I 118TH CONGRESS 1ST SESSION H. R. 3030 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 28, 2023 Mr. SORENSEN 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Stop The Overuse of 4 Petitions and Get Affordable Medicines to Enter Soon Act 5 of 2023’’ or the ‘‘STOP GAMES Act of 2023’’. 6 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3030 IH SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE 1 IS TO DELAY APPROVAL OF CERTAIN APPLI- 2 CATIONS. 3 (a) IN GENERAL.—Subparagraph (E) of section 4 505(q)(1) of the Federal Food, Drug, and Cosmetic Act 5 (21 U.S.C. 355(q)(1)) is amended to read as follows: 6 ‘‘(E) DENIAL BASED ON INTENT TO 7 DELAY.— 8 ‘‘(i) IN GENERAL.—If the Secretary 9 determines that a petition or a supplement 10 to the petition was submitted with the pri- 11 mary purpose of delaying the approval of 12 an application or the petition does not on 13 its face raise valid scientific or regulatory 14 issues, the Secretary may deny the petition 15 at any point based on such determination. 16 ‘‘(ii) FACTORS.—The Secretary may 17 issue guidance to describe the factors that 18 will be used to determine under this sub- 19 paragraph whether a petition is submitted 20 with the primary purpose of delaying the 21 approval of an application. Such factors 22 shall include the following: 23 ‘‘(I) Submission of a petition 24 where it appears, based on the date 25 that relevant information relied upon 26 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3030 IH in the petition became known to the 1 petitioner (or reasonably should have 2 been known to the petitioner), that 3 the petitioner has taken an unreason- 4 able length of time to submit the peti- 5 tion. 6 ‘‘(II) Submission of multiple or 7 serial petitions raising issues that rea- 8 sonably could have been known to the 9 petitioner at the time of submission of 10 the earlier petition or petitions. 11 ‘‘(III) Submission of a petition 12 close in time to a known, first date 13 upon which an application under sub- 14 section (b)(2) or (j) of this section or 15 under section 351(k) of the Public 16 Health Service Act could be approved 17 (such as submission close in time to 18 the expiration of a blocking patent or 19 exclusivity). 20 ‘‘(IV) Submission of a petition 21 without any data or information in 22 support of the scientific positions set 23 forth in the petition. 24 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3030 IH ‘‘(V) Submission of a petition 1 raising the same or substantially simi- 2 lar issues as a prior petition to which 3 the Food and Drug Administration 4 has already substantively responded, 5 particularly where the subsequent sub- 6 mission closely follows in time the ear- 7 lier response. 8 ‘‘(VI) Submission of a petition 9 concerning standards for approval of 10 a drug product for which— 11 ‘‘(aa) the Food and Drug 12 Administration has provided an 13 opportunity for public input 14 (such as when the Food and 15 Drug Administration has issued 16 draft or final product-specific 17 guidance applicable to the drug 18 product); and 19 ‘‘(bb) the petitioner has not 20 provided comment other than 21 through the petition. 22 ‘‘(VII) Submission of a petition 23 requesting that other applicants must 24 meet standards for testing, data, or 25 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3030 IH labeling for their products that are 1 more onerous or rigorous than the 2 standards applicable to the applicable 3 listed drug or the petitioner’s version 4 of the same product. 5 ‘‘(VIII) Other relevant consider- 6 ations, including the history of the pe- 7 titioner with the Food and Drug Ad- 8 ministration (such as whether the pe- 9 titioner has a history of submitting 10 petitions which the Food and Drug 11 Administration has determined were 12 submitted with the primary purpose of 13 delay). 14 ‘‘(iii) REFERRAL TO FTC.—If the Sec- 15 retary determines that a petition has been 16 submitted with the primary purpose of de- 17 laying the approval of an application, as 18 described in clause (i), the Secretary shall 19 refer the matter to the Federal Trade 20 Commission.’’. 21 (b) DEADLINE FOR SUBMISSION OF PETITIONS.— 22 (1) DEADLINE.—Clause (i) of section 23 505(q)(1)(A) of the Federal Food, Drug, and Cos- 24 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 3030 IH metic Act (21 U.S.C. 355(q)(1)(A)) is amended to 1 read as follows: 2 ‘‘(i) the request is in writing, is a pe- 3 tition submitted to the Secretary pursuant 4 to section 10.30, 10.31, or 10.35 of title 5 21, Code of Federal Regulations (or any 6 successor regulations), and is submitted 7 not later than 60 days after the informa- 8 tion upon which the petition is based first 9 became known to the party on whose be- 10 half the petition is submitted; and’’. 11 (2) CERTIFICATION.—Section 505(q)(1)(H) of 12 the Federal Food, Drug, and Cosmetic Act (21 13 U.S.C. 355(q)(1)(H)) is amended by striking ‘‘ ‘I 14 further certify that the information upon which I 15 have based the action requested herein first became 16 known to the party on whose behalf this petition is 17 submitted on or about the following date: 18 llll.’ ’’ and inserting ‘‘ ‘I further certify that 19 the information upon which I have based the action 20 requested herein first became known to the party on 21 whose behalf this petition is submitted on or about 22 llll, which date was not more than 60 days 23 before the date of submitting this petition.’ ’’. 24 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 3030 IH (c) REPORTING TO CONGRESS.—Section 505(q)(3) of 1 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2 355(q)(3)) is amended— 3 (1) in the matter before subparagraph (A), by 4 striking ‘‘specifies’’; 5 (2) in subparagraphs (A), (B), (C), and (D), by 6 striking ‘‘the number’’ and inserting ‘‘specifies the 7 number’’; 8 (3) in subparagraph (C), by striking ‘‘and’’ at 9 the end; 10 (4) in subparagraph (D), by striking the period 11 at the end and inserting ‘‘; and’’; and 12 (5) by adding at the end the following: 13 ‘‘(E)(i) lists each petition submitted during 14 such period and, for each, identifies the peti- 15 tioner; 16 ‘‘(ii) quantifies the time and resources ex- 17 pended on each such petition; 18 ‘‘(iii) states the timing of the petition rel- 19 ative to the expiration date of the patents speci- 20 fied in the pending application in the certifi- 21 cation under subsection (b)(2)(A) or 22 (j)(2)(A)(vii), as applicable; 23 ‘‘(iv) quantifies the delay, if any, caused by 24 any such petition on the approval of any appli- 25 VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 3030 IH cation submitted under subsection (b)(2) or (j), 1 including a description of how any such delay is 2 calculated and an estimate of when any delayed 3 approval would have been granted absent the 4 petition; and 5 ‘‘(v) in cases in which a pending applica- 6 tion and a petition with respect to such pending 7 application are disposed of on the same or near- 8 ly the same date, states when the Food and 9 Drug Administration would have disposed of 10 the pending application absent the petition.’’. 11 Æ VerDate Sep 11 2014 03:21 May 12, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H3030.IH H3030 pbinns on DSKJLVW7X2PROD with $$_JOB