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

S 705 — Innovation in Pediatric Drugs Act of 2025

Last action — Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)

  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 February 25, 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

Innovation in Pediatric Drugs Act of 2025This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to require pediatric studies on certain orphan drugs and to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements.Specifically, the bill would impose pediatric study requirements on drugs for rare diseases or conditions (i.e., orphan drugs) if the FDA determines that (1) the drug could improve the treatment, diagnosis, or prevention of a disease compared with currently available products for the relevant pediatric population; or (2) there is a need for additional options within the drug’s class or indication. (Under current law, pediatric study requirements generally do not apply to orphan drugs.) The FDA must issue guidance describing how these changes will be implemented, including information on how waivers will be granted. The bill also permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirements.Additionally, the bill authorizes the National Institutes of Health to allot a certain amount of funds for priority pediatric research, including research on drugs with no remaining patents on which pediatric studies are needed.Finally, the Government Accountability Office must report on the bill’s impact on rare disease drug development and on the availability of pediatric information on orphan drugs.

Bill Text

Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)

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
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Frequently asked questions

What does S 705 do?
Innovation in Pediatric Drugs Act of 2025This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to require pediatric studies on certain orphan drugs and to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements.Specifically, the bill would impose pediatric study requirements on drugs for rare diseases or conditions (i.e., orphan drugs) if the FDA determines that (1) the drug could improve the treatment, diagnosis, or prevention of a disease compared with currently available products for the relevant pediatric population; or (2) there is a need for additional options within the drug’s class or indication. (Under current law, pediatric study requirements generally do not apply to orphan drugs.) The FDA must issue guidance describing how these changes will be implemented, including information on how waivers will be granted. The bill also permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirements.Additionally, the bill authorizes the National Institutes of Health to allot a certain amount of funds for priority pediatric research, including research on drugs with no remaining patents on which pediatric studies are needed.Finally, the Government Accountability Office must report on the bill’s impact on rare disease drug development and on the availability of pediatric information on orphan drugs.
Who sponsors S 705?
S 705 is sponsored by Reed, Jack (Democratic) and Capito, Shelley Moore (Republican).
What is the current status of S 705?
This bill is in committee in the Senate. Introduced February 25, 2025. It must pass committee before a floor vote.
Where can I track S 705?
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Last checked for changes 3 months ago · updated continuously

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