118th Congress Health
H.R. 3030: STOP GAMES Act of 2023
Introduced
- Introduced (completed)
- Passed House (not reached)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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.
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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 Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Ann Kuster D-NH
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Other bills by Eric Sorensen
History
- Introduced in the House by Eric Sorensen.
Show the full action history (3 actions)
- Referred to the Subcommittee on Health.
- Introduced in House
- Referred to the House Committee on Energy and Commerce.