H.R. 1532 — Scientific EXPERT Act of 2025

This section establishes a process under which the Reagan-Udall Foundation for the Food and Drug Administration (Foundation)—a nonprofit corporation that supports the FDA's mission to modernize medical product development and enhance safety—must convene no fewer than four externally-led, science-focused drug development (EL-SFDD) meetings each year, with each meeting addressing a different rare disease or condition (or group thereof). The meetings enable medical experts, drug sponsors, scientific organizations, and patient organizations to discuss scientific challenges in rare disease drug development, identify approaches to facilitate FDA review and approval, and align on tools such as clinical trial designs, biomarkers, and natural history controls. (1) The Foundation must form a permanent multistakeholder steering committee—including FDA center representatives, academic experts, patient advocates, and industry—to recommend meeting topics based on criteria including unmet needs, patient population size, regulatory flexibility needs, and potential broader impacts; (2) prior to each meeting, the Foundation must consult FDA staff, the steering committee, industry, patients, and stakeholders to set objectives, agendas, and invitees, with FDA review division representatives required to participate; and (3) within 180 days after each meeting, the Foundation must publish on the FDA website a transcript, recording, and summary analysis identifying areas of consensus, needed clarifications, and agreed next steps with FDA. This section states that it does not preclude other organizations from holding similar meetings or require FDA to act on meeting outputs.