{"bill":{"id":"119-hr-1262","congress":119,"type":"HR","number":1262,"title":"Mikaela Naylon Give Kids a Chance Act","originChamber":"House","introducedDate":"2025-02-12","sponsors":[{"bioguideId":"M001157","fullName":"Rep. McCaul, Michael T. [R-TX-10]","party":"R","state":"TX","district":10}],"cosponsorsCount":313,"latestAction":{"actionDate":"2025-12-02","text":"Received in the Senate."},"policyArea":"Health","subjects":["Arab-Israeli relations","Bahrain","Cancer","Child health","Computers and information technology","Congressional oversight","Drug safety, medical device, and laboratory regulation","Executive agency funding and structure","Food and Drug Administration (FDA)","Government information and archives","Government studies and investigations","Health information and medical records","International law and treaties","Israel","Licensing and registrations","Medical research","Organ and tissue donation and transplantation","Performance measurement","Prescription drugs"],"actions":[{"date":"2025-12-02","text":"Received in the Senate.","type":"IntroReferral","chamber":"Senate","hasVote":false},{"date":"2025-12-01","text":"Motion to reconsider laid on the table Agreed to without objection.","type":"Floor","chamber":"House floor actions","hasVote":false},{"date":"2025-12-01","text":"On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)","type":"Floor","chamber":"House floor actions","hasVote":false},{"date":"2025-12-01","text":"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)","type":"Floor","chamber":"Library of Congress","hasVote":false},{"date":"2025-12-01","text":"DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.","type":"Floor","chamber":"House floor actions","hasVote":false},{"date":"2025-12-01","text":"Considered under suspension of the rules. (consideration: CR H4929-4935)","type":"Floor","chamber":"House floor actions","hasVote":false},{"date":"2025-12-01","text":"Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.","type":"Floor","chamber":"House floor actions","hasVote":false},{"date":"2025-10-31","text":"Placed on the Union Calendar, Calendar No. 304.","type":"Calendars","chamber":"House floor actions","hasVote":false},{"date":"2025-10-31","text":"Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.","type":"Committee","chamber":"House floor actions","hasVote":false},{"date":"2025-10-31","text":"Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.","type":"Committee","chamber":"Library of Congress","hasVote":false},{"date":"2025-09-17","text":"Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.","type":"Committee","chamber":"House committee actions","hasVote":false},{"date":"2025-09-17","text":"Committee Consideration and Mark-up Session Held","type":"Committee","chamber":"House committee actions","hasVote":false},{"date":"2025-02-12","text":"Referred to the House Committee on Energy and Commerce.","type":"IntroReferral","chamber":"House floor actions","hasVote":false},{"date":"2025-02-12","text":"Introduced in House","type":"IntroReferral","chamber":"Library of Congress","hasVote":false},{"date":"2025-02-12","text":"Introduced in House","type":"IntroReferral","chamber":"Library of Congress","hasVote":false}],"summary":"<p><strong>Give Kids a Chance Act of 2025</strong></p><p>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.&nbsp;</p><p>Specifically, the bill</p><ul><li>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;</li><li>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;</li><li>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</li><li>reauthorizes through FY2027 certain funding for the National Institutes of Health to support priority pediatric research.&nbsp;</li></ul><p>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 <em>Catalyst Pharmaceuticals, Inc. v. Becerra</em>, a court rejected the FDA’s interpretation and held that orphan drug exclusivity extends to all uses or indications for the disease or condition.)</p>","updateDate":"2026-04-01T20:36:37Z"},"markets":[],"stateBills":[],"meta":{"sources":["congress.gov"],"latencyMs":546,"ts":"2026-04-19T08:25:25.612Z"},"nextActions":{"inspect":[],"related":[{"description":"Search related legislation","method":"GET","url":"/api/public/query-gov?q=Mikaela%20Naylon%20Give%20Kids%20a%20Chance%20Act"}]}}