Legislation Tracker

February 2, 2026

Signedby President

The bill is signed into law by President Donald Trump as a part of the H.R.7148 - Consolidated Appropriations Act, 2026.

November 30, 2025

PassedThe House

Passed unanimously in the House. Press release by Representative Michael McCaul (R-TX.)

March 10, 2025

Bill reintroduced in the Senate for the 119th Congress (S.932).

February 12, 2025

Rep. Debbie Dingell's (D-MI) office published this press release.

February 11, 2025

Introduced

Bill reintroduced in the House for the 119th Congress (H.R. 1262). The House Childhood Cancer Caucus published this press release.

September 20, 2023

Bill reintroduced in the Senate for the 118th Congress (S.2897).

May 16, 2023

Introduced

Bill reintroduced in the House for the 118th Congress (H.R.3433).

May 11, 2022

Bill reintroduced in the Senate for the 117th Congress (S.4215).

March 7, 2022

Bill reintroduced in the House for the 117th Congress (H.R.6972).

About

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.)

See Full Bill

Quick Facts

Introduced: February 11, 2025
Sponsor: (House Lead) Rep. Michael McCaul (R-TX), (Senate Lead) Sen. Markwayne Mullin
Committee: House: Energy & Commerce; Ways and Means; Senate: Health, Education, Labor, and Pensions
Number of cosponsors: House: 313 Senate: 20 (as of December 11, 2025)

Give Kids a Chance Act 2025

Legislation Tracker