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