STOP GAMES Act of 2026
Sponsored By: Representative Sorensen, Eric [D-IL-17]
Introduced
Summary
Stop petition-based delays of drug approvals is the core aim of this bill. It would tighten filing deadlines, give FDA clear factors to deny petitions meant to stall approvals, enable FTC referrals for abusive filings, and expand reporting to Congress.
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- Patients and families would likely see shorter approval delays because FDA could deny petitions submitted primarily to stall reviews and must report estimated delay amounts to Congress.
- Generic and biosimilar developers would face less late-stage uncertainty because petitioners must file within 60 days of learning the basis and serial or untimely challenges can be treated as delay tactics.
- Petitioners and litigants would face tighter deadlines and consequences: FDA can refer suspected delay petitions to the Federal Trade Commission and courts may dismiss lawsuits that bypass or miss administrative petitions after 151 days.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Limits on petitions that delay drugs
If enacted, this bill would tighten when and how people can file FDA petitions that challenge drug approvals. Petitions would have to be in writing and filed within 60 days after the filer first learned the information. FDA could deny petitions that are mainly meant to delay approval and would refer such cases to the Federal Trade Commission. On or after 151 days after a petition is filed, FDA could treat the related application as approved. FDA would also have to report to Congress who filed each petition, time and resources spent, and estimated approval delays and how they were calculated.
Sponsors & CoSponsors
Sponsor
Sorensen, Eric [D-IL-17]
IL • D
Cosponsors
Rep. Bice, Stephanie I. [R-OK-5]
OK • R
Sponsored 5/19/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov