Mikaela Naylon Give Kids a Chance Act of 2025
Sponsored By: Senator Markwayne Mullin
Introduced
Summary
Clearer rules for molecularly targeted pediatric cancer studies. The Mikaela Naylon Give Kids a Chance Act of 2025 broadens when a pediatric investigation can target a drug alone or in combination with certain adult-approved cancer treatments, and it sets deadlines for FDA guidance and later Congress/GAO reviews.
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- Children and families: Trials must be designed to produce clinically meaningful pediatric data with appropriate age-group formulations, dosing, safety information, and preliminary efficacy to help inform pediatric labeling.
- Drug developers: The bill expands what counts as a molecularly targeted pediatric investigation, including certain combinations with adult-approved cancer drugs that are part of standard care, and may require relevant preclinical study results when submitting the initial pediatric study plan; the rules apply to applications submitted 3 years after enactment.
- FDA and oversight: The FDA must publish draft guidance within 12 months and finalize it within a year after the comment period; the law also requires a congressional report within 6 years and a later Government Accountability Office study to assess effectiveness.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Clear pediatric cancer trial rules
If enacted, the bill would redefine molecularly targeted pediatric cancer studies and set two clear ways FDA may allow combination testing. It would require studies to produce useful pediatric data for each age group, covering dosing, safety, and early effectiveness. The agency must decide which pathway applies before an applicant must file the initial pediatric study plan. FDA could ask for completed preclinical results with that plan. These rules would apply to applications submitted three years after enactment. The Secretary must publish draft guidance within 12 months and final guidance within 12 months after the draft comment period. The Comptroller General would study how these pediatric assessment rules work and report findings by 10 years after enactment.
Changes to rare pediatric vouchers
If enacted, the bill would let rare pediatric disease priority review vouchers be awarded through September 30, 2030. The priority review fee when a voucher is used would be due when the drug application is submitted. Other user fees for that application would still be due as required. The fee timing change would take effect on enactment. The Government Accountability Office must study the voucher program and report findings within five years after enactment.
Sponsors & CoSponsors
Sponsor
Markwayne Mullin
OK • R
Cosponsors
Michael Bennet
CO • D
Sponsored 12/2/2025
Amy Klobuchar
MN • D
Sponsored 12/2/2025
Jeanne Shaheen
NH • D
Sponsored 12/2/2025
Roger Marshall
KS • R
Sponsored 12/2/2025
Rick Scott
FL • R
Sponsored 12/2/2025
Susan Collins
ME • R
Sponsored 12/2/2025
Christopher Coons
DE • D
Sponsored 12/2/2025
Shelley Capito
WV • R
Sponsored 12/2/2025
Mark Kelly
AZ • D
Sponsored 12/2/2025
Jon Husted
OH • R
Sponsored 12/2/2025
Andy Kim
NJ • D
Sponsored 12/2/2025
Tim Sheehy
MT • R
Sponsored 12/2/2025
Ashley Moody
FL • R
Sponsored 12/2/2025
John Hickenlooper
CO • D
Sponsored 12/2/2025
Tammy Duckworth
IL • D
Sponsored 12/2/2025
John Boozman
AR • R
Sponsored 12/2/2025
Adam Schiff
CA • D
Sponsored 12/2/2025
John Kennedy
LA • R
Sponsored 12/2/2025
John Reed
RI • D
Sponsored 12/2/2025
Eric Schmitt
MO • R
Sponsored 12/2/2025
Edward Markey
MA • D
Sponsored 12/2/2025
Cory Booker
NJ • D
Sponsored 12/2/2025
James Justice
WV • R
Sponsored 12/2/2025
Ted Budd
NC • R
Sponsored 12/9/2025
Kirsten Gillibrand
NY • D
Sponsored 12/9/2025
Elissa Slotkin
MI • D
Sponsored 12/10/2025
Steve Daines
MT • R
Sponsored 12/16/2025
Mark Warner
VA • D
Sponsored 12/16/2025
Richard Blumenthal
CT • D
Sponsored 12/16/2025
John Curtis
UT • R
Sponsored 12/17/2025
Deb Fischer
NE • R
Sponsored 12/17/2025
Raphael Warnock
GA • D
Sponsored 12/17/2025
Martin Heinrich
NM • D
Sponsored 1/15/2026
Jim Banks
IN • R
Sponsored 1/15/2026
David McCormick
PA • R
Sponsored 1/15/2026
Chris Van Hollen
MD • D
Sponsored 1/29/2026
Ruben Gallego
AZ • D
Sponsored 1/29/2026
Roll Call Votes
No roll call votes available for this bill.
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