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FAIR Act: Faster Access to Life-Saving Medicines Through International Cooperation

This bill establishes a fast-track approval process for medicines treating life-threatening diseases that are already authorized by trusted partners like the EU or Canada. It aims to provide patients with quicker access to innovative therapies and cutting-edge clinical trials by reducing regulatory delays.
Key points
Drugs approved by trusted international regulators (e.g., EMA) can receive US marketing approval within 30 days.
The fast-track process is strictly limited to treatments for immediately life-threatening diseases or conditions.
Allows clinical trials to begin in the US based on authorizations already granted by trusted foreign authorities.
The FDA maintains the power to withdraw or suspend approval if new safety concerns or risks arise.
Designated trusted authorities include the European Medicines Agency, UK's MHRA, and Health Canada.
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Status:
Introduced
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Additional Information
FAIR ACT
Print number: HR 7953
Sponsor: Rep. Sessions, Pete [R-TX-17]
Process start date: 2026-03-17