Scientific EXPERT Act of 2025

This bill amends the Federal Food, Drug, and Cosmetic Act to establish a new process for externally led, science-focused drug development (EL-SFDD) meetings. These meetings, convened by the Reagan-Udall Foundation, aim to provide a forum for academic researchers, medical experts, drug sponsors, scientific organizations, and patient groups. Their primary purpose is to discuss science-related challenges, identify innovative approaches, and align on novel strategies to facilitate the development, review, and approval of drugs for rare diseases and conditions.

The Foundation is required to convene no fewer than four EL-SFDD meetings each year, with each focusing on a different rare disease or group of diseases. A permanent Steering Committee will advise the Foundation on selecting meeting topics, considering criteria such as unmet therapeutic needs, patient population size, and the potential for increased regulatory flexibility. Following each meeting, the Foundation must publicly release a transcript, recording, and a summary analysis of the input received, identifying areas of consensus, clarification needed, and agreed-upon next steps.

The bill mandates that appropriate representatives from the Food and Drug Administration's (FDA) review divisions participate in these meetings. Annually, the Secretary must submit a report to Congress summarizing the meetings' impact on FDA workload and how the input influenced regulatory decision-making. To support these activities, the bill authorizes an appropriation of $1,000,000 for each of fiscal years 2025 through 2029.