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119-s-822119th CongressWALLET

Scientific EXPERT Act of 2025

Sponsored By: Senator Klobuchar, Amy [D-MN]

Introduced

Summary

Would create a formal, externally led forum to align science for rare disease drug development. It would require the Reagan‑Udall Foundation to convene at least four meetings a year and would ask FDA reviewers to attend and publicly report whether meeting input influenced approval decisions.

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  • Patients and families: Aims to clarify trial designs, endpoints, biomarkers, and patient selection for rare diseases, which may reduce uncertainty around developing and testing new treatments.
  • Researchers and drug developers: The Foundation would run a permanent steering committee and hold at least four science-focused meetings a year to build consensus on novel development approaches and standards.
  • FDA and public accountability: FDA review-division staff would attend every meeting, the Foundation must post transcripts and summaries within 180 days, and FDA would state when meeting input shaped an approval decision.

*Would authorize $1.0 million per year for fiscal years 2025–2029, increasing federal outlays by that amount during those years.*

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 2 benefits, 0 costs, 1 mixed.

New rare-disease science meetings

If enacted, the bill would require the Reagan-Udall Foundation to run externally led science-focused drug development meetings on rare diseases. The Foundation would hold at least four meetings each year, each on a different rare disease or group. FDA review staff must participate in every meeting. The Foundation must post a transcript, recording, and a stakeholder-reviewed summary within 180 days of each meeting. The Secretary would need to say in related drug approvals whether a meeting was relevant and how meeting input affected the risk-benefit assessment.

Federal funding for rare disease meetings

If enacted, the bill would authorize $1 million a year for fiscal years 2025 through 2029 to support Foundation planning and operation of the meetings. It would also authorize $1 million a year for fiscal years 2025 through 2029 to support reporting and public statements about how meetings influenced approvals. The Foundation could also accept other funds to help plan or run meetings.

Limits on meeting legal effects

If enacted, the bill would say these meetings do not create legal rights to consultation. It would not force FDA to join meetings run by other groups. The bill would not change trade secret or other confidentiality protections or increase the number of drug review cycles. Other third parties would still be free to hold similar meetings.

Sponsors & CoSponsors

Sponsor

Klobuchar, Amy [D-MN]

MN • D

Cosponsors

  • Sen. Wicker, Roger F. [R-MS]

    MS • R

    Sponsored 3/3/2025

Roll Call Votes

No roll call votes available for this bill.

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