FAIR ACT
Sponsored By: Representative Sessions
Introduced
Summary
Reciprocal recognition of trusted foreign approvals to speed U.S. access to treatments and clinical trials for immediately life‑threatening diseases. The bill would create two parallel pathways that let covered drugs rely on authorizations from trusted international regulators while requiring U.S. labeling, postmarket studies, and safety safeguards.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Faster U.S. trials for critically ill
If enacted, this bill would let sponsors use a trusted foreign regulator's authorization to start the same clinical investigation in the U.S. The agency would treat the submission like a standard U.S. investigational application and must allow or deny it within 30 calendar days. The agency may request protocol changes but must still decide within 30 days. The rule would apply only to products for immediately life‑threatening diseases and trusted regulators include the EMA, MHRA, and Health Canada.
Faster access to drugs for critically ill
If enacted, this bill would let some drugs approved by trusted foreign regulators count as U.S. approvals for certain life‑threatening conditions. The agency would have 30 calendar days to grant or deny requests and to finalize labeling and postmarket study plans. Requests would be treated as applications for FDA user fees. The agency could suspend or withdraw approval quickly for new safety or mortality risks and could allow a phase‑out to reduce treatment disruption. The agency must report to Congress on program results not later than five years after enactment.
Sponsors & CoSponsors
Sponsor
Sessions
TX • R
Cosponsors
Peters
CA • D
Sponsored 3/17/2026
Roll Call Votes
No roll call votes available for this bill.
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