This Act adds two new sections to the Federal Food, Drug, and Cosmetic Act to set up "externally led, science-focused drug development" (EL-SFDD) meetings. The Reagan‑Udall Foundation must convene at least four EL-SFDD meetings each year on different rare diseases or groups of rare diseases. A permanent Science-Focused Drug Development Multistakeholder Steering Committee will advise on topics and planning. FDA review-division staff must participate in each meeting. Meeting planning must list objectives, agendas, and invitees and must consult FDA staff, the steering committee, industry, patient groups, and other stakeholders. Within 180 days after a meeting, the Foundation must post a transcript and a summary analysis on the FDA website that identifies areas of consensus, areas needing clarification, and agreed next steps with the FDA. The Act also requires that, when the FDA approves or licenses a drug, the agency publish a brief statement saying whether a relevant EL-SFDD meeting was held and describing how input from that meeting was incorporated into the agency's risk-benefit assessment. The FDA must also send an annual report to Congress about the number and topics of meetings, FDA participation, impact on workload and resources, and how meeting input was used in decisionmaking. The Act authorizes appropriations to carry out these sections.
The text states the purpose is to provide opportunities to discuss science-related challenges for rare diseases, identify scientific approaches to facilitate development and review of drugs, and align on novel approaches (such as trial design, endpoints, biomarkers, manufacturing standards, and use of natural history) to advance treatments for unmet medical needs.
No publicly available information.