H.R. 2843 · 117th Congress
STOP GAMES Act of 2021
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
LevinSponsorNo cosponsors.
Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021 or the STOP GAMES Act of 2021
What it does: CRS summary · Introduced in House · Apr 26, 2021
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: STOP GAMES Act of 2021
Also known as: Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021
Latest action (Apr 27, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 26, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.