Scientific EXPERT Act of 2025
Scientific EXPERT Act of 2025
Plain Language Summary
# Scientific EXPERT Act of 2025 - Plain Language Summary **What the bill would do:** The Scientific EXPERT Act would require the FDA to work with the Reagan-Udall Foundation (an independent organization that supports FDA work) to hold regular meetings focused on developing new treatments for rare diseases. These meetings would bring together scientists, drug developers, and FDA experts to discuss and align on the best approaches for creating new drugs for conditions that currently lack good treatment options.
The foundation would organize at least four meetings per year, each focusing on a different rare disease, and would create a committee to decide which diseases deserve attention based on factors like how many patients are affected and how urgently new treatments are needed. **Who it affects:** This bill primarily impacts patients with rare diseases who have limited treatment options, pharmaceutical companies developing drugs for rare conditions, and the FDA. It could help speed up and clarify the drug development process for these smaller patient populations, which often receive less research attention than common diseases. **Current status:** The bill was introduced by Senator Amy Klobuchar (D-Minnesota) in the 119th Congress and is currently in committee, meaning it hasn't yet been debated or voted on by the full Senate.
CRS Official Summary
Scientific External Process for Educated Review of Therapeutics Act of 2025 or the Scientific EXPERT Act of 2025This bill requires the Food and Drug Administration (FDA) to facilitate and participate in externally led, science-focused drug development meetings to discuss the development of treatments for rare diseases and conditions. The FDA must enter into an arrangement with the Reagan-Udall Foundation for the FDA under which the foundation agrees to convene such meetings. Meetings must be held at least four times a year, and each meeting must focus on a different rare disease or condition. The foundation must establish a permanent steering committee to review and recommend topics for each meeting. In evaluating potential topics, the committee must consider unmet therapeutic needs, patient population sizes for different diseases and conditions, and whether a disease or condition would benefit from clarity and alignment on drug development questions, among other factors. In planning each meeting, the foundation must develop a list of medical experts, drug sponsors, scientific organizations, patient organizations, and other entities to be invited to participate. Representatives of the FDA’s review divisions must attend each meeting. After each meeting, the foundation must make available a summary of the meeting noting areas of consensus, areas where additional clarification or information is needed, and next steps agreed upon with the FDA.The bill also requires the FDA to indicate whether it incorporated any input from these meetings when approving a new drug or biologic.
Latest Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.