Mikaela Naylon Give Kids a Chance Act
Introduced Feb 12, 2025 by Rep. Michael T. McCaul
The House passed it. The Senate has to pass it before it can reach the President.
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;
Read the full summary on Congress.govSummary by the Congressional Research Service.
No recorded roll-call vote on this bill — it may have passed by voice vote or unanimous consent, which don't record individual votes.
- Dec 2, 2025Received in the Senate.
- Dec 1, 2025Motion to reconsider laid on the table Agreed to without objection.
- Dec 1, 2025On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
- Dec 1, 2025Passed/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, 2025DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
- Dec 1, 2025Considered under suspension of the rules. (consideration: CR H4929-4935)
- Dec 1, 2025Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
- Oct 31, 2025Placed on the Union Calendar, Calendar No. 304.
- Oct 31, 2025Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
- Sep 17, 2025Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
- Sep 17, 2025Committee Consideration and Mark-up Session Held
- Feb 12, 2025Referred to the House Committee on Energy and Commerce.
- Feb 12, 2025Introduced in House