Creates a recurring, foundation-led process for externally led, science-focused drug development (EL–SFDD) meetings to tackle scientific challenges in developing medicines for rare diseases. It requires at least four meetings per year, establishes a permanent multi‑stakeholder Steering Committee, mandates public post‑meeting reports (including transcripts) within 180 days and annual reports to Congress, and directs participation by the Secretary and FDA review staff.

Authorizes $1,000,000 per year for fiscal years 2025–2029 to run the program and requires the Secretary to publicly state when meeting input was relevant to FDA approvals and explain how that input was considered in risk‑benefit assessments.