Scientific EXPERT Act of 2025

S 822, the Scientific EXPERT Act of 2025, establishes a new process for FDA-led meetings focused on drug development for rare diseases. It requires a Foundation to convene at least four annual "science-focused drug development meetings" each year, bringing together researchers, drug sponsors, patient groups, and FDA review staff to address scientific challenges like clinical trial design and biomarker use for rare conditions. The bill mandates public summaries of meeting outcomes and requires the FDA to disclose how input from these meetings influenced drug approval decisions. This directly affects FDA review divisions, rare disease drug developers, and patient advocacy groups by creating a structured forum to align on development strategies for unmet medical needs. The program is funded with $1 million annually from fiscal years 2025-2029.