Bill > HR1632

This bill, known as the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025, aims to create a new pathway for expediting the marketing approval of certain drugs, biological products, and medical devices in the United States by establishing a reciprocal marketing approval process. Under this legislation, the FDA can grant marketing approval to a product that is already legally marketed in select countries (including the United Kingdom) if the product meets specific criteria, such as demonstrating no safety concerns in its original markets, addressing an unmet medical need in the US, and not being a banned device. The FDA must make a decision within 30 days of receiving a request and can negotiate product labeling with the sponsor. The bill includes provisions for Congressional review of FDA decisions, allows for potential postmarket studies, and requires the FDA to conduct an outreach campaign to inform potential product sponsors about this new approval pathway. Importantly, products approved through this process would be subject to the same regulatory provisions as traditionally approved medical products, and sponsors would be required to pay standard application fees. The goal is to potentially accelerate access to innovative medical treatments that have already been deemed safe and effective in other developed countries.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/1632/all-info