Amends the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings (EL-SFDD).
Aims to facilitate discussions among medical experts, drug sponsors, scientific organizations, and patient organizations regarding challenges in drug development for rare diseases.
Requires the Secretary to develop a process for these meetings to identify scientific approaches and align on drug development strategies.
The Reagan-Udall Foundation will convene a minimum of four EL-SFDD meetings annually, each focusing on different rare diseases or conditions.
Establishes a permanent Science-Focused Drug Development Multistakeholder Steering Committee to advise on meeting topics and planning.
The Foundation will consider various criteria, such as unmet therapeutic needs and the size of the patient population, when selecting meeting topics.
Planning for each meeting will involve setting specific objectives, creating an agenda, and inviting relevant stakeholders.
Post-meeting reports must be made publicly available, including transcripts, summaries, areas of consensus, and next steps.
FDA representatives are required to participate in each EL-SFDD meeting.
The legislation does not prevent other organizations from holding similar meetings or alter existing confidentiality protections.
Authorizes $1,000,000 annually for fiscal years 2025 through 2029 to support the implementation of these provisions.
Requires the Secretary to incorporate input from EL-SFDD meetings into drug risk-benefit assessments and to report annually to Congress on the meetings’ impact and participation.
