Mikaela Naylon Give Kids a Chance Act of 2025

Sponsor: Markwayne Mullin (Republican-OK)

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Introduced

In Committee

Passed One Chamber

Passed Both Chambers

Signed into Law

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

Boosts research for kids' cancer drugs and extends incentives for rare disease treatments.

This bill would help speed up the development of new drugs for children with cancer by requiring more specific studies for these medicines. It would also extend a program that encourages drug companies to create treatments for rare childhood diseases until September 30, 2030.

What Would Change

Currently, the FDA has specific limits on requiring studies for molecularly targeted pediatric cancer drugs and combination therapies. Also, the program that offers incentives for rare pediatric disease drug development is set to expire on December 20, 2024. This bill would expand the types of pediatric cancer studies the FDA can require for new drugs. It would also extend the rare pediatric disease incentive program until September 30, 2030. This could lead to more targeted treatments for children.

Key Provisions

Expands the types of pediatric cancer drug studies the FDA can require for new medicines, including certain combination treatments.
These pediatric cancer studies must gather meaningful data on dosing, safety, and how well the drug works for children. They must use forms suitable for different age groups.
Extends the program that gives drug companies special vouchers to encourage them to develop treatments for rare childhood diseases until September 30, 2030.
Changes when drug companies would pay a fee for using these rare pediatric disease vouchers, making it due when they submit the drug application.
The FDA must issue draft guidelines on these pediatric cancer investigation changes within 12 months of the bill becoming law. They will then finalize them after a public comment period.

View on Congress.gov

S 3302 · 119th Congress · AI Summary by gemini-2.5-flash · 9/10

Lobbying Activity

4 filings mentioned this bill

Top Lobbying Clients

BIOTECHNOLOGY INNOVATION ORGANIZATION

$120K

2 filings

RAFAEL HOLDINGS, INC.

$24K

1 filing

GLAUKOS CORPORATION

1 filing

Top Lobbying Firms

1.AKIN GUMP STRAUSS HAUER & FELD2 filings

2.TWENTY-FIRST CENTURY GROUP, INC.1 filing

3.GLAUKOS CORPORATION1 filing

Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.

4 filings mentioned this bill

Top Lobbying Clients

BIOTECHNOLOGY INNOVATION ORGANIZATION

$120K

2 filings

RAFAEL HOLDINGS, INC.

$24K

1 filing

GLAUKOS CORPORATION

1 filing

Top Lobbying Firms

1.AKIN GUMP STRAUSS HAUER & FELD2 filings

2.TWENTY-FIRST CENTURY GROUP, INC.1 filing

3.GLAUKOS CORPORATION1 filing

Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.