I 

117TH CONGRESS 

1ST SESSION H. R. 2843 

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 purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 26, 2021 

Mr. LEVIN of Michigan 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 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 

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 ‘‘Stop The Overuse of 

5 Petitions and Get Affordable Medicines to Enter Soon Act 

6 of 2021’’ or the ‘‘STOP GAMES Act of 2021’’. 


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1 SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE 

2 IS TO DELAY APPROVAL OF CERTAIN APPLI3 CATIONS. 

4 (a) IN GENERAL.—Subparagraph (E) of section 

5 505(q)(1) of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 355(q)(1)) is amended to read as follows: 

7 ‘‘(E) DENIAL BASED ON INTENT TO

8 DELAY.— 

9 ‘‘(i) IN GENERAL.—If the Secretary 

10 determines that a petition or a supplement 

11 to the petition was submitted with the pri12 mary purpose of delaying the approval of 

13 an application or the petition does not on 

14 its face raise valid scientific or regulatory 

15 issues, the Secretary may deny the petition 

16 at any point based on such determination. 

17 ‘‘(ii) FACTORS.—The Secretary may 

18 issue guidance to describe the factors that 

19 will be used to determine under this sub20 paragraph whether a petition is submitted 

21 with the primary purpose of delaying the 

22 approval of an application. Such factors 

23 shall include the following: 

24 ‘‘(I) Submission of a petition 

25 where it appears, based on the date 

26 that relevant information relied upon 


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1 in the petition became known to the 

2 petitioner (or reasonably should have 

3 been known to the petitioner), that 

4 the petitioner has taken an unreason5 able length of time to submit the peti6 tion. 

7 ‘‘(II) Submission of multiple or 

8 serial petitions raising issues that rea9 sonably could have been known to the 

10 petitioner at the time of submission of 

11 the earlier petition or petitions. 

12 ‘‘(III) Submission of a petition 

13 close in time to a known, first date 

14 upon which an application under sub15 section (b)(2) or (j) of this section or 

16 under section 351(k) of the Public 

17 Health Service Act could be approved 

18 (such as submission close in time to 

19 the expiration of a blocking patent or 

20 exclusivity). 

21 ‘‘(IV) Submission of a petition 

22 without any data or information in 

23 support of the scientific positions set 

24 forth in the petition. 


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1 ‘‘(V) Submission of a petition 

2 raising the same or substantially simi3 lar issues as a prior petition to which 

4 the Food and Drug Administration 

5 has already substantively responded, 

6 particularly where the subsequent sub7 mission closely follows in time the ear8 lier response. 

9 ‘‘(VI) Submission of a petition 

10 concerning standards for approval of 

11 a drug product for which— 

12 ‘‘(aa) the Food and Drug 

13 Administration has provided an 

14 opportunity for public input 

15 (such as when the Food and 

16 Drug Administration has issued 

17 draft or final product-specific 

18 guidance applicable to the drug 

19 product); and 

20 ‘‘(bb) the petitioner has not 

21 provided comment other than 

22 through the petition. 

23 ‘‘(VII) Submission of a petition 

24 requesting that other applicants must 

25 meet standards for testing, data, or 


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1 labeling for their products that are 

2 more onerous or rigorous than the 

3 standards applicable to the applicable 

4 listed drug or the petitioner’s version 

5 of the same product. 

6 ‘‘(VIII) Other relevant consider7 ations, including the history of the pe8 titioner with the Food and Drug Ad9 ministration (such as whether the pe10 titioner has a history of submitting 

11 petitions which the Food and Drug 

12 Administration has determined were 

13 submitted with the primary purpose of 

14 delay). 

15 ‘‘(iii) REFERRAL TO FTC.—If the Sec16 retary determines that a petition has been 

17 submitted with the primary purpose of de18 laying the approval of an application, as 

19 described in clause (i), the Secretary shall 

20 refer the matter to the Federal Trade 

21 Commission.’’. 

22 (b) DEADLINE FOR SUBMISSION OF PETITIONS.— 

23 (1) DEADLINE.—Clause (i) of section 

24 505(q)(1)(A) of the Federal Food, Drug, and CosVerDate Sep 11 2014 02:42 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2843.IH H2843

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1 metic Act (21 U.S.C. 355(q)(1)(A)) is amended to 

2 read as follows: 

3 ‘‘(i) the request is in writing, is a pe4 tition submitted to the Secretary pursuant 

5 to section 10.30, 10.31, or 10.35 of title 

6 21, Code of Federal Regulations (or any 

7 successor regulations), and is submitted 

8 not later than 60 days after the informa9 tion upon which the petition is based first 

10 became known to the party on whose be11 half the petition is submitted; and’’. 

12 (2) CERTIFICATION.—Section 505(q)(1)(H) of 

13 the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 355(q)(1)) is amended by striking ‘‘I further 

15 certify that the information upon which I have based 

16 the action requested herein first became known to 

17 the party on whose behalf this petition is submitted 

18 on or about the following date: llll.’’ and in19 serting ‘‘I further certify that the information upon 

20 which I have based the action requested herein first 

21 became known to the party on whose behalf this pe22 tition is submitted on or about llll, which 

23 date was not more than 60 days before the date of 

24 submitting this petition.’’. 


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1 (c) REPORTING TO CONGRESS.—Section 505(q)(3) of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 355(q)(3)) is amended— 

4 (1) in the matter before subparagraph (A), by 

5 striking ‘‘specifies’’; 

6 (2) in subparagraphs (A), (B), (C), and (D), by 

7 striking ‘‘the number’’ and inserting ‘‘specifies the 

8 number’’; 

9 (3) in subparagraph (C), by striking ‘‘and’’ at 

10 the end; 

11 (4) in subparagraph (D), by striking the period 

12 at the end and inserting ‘‘; and’’; and 

13 (5) by adding at the end the following: 

14 ‘‘(E)(i) lists each petition submitted during 

15 such period and, for each, identifies the peti16 tioner; 

17 ‘‘(ii) quantifies the time and resources ex18 pended on each such petition; 

19 ‘‘(iii) states the timing of the petition rel20 ative to the expiration date of the patents speci21 fied in the pending application in the certifi22 cation under subsection (b)(2)(A) or 

23 (j)(2)(A)(vii), as applicable; 

24 ‘‘(iv) quantifies the delay, if any, caused by 

25 any such petition on the approval of any appliVerDate Sep 11 2014 02:42 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2843.IH H2843

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1 cation submitted under subsection (b)(2) or (j), 

2 including a description of how any such delay is 

3 calculated and an estimate of when any delayed 

4 approval would have been granted absent the 

5 petition; and 

6 ‘‘(v) in cases in which a pending applica7 tion and a petition with respect to such pending 

8 application are disposed of on the same or near9 ly the same date, states when the Food and 

10 Drug Administration would have disposed of 

11 the pending application absent the petition.’’. 

Æ 


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