Scientific EXPERT Act of 2024

The Scientific EXPERT Act of 2024 establishes a new process for FDA-led meetings focused on drug development for rare diseases. It requires the Reagan-Udall Foundation to convene at least four annual "science-focused drug development meetings" each year, bringing together medical experts, drug sponsors, patient groups, and FDA staff to discuss scientific challenges and align on approaches like clinical trial designs and endpoints. The bill mandates public reporting of meeting transcripts, summaries, and how FDA incorporated feedback into drug approval decisions, along with annual congressional reports on meeting impacts. This directly affects drug developers working on rare diseases, patient advocacy groups, and FDA review divisions, aiming to improve coordination in addressing unmet medical needs for rare conditions.