The bill would require the Reagan-Udall Foundation for the FDA to hold at least four science-focused meetings each year about developing drugs for rare diseases. The meetings would bring together FDA staff, researchers, drug sponsors, medical experts, and patient groups to discuss topics such as clinical trials, treatment measures, and biomarkers. Within 180 days after each meeting, the Foundation would publish a transcript, recording, and summary of the discussion. The FDA would also report to Congress each year and disclose whether relevant meeting input was used in a drug’s risk-benefit assessment.
People with rare diseases and their organizations could take part in discussions about drug development. The bill does not guarantee that a particular drug will be developed, approved, or covered.
The bill authorizes $1 million per year for fiscal years 2025 through 2029 to carry out the meeting process, and separately authorizes $1 million per year for the required follow-up actions. These are authorizations, not statements of actual spending. No publicly available information on personal costs.
No publicly available information.
No publicly available information.