3.0.0
1532
2025-12-05T22:52:14Z
2025-12-05T22:52:14Z
House
H
HR
2025-02-24
119
https://www.congress.gov/bill/119th-congress/house-bill/1532
[Congressional Record Volume 171, Number 36 (Monday, February 24, 2025)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. MATSUI:H.R. 1532.Congress has the power to enact this legislation pursuantto the following:section 8 of article I of the Constitution[Page H769]
- hsif00
Energy and Commerce Committee
House
Standing
  - Referred To
2025-02-24T17:04:05Z

- Scientific EXPERT Act of 2025
119
822
S
2025-03-03
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  - Related bill
CRS
- 2025-02-24
Referred to the House Committee on Energy and Commerce.
IntroReferral
H11100
2
House floor actions
  - hsif00
Energy and Commerce Committee
- 2025-02-24
Introduced in House
IntroReferral
Intro-H
9
Library of Congress
- 2025-02-24
Introduced in House
IntroReferral
1000
9
Library of Congress
- M001163
Rep. Matsui, Doris O. [D-CA-7]
Doris
Matsui
D
CA
O.
7
N
- B001257
Rep. Bilirakis, Gus M. [R-FL-12]
Gus
Bilirakis
R
FL
M.
12
2025-02-24
True
- T000469
Rep. Tonko, Paul [D-NY-20]
Paul
Tonko
D
NY
20
2025-06-10
False
Health
- Advisory bodies
2025-07-17T19:23:14Z
- Congressional oversight
2025-07-17T19:23:40Z
- Drug safety, medical device, and laboratory regulation
2025-07-17T19:23:02Z
- Government information and archives
2025-07-17T19:23:19Z
- Medical research
2025-07-17T19:22:56Z
- Research administration and funding
2025-07-17T19:23:07Z
Health
2025-03-17T15:58:01Z
00
2025-02-24
Introduced in House
2025-08-12T21:02:25Z
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.

Scientific EXPERT Act of 2025
- Display Title
45

Scientific EXPERT Act of 2025
2025-03-14T09:38:22Z
- Short Title(s) as Introduced
101

Scientific EXPERT Act of 2025
2025-03-14T09:38:19Z
Introduced in House
IH
- Short Title(s) as Introduced
101

Scientific External Process for Educated Review of Therapeutics Act of 2025
2025-03-14T09:38:19Z
Introduced in House
IH
- Official Title as Introduced
6

To amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes.
2025-03-14T09:33:25Z
Introduced in House
IH
- Introduced in House
2025-02-24T05:00:00Z
  - https://www.govinfo.gov/content/pkg/BILLS-119hr1532ih/xml/BILLS-119hr1532ih.xml
2025-02-24
Referred to the House Committee on Energy and Commerce.
text/xml
EN
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Congressional Research Service, Library of Congress
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