Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

Creates a new “reciprocal marketing approval” pathway that lets eligible drugs, biological products, and medical devices approved in specified foreign countries (including the United Kingdom) be treated like FDA‑approved or FDA‑cleared products in the United States. The FDA must apply safety checks, ensure U.S.‑compliant labeling, and make a decision within 30 days of a company’s request, with clear treatment of applicable fees.

It defines which products are covered, directs outreach to encourage eligible sponsors to apply, and allows Congress to review and disapprove specific FDA decisions made under this pathway.