Give Kids a Chance Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The Give Kids a Chance Act of 2025 aims to accelerate the development of cancer treatments for children by modifying regulations around clinical trials and prioritizing FDA review vouchers for rare pediatric diseases. Specifically, it allows for the use of existing, approved drugs in combination with other treatments, streamlines the process for pediatric cancer investigations, and extends the availability of priority review vouchers to encourage the development of drugs 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 combination drug therapies in pediatric cancer clinical trials.
- Extends the FDA’s authority to award priority review vouchers for rare pediatric diseases until September 30, 2029.
- Requires the FDA to provide guidance on implementing changes to molecularly targeted pediatric cancer investigations.
- Mandates a GAO study on the effectiveness of the bill’s changes in drug development.
- Modifies requirements for pediatric study data to ensure clinically meaningful results.
- Clarifies the application of requirements for drug applications.
- Extends the availability of priority review vouchers for rare pediatric diseases.
- Requires the Secretary of Health and Human Services to report on implementation efforts.
Who is affected
- Pediatric cancer patients and their families
Bill text
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Sponsors
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21 on record
Primary sponsor
Markwayne Mullin
Cosponsors
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