Bills · S 3302
IN COMMITTEE· 119TH CONGRESS
Senate BillS 3302Health
Mikaela Naylon Give Kids a Chance Act of 2025
INTRO DEC 2· LAST ACTION DEC 2
READING
10MIN
COSPONSORS
37BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because children with cancer often lack access to drugs specifically tested and approved for their age group and specific disease. Instead, doctors frequently use "off-label" adult medications, which means the drug hasn't been formally studied or approved for children, potentially leading to less effective dosing, unknown side effects, or treatments that aren't optimal. This bill aims to close that gap by requiring drug companies to conduct more thorough and relevant pediatric studies for cutting-edge, molecularly targeted cancer drugs.
If this bill becomes law, it could accelerate the development of safer and more effective cancer treatments specifically tailored for children, potentially leading to better survival rates and quality of life for young patients. If it doesn't become law, the current system might continue, where new cancer drugs, especially targeted therapies, might not be adequately studied for pediatric use, leaving children to rely on less precise or less-researched treatment options. It addresses a critical public health need by pushing for more research focused on the unique medical needs of children fighting cancer.
KEY PROVISIONS
5AI-extractedPROVISION 01
Requires drug companies to conduct pediatric cancer investigations for molecularly targeted drugs, including when used in combination with other approved drugs.
This expands the types of studies required for new cancer drugs to specifically address pediatric use, including combination therapies, which are common in cancer treatment.
PROVISION 02
Mandates that these pediatric investigations be designed to produce meaningful data on dosing, safety, and preliminary effectiveness for each age group, using appropriate formulations.
This ensures that the studies provide practical and useful information for treating children, rather than just fulfilling a general requirement.
PROVISION 03
Requires the FDA to clearly inform drug applicants early in the process about which specific pediatric study requirements apply to their new drug.
This provides clarity for drug companies, helping them plan their research more efficiently and avoid delays in bringing drugs to market.
PROVISION 04
Directs the FDA to issue guidance on implementing these new requirements within two years of the bill's enactment.
This ensures that drug companies and researchers have clear instructions on how to comply with the new law, facilitating its smooth adoption.
PROVISION 05
Mandates reports from the Secretary of HHS and a study from the Government Accountability Office (GAO) on the effectiveness of these requirements in developing pediatric cancer drugs.
These reports will help evaluate whether the new requirements are achieving their intended goal and identify any areas for improvement.
ACTION TIMELINE
2 EVENTSDEC 2
Introduced in Senate
DEC 2
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
BILL INFO
TypeSenate Bill
NumberS 3302
Congress119th
StatusIn Committee
IntroducedDec 2, 2025
Last actionDec 2, 2025
READER REACTIONS
OVERALL SENTIMENT
No reactions yet. Be the first to weigh in.
Discussion
Loading comments...
IN COMMITTEE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED DEC 2, 2025
Senate BillS 3302Health
Mikaela Naylon Give Kids a Chance Act of 2025
INTRODUCED DEC 2, 2025· LAST ACTION DEC 2, 2025
PASSAGE CHANCES
—%
READING
10 min
COSPONSORS
37
COMPLEXITY
Moderate
