Bill > HR1532

This bill establishes a new process for externally led, science-focused drug development meetings specifically targeting rare diseases, primarily administered through the Reagan-Udall Foundation. The Foundation will be required to convene at least four meetings annually, focusing on different rare diseases or groups of rare diseases, with a diverse Steering Committee that includes representatives from FDA centers, academic experts, patient advocates, and industry professionals. These meetings will provide a platform for medical experts, drug sponsors, scientific organizations, and patient groups to discuss scientific challenges in drug development, identify innovative approaches, and align on critical aspects like clinical trial designs, manufacturing standards, and potential treatment strategies. The meetings will aim to expedite drug development by creating opportunities for collaborative problem-solving and knowledge sharing. After each meeting, a public report will be generated within 180 days, detailing meeting transcripts, areas of consensus, needed clarifications, and agreed-upon next steps. The FDA will be required to participate in these meetings and, when approving drugs, must publicly explain how insights from these meetings were incorporated into their risk-benefit assessments. The bill authorizes $1,000,000 annually from fiscal years 2026 through 2030 to support this initiative, with the goal of advancing treatment options for rare diseases and addressing unmet medical needs.

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https://www.congress.gov/bill/119th-congress/house-bill/1532/all-info