HR 1262 · 119th Congress · Health

Mikaela Naylon Give Kids a Chance Act

Introduced February 12, 2025 Latest action December 02, 2025 313 cosponsors

Sponsor

Latest action

Received in the Senate.

Action timeline

Every recorded action on this bill, newest first. Stage badges color-code the legislative path.

Dec 02, 2025

introduced Received in the Senate.

Dec 01, 2025

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

Dec 01, 2025

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

Dec 01, 2025

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

Dec 01, 2025

passed 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)

Text versions

Each stage of the bill — official text published by GPO. Click any format to read on congress.gov / govinfo.

Dec 01, 2025 Engrossed in House

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Oct 31, 2025 Reported in House

XML

Feb 12, 2025 Introduced in House

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CRS summaries

Plain-English summaries written by the Congressional Research Service — neutral, nonpartisan staff who summarize bills as they advance through stages. The authoritative description of what each version of the bill does.

00 Introduced in House Feb 12, 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.)

via Congressional Research Service · published through congress.gov

Changelog

ⓘ

How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.

`ih` / `is` — Introduced in House / Senate. First filed version.

`rfh` / `rfs` — Referred to a committee for review.

`rh` / `rs` — Reported back by the committee to the floor (often with amendments — this is where most language changes happen).

`pcs` / `pch` — Placed on Calendar for floor consideration.

`eh` / `es` — Engrossed. Passed by the originating chamber. Text is now what was actually voted on.

`rdh` / `rds` — Received by the other chamber.

`eah` / `eas` — Engrossed Amendment. The other chamber passed an amended version.

`ath` / `ats` — Agreed to. Both chambers settled on the same text.

`enr` — Enrolled. Final reconciled text, sent to the President.

`pl` — Public Law. Signed by the President. It's now law.

`pp` — Public Print. Official printing post-enactment.

Most bills die before `eh`/`es`. Going from `pcs` → `enr` is the full path through both chambers.

Line-level diff between text versions of this bill — what actually changed at each legislative stage.

+17 −125 42 unchanged

--- Reported (House)

+++ Engrossed (House)

@@ -1,127 +1,27 @@

[From the U.S. Government Publishing Office]

-[H.R. 1262 Reported in House (RH)]

+[H.R. 1262 Engrossed in House (EH)]

<DOC>

-Union Calendar No. 304

119th CONGRESS

1st Session

H. R. 1262

-[Report No. 119-352]

+_______________________________________________________________________

+AN ACT

To amend the Federal Food, Drug, and Cosmetic Act with respect to

molecularly targeted pediatric cancer investigations, and for other

purposes.

-_______________________________________________________________________

-IN THE HOUSE OF REPRESENTATIVES

-February 12, 2025

-Mr. McCaul (for himself, Mr. Bilirakis, Mrs. Dingell, Ms. Schrier, Mrs.

-Harshbarger, Ms. Matsui, Mr. Crenshaw, Ms. Castor of Florida, Mr. Kelly

-of Pennsylvania, Mrs. Trahan, and Mr. Weber of Texas) introduced the

-following bill; which was referred to the Committee on Energy and

-Commerce

-October 31, 2025

-Additional sponsors: Mr. Wittman, Mr. Allen, Mr. Zinke, Mr. Evans of

-Colorado, Mr. Higgins of Louisiana, Mr. Gimenez, Mrs. Miller of West

-Virginia, Mr. Cline, Mr. Sessions, Mr. Rulli, Mr. Mullin, Mr. Soto, Mr.

-Keating, Mrs. McIver, Mr. Case, Mr. Castro of Texas, Ms. Sewell, Ms.

-Wasserman Schultz, Ms. Norton, Mr. McGarvey, Mr. Diaz-Balart, Mr.

-Wilson of South Carolina, Mr. LaHood, Mr. Van Drew, Ms. Malliotakis,

-Mr. Larson of Connecticut, Mr. Bishop, Ms. DelBene, Mr. Harder of

-California, Mr. Grijalva, Mr. Schneider, Ms. Scanlon, Mr. Finstad, Mr.

-Huizenga, Mrs. Miller of Illinois, Mr. Yakym, Mr. Costa, Ms. McCollum,

-Mrs. Hayes, Mr. Garcia of California, Mr. Davis of North Carolina, Mr.

-Graves, Mr. LaMalfa, Mr. Carey, Mrs. Kim, Mr. Lawler, Mr. Grothman, Ms.

-Titus, Ms. Salinas, Ms. Brownley, Mr. Ciscomani, Ms. Bonamici, Mr.

-Fitzpatrick, Mr. Vicente Gonzalez of Texas, Mr. Owens, Mrs. Cherfilus-

-McCormick, Mr. Joyce of Pennsylvania, Mr. Nehls, Mr. Bacon, Ms. Letlow,

-Mr. Balderson, Mr. Takano, Ms. Jayapal, Mr. Cohen, Mr. Panetta, Mr.

-Nadler, Mr. McGuire, Mr. Mann, Mrs. Kiggans of Virginia, Ms. Leger

-Fernandez, Mr. Quigley, Mr. Cleaver, Ms. Tenney, Mr. Krishnamoorthi,

-Mr. Kiley of California, Mr. Auchincloss, Mr. Turner of Ohio, Mr.

-Moulton, Mr. Austin Scott of Georgia, Mr. Pocan, Mrs. Houchin, Ms.

-McBride, Mr. Landsman, Mr. Alford, Mr. Calvert, Mr. Latimer, Mr.

-Moylan, Ms. Ross, Mr. Cole, Ms. Davids of Kansas, Mr. Smith of

-Nebraska, Ms. Omar, Mr. Steube, Mr. Suozzi, Ms. McClellan, Mr.

-Carbajal, Mr. Norcross, Mr. Peters, Mr. Magaziner, Mr. Valadao, Mr.

-Scott Franklin of Florida, Mr. Meuser, Mr. Miller of Ohio, Mr. Rouzer,

-Mr. Thompson of Pennsylvania, Mr. Shreve, Mr. Edwards, Mr. Moolenaar,

-Ms. Gillen, Ms. Stansbury, Mr. Williams of Texas, Mr. Fallon, Mr.

-Westerman, Mr. Newhouse, Mr. Hamadeh of Arizona, Mr. Baumgartner, Mr.

-Cuellar, Ms. Houlahan, Ms. Stefanik, Mr. Smith of New Jersey, Ms. Meng,

-Mr. Crow, Mr. Lieu, Mr. Vindman, Ms. Bynum, Mr. Kennedy of New York,

-Mr. Taylor, Mr. Smucker, Mr. Fleischmann, Ms. Craig, Mr. Mrvan, Mr.

-Evans of Pennsylvania, Ms. Salazar, Mr. Van Orden, Ms. Brown, Mr. Ruiz,

-Mrs. Hinson, Mr. Garamendi, Mr. Morelle, Mr. Jackson of Illinois, Mr.

-Mills, Mr. Moore of North Carolina, Mrs. Luna, Mr. Tran, Mr. Thompson

-of Mississippi, Mrs. Foushee, Mr. Boyle of Pennsylvania, Mr. Deluzio,

-Mr. Wied, Mr. Torres of New York, Mr. Veasey, Ms. Lee of Pennsylvania,

-Mr. Gottheimer, Mr. Nunn of Iowa, Mr. Figures, Mr. Subramanyam, Ms.

-Clarke of New York, Mr. Green of Texas, Mr. Riley of New York, Mr.

-Lynch, Mrs. Bice, Mr. Vargas, Ms. Wilson of Florida, Mr. Fields, Mr.

-Frost, Mr. Swalwell, Mr. Tonko, Ms. Scholten, Mr. Jackson of Texas, Ms.

-Kaptur, Ms. Ansari, Mrs. Radewagen, Mr. Schmidt, Mrs. Fletcher, Mr.

-Steil, Mr. Moran, Mr. McGovern, Mr. Correa, Mr. Webster of Florida, Mr.

-Bresnahan, Mr. Garbarino, Mr. Burchett, Ms. Budzinski, Ms. Sherrill,

-Ms. Johnson of Texas, Mr. Conaway, Ms. Tokuda, Mr. Bentz, Mr. Vasquez,

-Mr. Flood, Mr. Pfluger, Ms. Pettersen, Mr. Stanton, Mr. Loudermilk, Ms.

-Dean of Pennsylvania, Mr. Walberg, Mr. Messmer, Mr. Carter of

-Louisiana, Ms. Strickland, Mrs. Sykes, Ms. Jacobs, Mr. Casten, Ms.

-Adams, Mr. Sorensen, Mr. Espaillat, Mrs. McClain Delaney, Ms. Waters,

-Ms. Kelly of Illinois, Mr. Bera, Ms. Schakowsky, Mr. Foster, Mr.

-Moskowitz, Mr. Langworthy, Mr. LaLota, Mr. Aderholt, Mr. Rutherford,

-Mr. Kennedy of Utah, Mr. Bost, Mr. Amodei of Nevada, Mr. Johnson of

-Georgia, Ms. Pou, Mr. Garcia of Illinois, Ms. Velazquez, Ms. Elfreth,

-Ms. Goodlander, Mr. Khanna, Ms. King-Hinds, Mr. Buchanan, Ms. Lee of

-Florida, Mr. Goldman of Texas, Ms. Crockett, Ms. Stevens, Mr. Carson,

-Mr. Levin, Mr. Raskin, Mr. Thompson of California, Mr. Obernolte, Mr.

-Reschenthaler, Ms. Lofgren, Mr. Davis of Illinois, Mr. Mannion, Mrs.

-Miller-Meeks, Mr. Kustoff, Mr. Cloud, Mr. Menendez, Mr. Neguse, Mr.

-Goldman of New York, Mr. Ezell, Mr. Harrigan, Mr. Crank, Mr. Cisneros,

-Mr. Haridopolos, Mr. Min, Mr. Hernandez, Mr. Timmons, Mrs. McBath, Mr.

-Kean, Mr. Pappas, Mr. Himes, Ms. Escobar, Mr. Olszewski, Mr. Smith of

-Washington, Ms. Sanchez, Ms. Randall, Ms. Pingree, Ms. Tlaib, Ms.

-Rivas, Ms. McDonald Rivet, Ms. Friedman, Mr. Gooden, Mr. Feenstra, Ms.

-Kamlager-Dove, Ms. Perez, Mr. Huffman, Mr. Amo, Mr. DeSaulnier, Ms.

-DeGette, Mr. Hurd of Colorado, Mr. Moore of Utah, Mr. McCormick, Mr.

-Womack, Mr. Bergman, Mr. Bell, Ms. Chu, Ms. Lee of Nevada, Mr.

-Whitesides, Mr. David Scott of Georgia, Mr. Walkinshaw, Mr. Arrington,

-Mr. Thanedar, Ms. Hoyle of Oregon, Mrs. Watson Coleman, Ms. Balint, Mr.

-Gray, Mr. Crawford, Mr. Mackenzie, Mr. Simpson, Mr. Carter of Georgia,

-Mr. Baird, Mr. Mfume, Mr. Davidson, Mr. Bean of Florida, and Mr.

-Sherman

-October 31, 2025

-Reported with an amendment, committed to the Committee of the Whole

-House on the State of the Union, and ordered to be printed

-[Strike out all after the enacting clause and insert the part printed

-in italic]

-[For text of introduced bill, see copy of bill as introduced on

-February 12, 2025]

-_______________________________________________________________________

-A BILL

-To amend the Federal Food, Drug, and Cosmetic Act with respect to

-molecularly targeted pediatric cancer investigations, and for other

-purposes.

Be it enacted by the Senate and House of Representatives of the

United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

-(a) Short Title.--This Act may be cited as the ``Give Kids a Chance

-Act of 2025''.

+(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

follows:

@@ -610,8 +510,8 @@

including related recommendations, as applicable.

``(6) Sunset.--The authority to collect registration fees

under paragraph (1) shall expire on the date that is 3 years

-after the date of enactment of the Give Kids a Chance Act of

-2025.''.

+after the date of enactment of the Mikaela Naylon Give Kids a

+Chance Act.''.

SEC. 9. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE WITHIN FOOD AND DRUG

ADMINISTRATION.

@@ -767,32 +667,24 @@

SEC. 11. MEDICARE IMPROVEMENT FUND.

Section 1898(b)(1) of the Social Security Act (42 U.S.C.

-1395iii(b)(1)) is amended--

-(1) by striking ``fiscal year 2026'' and inserting ``fiscal

-year 2027''; and

-(2) by striking ``$1,804,000,000'' and inserting

-``$3,047,000,000''.

-Union Calendar No. 304

+1395iii(b)(1)) is amended by striking ``$1,403,000,000'' and inserting

+``$2,622,000,000''.

+Passed the House of Representatives December 1, 2025.

+Attest:

+Clerk.

119th CONGRESS

1st Session

H. R. 1262

-[Report No. 119-352]

_______________________________________________________________________

-A BILL

+AN ACT

To amend the Federal Food, Drug, and Cosmetic Act with respect to

molecularly targeted pediatric cancer investigations, and for other

purposes.

-_______________________________________________________________________

-October 31, 2025

-Reported with an amendment, committed to the Committee of the Whole

-House on the State of the Union, and ordered to be printed

Lobbying activity

Organizations whose LDA filings reference this bill, ranked by filing count. Position not disclosed — LDA does not require lobbyists to report support / oppose / monitor. Bill-number references can be stale (lobbyists sometimes copy text year-over-year), so verify against the filing description.

NOVARTIS

HCR

filings · 2026 Q3

BAYER CORPORATION (CONSOLIDATED REPORT)

HCR

filings · 2026 Q3

DANA-FARBER CANCER INSTITUTE

HCRMED

filings · 2026 Q3

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

HCR

filings · 2026 Q3

ASTRAZENECA PHARMACEUTICALS LP

HCR

filings · 2026 Q3

BRIDGEBIO PHARMA, INC.

PHA

filings · 2026 Q3

BIOTECHNOLOGY INNOVATION ORGANIZATION

HCRMMMTAX

filings · 2026 Q3

ORCHARD THERAPEUTICS NORTH AMERICA

HCR

filings · 2025 Q3

PTC THERAPEUTICS, INC.

HCR

filings · 2026 Q3

BLOOD CANCER UNITED (FKA THE LEUKEMIA & LYMPHOMA SOCIETY)

HCR

filings · 2026 Q3

via Senate LDA · self-reported quarterly. Filing count = filings mentioning this bill (no position required), not money spent on it. Click a client to see all bills they've filed on.

Cosponsors (307)

Members who signed on to support this bill.