Mikaela Naylon Give Kids a Chance Act
Latest action. Received in the Senate.
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.)
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on February 12, 2025. It describes the bill, it is not the legal text.
Received in the Senate.
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Where is it in the process, and what happens next?
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The record's latest action, on December 2, 2025: Received in the Senate.
How likely is it to become law?
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In the 118th Congress (2023-24), 274 of the 16,565 bills and joint resolutions introduced became law, about 1.7 percent. That count covers every measure at every stage, including the many that never left committee.
This one has no outstanding steps listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Michael McCaul (R-TX) introduced it on February 12, 2025, and 313 members have since signed on as cosponsors.
They come from both major parties: 180 Democrats, 133 Republicans.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on February 12, 2025, 575 days ago. The most recent recorded action was 282 days ago, on December 2, 2025.
Measures do not carry over. Anything the 119th Congress has not finished by January 3, 2027 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- HouseReceived in the Senate.
- SenateNot stated in the latest action
- PresidentNot stated in the latest action