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.
About This Bill
Committee
Latest Action · May 19, 2026
Referred to the House Committee on Energy and Commerce.
The STOP GAMES Act of 2026 amends federal drug approval law to make it easier for the FDA to reject petitions that are primarily intended to delay the approval of generic drugs or biosimilars. The bill establishes specific factors the FDA should consider when determining whether a petition is filed to obstruct approvals, including submitting petitions long after relevant information became available, filing multiple similar petitions, submitting petitions timed to block patent expiration dates, or raising issues already addressed by the FDA. The law also requires anyone filing a lawsuit against the FDA over drug approvals to first submit a timely petition, and establishes stricter timelines and penalties for those who fail to do so. Additionally, the bill requires the FDA to report annually to Congress on all petitions received, including the time spent reviewing each one and any delays caused to drug approvals. The legislation aims to prevent companies from using the petition process as a tactic to keep cheaper generic and biosimilar drugs off the market.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.