FAIR ACT

This bill would let the Food and Drug Administration (FDA) approve certain drugs and biological products for sale in the U.S. if they are already lawfully sold in another country under approval from a trusted foreign regulator, such as the European Medicines Agency, the United Kingdom's medicines agency, or Health Canada. The product must be meant to diagnose, treat, or ease an immediately life-threatening disease or condition, and the FDA would have to decide on each request within 30 days. The FDA could withdraw or suspend this approval if new evidence shows serious risks or if the foreign regulator pulls its approval. The bill would also let manufacturers ask to run clinical trials in the U.S. based on a trusted foreign regulator's authorization of the same trial, with an FDA decision due within 30 days. The FDA would report to Congress on the program within 5 years.

Full text and official record on Congress.gov

Sponsors

• Pete Sessions Republican sponsor
• 4 cosponsors