Bill · S. 705· Senate(119-S-705)
Innovation in Pediatric Drugs Act of 2025
- Introduced
- 2/25/2025
- Last activity
- 2/25/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
- Sponsored by
- John Reed
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
The "Innovation in Pediatric Drugs Act of 2025" seeks to amend the Federal Food, Drug, and Cosmetic Act regarding molecularly targeted pediatric cancer investigations. It establishes new accountability measures for pediatric study requirements, including a due diligence review process before enforcement actions are taken. The bill updates FDA reporting requirements to include evaluations of compliance with study deadlines and details regarding penalties or settlements. It also authorizes the NIH Director to allocate up to one percent of pediatric research funding for specific purposes. Additionally, the Act addresses how pediatric study requirements apply to drugs with orphan drug designations.
Yes· 3 of 5
Would children be better off under this?+5
The bill enhances funding and regulatory processes specifically aimed at improving pediatric drug research and availability.
Does this make health care easier to get in general?+3
The bill authorizes the NIH Director to allocate up to one percent of pediatric research funds toward specific pediatric research goals.
Would women be better off under this?+1
Improved pediatric research can benefit families and women in caregiving roles.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
-
Increased Accountability for Study Requirements: The bill adds a "due diligence" requirement, meaning the Secretary must issue a noncompliance letter and allow 45 days for a response before concluding a person failed to meet requirements (Section 2(b)).
-
Protection for Discontinued Products: The Secretary is prohibited from issuing enforcement actions for failures regarding drugs or biological products that are no longer being marketed (Section 2(a)(3)).
-
Enhanced Transparency via FDA Reporting: The FDA will be required to report on compliance with deadlines for deferrals and extensions, as well as provide a listing of penalties, settlements, or payments, including the name of the drug and the sponsor (Section 3).
-
Increased Funding for Pediatric Research: The Director of NIH is authorized to make available up to one percent of certain pediatric research funds for specific pediatric research (Section 4).
-
Streamlined Waiver Process for Certain Diseases: The Secretary will maintain an "Automatic full waiver list" of adult-related diseases where studies are impossible or highly impracticable, allowing for automatic waivers (Section 5(f)).
Potential Negative Impacts for People
-
Potential Burden on Drug Development for Rare Diseases: The bill includes requirements for the Secretary to create guidance on how pediatric study requirements apply to drugs with orphan drug designations, which may impact the development process (Section 5(a)).
-
Uncertainty Regarding Impact on Rare Disease Development: The GAO is tasked with studying the impacts of this Act on rare disease drug development and the availability of pediatric information, suggesting there may be unknown consequences to monitor (Section 5(d)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Children+5Good For Women+1
- Healthcare
- Improves Healthcare Access+3
- Economy And Finance
- Improves Small Business Support+1
- Social Issues And Justice
- Improves Childcare Affordability+1
- 2/25/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347)
- 1 Cosponsor added.
- Introduced in Senate
Shelley CapitoRepublican · West Virginia