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.
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.
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