S. 822 — Scientific EXPERT Act of 2025

This section establishes a process, led by the Reagan-Udall Foundation for the Food and Drug Administration (Foundation)—a nonprofit created to advance the FDA's mission in modernizing medical product development, accelerating innovation, and enhancing product safety—for science-focused drug development (EL-SFDD) meetings to enable academic researchers, medical experts, drug sponsors, scientific organizations, and patient organizations to discuss scientific challenges in developing drugs for rare diseases and conditions; identify approaches to facilitate development, review, and approval; and align on novel strategies such as clinical trial designs, biomarkers as surrogate endpoints, and natural history controls. (Thus, these meetings aim to expedite treatments for unmet medical needs in rare diseases.) The section directs the FDA Secretary to enter an arrangement with the Foundation requiring at least 4 EL-SFDD meetings annually—each focused on a different rare disease or condition or group thereof—with a permanent multistakeholder steering committee to recommend topics based on criteria including unmet needs, patient population size, development pipelines, regulatory flexibility needs, drug development clarity, and broader impacts; planning processes involving stakeholder consultations for objectives, agendas, and invitees; mandatory participation by FDA review division representatives; and public posting on the FDA website within 180 days post-meeting of transcripts, recordings, and summary analyses identifying consensus areas, clarification needs, and agreed next steps with FDA.