Give Kids a Chance Act of 2025
Senate Committee Reviews Give Kids a Chance Act to Expand FDA Authority Over Pediatric Cancer Drug Studies
Stalled
No legislative action in over 90 days.
Legislative Progress
Key Points
- Makes it easier for FDA to require drug companies to study some cancer drugs in kids, including certain drug combinations aimed at a specific tumor target.
- Sets rules for those required kids’ studies so results are useful for real care, including the right medicine forms and dosing for different age groups.
- Tells FDA to write and finalize public guidance on how to apply these new pediatric cancer study rules, on set timelines after the bill becomes law.
- Delays when the new pediatric cancer study requirements would start: they apply to certain new drug applications filed 3 years after enactment.
- Extends a program that rewards companies for developing treatments for rare pediatric diseases by keeping priority review vouchers available through Sept. 30, 2029, and orders government reports on how well the program works.
Impact Analysis
Personal Impact
How this policy affects specific groups of people
Milestones
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
Votes
No votes have been recorded for this legislation yet.
Related News
4 articlesMcCaul’s pediatric cancer bill passes House
The House unanimously passed the Mikaela Naylon Give Kids A Chance Act of 2025, which expands FDA authority to require pediatric research on drug combinations and reauthorizes the priority review voucher (PRV) program to spur development for rare childhood diseases.
House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
The Mikaela Naylon Give Kids a Chance Act combines initiatives to reauthorize the rare pediatric disease priority review voucher program and grant the FDA new authority to direct companies to study combinations of cancer drugs and therapies in pediatric trials.
US Senate ends 2025 with no gift for kids with cancer
Despite unanimous House passage, the Mikaela Naylon Give Kids a Chance Act faced a year-end delay in the Senate due to objections over broader healthcare package costs, stalling the reauthorization of the critical priority review voucher program for rare pediatric diseases.
Source Information
Document Type
Congressional Bill
Official Title
Give Kids a Chance Act of 2025
Data Sources
Sponsor
Cosponsors
(20)Analysis generated by AI. Always verify with official sources.