FAIR ACT
Sponsored By: Representative Sessions
Introduced
Summary
Reciprocal regulatory approval to speed U.S. access to drugs and trials for immediately life‑threatening diseases by recognizing certain trusted foreign authorizations and creating a parallel clinical‑trial allowance. The bill pairs a marketing‑approval pathway with a clinical‑investigation pathway, and sets 30‑day decision windows for sponsor requests while preserving postmarket safety controls.
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- Patients and families: People with immediately life‑threatening conditions would get faster access to therapies and clinical trials that are already authorized by trusted foreign regulators. Decisions on requests would be issued within 30 days.
- Manufacturers and sponsors: Drug makers could submit foreign authorization dossiers and English translations from trusted regulators such as the European Medicines Agency, the UK Medicines and Healthcare Products Regulatory Agency, or Health Canada to request reciprocity. Those requests would be treated like standard applications for fee purposes.
- Safety and oversight: The Secretary could set labeling, require postmarket studies, and suspend or withdraw reciprocal approval if new clinical or real‑world evidence shows unreasonable risk. If adverse events occur in the first 30 days the Secretary may publicly order an immediate stop and use phase‑out plans to protect patients. A report to Congress on program outcomes is required within 5 years.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Faster access to life-saving drugs
If enacted, drug makers could ask FDA to treat certain trusted foreign approvals as meeting U.S. approval rules. FDA would have 30 days to grant or deny that request and to set U.S. labeling and any postmarket study rules. The bill would also let sponsors use a trusted foreign regulator's trial authorization to start the same U.S. clinical trial, with FDA deciding within 30 days. Trusted regulators named include the European Medicines Agency, the UK regulator, and Health Canada, and FDA could add others. FDA would be able to quickly suspend or withdraw marketing if new safety evidence appears and may require patient transition plans when stopping a product.
Higher application fees for manufacturers
If enacted, a request for reciprocal marketing approval would be treated like a regular FDA application for fee purposes. Sponsors would owe the same FDA user fees that apply to 505(c), 510(k), or 351(a) submissions. The bill would not change fee amounts or create new fee exemptions.
Sponsors & CoSponsors
Sponsor
Sessions
TX • R
Cosponsors
Peters
CA • D
Sponsored 3/17/2026
Rep. Moulton, Seth [D-MA-6]
MA • D
Sponsored 5/12/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov