Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

Creates a new “reciprocal marketing approval” pathway that lets the FDA treat certain drugs, biological products, or medical devices already lawfully marketed in specified foreign countries or the United Kingdom as if they have U.S. approval or clearance when a sponsor asks and defined conditions are met. The Secretary can deny a request on safety grounds, require postmarket studies or other conditions, must decide on requests within 30 days, and must report denied requests monthly to certain congressional committees.