Mikaela Naylon Give Kids a Chance Act of 2025
Senate Bill Would Expand FDA Authority to Require Pediatric Cancer Drug Studies in Children
Stalled
No legislative action in over 90 days.
Legislative Progress
Key Points
- Congress would broaden when the FDA can require drugmakers to study certain cancer drugs in children, including some drug combinations.
- These required pediatric cancer studies must aim for useful results for kids, including the right drug form for different ages and data on dose, safety, and early signs it works.
- The FDA would have to decide early whether a drug application falls under the pediatric study rules, so companies know expectations sooner in development.
- Health and Human Services would have to publish guidance on how the new pediatric cancer study rules work, and the changes would start 3 years after the law is enacted.
- Congress would extend the rare pediatric disease “priority review voucher” program through September 30, 2030, and change when the voucher user fee is due (when the application is submitted).
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
3 articlesUS Senate ends 2025 with no gift for kids with cancer
The bipartisan Mikaela Naylon Give Kids a Chance Act was blocked in the Senate by Bernie Sanders, who objected to a unanimous consent request. The bill would reauthorize the rare pediatric disease priority review voucher and grant the FDA authority to require combination cancer drug trials.
Bernie Sanders Singlehandedly Kills Pediatric Cancer Bill
Senator Bernie Sanders blocked the Mikaela Naylon Give Kids a Chance Act, which would have empowered the FDA to push drug companies to study combination therapies. Sanders justified his blockade by demanding that savings in the bill fund community health centers.
Americans fighting rare diseases deserve effective solutions
The Give Kids a Chance Act was signed into law this month, accelerating pediatric cancer treatments and expanding access to therapies. The package strengthens incentives for drug development and codifies orphan drug exclusivity based on FDA-approved indications.
Source Information
Document Type
Congressional Bill
Official Title
Mikaela Naylon Give Kids a Chance Act of 2025
Data Sources
Sponsor
Cosponsors
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