S.3081

The bill proposes reciprocal marketing approval for drugs, biological products, and devices authorized abroad.

The Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to allow for reciprocal marketing approval of drugs, biological products, and devices authorized abroad. The Secretary of Health and Human Services can grant approval if the product is authorized in specified countries or the UK, not already approved in the U.S., and meets safety and effectiveness standards. The bill includes provisions for labeling, device classification, and postmarket studies. It also allows for Congressional disapproval of approval denials.