STOP GAMES Act of 2026
- Sponsor
- Rep. Sorensen, Eric [D-IL-17]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- May 19, 2026
Bottom line
The STOP GAMES Act aims to expedite the approval and market entry of generic and biosimilar drugs by curbing the use of citizen petitions as a tactic to delay competition and lower drug costs.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to strengthen the Food and Drug Administration's (FDA) ability to deny citizen petitions that are primarily intended to delay the approval of generic or biosimilar drug applications. It clarifies factors for determining dilatory intent, shortens the window for submitting petitions, and modifies administrative remedy exhaustion rules for related civil actions, including mandatory referral of dilatory petitions to the Federal Trade Commission (FTC).
Proponents argue
Proponents argue that the bill will reduce 'patent thickets' and 'evergreening' strategies by brand-name drug manufacturers, fostering competition, lowering drug costs for consumers, and increasing access to affordable medicines. They contend it streamlines the FDA approval process by preventing the abuse of administrative procedures that currently delay the availability of cheaper alternatives.
Opponents contend
Opponents, likely brand-name pharmaceutical companies or their advocates, might argue that the bill could limit legitimate avenues for raising scientific or regulatory concerns about generic or biosimilar applications, potentially compromising patient safety or drug quality. They may also contend that the proposed 60-day submission window is too short for complex issues, leading to rushed or incomplete reviews.
The bill is concise, allowing for a quick understanding of its core intent and mechanisms within a reasonable timeframe.
Section 2(a)(1)
Clarified Petition Submission Timeline
This provision amends Section 505(q)(1)(A)(i) of the FFDCA, requiring that citizen petitions related to drug applications must be submitted no later than 60 days after the information upon which the petition is based first became known to the petitioner. This significantly shortens the previous, less defined timeframe for submitting such petitions to the FDA.
Supporters argue
Supporters argue this change prevents petitioners from strategically delaying submissions until just before a generic drug's approval, a tactic used to maximize market exclusivity. It forces timely engagement with regulatory issues.
Critics contend
Opponents might argue that complex scientific or regulatory issues may require more than 60 days to fully investigate and prepare a robust petition, potentially leading to rushed or incomplete submissions that fail to raise valid concerns effectively.
Tradeoffs
This provision balances the need for timely regulatory review and market entry against the right of stakeholders to raise legitimate concerns, potentially sacrificing thoroughness for speed.
Section 2(a)(2)
Enhanced FDA Authority to Deny Delaying Petitions and Factors
This provision amends Section 505(q)(1)(E) to explicitly allow the FDA to deny a petition at any point if it determines the primary purpose is to delay application approval or if it doesn't raise valid scientific/regulatory issues. It also mandates the FDA to issue guidance on factors for determining dilatory intent, including unreasonable submission time, multiple serial petitions, submission close to patent expiration, lack of supporting data, repeated issues, and requests for more onerous standards for competitors.
Section 2(a)(2)(E)(iii)
Mandated Referral of Dilatory Petitions to FTC
If the FDA determines a petition was submitted with the primary purpose of delaying application approval, this provision mandates that the Secretary shall refer the matter to the Federal Trade Commission (FTC). This introduces a potential antitrust or unfair competition review for such actions, adding another layer of scrutiny.
Section 2(b)
Revised Rules for Judicial Review of Petitions
This section amends FFDCA 505(q)(2) to revise the conditions under which civil actions related to drug applications can be filed. It mandates dismissal without prejudice if a civil action is filed without first submitting a petition to the FDA, and dismissal with prejudice if a petition is filed after the 60-day deadline. It also clarifies that civil actions filed before the FDA takes final agency action on a timely petition will be dismissed without prejudice for failure to exhaust administrative remedies.
Section 2(c)
Enhanced Congressional Reporting on Petitions
This provision amends FFDCA 505(q)(3) to require more detailed annual reporting to Congress by the FDA regarding citizen petitions. The report must now list each petition and petitioner, quantify time and resources expended, state timing relative to patent expiration, quantify any approval delays caused by petitions (with calculation methods and estimated approval dates absent the petition), and state when applications would have been disposed of if not for co-occurring petitions.