Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

This bill establishes a new pathway for reciprocal marketing approval for certain drugs, biological products, and devices under the Federal Food, Drug, and Cosmetic Act. It aims to streamline the availability of treatments by allowing products already authorized in specific foreign countries, such as those on a designated list or in the United Kingdom, to gain expedited approval in the United States. This pathway is specifically for products not yet approved or cleared for marketing in the U.S. and for which there is a public health or unmet medical need . To qualify, a product's sponsor must submit a request demonstrating that the product is lawfully marketed abroad and that its foreign authorization has not been rescinded due to safety or effectiveness concerns. The Secretary of Health and Human Services, acting through the FDA, must issue a decision to grant or decline approval within 30 days of receiving a complete request. While the Secretary may decline approval if there are affirmative safety or effectiveness concerns, such denials must be reported to Congress monthly and can be overturned by a joint resolution of disapproval from Congress, effectively granting the approval. Products receiving reciprocal marketing approval will be subject to the same regulatory provisions and fees as conventionally approved or cleared products. The bill also requires the Secretary to conduct an outreach campaign, encouraging eligible product sponsors to utilize this new streamlined approval mechanism. This initiative seeks to accelerate access to potentially life-saving treatments by leveraging international regulatory approvals.