H.R. 8908

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8908 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8908

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

May 19, 2026

Mr. Sorensen (for himself and Mrs. Bice) 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.

Be it enacted by the Senate and House of Representatives 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 2026'' or the ``STOP 
GAMES Act of 2026''.

SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE IS TO DELAY APPROVAL 
OF CERTAIN APPLICATIONS.

(a) In General.--Section 505(q)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(q)(1))--
(1) in subparagraph (A), by amending clause (i) to read as 
follows:
``(i) the request is in writing, is a 
petition 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 
the date that is 60 days after the information 
upon which the petition is based first became 
known to the party on whose behalf the petition 
is submitted; and'';
(2) by amending subparagraph (E) 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 primary 
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 subparagraph 
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 
in the petition became known to the 
petitioner (or reasonably should have 
been known to the petitioner), that the 
petitioner has taken an unreasonable 
length of time to submit the petition.
``(II) Submission of multiple or 
serial petitions raising issues that 
reasonably 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 
subsection (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.
``(V) Submission of a petition 
raising the same or substantially 
similar issues as a prior petition to 
which the Food and Drug Administration 
has already substantively responded, 
particularly where the subsequent 
submission closely follows in time the 
earlier 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 
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 
considerations, including the history 
of the petitioner with the Food and 
Drug Administration (such as whether 
the petitioner 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 Secretary 
determines that a petition has been submitted 
with the primary purpose of delaying the 
approval of an application, as described in 
clause (i), the Secretary shall refer the 
matter to the Federal Trade Commission.'';
(3) by striking subparagraph (F);
(4) by redesignating subparagraphs (G) through (I) as 
subparagraphs (F) through (H), respectively;
(5) in subparagraph (G), as so redesignated, 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: __________.''' 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 __________, which 
date was not more than 60 days before the date of submitting 
this petition.'''; and
(6) in subparagraph (H), as so redesignated, by striking 
```submission of this petition''' and inserting ```submission 
of this document'''.
(b) Exhaustion of Administrative Remedies.--Section 505(q)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(2)) is 
amended--
(1) in subparagraph (A)--
(A) in the heading, by striking ``within 150 
days'';
(B) in clause (i), by striking ``during the 150-day 
period referred to in paragraph (1)(F),''; and
(C) by amending clause (ii) to read as follows:
``(ii) on or after the date that is 151 
days after the date of submission of the 
petition, the Secretary approves or has 
approved the application that is the subject of 
the petition without having made such a final 
decision.''; and
(2) by amending subparagraph (B) to read as follows:
``(B) Dismissal of certain civil actions.--
``(i) Petition.--If a person files a civil 
action against the Secretary in which a person 
seeks to set aside, delay, rescind, withdraw, 
or prevent submission, review, or approval of 
an application submitted under subsection 
(b)(2) or (j) of this section or section 351(k) 
of the Public Health Service Act without first 
submitting a petition to the Secretary under 
paragraph (1) that describes all information 
and arguments that form the basis of the relief 
requested in such civil action, the court shall 
dismiss without prejudice the action for 
failure to exhaust administrative remedies.
``(ii) Timeliness.--If a person files a 
civil action against the Secretary in which a 
person seeks to set aside, delay, rescind, 
withdraw, or prevent submission, review, or 
approval of an application submitted under 
subsection (b)(2) or (j) of this section or 
section 351(k) of the Public Health Service Act 
after the date described in paragraph 
(1)(A)(i), the court shall dismiss with 
prejudice the action for failure to timely file 
a petition.
``(iii) Final response.--If a civil action 
is filed against the Secretary with respect to 
any issue raised in a petition timely filed 
under paragraph (1) in which the petitioner 
requests that the Secretary take any form of 
action that could, if taken, set aside, delay, 
rescind, withdraw, or prevent submission, 
review, or approval of an application submitted 
under subsection (b)(2) or (j) of this section 
or section 351(k) of the Public Health Service 
Act before the Secretary has taken final agency 
action on the petition within the meaning of 
subparagraph (A), the court shall dismiss 
without prejudice the action for failure to 
exhaust administrative remedies.''.
(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 petitioner;
``(ii) quantifies the time and resources expended 
on each such petition;
``(iii) states the timing of the petition relative 
to the expiration date of the patents specified in the 
pending application in the certification 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 application 
submitted under subsection (b)(2) or (j), including a 
description of how any such delay is calculated and an 
estimate of when any delayed approval would have been 
granted absent the petition; and
``(v) in cases in which a pending application and a 
petition with respect to such pending application are 
disposed of on the same or nearly the same date, states 
when the Food and Drug Administration would have 
disposed of the pending application absent the 
petition.''.
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