Congress·Passed House·H.R. 1262

House Passes Mikaela Naylon Give Kids a Chance Act to Boost Pediatric Cancer Research

Mikaela Naylon Give Kids a Chance Act

4 months ago·View on Congress.gov

Part of: Congress Extends Rare Disease Vouchers and Boosts Pediatric Cancer Research

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Stalled

No legislative action in over 90 days.

Legislative Progress

✓ House

Senate

President

Law

Key Points

Drug companies will be required to study how new cancer treatments work for children, especially when used in combination with existing medicines. This aims to find better treatments for childhood cancers that are often overlooked by researchers focusing on adults.
From policy text
“the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of-- ``(i) the drug or biological product for which the application referred to in such paragraph is submitted; or ``(ii) such drug or biological product used in combination with-- ``(I) an active ingredient of a drug or biological product”
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The bill extends a program until 2029 that rewards companies for developing drugs for rare childhood diseases. These rewards, known as vouchers, allow companies to get a future drug reviewed faster by the government, which encourages them to invest in medicines for small groups of sick children.
It changes rules for 'orphan drugs' to prevent companies from having a total monopoly on a rare disease. Special protections will now only apply to the specific use of the drug that was approved, rather than the entire disease, making it easier for other companies to develop different treatments.
From policy text
“by striking ``same disease or condition'' and inserting ``same approved use or indication within such rare disease or condition''”
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The national organ transplant system will get a technology upgrade to help more patients. This includes better electronic record sharing between hospitals and a new public dashboard to track how many transplants are happening and how many organs are unfortunately going unused.
From policy text
“encourage the integration of electronic health records systems through application programming interfaces (or successor technologies) among hospitals, organ procurement organizations, and transplant centers, including the use of automated electronic hospital referrals and the grant of remote, electronic access to hospital electronic health records of potential donors by organ procurement organizations”
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Generic drug makers will get more help from the government to make sure their products match brand-name drugs exactly. By providing more transparency about ingredients, the government hopes to help cheaper generic medicines reach the market faster.
From policy text
“the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary's own initiative during the review of an abbreviated application under this subsection for such drug.”
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The bill increases funding for a Medicare improvement fund by over $1.2 billion and creates a new international office to help partner countries in the Middle East meet safety standards for medical products.
From policy text
“Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking ``$1,403,000,000'' and inserting ``$2,622,000,000''.”
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Healthcare

Impact Analysis

Personal Impact

Who is affectedScoreImpactCertaintyScopeDurationSentiment

Scores: 1 = low, 5 = highSentiment: -5 to +5 (net benefit)

Milestones

3 milestones13 actions

Dec 2, 2025Senate

Received in the Senate.

Dec 1, 2025House

Motion to reconsider laid on the table Agreed to without objection.

Dec 1, 2025House

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)

Dec 1, 2025

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)

Dec 1, 2025House

DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.

What Happens Next

Projected impacts based on AI analysis

180 days after enactment

New enforcement rules for pediatric study requirements take effect

Drug companies that fail to complete required studies on how their medicines work in children can now face penalties, pushing them to prioritize pediatric research.

3 years after enactment

New pediatric cancer investigation requirements begin applying to drug applications

Drug companies submitting new cancer drug applications will be required to also study how their treatments work in children, including combination therapies, potentially leading to more treatment options for kids with cancer.

Related News

2 articles

BioSpace·about 2 months ago

Rare Pediatric Disease Vouchers Reauthorized, PBM Reform Funded in Narrowly Passed Spending Bill

The signing of the Mikaela Naylon Give Kids a Chance Act ends a year of uncertainty for rare disease drug developers. The law reauthorizes the FDA's rare pediatric disease priority review voucher (PRV) program through 2029, providing financial incentives for companies to develop pediatric therapies.

Washington Times·26 days ago

Americans fighting rare diseases deserve effective solutions

The Give Kids a Chance Act, recently signed into law, codifies orphan drug exclusivity based on specific FDA-approved indications rather than broad disease categories. This reform ensures companies continue developing targeted therapies for small patient populations while preventing monopolies.

R+

Related Bills

9 bills

S. 3716Related bill

RARE Act

Jan 28 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Feb 3 — Became Public Law No: 119-75.

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Mar 11 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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