STOP GAMES Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 2387 To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other pur- poses. IN THE HOUSE OF REPRESENTATIVES APRIL 29, 2019 Mr. LEVIN of Michigan (for himself and Mr. ROONEY of Florida) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for deny- ing certain petitions whose primary purpose is to delay the approval of an application submitted under sub- section (b)(2) or (j) of such section 505, 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 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 2 •HR 2387 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Stop The Overuse of 2 Petitions and Get Affordable Medicines to Enter Soon Act 3 of 2019’’ or the ‘‘STOP GAMES Act of 2019’’. 4 SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE 5 IS TO DELAY APPROVAL OF CERTAIN APPLI- 6 CATIONS. 7 (a) IN GENERAL.—Subparagraph (E) of section 8 505(q)(1) of the Federal Food, Drug, and Cosmetic Act 9 (21 U.S.C. 355(q)(1)) is amended to read as follows: 10 ‘‘(E) DENIAL BASED ON INTENT TO 11 DELAY.— 12 ‘‘(i) IN GENERAL.—If the Secretary 13 determines that a petition or a supplement 14 to the petition was submitted with the pri- 15 mary purpose of delaying the approval of 16 an application or the petition does not on 17 its face raise valid scientific or regulatory 18 issues, the Secretary may deny the petition 19 at any point based on such determination. 20 ‘‘(ii) FACTORS.—The Secretary may 21 issue guidance to describe the factors that 22 will be used to determine under this sub- 23 paragraph whether a petition is submitted 24 with the primary purpose of delaying the 25 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 3 •HR 2387 IH approval of an application. Such factors 1 shall include the following: 2 ‘‘(I) Submission of a petition 3 where it appears, based on the date 4 that relevant information relied upon 5 in the petition became known to the 6 petitioner (or reasonably should have 7 been known to the petitioner), that 8 the petitioner has taken an unreason- 9 able length of time to submit the peti- 10 tion. 11 ‘‘(II) Submission of multiple or 12 serial petitions raising issues that rea- 13 sonably could have been known to the 14 petitioner at the time of submission of 15 the earlier petition or petitions. 16 ‘‘(III) Submission of a petition 17 close in time to a known, first date 18 upon which an application under sub- 19 section (b)(2) or (j) of this section or 20 under section 351(k) of the Public 21 Health Service Act could be approved 22 (such as submission close in time to 23 the expiration of a blocking patent or 24 exclusivity). 25 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 4 •HR 2387 IH ‘‘(IV) Submission of a petition 1 without any data or information in 2 support of the scientific positions set 3 forth in the petition. 4 ‘‘(V) Submission of a petition 5 raising the same or substantially simi- 6 lar issues as a prior petition to which 7 the Food and Drug Administration 8 has already substantively responded, 9 particularly where the subsequent sub- 10 mission closely follows in time the ear- 11 lier response. 12 ‘‘(VI) Submission of a petition 13 concerning standards for approval of 14 a drug product for which— 15 ‘‘(aa) the Food and Drug 16 Administration has provided an 17 opportunity for public input 18 (such as when the Food and 19 Drug Administration has issued 20 draft or final product-specific 21 guidance applicable to the drug 22 product); and 23 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 5 •HR 2387 IH ‘‘(bb) the petitioner has not 1 provided comment other than 2 through the petition. 3 ‘‘(VII) Submission of a petition 4 requesting that other applicants must 5 meet standards for testing, data, or 6 labeling for their products that are 7 more onerous or rigorous than the 8 standards applicable to the applicable 9 listed drug or the petitioner’s version 10 of the same product. 11 ‘‘(VIII) Other relevant consider- 12 ations, including the history of the pe- 13 titioner with the Food and Drug Ad- 14 ministration (such as whether the pe- 15 titioner has a history of submitting 16 petitions which the Food and Drug 17 Administration has determined were 18 submitted with the primary purpose of 19 delay). 20 ‘‘(iii) REFERRAL TO FTC.—If the Sec- 21 retary determines that a petition has been 22 submitted with the primary purpose of de- 23 laying the approval of an application, as 24 described in clause (i), the Secretary shall 25 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 6 •HR 2387 IH refer the matter to the Federal Trade 1 Commission.’’. 2 (b) DEADLINE FOR SUBMISSION OF PETITIONS.— 3 (1) DEADLINE.—Clause (i) of section 4 505(q)(1)(A) of the Federal Food, Drug, and Cos- 5 metic Act (21 U.S.C. 355(q)(1)(A)) is amended to 6 read as follows: 7 ‘‘(i) the request is in writing, is a pe- 8 tition submitted to the Secretary pursuant 9 to section 10.30, 10.31, or 10.35 of title 10 21, Code of Federal Regulations (or any 11 successor regulations), and is submitted 12 not later than 60 days after the informa- 13 tion upon which the petition is based first 14 became known to the party on whose be- 15 half the petition is submitted; and’’. 16 (2) CERTIFICATION.—Section 505(q)(1)(H) of 17 the Federal Food, Drug, and Cosmetic Act (21 18 U.S.C. 355(q)(1)) is amended by striking ‘‘I further 19 certify that the information upon which I have based 20 the action requested herein first became known to 21 the party on whose behalf this petition is submitted 22 on or about the following date: llll.’’ and in- 23 serting ‘‘I further certify that the information upon 24 which I have based the action requested herein first 25 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 7 •HR 2387 IH became known to the party on whose behalf this pe- 1 tition is submitted on or about llll, which 2 date was not more than 60 days before the date of 3 submitting this petition.’’. 4 (c) REPORTING TO CONGRESS.—Section 505(q)(3) of 5 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 6 355(q)(3)) is amended— 7 (1) in the matter before subparagraph (A), by 8 striking ‘‘specifies’’; 9 (2) in subparagraphs (A), (B), (C), and (D), by 10 striking ‘‘the number’’ and inserting ‘‘specifies the 11 number’’; 12 (3) in subparagraph (C), by striking ‘‘and’’ at 13 the end; 14 (4) in subparagraph (D), by striking the period 15 at the end and inserting ‘‘; and’’; and 16 (5) by adding at the end the following: 17 ‘‘(E)(i) lists each petition submitted during 18 such period and, for each, identifies the peti- 19 tioner; 20 ‘‘(ii) quantifies the time and resources ex- 21 pended on each such petition; 22 ‘‘(iii) states the timing of the petition rel- 23 ative to the expiration date of the patents speci- 24 fied in the pending application in the certifi- 25 VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS 8 •HR 2387 IH cation under subsection (b)(2)(A) or 1 (j)(2)(A)(vii), as applicable; 2 ‘‘(iv) quantifies the delay, if any, caused by 3 any such petition on the approval of any appli- 4 cation submitted under subsection (b)(2) or (j), 5 including a description of how any such delay is 6 calculated and an estimate of when any delayed 7 approval would have been granted absent the 8 petition; and 9 ‘‘(v) in cases in which a pending applica- 10 tion and a petition with respect to such pending 11 application are disposed of on the same or near- 12 ly the same date, states when the Food and 13 Drug Administration would have disposed of 14 the pending application absent the petition.’’. 15 Æ VerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H2387.IH H2387 kjohnson on DSK79L0C42 with BILLS