Bill > S822

This bill establishes a new process for science-focused drug development meetings specifically targeting rare diseases, to be led by the Reagan-Udall Foundation in collaboration with the Food and Drug Administration (FDA). Under this legislation, the Foundation will convene at least 4 meetings annually, focusing on different rare diseases or groups of rare diseases, with the goal of bringing together academic researchers, medical experts, drug sponsors, scientific organizations, and patient groups to discuss scientific challenges in drug development. A permanent Steering Committee will be created to help select meeting topics based on criteria such as unmet therapeutic needs, patient population size, and potential for regulatory flexibility. These meetings, called EL-SFDD (Externally Led Science-Focused Drug Development) meetings, will aim to identify scientific approaches to facilitate drug development, align on novel development strategies, and address clinical trial design challenges. After each meeting, the Foundation must publish a public report detailing meeting outcomes, areas of consensus, and next steps. The FDA will be required to participate in these meetings and, when approving drugs, must publicly explain how input from these meetings influenced their risk-benefit assessments. The bill authorizes $1,000,000 annually from 2025 to 2029 to support this initiative, with the broader purpose of expediting drug development for rare diseases and improving treatment options for patients with unmet medical needs.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/822/all-info