Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021 or the STOP GAMES Act of 2021
This bill specifies factors that the Food and Drug Administration (FDA) must use in determining if a petition is submitted with the primary purpose of delaying the approval of a pending new or generic drug application. (Current law allows third parties, including interested parties, to file petitions asking the FDA to take various actions, such as to consider certain issues pertaining to an application for market approval for a drug; current law also allows the FDA to deny a petition that is submitted with the primary purpose of delaying approval of an application.)
The factors include (1) whether the petitioner filed serial petitions raising issues that could have been known to the petitioner when an earlier petition was filed, and (2) whether the petition has any data or information to support its scientific positions.
If the FDA finds that delay is the primary purpose of the petition, it must refer the matter to the Federal Trade Commission.
A party filing a petition must do so within 60 days of when the party first learned of the information on which the petition is based.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2843 Introduced in House (IH)]
<DOC>
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.
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 2021'' or the ``STOP
GAMES Act of 2021''.
SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE IS TO DELAY APPROVAL
OF CERTAIN APPLICATIONS.
(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 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.''.
(b) Deadline for Submission of Petitions.--
(1) Deadline.--Clause (i) of section 505(q)(1)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(A))
is amended 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
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) Certification.--Section 505(q)(1)(H) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)) 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: ____.'' 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.''.
(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.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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