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119th Congress Health

H.R. 1262: Mikaela Naylon Give Kids a Chance Act

Passed HouseDec 1, 2025

  1. Introduced (completed)Feb 12, 2025
  2. Passed House (completed)Dec 1, 2025
  3. Passed Senate (not reached)
  4. To the President (not reached)
  5. Became law (not reached)

Summary

Introduced in House, Feb 12, 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.
Read the full summary

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 the Congressional Research Service, Library of Congress.

Roll calls

0 votes on this bill

No roll call votes have been held on this bill.

Amendments

0 offered

No amendments were offered to this bill.

Cosponsors

313

Bipartisan support.

Who scored on this bill

1,338 points earned
  1. 1Michael McCaul R-TX SponsorDrew cross-party cosponsors, introduced, reached a cosponsor milestone, marked up, reported, passed House8 events+86
  2. 2Alma Adams D-NCCosponsored; cosponsored bill passed2 events+4
  3. 2Robert Aderholt R-ALCosponsored; cosponsored bill passed2 events+4
  4. 2Mark Alford R-MOCosponsored; cosponsored bill passed2 events+4
  5. 2Rick Allen R-GACosponsored; cosponsored bill passed2 events+4
See all scorers and every scoring event

Introductions and cosponsorships count toward weekly caps and show no points.

Other bills by Michael McCaul

History

  1. Dec 1, 2025Passed the House by voice vote.
  2. Feb 12, 2025Introduced in the House by Michael McCaul.
Show the full action history (13 actions)
  1. Dec 2, 2025Received in the Senate.
  2. Dec 1, 2025Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
  3. Dec 1, 2025Considered under suspension of the rules. (consideration: CR H4929-4935)
  4. Dec 1, 2025DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
  5. 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)
  6. Dec 1, 2025On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
  7. Dec 1, 2025Motion to reconsider laid on the table Agreed to without objection.
  8. Oct 31, 2025Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
  9. Oct 31, 2025Placed on the Union Calendar, Calendar No. 304.
  10. Sep 17, 2025Committee Consideration and Mark-up Session Held
  11. Sep 17, 2025Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
  12. Feb 12, 2025Introduced in House
  13. Feb 12, 2025Referred to the House Committee on Energy and Commerce.