118th Congress · HOUSE BILLBILL

H.R. 3030 — STOP GAMES Act of 2023

“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.”

Health

Introduced Apr 28, 2023

Last action May 5, 2023

Pipeline · Bill → Law

Step 1

Introduced

Apr 28, 2023

Step 2

Referred

May 5, 2023

E&C

Step 3

Committee

Step 4

House floor

Step 5

Senate

Step 6

Resolve Changes

Step 7

Signed

SummaryCRS 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 petition...

Provisions · 2 sectionsIntroduced in House

Timeline · 3 actions

May 5, 2023

Referred to the Subcommittee on Health.

Apr 28, 2023

Introduced in House

Apr 28, 2023

Referred to the House Committee on Energy and Commerce.