Bills · S 822
IN COMMITTEE· 119TH CONGRESS
Senate BillS 822Drug safety, medical device, and laboratory regulationMedical research
Scientific EXPERT Act of 2025
INTRO MAR 3· LAST ACTION MAR 3
READING
8MIN
COSPONSORS
1
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because rare diseases often lack effective treatments, leaving patients with limited or no options. Developing drugs for these conditions is especially difficult due to small patient populations, a lack of scientific understanding, and challenges in conducting traditional clinical trials. This legislation creates a structured way for all key players – scientists, drug developers, patient advocates, and the FDA – to come together and tackle these unique scientific hurdles.
If this bill becomes law, it could lead to faster, more efficient development of new therapies for thousands of rare diseases by fostering collaboration and establishing clearer, more aligned scientific paths. This could mean quicker access to life-saving or life-improving medicines for people who currently have few options. If it doesn't become law, the existing, less coordinated approach to rare disease drug development would continue, potentially prolonging the wait for critical treatments.
KEY PROVISIONS
5AI-extractedPROVISION 01
Establishes a formal process for "science-focused drug development meetings" to discuss scientific challenges and opportunities for drugs treating rare diseases.
Creates a structured environment for experts and stakeholders to collaboratively address the unique scientific hurdles in rare disease drug development.
PROVISION 02
Designates the Reagan-Udall Foundation for the FDA to lead and convene these meetings, ensuring at least four meetings are held annually, each focusing on a different rare disease.
Provides an independent, neutral entity to facilitate discussions and ensures a regular cadence of focused engagement on various rare diseases.
PROVISION 03
Creates a permanent "Science-Focused Drug Development Multistakeholder Steering Committee" to advise the Foundation on meeting topics, with members from FDA, academia, patients, and industry.
Ensures that meeting topics are chosen strategically based on unmet needs and broad input, and that the discussions are well-informed by diverse perspectives.
PROVISION 04
Requires detailed planning for each meeting, involving key stakeholders, to define objectives, agenda, and participants.
Guarantees that meetings are focused, well-prepared, and designed to achieve specific goals for accelerating drug development.
PROVISION 05
Mandates public availability of meeting transcripts, recordings, and a summary analysis (including areas of consensus and next steps) on the FDA website within 180 days.
Increases transparency and provides a public record of discussions and agreed-upon pathways, potentially guiding future research and development efforts.
SPONSORSHIP
1 + 1
D· Minnesota
YRS IN OFFICE
19
BILLS LED
96
COSPONSOR BREAKDOWNBIPARTISAN · 0%
DEM 0 REP 1 IND 0
ACTION TIMELINE
2 EVENTSMAR 3
Introduced in Senate
MAR 3
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
BILL INFO
TypeSenate Bill
NumberS 822
Congress119th
StatusIn Committee
IntroducedMar 3, 2025
Last actionMar 3, 2025
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IN COMMITTEE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED MAR 3, 2025
Senate BillS 822Drug safety, medical device, and laboratory regulationMedical research
Scientific EXPERT Act of 2025
INTRODUCED MAR 3, 2025· LAST ACTION MAR 3, 2025
PASSAGE CHANCES
—%
READING
8 min
COSPONSORS
1
COMPLEXITY
Moderate
