S. 822 · Where this bill is now
In committee
Introduced in the Senate, Mar 3, 2025
What this bill does
In plain words · AI-written from the official summaryFDA hosts meetings to speed rare disease treatments
This bill requires the FDA to work with the Reagan-Udall Foundation to hold regular meetings focused on developing treatments for rare diseases. At least four times a year, medical experts, drug companies, patient groups, and FDA officials will meet to discuss how to develop new treatments and clear up confusing questions. After each meeting, the foundation will share what everyone agreed on and what steps come next.
How it affects you
If you or someone you know has a rare disease, this could eventually help bring new treatments to market faster by making sure drug developers and the FDA are on the same page early in the process. The direct day-to-day impact depends on whether these meetings actually speed up drug development for specific diseases.
Read the official summary (Introduced in Senate, Mar 3, 2025)
Scientific External Process for Educated Review of Therapeutics Act of 2025 or the Scientific EXPERT Act of 2025
This 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.
Written by AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionS. 822
A BILL
Scientific EXPERT Act of 2025
Sponsor: Sen. Amy Klobuchar (D-MN) · Introduced Mar 3, 2025 · Health · 1 version of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Mar 3, 2025: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions.”