The Scientific EXPERT Act of 2024 establishes a new process for discussing drug development challenges related to rare diseases. Under the bill, the Reagan-Udall Foundation (a private nonprofit partner of the FDA) would organize at least four science-focused drug development meetings per year, bringing together medical experts, drug manufacturers, patient advocates, and FDA officials to identify scientific approaches and align on clinical trial designs, manufacturing standards, and other development strategies for rare disease treatments. The bill affects pharmaceutical companies, patient organizations, medical researchers, and the FDA, all of whom would participate in these stakeholder meetings. A permanent steering committee would recommend meeting topics based on unmet medical needs and opportunities to expedite drug approval. The FDA would be required to publicly report how it used input from these meetings when approving drugs and to submit annual reports to Congress on the program's impact. The legislation authorizes one million dollars annually for fiscal years 2025 through 2029 to support these activities.
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