119th Congress Health
S. 3302: Mikaela Naylon Give Kids a Chance Act of 2025
Introduced
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
This bill authorizes certain targeted clinical trials involving combinations of drugs to treat pediatric cancer, and renews the Food and Drug Administration’s (FDA’s) authority to award priority review vouchers (PRVs) to sponsors of new products for rare pediatric diseases.
Specifically, the bill modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs used in combination with active ingredients that have already been approved and that (1) have been determined to be part of the standard of care for treating a pediatric cancer, or (2) have been approved to treat an adult cancer and are directed at molecular targets for pediatric cancer.
The FDA must issue guidance on the implementation of these provisions and report to Congress on its efforts to ensure implementation. The Government Accountability Office (GAO) must report on the effectiveness of the bill's changes with respect to the development of pediatric cancer drugs.
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The bill also renews the FDA’s authority to issue PRVs to sponsors of new products intended to treat rare pediatric diseases through September 30, 2030. This is known as the Rare Pediatric Disease PRV program. The program expired in December 2024.
GAO must report on the effectiveness of the Rare Pediatric Disease PRV program, including to what extent PRVs were successful in promoting drug development and expediting patient access to drugs for the treatment or prevention of rare pediatric diseases.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- John Boozman R-AROriginal
- Michael Bennet D-COOriginal
- Cory Booker D-NJOriginal
- Susan Collins R-MEOriginal
- Shelley Capito R-WVOriginal
- Christopher Coons D-DEOriginal
- Tammy Duckworth D-ILOriginal
- John Hickenlooper D-COOriginal
- Jon Husted R-OHOriginal
- Jim Justice R-WVOriginal
- Amy Klobuchar D-MNOriginal
- Mark Kelly D-AZOriginal
- John Kennedy R-LAOriginal
- Andy Kim D-NJOriginal
- Edward Markey D-MAOriginal
- Roger Marshall R-KSOriginal
- Ashley Moody R-FLOriginal
- John Reed D-RIOriginal
- Adam Schiff D-CAOriginal
- Jeanne Shaheen D-NHOriginal
- Rick Scott R-FLOriginal
- Eric Schmitt R-MOOriginal
- Tim Sheehy R-MTOriginal
- Ted Budd R-NC
- Kirsten Gillibrand D-NY
- Elissa Slotkin D-MI
- Richard Blumenthal D-CT
- Steve Daines R-MT
- Mark Warner D-VA
- John Curtis R-UT
- Deb Fischer R-NE
- Raphael Warnock D-GA
- Jim Banks R-IN
- Martin Heinrich D-NM
- Dave McCormick R-PA
- Ruben Gallego D-AZ
- Chris Van Hollen D-MD
Who scored on this bill
- 1Markwayne Mullin SponsorDrew cross-party cosponsors, introduced, reached a cosponsor milestone3 events+12
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Introductions and cosponsorships count toward weekly caps and show no points.
Other bills by Markwayne Mullin
- S. 550: To provide for the equitable settlement of certain Indian land disputes regarding land in Illinois, and for other purposes
- S. 2257: Legislative Branch Appropriations Act, 2026
- S. 4755: Traumatic Brain Injury Program Reauthorization Act of 2024
- S. 2796: To provide for the equitable settlement of certain Indian land disputes regarding land in Illinois, and for other purposes
- S.J.Res. 24: Disapproval of United States Fish and Wildlife Service rule: Endangered and Threatened Wildlife and Plants; Endangered Species Status for Northern Long-Eared Bat
History
- Introduced in the Senate by Markwayne Mullin.
Show the full action history (2 actions)
- Introduced in Senate
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.