HR 1262 · 119th Congress 2025–2027

Mikaela Naylon Give Kids a Chance Act

Latest action · Dec 2, 2025 Received in the Senate.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedFeb 12, 2025
  2. Passed HouseDec 1, 2025
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

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.)

Cosponsors 313

Members who signed on, in the order they did. Signatures ran from Feb 12, 2025 to Oct 31, 2025; 10 are original cosponsors, there from the day it was introduced.

SeatCosponsorSigned on
R-TXDan CrenshawOriginalFeb 12, 2025
D-MIDebbie DingellOriginalFeb 12, 2025
R-TNDiana HarshbargerOriginalFeb 12, 2025
D-CADoris O. MatsuiOriginalFeb 12, 2025
R-FLGus M. BilirakisOriginalFeb 12, 2025
D-FLKathy CastorOriginalFeb 12, 2025
D-WAKim SchrierOriginalFeb 12, 2025
D-MALori TrahanOriginalFeb 12, 2025
R-PAMike KellyOriginalFeb 12, 2025
R-TXRandy K. Weber, Sr.OriginalFeb 12, 2025
R-VABen ClineFeb 24, 2025
R-FLCarlos A. GimenezFeb 24, 2025
R-WVCarol D. MillerFeb 24, 2025
R-LAClay HigginsFeb 24, 2025
D-FLDarren SotoFeb 24, 2025
D-FLDebbie Wasserman SchultzFeb 24, 2025
D-HIEd CaseFeb 24, 2025
D-DCEleanor Holmes NortonFeb 24, 2025
R-COGabe EvansFeb 24, 2025
D-TXJoaquin CastroFeb 24, 2025
D-CAKevin MullinFeb 24, 2025
D-NJLaMonica McIverFeb 24, 2025
R-OHMichael A. RulliFeb 24, 2025
D-KYMorgan McGarveyFeb 24, 2025
R-TXPete SessionsFeb 24, 2025
R-GARick W. AllenFeb 24, 2025
R-VARobert J. WittmanFeb 24, 2025
R-MTRyan K. ZinkeFeb 24, 2025
D-ALTerri A. SewellFeb 24, 2025
D-MAWilliam R. KeatingFeb 24, 2025
R-MIBill HuizengaFeb 25, 2025
R-MNBrad FinstadFeb 25, 2025
D-ILBradley Scott SchneiderFeb 25, 2025
R-ILDarin LaHoodFeb 25, 2025
D-NJJefferson Van DrewFeb 25, 2025
R-SCJoe WilsonFeb 25, 2025
D-CTJohn B. LarsonFeb 25, 2025
D-CAJosh HarderFeb 25, 2025
R-FLMario Diaz-BalartFeb 25, 2025
D-PAMary Gay ScanlonFeb 25, 2025
R-NYNicole MalliotakisFeb 25, 2025
D-AZRaúl M. GrijalvaFeb 25, 2025
D-GASanford D. Bishop, Jr.Feb 25, 2025
D-WASuzan K. DelBeneFeb 25, 2025
D-MNBetty McCollumFeb 26, 2025
D-CAJim CostaFeb 26, 2025
R-ILMary E. MillerFeb 26, 2025
R-INRudy Yakym IIIFeb 26, 2025
D-NCDonald G. DavisFeb 27, 2025
R-CADoug LaMalfaFeb 27, 2025
D-CTJahana HayesFeb 27, 2025
R-OHMike CareyFeb 27, 2025
D-CARobert GarciaFeb 27, 2025
R-MOSam GravesFeb 27, 2025
D-ORAndrea SalinasMar 3, 2025
D-NVDina TitusMar 3, 2025
R-WIGlenn GrothmanMar 3, 2025
D-CAJulia BrownleyMar 3, 2025
R-NYMichael LawlerMar 3, 2025
R-CAYoung KimMar 3, 2025
R-PABrian K. FitzpatrickMar 4, 2025
R-AZJuan CiscomaniMar 4, 2025
D-ORSuzanne BonamiciMar 4, 2025
D-TXVicente GonzalezMar 4, 2025
R-UTBurgess OwensMar 10, 2025
R-NEDon BaconMar 10, 2025
D-NYJerrold NadlerMar 10, 2025
D-CAJimmy PanettaMar 10, 2025
R-PAJohn JoyceMar 10, 2025
R-LAJulia LetlowMar 10, 2025
D-CAMark TakanoMar 10, 2025
D-WAPramila JayapalMar 10, 2025
D-FLSheila Cherfilus-McCormickMar 10, 2025
D-TNSteve CohenMar 10, 2025
R-OHTroy BaldersonMar 10, 2025
R-TXTroy E. NehlsMar 10, 2025
R-NYClaudia TenneyMar 11, 2025
D-MOEmanuel CleaverMar 11, 2025
R-VAJennifer A. KiggansMar 11, 2025
R-VAJohn J. McGuire IIIMar 11, 2025
D-ILMike QuigleyMar 11, 2025
D-ILRaja KrishnamoorthiMar 11, 2025
D-NMTeresa Leger FernandezMar 11, 2025
R-KSTracey MannMar 11, 2025
R-GAAustin ScottMar 25, 2025
D-NCDeborah K. RossMar 25, 2025
R-INErin HouchinMar 25, 2025
D-NYGeorge LatimerMar 25, 2025
D-OHGreg LandsmanMar 25, 2025
D-MAJake AuchinclossMar 25, 2025
R-GUJames C. MoylanMar 25, 2025
R-CAKen CalvertMar 25, 2025
R-CAKevin KileyMar 25, 2025
R-MOMark AlfordMar 25, 2025
D-WIMark PocanMar 25, 2025
R-OHMichael R. TurnerMar 25, 2025
D-DESarah McBrideMar 25, 2025
D-MASeth MoultonMar 25, 2025
D-KSSharice DavidsMar 25, 2025
R-OKTom ColeMar 25, 2025
R-NEAdrian SmithMar 26, 2025
D-MNIlhan OmarMar 26, 2025
R-PADaniel MeuserMar 31, 2025
R-CADavid G. ValadaoMar 31, 2025
R-NCDavid RouzerMar 31, 2025
D-NJDonald NorcrossMar 31, 2025
D-VAJennifer L. McClellanMar 31, 2025
R-OHMax L. MillerMar 31, 2025
D-CASalud O. CarbajalMar 31, 2025
R-FLScott FranklinMar 31, 2025
D-CAScott H. PetersMar 31, 2025
D-RISeth MagazinerMar 31, 2025
D-NYThomas R. SuozziMar 31, 2025
R-FLW. Gregory SteubeMar 31, 2025
R-NCChuck EdwardsApr 1, 2025
R-PAGlenn ThompsonApr 1, 2025
R-INJefferson ShreveApr 1, 2025
R-MIJohn R. MoolenaarApr 1, 2025
R-AZAbraham J. HamadehApr 3, 2025
R-ARBruce WestermanApr 3, 2025
R-WADan NewhouseApr 3, 2025
D-NYLaura GillenApr 3, 2025
D-NMMelanie A. StansburyApr 3, 2025
R-TXPat FallonApr 3, 2025
R-TXRoger WilliamsApr 3, 2025
R-WAMichael BaumgartnerApr 7, 2025
D-PAChrissy HoulahanApr 8, 2025
R-NJChristopher H. SmithApr 8, 2025
R-NYElise M. StefanikApr 8, 2025
D-TXHenry CuellarApr 8, 2025
D-NYGrace MengApr 10, 2025
D-COJason CrowApr 10, 2025
R-TNCharles J. "Chuck" FleischmannApr 24, 2025
R-OHDavid J. TaylorApr 24, 2025
D-VAEugene Simon VindmanApr 24, 2025
D-ORJanelle S. BynumApr 24, 2025
R-PALloyd SmuckerApr 24, 2025
D-CATed LieuApr 24, 2025
D-NYTimothy M. KennedyApr 24, 2025
D-MNAngie CraigApr 28, 2025
D-INFrank J. MrvanApr 28, 2025
D-PADwight EvansMay 1, 2025
R-WIDerrick Van OrdenMay 5, 2025
R-FLMaria Elvira SalazarMay 5, 2025
D-CARaul RuizMay 5, 2025
D-OHShontel M. BrownMay 5, 2025
R-IAAshley HinsonMay 6, 2025
D-CAJohn GaramendiMay 6, 2025
D-ILJonathan L. JacksonMay 7, 2025
D-NYJoseph D. MorelleMay 7, 2025
R-FLAnna Paulina LunaMay 13, 2025
D-MSBennie G. ThompsonMay 13, 2025
D-PABrendan F. BoyleMay 13, 2025
D-PAChristopher R. DeluzioMay 13, 2025
R-FLCory MillsMay 13, 2025
D-CADerek TranMay 13, 2025
R-NCTim MooreMay 13, 2025
D-NCValerie P. FousheeMay 13, 2025
R-WITony WiedMay 14, 2025
D-NJJosh GottheimerMay 20, 2025
D-TXMarc A. VeaseyMay 20, 2025
D-NYRitchie TorresMay 20, 2025
D-ALShomari FiguresMay 20, 2025
D-VASuhas SubramanyamMay 20, 2025
D-PASummer L. LeeMay 20, 2025
D-NYYvette D. ClarkeMay 20, 2025
R-IAZachary NunnMay 20, 2025
D-TXAl GreenMay 21, 2025
D-NYJosh RileyMay 21, 2025
D-MAStephen F. LynchMay 21, 2025
D-LACleo FieldsJun 3, 2025
D-CAEric SwalwellJun 3, 2025
D-FLFrederica S. WilsonJun 3, 2025
D-CAJuan VargasJun 3, 2025
D-FLMaxwell FrostJun 3, 2025
D-NYPaul TonkoJun 3, 2025
R-OKStephanie I. BiceJun 3, 2025
D-MIHillary J. ScholtenJun 4, 2025
R-TXRonny JacksonJun 6, 2025
D-OHMarcy KapturJun 9, 2025
D-AZYassamin AnsariJun 10, 2025
R-ASAumua Amata Coleman RadewagenJun 11, 2025
R-KSDerek SchmidtJun 11, 2025
D-TXLizzie FletcherJun 11, 2025
R-WIBryan SteilJun 23, 2025
R-TXNathaniel MoranJun 23, 2025
R-FLDaniel WebsterJun 26, 2025
D-CAJ. Luis CorreaJun 26, 2025
D-MAJames P. McGovernJun 26, 2025
R-PARobert P. Bresnahan, Jr.Jun 27, 2025
R-NYAndrew R. GarbarinoJul 2, 2025
R-ORCliff BentzJul 14, 2025
D-NJHerbert C. Conaway, Jr.Jul 14, 2025
D-HIJill N. TokudaJul 14, 2025
D-TXJulie JohnsonJul 14, 2025
D-NJMikie SherrillJul 14, 2025
D-ILNikki BudzinskiJul 14, 2025
R-TNTim BurchettJul 14, 2025
R-TXAugust PflugerJul 15, 2025
D-NMGabe VasquezJul 15, 2025
R-NEMike FloodJul 15, 2025
R-GABarry LoudermilkJul 16, 2025
D-COBrittany PettersenJul 16, 2025
D-AZGreg StantonJul 16, 2025
D-PAMadeleine DeanJul 16, 2025
D-NYAdriano EspaillatJul 17, 2025
D-NCAlma S. AdamsJul 17, 2025
D-CAAmi BeraJul 17, 2025
D-MDApril McClain DelaneyJul 17, 2025
D-ILBill FosterJul 17, 2025
D-OHEmilia Strong SykesJul 17, 2025
D-ILEric SorensenJul 17, 2025
D-ILJanice D. SchakowskyJul 17, 2025
D-FLJared MoskowitzJul 17, 2025
D-WAMarilyn StricklandJul 17, 2025
R-INMark B. MessmerJul 17, 2025
D-CAMaxine WatersJul 17, 2025
D-ILRobin L. KellyJul 17, 2025
D-CASara JacobsJul 17, 2025
D-ILSean CastenJul 17, 2025
R-MITim WalbergJul 17, 2025
D-LATroy A. CarterJul 17, 2025
R-NYNicholas A. LangworthyJul 21, 2025
R-NYNick LaLotaJul 21, 2025
R-FLJohn H. RutherfordJul 22, 2025
R-ALRobert B. AderholtJul 22, 2025
R-ILMike BostJul 23, 2025
R-UTMike KennedyJul 23, 2025
R-NVMark E. AmodeiJul 25, 2025
R-TXCraig A. GoldmanAug 1, 2025
D-MIHaley M. StevensAug 1, 2025
D-GAHenry C. "Hank" Johnson, Jr.Aug 1, 2025
D-TXJasmine CrockettAug 1, 2025
D-ILJesús G. "Chuy" GarcíaAug 1, 2025
R-MPKimberlyn King-HindsAug 1, 2025
R-FLLaurel M. LeeAug 1, 2025
D-NHMaggie GoodlanderAug 1, 2025
D-NJNellie PouAug 1, 2025
D-NYNydia M. VelázquezAug 1, 2025
D-CARo KhannaAug 1, 2025
D-MDSarah ElfrethAug 1, 2025
R-FLVern BuchananAug 1, 2025
D-INAndré CarsonAug 8, 2025
R-PAGuy ReschenthalerAug 8, 2025
D-MDJamie RaskinAug 8, 2025
R-CAJay ObernolteAug 8, 2025
D-CAMike LevinAug 8, 2025
D-CAMike ThompsonAug 8, 2025
D-ILDanny K. DavisAug 19, 2025
D-NYJohn W. MannionAug 19, 2025
D-CAZoe LofgrenAug 19, 2025
D-NYDaniel S. GoldmanSep 2, 2025
R-TNDavid KustoffSep 2, 2025
D-COJoe NeguseSep 2, 2025
R-IAMariannette Miller-MeeksSep 2, 2025
R-TXMichael CloudSep 2, 2025
R-MSMike EzellSep 2, 2025
R-NCPat HarriganSep 2, 2025
D-NJRobert MenendezSep 2, 2025
D-CADave MinSep 3, 2025
D-CAGilbert Ray Cisneros, Jr.Sep 3, 2025
R-COJeff CrankSep 3, 2025
R-FLMike HaridopolosSep 3, 2025
D-PRPablo José HernándezSep 3, 2025
D-GALucy McBathSep 4, 2025
R-SCWilliam R. Timmons IVSep 4, 2025
D-NHChris PappasSep 15, 2025
R-NJThomas H. Kean, Jr.Sep 15, 2025
D-WAAdam SmithSep 16, 2025
D-MEChellie PingreeSep 16, 2025
D-WAEmily RandallSep 16, 2025
D-CTJames A. HimesSep 16, 2025
D-CAJared HuffmanSep 16, 2025
D-MDJohnny Olszewski, Jr.Sep 16, 2025
D-MIKristen McDonald RivetSep 16, 2025
R-TXLance GoodenSep 16, 2025
D-CALaura FriedmanSep 16, 2025
D-CALinda T. SánchezSep 16, 2025
D-CALuz M. RivasSep 16, 2025
D-WAMarie Gluesenkamp PerezSep 16, 2025
R-IARandy FeenstraSep 16, 2025
D-MIRashida TlaibSep 16, 2025
D-CASydney Kamlager-DoveSep 16, 2025
D-TXVeronica EscobarSep 16, 2025
D-RIGabe AmoSep 17, 2025
D-CODiana DeGetteSep 18, 2025
R-COJeff HurdSep 18, 2025
D-CAMark DeSaulnierSep 18, 2025
R-UTBlake D. MooreSep 26, 2025
D-CAGeorge WhitesidesSep 26, 2025
R-MIJack BergmanSep 26, 2025
D-CAJudy ChuSep 26, 2025
R-GARichard McCormickSep 26, 2025
R-ARSteve WomackSep 26, 2025
D-NVSusie LeeSep 26, 2025
D-MOWesley BellSep 26, 2025
D-GADavid ScottSep 30, 2025
D-VAJames R. WalkinshawSep 30, 2025
R-TXJodey C. ArringtonOct 3, 2025
D-MIShri ThanedarOct 3, 2025
D-CAAdam GrayOct 8, 2025
D-VTBecca BalintOct 8, 2025
D-NJBonnie Watson ColemanOct 8, 2025
R-AREric A. "Rick" CrawfordOct 8, 2025
D-ORVal T. HoyleOct 8, 2025
R-PARyan MackenzieOct 10, 2025
R-IDMichael K. SimpsonOct 14, 2025
R-GAEarl L. "Buddy" CarterOct 17, 2025
R-INJames R. BairdOct 17, 2025
D-MDKweisi MfumeOct 17, 2025
R-FLAaron BeanOct 28, 2025
R-OHWarren DavidsonOct 28, 2025
D-CABrad ShermanOct 31, 2025

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

ChamberCommitteeWhat it did
HouseEnergy and Commerce Committee
Referred Feb 12, 2025Markup Sep 17, 2025Reported Oct 31, 2025

Actions 12

Everything that happened, newest first.

  1. Dec 2, 2025Received in the Senate.
  2. Dec 1, 2025Considered under suspension of the rules. (consideration: CR H4929-4935)
  3. 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)
  4. Dec 1, 2025Mr. Carter (GA) moved to suspend the rules and pass the bill, as amended.
  5. Dec 1, 2025DEBATE - The House proceeded with forty minutes of debate on H.R. 1262.

In the Congressional Record 4

Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.

WhereIn the RecordMembersDate
SenateDebate and remarks S8820–S8822Bernard Sanders I-VT, Bill Cassidy R-LA, Margaret Wood Hassan D-NH, Markwayne Mullin R-OKDec 17, 2025
HouseDebate and remarks H4929–H4935Text printed H4929–H4932Debbie Dingell D-MI, Earl L. "Buddy" Carter R-GA, Frank Pallone, Jr. D-NJ, Gus M. Bilirakis R-FL, Jay Obernolte R-CA, Michael T. McCaul R-TXDec 1, 2025
ExtensionsDebate and remarks E898Lori Trahan D-MASep 26, 2025
HouseDebate and remarks H1341John Joyce R-PAMar 31, 2025

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Committee report

Constitutional authority

Congress has the power to enact this legislation pursuant to the following: Article 1, Section 8,

The sponsor’s statement, as printed in the Congressional Record, vol. 171, no. 29, February 12, 2025, page H678.

Related bills 10

Companion bills and other measures the record links to this one.

BillTitleRelationshipLatest action
S 532OPTN Fee Collection Authority ActRelated billFeb 12, 2025
S 891Bipartisan Health Care ActRelated billMar 6, 2025
S 932Give Kids a Chance Act of 2025Related billMar 11, 2025
HR 1768Lower Costs for Everyday Americans ActRelated billMar 3, 2025
HR 1794United States-Abraham Accords Cooperation and Security Act of 2025Related billMar 3, 2025

Titles 5

Every title it has carried, official and short, at each stage.

Official Title as Introduced
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
Short Title(s) as Introduced
Give Kids a Chance Act of 2025
Short Title(s) as Reported to House
Give Kids a Chance Act of 2025
Short Title(s) as Passed House
Mikaela Naylon Give Kids a Chance Act
Official Title from EH (Engrossed in House) bill text
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 3

Each version as it was printed, newest first.

  1. Dec 1, 2025Engrossed in House
  2. Oct 31, 2025Reported in House
  3. Feb 12, 2025Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.