PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Feb 12, 2025
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
Showing the opening paragraphs of the official summary.
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.)
People & committees
Rep. McCaul, Michael T. [R-TX-10] · R–TX
Legislative record
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Received in the Senate.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
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)
DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
Considered under suspension of the rules. (consideration: CR H4929-4935)
Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 304.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
Committee Consideration and Mark-up Session Held
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Jul 18, 2026. Consult Congress.gov for the current record.
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Analyze H.R.1262 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
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