U.S. Congress legislation · 119th Congress
HB1262: Mikaela Naylon Give Kids a Chance Act
Status: Passed one chamber, December 2, 2025
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
What the bill says
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
From the engrossed text, December 1, 2025:
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. SECTION 1. Short title; table of contents (a) Short title This Act may be cited as the Mikaela Naylon Give Kids a Chance Act . (b) Table of contents The table of contents for this Act is as table of contents. Sec. 2. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs. Sec. 3. Ensuring completion of pediatric study requirements. Sec. 4. FDA report on PREA enforcement. Sec. 5. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases. Sec. 6. Limitations on exclusive approval or licensure of orphan drugs. Sec. 7. Program for pediatric studies of drugs. Sec. 8. Organ Procurement and Transplantation Network. Sec. 9. Establishment of Abraham Accords Office within Food and Drug Administration. Sec. 10. Increasing transparency in generic drug applications. Sec. 11. Medicare Improvement Fund. SECTION 2. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs (a) In general (1) Additional active ingredient for application drug; limitation regarding novel-combination application drug Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355c(a)(3) ) is amended-- (A) by redesignating …
Sponsors
- Michael McCaul (R, HD-010) · primary sponsor
- Gus Bilirakis (R, HD-FL-12)
- Debbie Dingell (D, HD-006)
- Kim Schrier (D, HD-008)
- Diana Harshbarger (R, HD-001)
- Doris Matsui (D)
- Dan Crenshaw (R, HD-002)
- Kathy Castor (D, HD-014)
- Mike Kelly (R, HD-PA-16)
- Lori Trahan (D, HD-003)
- Randy Weber (R, HD-014)
- Robert Wittman (R, HD-001)
Latest actions
- : Received in the Senate.
- : Motion to reconsider laid on the table Agreed to without objection.
- : On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4929-4932)
- : 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)
- : DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.
- : Considered under suspension of the rules. (consideration: CR H4929-4935)
- : Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
- : Placed on the Union Calendar, Calendar No. 304.
- : Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-352.
- : Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 47 - 0.
Subjects: Health information and medical records, Organ and tissue donation and transplantation, Executive agency funding and structure, Bahrain, Computers and information technology, Performance measurement, Child health, Research administration and funding
Common questions
- What is HB1262?
- HB1262 is a bill in Congress (119th Congress): Mikaela Naylon Give Kids a Chance Act.
- What does HB1262 do?
- In its own words: To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
- What is the status of HB1262?
- Passed one chamber as of December 2, 2025. Latest action: Received in the Senate. (December 2, 2025).
- Who sponsored HB1262?
- Michael McCaul (R, HD-010), with 11 co-sponsors.
- Where is the official record for HB1262?
- On the Congress website: https://www.congress.gov/bill/119th-congress/house-bill/1262
Source: official Congress record. Tracked by Delilah, AI for legislation across all 50 states and Congress.