S. 3081 — Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

This section establishes a reciprocal marketing approval pathway under new section 524C of the Federal Food, Drug, and Cosmetic Act for covered drugs, biological products, and devices (i.e., those authorized for marketing in countries listed under section 802(b)(1)—such as Australia, Canada, the EU, Japan, and others—or the United Kingdom) that address a U.S. public health need or unmet medical need and are not already approved or cleared in the United States. The Secretary of Health and Human Services must grant such approval within 30 days of a sponsor's request if eligibility criteria are met—including no prior safety- or effectiveness-based rescissions or withdrawals of approval in the United States or relevant foreign countries and no banned-device status—and may condition it on postmarket studies (including under a risk evaluation and mitigation strategy). The Secretary may decline approval upon an affirmative determination of lack of safety or effectiveness and must report monthly denials to specified congressional committees; such denials do not take effect if Congress enacts a joint resolution of disapproval under expedited procedures (thus, enabling congressional override to grant approval). Reciprocally approved products are deemed approved or cleared under sections 505(c), 510(k), or 515 of the FD&C Act or section 351(a) of the PHS Act (as applicable), are subject to the same statutory provisions as traditionally approved products, and incur fees as if they were standard applications; during the 30-day review, the Secretary must finalize labeling with the sponsor and classify devices as needed.