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Congress·In Committee·12 months ago

Senate Committee Reviews Give Kids a Chance Act to Expand FDA Authority Over Pediatric Cancer Drug Studies

Also known as: Give Kids a Chance Act of 2025

Legislative Progress

✓ Filed
Review
Senate
House
President

Impacts

Mixed Impacts(1)
Federal Employee
Neutral
Positive Impacts(2)
Chronic Illness
Helps
Child Tax Credit
Helps

Key Points

  • Makes it easier for FDA to require drug companies to study some cancer drugs in kids, including certain drug combinations aimed at a specific tumor target.
  • Sets rules for those required kids’ studies so results are useful for real care, including the right medicine forms and dosing for different age groups.
  • Tells FDA to write and finalize public guidance on how to apply these new pediatric cancer study rules, on set timelines after the bill becomes law.
  • Delays when the new pediatric cancer study requirements would start: they apply to certain new drug applications filed 3 years after enactment.
  • Extends a program that rewards companies for developing treatments for rare pediatric diseases by keeping priority review vouchers available through Sept. 30, 2029, and orders government reports on how well the program works.
HealthcarePrescription Drugs

Milestones

2 milestones2 actions
Mar 11, 2025Senate

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Mar 11, 2025

Introduced in Senate

What Happens Next

Projected impacts based on AI analysis

Within 12 months after the bill is enacted

FDA issues draft guidance on the new pediatric cancer study requirements

Drug companies and pediatric cancer experts get clearer instructions on what studies are expected and what data must be collected for kids.

After the draft guidance is released; exact length not stated in the bill

Public comment period on FDA draft guidance (expected)

Doctors, hospitals, patient groups, and companies can point out problems or suggest changes before the guidance is final.

Within 12 months after the draft guidance comment period closes

FDA finalizes the guidance

The rules of the road become more settled, so companies can plan pediatric studies earlier and families may start seeing more child-focused trials open up over time.

Starting 3 years after the bill is enacted

New pediatric cancer study requirements start applying to certain new drug applications

After this start date, some adult-cancer drugs that hit targets relevant to pediatric cancers may have to include pediatric study plans and data, which can lead to more child-specific dosing and safety information later.

2029-09-30

Rare pediatric disease priority review voucher authority remains available through Sept. 30, 2029

Companies can keep using this incentive to pursue rare pediatric disease drugs, which may increase the number of development programs that reach FDA review.

By 6 years after the bill is enacted

HHS sends an implementation report to Congress

The public gets an update on whether the new pediatric cancer study requirements are actually being used and whether they are working as intended.

By 8 years after the bill is enacted

GAO studies how well the pediatric cancer study requirements are working

An outside watchdog checks for real benefits (better child-cancer drug options) and real burdens (delays, costs, feasibility).

By 10 years after the bill is enacted

GAO reports findings on pediatric cancer study requirements to Congress

Congress gets evidence it can use to tighten, expand, or fix the policy.

By 5 years after the bill is enacted

GAO report on whether rare pediatric disease vouchers actually drive new drug development

Helps determine whether the voucher program is worth continuing and whether it’s helping kids get new treatments faster.

Related News

4 articles
The Ripon Advance·3 months ago

McCaul’s pediatric cancer bill passes House

The House unanimously passed the Mikaela Naylon Give Kids A Chance Act of 2025, which expands FDA authority to require pediatric research on drug combinations and reauthorizes the priority review voucher (PRV) program to spur development for rare childhood diseases.

CR+
Pharmaceutical Technology·3 months ago

House passes bill that reauthorises the FDA’s paediatric priority voucher pathway

The Mikaela Naylon Give Kids a Chance Act combines initiatives to reauthorize the rare pediatric disease priority review voucher program and grant the FDA new authority to direct companies to study combinations of cancer drugs and therapies in pediatric trials.

C=
BioWorld·2 months ago

US Senate ends 2025 with no gift for kids with cancer

Despite unanimous House passage, the Mikaela Naylon Give Kids a Chance Act faced a year-end delay in the Senate due to objections over broader healthcare package costs, stalling the reauthorization of the critical priority review voucher program for rare pediatric diseases.

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Source Information

Document Type

Congressional Bill

Official Title

Give Kids a Chance Act of 2025

Bill NumberS 932
Congress119th Congress
ChamberSenate
Latest ActionRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsor

Cosponsors

(20)
D: 10R: 10

Analysis generated by AI. While we strive for accuracy, this should not be considered legal or professional advice. Always verify information with official government sources.