Bills · HR 1532
IN COMMITTEE· 119TH CONGRESS
House BillHR 1532Drug safety, medical device, and laboratory regulationMedical research
Scientific EXPERT Act of 2025
INTRO FEB 24· LAST ACTION FEB 24
READING
7MIN
COSPONSORS
5BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenVoters should care about this bill because it addresses a critical challenge in healthcare: bringing new treatments to patients with rare diseases. These conditions often lack sufficient research and development because they affect small populations, making it less profitable for drug companies to invest in them. By creating a structured way for experts, industry, and patients to collaborate directly with the FDA on scientific issues, the bill could significantly speed up the drug development process.
If this bill becomes law, it could lead to faster innovation and more effective therapies for diseases that currently have limited or no treatment options. If it doesn't pass, the current, often slower, and more fragmented process for discussing scientific challenges in rare disease drug development would continue, potentially delaying life-changing medications for many patients.
KEY PROVISIONS
4AI-extractedPROVISION 01
Requires the Secretary (via FDA) to develop and implement a process for externally led, science-focused drug development meetings.
This establishes a formal mechanism for vital discussions between stakeholders and the FDA, specifically targeting rare diseases.
PROVISION 02
Designates the Reagan-Udall Foundation for the FDA to convene at least four of these meetings annually, each focusing on a different rare disease or group of diseases.
This ensures consistent, organized, and frequent collaboration focused on a minimum number of rare diseases each year, providing a dedicated external body to manage logistics.
PROVISION 03
Establishes a permanent Science-Focused Drug Development Multistakeholder Steering Committee to advise on meeting topics and implementation.
This committee ensures that meeting topics are chosen strategically based on criteria like unmet needs and potential impact, with input from diverse stakeholders.
PROVISION 04
Mandates that within 180 days after a meeting, the Foundation publicly releases a transcript, recording, and a summary analysis on the FDA website.
This provision promotes transparency and allows the broader scientific and patient communities to benefit from the discussions and agreed-upon next steps.
SPONSORSHIP
1 + 5
D· California
YRS IN OFFICE
21
BILLS LED
29
COSPONSOR BREAKDOWNBIPARTISAN · 80%
DEM 3 REP 2 IND 0
ACTION TIMELINE
2 EVENTSFEB 24
Introduced in House
FEB 24
Referred to the House Committee on Energy and Commerce.
BILL INFO
TypeHouse Bill
NumberHR 1532
Congress119th
StatusIn Committee
IntroducedFeb 24, 2025
Last actionFeb 24, 2025
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IN COMMITTEE· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED FEB 24, 2025
House BillHR 1532Drug safety, medical device, and laboratory regulationMedical research
Scientific EXPERT Act of 2025
INTRODUCED FEB 24, 2025· LAST ACTION FEB 24, 2025
PASSAGE CHANCES
—%
READING
7 min
COSPONSORS
5
COMPLEXITY
Moderate
