Mikaela Naylon Give Kids a Chance Act of 2025
Take action
Record your position on this measure.
Create an account to record your position, submit testimony, or contact your legislator.
Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The Mikaela Naylon Give Kids a Chance Act of 2025 aims to improve the treatment of pediatric cancer by allowing for combined drug trials and renewing the FDA’s authority to award priority review vouchers for rare pediatric diseases. Specifically, it modifies requirements for molecularly targeted cancer investigations to permit the use of previously approved drugs in combination, and it extends the availability of priority review vouchers to encourage the development of treatments for rare pediatric diseases. The bill also includes reporting requirements to assess the effectiveness of these changes and the priority voucher program.
Key provisions
- Allows for combined drug trials in pediatric cancer investigations using previously approved drugs.
- Renews the FDA’s authority to award priority review vouchers for rare pediatric diseases until September 30, 2030.
- Modifies requirements for molecularly targeted pediatric cancer investigations to accommodate the use of standard-of-care drugs.
- Requires the Secretary of Health and Human Services to issue guidance on the implementation of the amendments.
- Mandates a GAO study on the effectiveness of the bill's changes in developing pediatric cancer drugs.
- Extends the availability of priority review vouchers for rare pediatric diseases.
- Updates the user fee structure for priority review vouchers.
- Requires GAO to assess the impact of priority review vouchers on rare pediatric disease drug development.
Who is affected
Bill text
Read the latest version inline or switch to a previous version.
Text extraction is in progress. View the official source.
Sponsors
Official sponsors from legislative records.
38 on record
Primary sponsor
Markwayne Mullin
Cosponsors
Arguments
Reasons offered for and against this legislation.
Arguments in favor
No arguments in favor have been submitted.
Submit yoursArguments opposed
No arguments opposed have been submitted.
Submit yours