HR 1262 119th Congress
Mikaela Naylon Give Kids a Chance Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the House.
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Referred to the House Committee on Energy and Commerce.
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Introduced in House
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Introduced in House
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Introduced in House
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Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
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Committee Consideration and Mark-up Session Held
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Placed on the Union Calendar, Calendar No. 304.
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Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
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Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
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Reported in House
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Engrossed in House
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Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
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Considered under suspension of the rules. (consideration: CR H4929-4935)
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DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
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On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
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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)
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Motion to reconsider laid on the table Agreed to without objection.
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Received in the Senate.
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the House. | Congress.gov | |
| Official actionReferred to the House Committee on Energy and Commerce. | No additional detail supplied.IntroReferral · House floor actions · Code H11100 | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code Intro-H | Congress.gov | |
| Official actionIntroduced in House | No additional detail supplied.IntroReferral · Library of Congress · Code 1000 | Congress.gov | |
| Text versionIntroduced in House | A dated text-version record is available. | Congress.gov | |
| Official actionOrdered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0. | No additional detail supplied.Committee · House committee actions · Code H19000 | Congress.gov | |
| Official actionCommittee Consideration and Mark-up Session Held | No additional detail supplied.Committee · House committee actions · Code H15001 | Congress.gov | |
| Official actionPlaced on the Union Calendar, Calendar No. 304. | No additional detail supplied.Calendars · House floor actions · Code H12410 | Congress.gov | |
| Official actionReported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352. | No additional detail supplied.Committee · House floor actions · Code H12200 | Congress.gov | |
| Official actionReported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352. | No additional detail supplied.Committee · Library of Congress · Code 5000 | Congress.gov | |
| Text versionReported in House | A dated text-version record is available. | Congress.gov | |
| Text versionEngrossed in House | A dated text-version record is available. | Congress.gov | |
| Official actionMr. Carter (GA) moved to suspend the rules and pass the bill, as amended. | No additional detail supplied.Floor · House floor actions · Code H30300 | Congress.gov | |
| Official actionConsidered under suspension of the rules. (consideration: CR H4929-4935) | No additional detail supplied.Floor · House floor actions · Code H30000 | Congress.gov | |
| Official actionDEBATE - The House proceeded with forty minutes of debate on H.R. 1262. | No additional detail supplied.Floor · House floor actions · Code H8D000 | Congress.gov | |
| Official actionOn motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932) | No additional detail supplied.Floor · House floor actions · Code H37300 | Congress.gov | |
| Official actionPassed/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) | No additional detail supplied.Floor · Library of Congress · Code 8000 | Congress.gov | |
| Official actionMotion to reconsider laid on the table Agreed to without objection. | No additional detail supplied.Floor · House floor actions · Code H38310 | Congress.gov | |
| Official actionReceived in the Senate. | No additional detail supplied.IntroReferral · Senate | Congress.gov |
House roll calls join only on matching Congress, legislation type, and number. Senate roll calls join only on matching source-supplied document type and number, not question text. Committee and related-measure relationships have no date in their relationship records and therefore are counted above but never placed on the chronology.
Congressional Research Service
CRS summary
Give Kids a Chance Act of 2025This 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 billmodifies 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; andreauthorizes 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.)
Official documents
Text versions
- Engrossed in HouseDec 1, 2025
- Reported in HouseOct 31, 2025
- Introduced in HouseFeb 12, 2025