Scientific EXPERT Act of 2025
Sponsored By: Representative Matsui, Doris O. [D-CA-7]
Introduced
Summary
Creates an externally led, science-focused meeting program to help speed development of drugs for rare diseases. The bill would set up Science-Focused Drug Development meetings convened by the Reagan‑Udall Foundation for the FDA to bring patients, medical experts, sponsors, and FDA staff together to align on trial design, endpoints, biomarkers, manufacturing, and uses of natural history as a control.
Show full summary
- Patients and families: Gives patient groups a formal forum to raise unmet needs and influence trial design and acceptable endpoints so developers and regulators have clearer paths for rare-disease therapies.
- Drug developers and researchers: Provides structured, multi-stakeholder feedback on clinical trial designs, biomarkers, patient populations, and manufacturing to reduce scientific uncertainty during drug development.
- FDA and regulators: Requires appropriate FDA review-division participation, directs FDA to consider EL-SFDD input in risk-benefit assessments and publicly state how that input was used, and mandates an annual congressional report on meetings, participation, workload impact, and use of input.
*Would authorize about $1.0 million in federal funding each year from 2026 through 2030, increasing federal spending during those years.*
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Expert FDA meetings on rare diseases
This bill would set up expert, externally led meetings on rare disease drugs. The Reagan-Udall Foundation would run at least four meetings each year with FDA review staff, guided by a standing steering committee of FDA, patients, doctors, and industry. Within 180 days, the Foundation would post a transcript, recording, and a short analysis, and HHS would send Congress a yearly report. When FDA approves some drugs, it would say whether and how it used meeting input in its risk-benefit review. It would authorize $1 million a year for meetings and $1 million a year for follow-up from 2026–2030, if later appropriated.
Sponsors & CoSponsors
Sponsor
Matsui, Doris O. [D-CA-7]
CA • D
Cosponsors
Bilirakis
FL • R
Sponsored 2/24/2025
Rep. Tonko, Paul [D-NY-20]
NY • D
Sponsored 6/10/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov