Scientific EXPERT Act of 2025

HR 1532, the Scientific EXPERT Act of 2025, creates a new process for FDA to host annual "science-focused drug development meetings" (EL-SFDD meetings) specifically for rare diseases. The bill requires the Reagan-Udall Foundation to convene at least four such meetings yearly, bringing together FDA staff, drug developers, medical experts, patient groups, and scientific organizations to discuss scientific challenges and align on approaches like clinical trial designs and endpoints. The FDA must publicly summarize meeting outcomes and explain how input influenced drug approvals, while also reporting annually on meeting impact. This directly affects rare disease drug developers, FDA review divisions, and patient advocacy groups participating in these structured scientific discussions. The bill does not change drug approval standards but aims to streamline development through better scientific alignment.