Scientific EXPERT Act of 2025

Key Points

• The bill directs the FDA to set up a formal process for meetings between medical experts, drug companies, scientific groups, and patient organizations focused on solving scientific problems in developing rare disease drugs.
• The FDA must partner with the Reagan-Udall Foundation, a nonprofit tied to the agency, to hold at least four of these meetings every year, each covering a different rare disease or group of related conditions.
• A permanent steering committee with FDA officials, academic experts, patient representatives, and industry representatives will recommend which diseases get priority based on factors like unmet need and small patient population size.
• Within 180 days of each meeting, the FDA must publicly post a transcript and a summary showing where experts agreed, where more clarity is needed, and what happens next.
• When approving a drug, the FDA must publicly state whether a related meeting happened and how the input was used in its risk-benefit decision, plus submit an annual report to Congress on the meetings' impact.
• Congress would authorize $1 million per year from 2026 through 2030 for the meetings, plus another $1 million per year for the follow-up reporting requirements, totaling about $10 million over five years.