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Congress·In Committee·3 months ago

Senate Bill Would Expand FDA Authority to Require Pediatric Cancer Drug Studies in Children

Also known as: Mikaela Naylon 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

  • Congress would broaden when the FDA can require drugmakers to study certain cancer drugs in children, including some drug combinations.
  • These required pediatric cancer studies must aim for useful results for kids, including the right drug form for different ages and data on dose, safety, and early signs it works.
  • The FDA would have to decide early whether a drug application falls under the pediatric study rules, so companies know expectations sooner in development.
  • Health and Human Services would have to publish guidance on how the new pediatric cancer study rules work, and the changes would start 3 years after the law is enacted.
  • Congress would extend the rare pediatric disease “priority review voucher” program through September 30, 2030, and change when the voucher user fee is due (when the application is submitted).
HealthcarePrescription Drugs

Milestones

2 milestones2 actions
Dec 2, 2025Senate

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

Dec 2, 2025

Introduced in Senate

What Happens Next

Projected impacts based on AI analysis

Right after the bill becomes law

FDA starts working on new guidance for the pediatric cancer study requirement changes

Drug makers and children’s hospitals would begin preparing for new expectations, but patients likely won’t feel changes yet

Within 12 months after the bill becomes law

FDA issues draft guidance on how the new pediatric cancer study rules will work

Companies and researchers get a clearer playbook for what studies FDA expects and can comment before it is finalized

Within 12 months after the draft guidance comment period closes

FDA finalizes the guidance after the public comment period closes

More predictable rules for companies; hospitals and trial sites can plan for likely increases in pediatric study activity

Starting 3 years after the bill becomes law

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

More new cancer drugs (and some combinations) seeking approval may have to include pediatric cancer study plans and data, potentially expanding kid-focused trials over time

2030-09-30

Rare pediatric disease priority review vouchers remain available through Sept. 30, 2030

Companies keep a valuable incentive to develop drugs for rare pediatric diseases, which could increase new treatment attempts over time

Not later than 6 years after the bill becomes law

HHS sends Congress a report on how implementation is going

Public accountability check on whether FDA and industry are actually carrying out the new pediatric cancer study expectations

Not later than 8 years after the bill becomes law

GAO completes a study on whether the pediatric cancer study requirements are helping and what burdens they create

Could lead to future fixes if the policy is not working well (too slow, too costly, or not producing useful child-specific data)

Not later than 10 years after the bill becomes law

GAO reports to Congress on the pediatric cancer study requirement results

Congress may use findings to strengthen, narrow, or expand the rules based on real-world results

Not later than 5 years after the bill becomes law

GAO reports on whether rare pediatric disease vouchers are actually driving new drug development

Could affect whether Congress renews, changes, or ends the voucher program later

Related News

3 articles
BioWorld·2 months ago

US Senate ends 2025 with no gift for kids with cancer

The bipartisan Mikaela Naylon Give Kids a Chance Act was blocked in the Senate by Bernie Sanders, who objected to a unanimous consent request. The bill would reauthorize the rare pediatric disease priority review voucher and grant the FDA authority to require combination cancer drug trials.

C−
The Daily Wire·2 months ago

Bernie Sanders Singlehandedly Kills Pediatric Cancer Bill

Senator Bernie Sanders blocked the Mikaela Naylon Give Kids a Chance Act, which would have empowered the FDA to push drug companies to study combination therapies. Sanders justified his blockade by demanding that savings in the bill fund community health centers.

R−
The Washington Times·6 days ago

Americans fighting rare diseases deserve effective solutions

The Give Kids a Chance Act was signed into law this month, accelerating pediatric cancer treatments and expanding access to therapies. The package strengthens incentives for drug development and codifies orphan drug exclusivity based on FDA-approved indications.

R+

Source Information

Document Type

Congressional Bill

Official Title

Mikaela Naylon Give Kids a Chance Act of 2025

Bill NumberS 3302
Congress119th Congress
ChamberSenate
Latest ActionRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsor

Cosponsors

(35)
D: 18R: 17

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.