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S. 705 119th Congress Senate

Innovation in Pediatric Drugs Act of 2025

Official title: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.

Introduced: February 25, 2025 Introduced by: Jack Reed Democratic · Rhode Island See on congress.gov
Health CancerChild healthCongressional oversightDrug safety, medical device, and laboratory regulation
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 25, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
Feb 25, 2025
Introduced in Senate
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What's happening now February 25, 2025

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

 Plain-English summary Congressional Research Service

Innovation in Pediatric Drugs Act of 2025

This 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 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 36

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

A filing lists the bills it worked on and the parts of government it contacted in separate sections, so these are the bodies those filers named anywhere in the filing, not a per-bill breakdown.

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 Cosponsors 1
All 1 Republican 1
R
Capito, Shelley Moore
West Virginia · Feb 25, 2025
Cite this page click to expand
APA
U.S. Congress. (2026). S. 705: Innovation in Pediatric Drugs Act of 2025. 119th Congress. Open America. https://openamerica.io/bill/119-S-705/
MLA
"S. 705: Innovation in Pediatric Drugs Act of 2025." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-705/.
Bluebook (legal)
S. 705, 119th Cong. (2026), https://openamerica.io/bill/119-S-705/.
Markdown link
[S. 705: Innovation in Pediatric Drugs Act of 2025](https://openamerica.io/bill/119-S-705/)
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