United States 119th Congress Status: In Committee Bipartisan · 1 D · 1 R cosponsors

S 822 — Scientific EXPERT Act of 2025

Last action — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill is in committee in the Senate. Introduced March 03, 2025. It must pass committee before a floor vote.

Next likely step: a committee vote, then a floor vote in the Senate.

Prognosis

Advancing 34% · moderate confidence

Where this bill stands today.

Odds of enactment

Low

How often bills like it became law.

  • In Committee

    Current position in the legislative process.

  • 2 sponsors

    1 primary, 1 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (1 D · 1 R) — cross-party backing.

Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.

Summary

Scientific External Process for Educated Review of Therapeutics Act of 2025 or the Scientific EXPERT Act of 2025This 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.

Bill Text

How this bill changes current law

5 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill establishes a new section in the Federal Food, Drug, and Cosmetic Act to create a process for science-focused drug development meetings targeting rare diseases.

  • 21 U.S.C. 379dd

    SEC. 770A. SCIENCE-FOCUSED DRUG DEVELOPMENT MEETINGS. (a) In General.--The Secretary shall develop and implement a process for Foundation led, science-focused drug development meetings to provide an opportunity for academic researchers and medical experts, drug sponsors, scientific organizations, and patient organizations to-- (1) discuss science-related challenges impacting the development of drugs for rare diseases and conditions; (2) identify scientific approaches and opportunities to facilitate the development, review, and approval of such drugs; and (3) align on novel approaches for the development of drugs for particular diseases, including appropriate clinical trial designs and metrics, manufacturing standards, patient populations, clinical endpoints, the use of biomarkers as surrogate endpoints, and natural history as a control, to advance treatment options to address unmet medical needs.

    This creates a new process for organizing drug development meetings to address issues specifically for drugs targeting rare diseases.

  • 21 U.S.C. 379dd

    SEC. 770B. REQUIRED ACTIONS FOLLOWING EL-SFDD MEETINGS. (a) Incorporation of Input Into Risk-Benefit Assessments.--In approving or licensing a drug under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of the Public Health Service Act, the Secretary shall make public-- (1) a statement of whether any EL-SFDD meeting under section 770A was held that was relevant to such approval or licensure; and (2) if a meeting described in paragraph (1) was held, a description of how the Secretary incorporated input from such meeting in the risk-benefit assessment described in section 505(d).

    This new requirement mandates transparency regarding the influence of EL-SFDD meetings on drug risk-benefit assessments.

  • 21 U.S.C. 379dd

    SEC. 770A(f) AUTHORIZATION OF APPROPRIATIONS.--(1) In general.--To carry out this section, there is authorized to be appropriated $1,000,000 for each of fiscal years 2025 through 2029.

    This establishes funding for the new process regarding science-focused drug development meetings.

  • 21 U.S.C. 379dd

    SEC. 770B.(d) Authorization of Appropriations.--To carry out this section, there is authorized to be appropriated $1,000,000 for each of fiscal years 2025 through 2029.

    This also allocates funding for the actions following the EL-SFDD meetings.

  • 21 U.S.C. 379dd

    SEC. 770A(b)(1) Qualified third party convenor.--The Secretary shall enter into an arrangement with the Foundation under which the Foundation agrees to convene EL-SFDD meetings regarding drugs for rare diseases or conditions in accordance with this section.

    This specifies the role of the Reagan-Udall Foundation in organizing the new drug development meetings.

Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Sponsorship breakdown

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1 sponsors · 1 co-sponsors · 545 not signed on

Sponsors (1)

Co-sponsors (1)

Not signed on (545)

545 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare health-insurance technology
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does S 822 do?
Scientific External Process for Educated Review of Therapeutics Act of 2025 or the Scientific EXPERT Act of 2025This 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.
Who sponsors S 822?
S 822 is sponsored by Klobuchar, Amy (Democratic) and Wicker, Roger F. (Republican).
What is the current status of S 822?
This bill is in committee in the Senate. Introduced March 03, 2025. It must pass committee before a floor vote.
Where can I track S 822?
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