBUTION.—With respect to a product subject to a 5 REMS impacting product distribution, no aspect of such 6 a REMS shall be construed or applied by the REMS prod- 7 uct’s license holder in a way that prohibits or restricts the 8 supply, at commercially reasonable, market-based prices, 9 of such REMS product from the REMS product’s license 10 holder to an eligible product developer with an applicable 11 individual covered product authorization obtained pursu- 12 ant to subsection (e) for development and testing pur- 13 poses. 14 ‘‘(d) SINGLE, SHARED SYSTEM OF ELEMENTS TO 15 ASSURE SAFE USE.—Where an eligible product developer 16 seeks approval of an application under 505(j) referencing 17 a REMS product whose REMS includes elements to as- 18 sure safe use— 19 ‘‘(1) no license holder shall take any step that 20 impedes— 21 ‘‘(A) the prompt development on commer- 22 cially reasonable terms of a single, shared sys- 23 tem of elements to assure safe use under sec- 24 tion 505–1; or 25 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 8 •HR 985 IH ‘‘(B) the prompt entry on commercially 1 reasonable terms of an eligible product devel- 2 oper into a previously approved system of ele- 3 ments to assure safe use; and 4 ‘‘(2) license holders shall negotiate in good faith 5 towards the prompt development of (or entry into) 6 a single, shared system of elements to assure safe 7 use under section 505–1(i) on commercially reason- 8 able terms. 9 ‘‘(e) PROCEDURES FOR OBTAINING ACCESS TO COV- 10 ERED PRODUCTS.— 11 ‘‘(1) COMPETITIVE ACCESS TO PRODUCTS NOT 12 SUBJECT TO REMS IMPACTING PRODUCT DISTRIBU- 13 TION.—Notwithstanding any other provision of law, 14 a license holder that receives a request from an eligi- 15 ble product developer or its agent for sufficient sup- 16 plies of a covered product (that is not subject to a 17 REMS impacting product distribution) to conduct 18 testing necessary to support an application under 19 section 505(b)(2) or 505(j) or under section 351(k) 20 of the Public Health Service Act (or otherwise meet 21 the requirements for approval of such an applica- 22 tion) shall provide to the eligible product developer 23 or its agent the quantity requested within 30 days 24 of receipt of the request at a nondiscriminatory, 25 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 9 •HR 985 IH commercially reasonable, market-based price for 1 which such covered product has been previously sold 2 by the license holder to third parties in the open 3 market. 4 ‘‘(2) COMPETITIVE ACCESS TO PRODUCTS SUB- 5 JECT TO REMS IMPACTING PRODUCT DISTRIBUTION: 6 INDIVIDUAL COVERED PRODUCT AUTHORIZATION.— 7 Any eligible product developer may seek an author- 8 ization to obtain an individual covered product sub- 9 ject to a REMS impacting product distribution for 10 development and testing purposes by making a writ- 11 ten request to the Secretary. Within 120 days of re- 12 ceiving such a request, the Secretary shall, by writ- 13 ten notice, issue such authorization for purposes 14 of— 15 ‘‘(A) development and testing that does 16 not involve human clinical trials, if the eligible 17 product developer has agreed to comply with 18 any conditions the Secretary determines nec- 19 essary; or 20 ‘‘(B) development and testing that involves 21 human clinical trials if the eligible product de- 22 veloper has— 23 ‘‘(i) submitted a protocol for testing 24 that includes protections that will provide 25 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 10 •HR 985 IH an assurance of safety comparable to the 1 assurance of safety provided by any dis- 2 tribution restrictions governing the ap- 3 proval or licensure of the covered product; 4 or 5 ‘‘(ii) otherwise satisfied the Secretary 6 that such protections will be provided. 7 ‘‘(3)(A) PROCESS FOR OBTAINING PRODUCT 8 PURSUANT TO AN AUTHORIZATION.— 9 ‘‘(i) An eligible product developer shall be 10 entitled to obtain, from the license holder of a 11 covered product subject to a REMS impacting 12 distribution, sufficient quantities of the covered 13 product for purposes of development and test- 14 ing necessary to support an application under 15 section 505(b)(2) or 505(j) or under section 16 351(k) of the Public Health Service Act, or oth- 17 erwise meet the requirements for approval of 18 such application, if the eligible product devel- 19 oper has obtained an applicable authorization 20 under paragraph (2). 21 ‘‘(ii) Each license holder shall publicly des- 22 ignate at least one wholesaler or specialty dis- 23 tributor to receive and fulfill requests for cov- 24 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 11 •HR 985 IH ered products submitted pursuant to paragraph 1 (1) or clause (i) of this paragraph. 2 ‘‘(iii) An eligible product developer shall 3 initiate its acquisition of a covered product 4 under clause (i) by providing or having its 5 agent provide a written request for specific 6 quantities of such covered product to the license 7 holder. 8 ‘‘(B) REQUEST CONTENTS AND RESPONSE.—A 9 request under subparagraph (A)(iii) shall include a 10 statement regarding the quantity of covered product 11 sought for development or testing purposes, and 12 state that the eligible product developer has an au- 13 thorization under paragraph (2) to obtain the spe- 14 cific covered product. Within 30 days of receiving 15 such a request, the wholesaler or specialty dis- 16 tributor shall provide the requested quantity of the 17 covered product at a nondiscriminatory, commer- 18 cially reasonable, market-based price for which such 19 covered product has been previously sold by the li- 20 cense holder to third parties in the open market. 21 ‘‘(C) DISCLOSURE OF INFORMATION BY 22 WHOLESALERS AND SPECIALTY DISTRIBUTORS.—In 23 the event that a request is made to a wholesaler or 24 specialty distributor under this paragraph, the 25 VerDate Sep 11 2014 22:04 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H985.IH H985 pbinns on DSK79D2C42PROD with BILLS 12 •HR 985 IH wholesaler or specialty distributor shall not disclose 1 to the license holder of the covered product involved 2 the identity of the eligible product developer, but 3 may disclose to such license holder— 4 ‘‘(i) the fact that a request has been made; 5 ‘‘(ii) the dates on which the request was 6 made and fulfilled; 7 ‘‘(iii) the commercial terms on which the 8 request was fulfilled; and 9 ‘‘(iv) th [Text truncated for display. 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