PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Apr 28, 2023
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2023 or the STOP GAMES Act of 2023
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Sorensen, Eric [D-IL-17] · D–IL
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Jul 24, 2024. Consult Congress.gov for the current record.
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