H.R. 1262

119th Congress

Introduced

Mikaela Naylon Give Kids a Chance Act

Sponsored byRepublican:Rep. McCaul, Michael T. [R-TX-10]TX· Introduced 12 February 2025
Open on Congress.gov

313

Cosponsors

15

Actions

0

Amendments

1

Committees

—

Since introduced

Introduced
Committee
Passed Chamber
Passed Both
Enacted
Step 0 of 0
Latest action

Received in the Senate.

2 December 2025·7 months ago

Summary

Introduced in House · Updated 5 August 2025

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.)

Timeline

15 actions

  1. Received in the Senate.

    2 December 2025 · IntroReferral

  2. Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.

    1 December 2025 · Floor

  3. DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.

    1 December 2025 · Floor

  4. Considered under suspension of the rules. (consideration: CR H4929-4935)

    1 December 2025 · Floor

  5. 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)

    1 December 2025 · Floor

  6. On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)

    1 December 2025 · Floor

  7. Motion to reconsider laid on the table Agreed to without objection.

    1 December 2025 · Floor

  8. Placed on the Union Calendar, Calendar No. 304.

    31 October 2025 · Calendars

  9. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.

    31 October 2025 · Committee

  10. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.

    31 October 2025 · Committee

  11. Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.

    17 September 2025 · Committee

  12. Committee Consideration and Mark-up Session Held

    17 September 2025 · Committee

  13. Referred to the House Committee on Energy and Commerce.

    12 February 2025 · IntroReferral

  14. Introduced in House

    12 February 2025 · IntroReferral

  15. Introduced in House

    12 February 2025 · IntroReferral

Sponsorship

313 cosponsors

Sponsor

Republican:Rep. McCaul, Michael T. [R-TX-10]TX

Cosponsors

  • Democrat3366%
  • Republican1734%
View all on Congress.gov

Classification

Policy area

Health

Legislative subjects

Arab-Israeli relationsBahrainCancerChild healthComputers and information technologyCongressional oversightDrug safety, medical device, and laboratory regulationExecutive agency funding and structureFood and Drug Administration (FDA)Government information and archivesGovernment studies and investigationsHealth information and medical records

Committees

1

  • Energy and Commerce Committee

    House · Standing

    • Referred To12 Feb 2025
    • Markup By17 Sept 2025
    • Reported By31 Oct 2025

Reports

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