Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

The proposed legislation aims to amend the Federal Food, Drug, and Cosmetic Act by creating a new pathway for reciprocal marketing approval. This pathway would allow certain drugs, biological products, and devices that are already lawfully marketed in specified foreign countries to be deemed approved for marketing in the United States. The primary goal is to streamline the availability of treatments, particularly those addressing a public health or unmet medical need. To qualify for reciprocal marketing approval, a product's sponsor must submit a request demonstrating several key conditions. The product must be authorized for marketing in the United Kingdom or one of the countries listed under section 802(b)(1) of the Federal Food, Drug, and Cosmetic Act, which typically includes nations with robust regulatory systems. Furthermore, the product must not already be FDA-approved or cleared, and neither the FDA nor the foreign regulatory body should have rescinded its authorization due to safety or effectiveness concerns. A crucial requirement is that there must be a public health or unmet medical need for the product in the United States. While the Secretary of Health and Human Services is generally mandated to grant approval if eligibility criteria are met, they retain the authority to decline if they affirmatively determine the product is not safe and effective. The Secretary must issue a decision on a request within a strict 30-day timeframe. Additionally, the bill includes a mechanism for Congressional disapproval of the Secretary's decision to deny reciprocal marketing approval, effectively allowing Congress to override a denial and enable the product's approval. The Secretary is also required to conduct outreach to encourage eligible product sponsors to utilize this new pathway.