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HR 1532119th CongressIntroduced
Scientific EXPERT Act of 2025
Introduced: Oct 29, 2025
Standard Summary
Comprehensive overview in 1-2 paragraphs
Establishes a process for externally led, science-focused drug development meetings to address challenges in rare disease drug development through collaboration between FDA, medical experts, patient organizations, and industry stakeholders.
Key Points
- 1Creates EL-SFDD (Externally Led Science-Focused Drug Development) meetings
- 2Requires Reagan-Udall Foundation to convene at least four meetings annually
- 3Establishes multistakeholder steering committee with diverse representation
- 4Mandates post-meeting reports with transcript and analysis within 180 days
- 5Requires FDA review division participation in meetings
- 6Authorizes $1 million annually for fiscal years 2026-2030
Impact Areas
Rare disease patients and advocacy groupsPharmaceutical industry developing rare disease treatmentsFDA drug approval processMedical research communityHealthcare providers treating rare diseases
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