HR1262Passed House

Mikaela Naylon Give Kids a Chance Act

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Introduced
In Committee
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-02-12
Introduced
313
Cosponsors
HR
ⓘ
Type

Sponsor

Michael T. McCaul
Michael T. McCaul
Republican · TX · Representative
Votes with party: 97.1% (479 recorded votes)

Full profile: /officials/M001157

Source: Congress.gov · FEC

Cosponsors (313)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Received in the Senate.

2025-12-02

Source: Congress.gov

Committee Activity

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Plain-English Summary

Give Kids a Chance Act of 2025 This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research. Specifically, the bill modifies requirements relating to molecularly targeted pediatric cancer investigations to permit research on new drugs in combination with active ingredients that have already been approved, provided certain conditions are met; permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirement; renews the FDA’s authority to award priority review vouchers to sponsors of new products intended to treat rare pediatric diseases through September 30, 2029; and reauthorizes through FY2027 certain funding for the National Institutes of Health to support priority pediatric research. The bill also provides statutory authority for the FDA’s interpretation of the orphan drug exclusivity period. The bill specifies, consistent with FDA regulations, that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drugs) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. (In Catalyst Pharmaceuticals, Inc. v. Becerra , a court rejected the FDA’s interpretation and held that orphan drug exclusivity extends to all uses or indications for the disease or condition.)

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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