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HR 2387 116th Congress House

STOP GAMES Act of 2019

Official title: 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 i… Show full official titleShow less

Official title: 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.

Introduced: July 18, 2019 See on congress.gov
Health Administrative remediesCongressional oversightFood and Drug Administration (FDA)Government information and archivesPrescription drugs
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 13, 2019
Forwarded by Subcommittee to Full Committee by Voice Vote .
Nov 13, 2019
Subcommittee Consideration and Mark-up Session Held.
Apr 30, 2019
Referred to the Subcommittee on Health.
Apr 29, 2019
Referred to the House Committee on Energy and Commerce.
Apr 29, 2019
Introduced in House
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 Latest action November 13, 2019

Forwarded by Subcommittee to Full Committee by Voice Vote .

 Plain-English summary Congressional Research Service

Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2019 or the STOP GAMES Act of 2019

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 10
All 10 Democratic 8
D
Welch, Peter
Vermont · Sep 18, 2019
 D
Tlaib, Rashida
Michigan · Aug 27, 2019
 D
Green, Al
Texas · Jul 18, 2019
 D
Schakowsky, Janice D.
Illinois · Jul 16, 2019
JOHNSON, EDDIE
· Jun 19, 2019
 D
Khanna, Ro
California · Jun 13, 2019
 D
Garamendi, John
California · Jun 3, 2019
 D
Tonko, Paul
New York · Jun 3, 2019
 D
Doggett, Lloyd
Texas · May 30, 2019
Rooney, Francis
· Apr 29, 2019
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 2387: STOP GAMES Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-2387/
MLA
"H.R. 2387: STOP GAMES Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-2387/.
Bluebook (legal)
H.R. 2387, 116th Cong. (2026), https://openamerica.io/bill/116-HR-2387/.
Markdown link
[H.R. 2387: STOP GAMES Act of 2019](https://openamerica.io/bill/116-HR-2387/)
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