S 705 119th Congress
Innovation in Pediatric Drugs Act of 2025
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
Official Title as Introduced Congress.gov
Open official Congress.gov recordSource-linked procedural record
Bill journey
This is a chronology, not a progress score. Politically.com does not classify stages or infer what comes next. Records sharing a date are grouped because not every source field supplies a time.
Congress.gov Recently refreshed
U.S. Senate XML Recently refreshed
-
Introduction Congress.gov
Introduced
Introduced in the Senate.
Open bill recordOfficial action Congress.gov
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
Open bill recordOfficial action Congress.gov
Introduced in Senate
Open bill recordText version Congress.gov
Introduced in Senate
A dated text-version record is available.
Open text record
View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347) | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov |
House roll calls join only on matching Congress, legislation type, and number. Senate roll calls join only on matching source-supplied document type and number, not question text. Committee and related-measure relationships have no date in their relationship records and therefore are counted above but never placed on the chronology.
Congressional Research Service
CRS 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.
Official documents
Text versions
- Introduced in SenateFeb 25, 2025