Bill · S. 822· Senate(119-S-822)
Scientific EXPERT Act of 2025
- Introduced
- 3/3/2025
- Last activity
- 3/3/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Amy Klobuchar
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
The Scientific EXPERT Act of 2025 aims to amend the Federal Food, Drug, and Cosmetic Act to create a new process for drug development meetings. These science-focused meetings will be led by the Reagan-Udall Foundation rather than the FDA directly. The goal is to help researchers, medical experts, and patient organizations discuss challenges regarding drugs for rare diseases and conditions. The meetings will focus on aligning on scientific approaches, such as clinical trial designs and manufacturing standards. This process aims to expedite the development of treatments for unmet medical needs.
Yes· 3 of 4
Does this make what the government does easier for the public to see?+7
The bill requires the Foundation to make meeting transcripts, recordings, and summary analyses publicly available on the FDA website.
Does this make health care easier to get in general?+6
The bill aims to expedite drug development for rare diseases, which helps increase access to necessary treatments.
Does this put more money into medical research?+5
The bill authorizes up to $1,000,000 annually for the Reagan-Udall Foundation to facilitate science-focused drug development meetings.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Addressing Unmet Medical Needs: The process allows stakeholders to align on novel approaches for drug development, which helps advance treatment options for people facing rare diseases (Section 2(a)(3)).
-
Improved Drug Development Clarity: The Foundation will consider topics that could benefit from increased regulatory flexibility or clarity on issues like clinical trial design and appropriate clinical endpoints to expedite drug development (Section 2(b)(3)(B)(v)).
-
Increased Transparency for Patients and Researchers: After meetings, the Foundation must make a transcript, recording, and a summary analysis publicly available on the FDA website (Section 2(b)(6)(A)).
-
Inclusion of Patient Voices: The establishment of a permanent steering committee and a planning process specifically includes consultation with patient representatives (Section 2(b)(3)(C) and Section 2(b)(5)(D)).
-
Accountability in Drug Approvals: When approving or licensing a drug, the Secretary must publicly state if a relevant meeting was held and describe how the input from that meeting was used in the risk-benefit assessment (Section 2(770B)(a)).
Potential Negative Impacts for People
- No specific negative impacts are listed in the text; however, the bill includes rules of construction that prevent the act from altering protections for confidential commercial or trade secret information (Section 2(d)(3)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Healthcare
- Improves Healthcare Access+6Increases Research Funding+5
- Governance And Ideology
- Improves Government Transparency+7
- Demographic And Interest Groups
- Good For People With Disabilities+5
- 3/3/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Roger WickerRepublican · Mississippi