HR 1262 · Mikaela Naylon Give Kids a Chance Act
Received in the Senate.
- Introduced
- Feb 12, 2025
- Latest action
- Dec 2, 2025
- Sponsor
- Rep. Michael T. McCaul [R-TX-10]
- Policy area
- Health
- Cosponsors
- 313
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.)
Recent actions
- Dec 2, 2025 Received in the Senate.
- Dec 1, 2025 Motion to reconsider laid on the table Agreed to without objection.
- Dec 1, 2025 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, 2025 DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
- Dec 1, 2025 Considered under suspension of the rules. (consideration: CR H4929-4935)
- Dec 1, 2025 Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
- Oct 31, 2025 Placed on the Union Calendar, Calendar No. 304.
Votes
No recorded votes are available for this bill.