S. 705In Committee
Innovation in Pediatric Drugs Act of 2025
Expands FDA authority over pediatric studies for orphan drugs used in rare pediatric diseases and strengthens related research, enforcement, and reporting requirements
Plain-English overview
What this bill does
Expands FDA authority over pediatric studies for orphan drugs used in rare pediatric diseases and strengthens related research, enforcement, and reporting requirements
Key points
- Require GAO impact report
- Authorize enforcement against noncompliant sponsors
- Allow pediatric studies for orphan drugs
- Fund priority pediatric research
Current status
Where it stands
Status
In Committee
Latest action
2025-02-25 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
Related context
Topics and policy areas
undefinedCancerChild healthCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyGovernment information and archivesGovernment studies and investigations