H.R. 1632 — Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2025

This section establishes a reciprocal marketing approval pathway deeming drugs, biological products, and devices (covered products) authorized for marketing in countries listed under section 802(b)(1) (i.e., Australia, Canada, the European Union, Japan, New Zealand, Switzerland) or the United Kingdom as approved or cleared under FDA requirements (sections 505(c), 510(k), 515, or section 351(a) of the Public Health Service Act), if a sponsor's request demonstrates eligibility criteria including U.S. public health need, lack of prior U.S. approval, and no safety- or effectiveness-related rescissions abroad or domestically. The Secretary must act on requests within 30 days, finalizing labeling and (for devices) classification during that period; may condition approval on postmarket studies; and must report monthly denials to congressional committees, which are subject to expedited joint resolution of disapproval. Other FDCA provisions and user fees apply to such products as if traditionally approved.