Bill > S3081

This bill (the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025) establishes a new process for expediting the marketing approval of drugs, biological products, and medical devices in the United States by creating a "reciprocal marketing approval" mechanism. Under this process, the FDA can grant marketing approval to a product that is already legally marketed in certain foreign countries (including those on a specific list and the United Kingdom) if the product meets specific criteria. To be eligible, the product must not already be approved in the U.S., must not have been withdrawn from foreign markets due to safety concerns, and must address a public health or unmet medical need. The FDA has 30 days to review a reciprocal approval request and can decline approval if the product is deemed unsafe or ineffective, but such a decision can be overridden by a congressional joint resolution. The bill also requires the FDA to negotiate product labeling with the sponsor and classify devices appropriately. Additionally, the legislation mandates that the FDA conduct an outreach campaign to encourage potential product sponsors to seek reciprocal marketing approval, and treats these requests similarly to standard FDA approval processes for fee and regulatory purposes.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3081/all-info