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HR 3030 118th Congress House Health Administrative remedies Congressional oversight Food and Drug Administration (FDA) Government information and archives Prescription drugs

STOP GAMES Act of 2023

Introduced: April 28, 2023 Introduced by: Sorensen, Eric Democratic · Illinois See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 5, 2023
Referred to the Subcommittee on Health.
Apr 28, 2023
Referred to the House Committee on Energy and Commerce.
Apr 28, 2023
Introduced in House
 Plain-English summary Congressional Research Service

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.

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.

What's happening now May 5, 2023

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2