Scientific EXPERT Act of 2024

This bill amends the Federal Food, Drug, and Cosmetic Act to create a process for externally led, science-focused drug development meetings (EL-SFDD meetings) to address challenges in developing drugs for rare diseases. It also requires the FDA to report how input from these meetings is used in drug approvals.

Sec. 770A, Science-focused drug development meetings: The FDA Secretary must develop a process for EL-SFDD meetings where medical experts, drug sponsors, scientific organizations, and patient organizations discuss science-related challenges, identify approaches to facilitate drug development, and align on novel development methods for rare diseases. The Secretary must arrange with the Reagan-Udall Foundation to convene at least four such meetings per year, each focused on a different rare disease or condition. The Foundation must establish a permanent steering committee with FDA, academic, patient, and industry representatives to recommend meeting topics based on criteria like unmet needs, patient population size, and potential for broader impact. The Foundation, in consultation with stakeholders, plans each meeting, and within 180 days must publicly post a transcript, recording, and summary analysis of input, including areas of consensus and next steps. FDA review division representatives must participate. The section does not prevent other organizations from holding similar meetings, alter confidentiality protections, or create a legal right to consultation. $1,000,000 per year is authorized for fiscal years 2025 through 2029.

Sec. 770B, Required actions following EL-SFDD meetings: When approving or licensing a drug, the Secretary must publicly state whether a relevant EL-SFDD meeting was held and describe how input from that meeting was incorporated into the risk-benefit assessment. The Secretary must also submit an annual report to Congress summarizing the number and topics of meetings, FDA participation, impact on FDA workload and resources, and how input was used in drug development deliberations, regulatory decisions, and recommendations for future meetings. $1,000,000 per year is authorized for fiscal years 2025 through 2029.