What does Preamble of STOP GAMES Act of 2026 do?

This bill proposes to amend section 505 of the Federal Food, Drug, and Cosmetic Act. The amendment aims to clarify the process for denying petitions intended to delay the approval of applications. Specifically, it addresses petitions whose primary purpose is to delay applications submitted under subsections (b)(2) or (j) of section 505.

What does SHORT TITLE. of STOP GAMES Act of 2026 do?

This bill is formally titled the 'Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2026' or the 'STOP GAMES Act of 2026'.

What does DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE IS TO DELAY APPROVAL of STOP GAMES Act of 2026 do?

This section amends Section 505(q) of the Federal Food, Drug, and Cosmetic Act to address petitions submitted with the primary purpose of delaying the approval of applications. It allows the Secretary to deny petitions determined to be submitted with the primary purpose of delaying approval or lacking valid scientific or regulatory issues. The Secretary may issue guidance outlining factors to determine if a petition is submitted for delay, including timing of submission relative to patent expirations and submission of multiple petitions. If the Secretary determines a petition is for delay, the matter is referred to the Federal Trade Commission. The section modifies exhaustion of administrative remedies requirements, specifying timelines and consequences for failing to submit a petition before filing a civil action. It requires the Secretary to report to Congress on petitions submitted, including information on timing, resources expended, and any delays caused to application approvals.

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STOP GAMES Act of 2026

Last updated: 5/19/2026 · Introduced: 5/19/2026

Author: Eric Sorensen (D-IL)

TL;DR (AI)

The bill allows the Food and Drug Administration (FDA) Secretary to deny petitions submitted primarily to delay the approval of drug applications.
The FDA Secretary may issue guidance to determine if a petition's intent is to cause delay, considering factors like timing relative to patent expirations.
Petitions determined to be for delay will be referred to the Federal Trade Commission, and the FDA must report to Congress on petition activity and its impact on application approval timelines.

119th Congressin committeeOfficial page

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