Montana’s plan to become an experimental medical hub just pushed forward
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Summary
As of this week in Montana, any biotech company with an experimental drug has a clear path to selling it to consumers. Companies whose drugs have been through preliminary testing—sometimes in as few as 10 healthy people—can pay 12,500toapplytoanewlyestablishedreviewboardforapproval.Onceitstreatmentisrubber−stamped,thecompanycansetthepriceofthedrugandsellitviaexperimentaltreatmentclinics,thefirstofwhichislikelytobeupandrunningaroundtheendofthisyear.Montana’slatestright−to−trylegislationisunique.Whileotherjurisdictionswithsimilarlawslimitaccesstodrugstopeoplewithterminalillness,inMontanaaccessistheoreticallyavailabletoanyonewhogivesinformedconsentandcanpay.Thatincludespeopledesperatefortreatmentsforrarediseases.Italsoincludesthosewhoareinterestedinlongevityandwanttotryoutdrugspitchedaspreventivetherapies.Thestate’sDepartmentofHealthandHumanServicesrecentlyfinalizedrulestoimplementthelaw.TherulesstipulatethatpatientconsumersprovidefullyinformedconsentandthateachapplicationbereviewedbyaboardthatincludesaMontana−certifieddoctor,expertscientists,andanethicist.Supportersofthelawstressthattheywanttheprocesstoberesponsible.“Itwillbedoneinaveryrigorousway,withqualifiedmedicalprofessionalsandappropriateoversight,”saysMattKaeberlein,ascientistonthefirstboard,whichwasformedindependentlyofthestatehealthdepartment.ButotherexpertsareworriedaboutthepotentialforharminsellingunproventreatmentstopeoplewithoutoversightfromtheUSFoodandDrugAdministration.“Iwouldbeconcerned,”saysAaronKesselheim,aprofessorofmedicineatHarvardMedicalSchoolwithexpertiseinhealthpolicyanddrugregulation.Montanafirstpassedaright−to−trylawin2015.In2023,withthesupportofstatesenatorKenBogner,thestateexpandedthelawtoincludeallpatients,notthosejustwithterminaldisease.Lastyear,BognertoldMITTechnologyReviewthathisvisionwastofocus“moreonpreventativemedicine”ratherthan“justtreatingdiseasesoncetheyshowup.”Bognersayshehad“startedworkingonabill”thatwouldbecomethe2023lawwhentheAllianceforLongevityInitiatives(A4LI),anonprofit“dedicatedtoadvancinglegislationandpoliciesaimedatincreasinghealthyhumanlifespan,”gotintouch.A4LIconnectedBognerwithotherswhohelpeddraftthebillandtestifiedinsupportofit.Oncethatlawwasinplace,thetechentrepreneurandlongevityenthusiastNiklasAnzingergotinvolved.Anzingerhasbeenworkingtoestablishajurisdictiontofast−trackthesearchfordrugsthatmightdeliverradicallifeextension.HeisbasedinProˊspera—aprivatecityand“specialeconomiczone”inRoataˊn,Honduras,whichisalreadyhometoaseparateclinicthatsellsexperimentalstem−cellandgenetherapies.AnzingerfoundedacommunitytherecalledInfinitaCity;hehasalsofoundedaninvestmentcompanyanda“serviceproviding”company,bothofwhichincludethenameInfinita.Overthelastcoupleofyears,AnzingerhasswitchedhisfocustotheUS.“NowwethinkthatMontanaisabettermodel,becauseit’sbuildingon…existingregulatoryprecedents,”hesays.OnceMontana’s2023lawwaspassed,headds,heworkedwithahandfulofunnamedbiotechcompaniestodraftasecondbill—onethatlaidoutthespecifictermsunderwhichclinicscanofferunapproveddrugs.ThatlawwaspassedinApril2025andadoptedthefollowingmonth.Sincethen,Anzinger,Bogner,andothershavebeenwaitingforthestate’sDepartmentofHealthandHumanServicestofinalizespecificrulesfortreatmentcenters—asetofoperationalguidelinesandrequirementsthatanyclinicofferingtreatmentsunapprovedbytheFDAmustmeetunderMontana’slaw.“Theruleshavebeentakingaverylongtime,”saysAnzinger.“ThenonFriday,weheardtheywereeffective…fromSaturday[July25].”Theruleshavesincebeenpublishedonline.FollowingtherulesWiththenewrulesinhand,AnzingerandhiscolleagueStephenMartin,Infinita’sUSlead,gottowork.Thefirststepwastoestablishanindependentexperimentaltreatmentreviewboard—apaneloffiveexpertstoevaluateapplicationsforaccess.AnzingerandMartinstartedrecruitingcandidatesmonthsago.Thestate’sfirstboard,namedtheMontanaETRB,wasofficiallyannouncedbyInfinitaearlierthisweek.Forthetimebeing,itisthestate’sonlyreviewboard,althoughAnzingersaysthatothergroupsarefreetoestablishtheirown.AfterBognerraisedconcernsthattheboard’swebsitewronglyimpliedthatitwasanofficialstatebody,thesitewasupdatedtonotethat“ItisaprivateservicerunbyMontanaGovernanceServicesInc.”Thatcompanyis“alocalMontanaregisteredentity,butitisundertheInfinitaumbrella,”saysAnzinger.Infinitawillpayboardmembersaflatfee,fundedbythe12,500 companies will have to pay to have their applications reviewed. Anzinger stresses that the board members, and their decisions, will be independent of Infinita.
In accordance with the rules, the board includes a Montana-licensed doctor: James Burke, an oncologist. It also includes a bioethicist: Jessica Flanigan, a libertarian who is known for her strong views in support of self-medication and her book Pharmaceutical Freedom.
The other three members are familiar faces in the longevity community—all of whom are well respected in the field. “When we looked at our own network, these were some of the best guys,” says Martin. They include Felipe Sierra, who formerly held a senior role at the National Institutes of Health’s arm focused on aging. More recently, Sierra served as chief scientific officer at Hevolution Foundation, a nonprofit that funds research into extending healthy lifespan with the support of the government of Saudi Arabia.
Matt Kaeberlein, who formerly led the Dog Aging Project and has studied the potential for rapamycin as a longevity therapeutic, also features. So does Jamie Justice, a gerontologist who is also executive director of the X Prize Healthspan competition, which has 101millioninprizemoneyupforgrabsforresearcherswhofindwaystotreatthesignsofaging.“Isawanopportunitytohelpbuildasafe,transparent,andscientificallyrigorousprocessforimplementingMontana′snewlyexpandedright−to−trylegislation,particularlyasitappliestolongevitymedicinesandaging−relatedinterventions,”saysJustice.“Scienceismovingquickly,andIwantedtohelpensurethatasitdevelops,itdoessowithrealrigorandaccountability.”Kaeberlein,whohasaprominentmediapresence,haslongraisedhisownconcernsaboutaccesstootherunproventreatments,includingpeptidesandstem−celltherapies.HeseesMontana’ssetupasofferingamoreregulatedenvironment—onethatoffersscientificoversight,ensuresinformedconsent,andallowsfordatacollection.ApplicationsincomingWhilemanyofthebill’soriginalsupporterswereinterestedinlongevity,theinitialinterestinmakingdrugsmoreaccessibleinMontanaiscomingfromcompaniesandindividualslookingtotreatspecificdiseases.“Wewereactuallysurprisedthatmuchoftheinterest…isactuallymorefromoncology[and]neurodegenerativedisease,”saysAnzinger.Thisfocus,hesays,is“verycompatible”withInfinita’smission.“We’renottryingtoconvinceeveryone…tosupportradicallifeextension,”hesays.Anythingthatextendshealthandhumanlife,includingtreatingcancerandneurodegenerativedisease,ispartofwhatlongevitymeanstohim,hesays.Martinsaysthattwoapplicationshavealreadybeensubmittedtothenewlyformedreviewboard.They’vecomefrombiotechcompaniesthataredevelopingdrugsforneuropathyandhearingloss,hesays.“Iexpectwe’regoingtogetstartedonthemthisweek,”hesays.OneoftheapplicationswassubmittedbyStanleyKim,CEOofWinSanTor.Hiscompanyisdevelopingatreatmentforperipheralneuropathy,apainfulnerveconditionthatcanbeaconsequenceofcancertreatmentordiabetes.ThedrugiscurrentlyinphaseIItrials,butKimsaysheregularlyreceivesmessagesfrompeoplewhoaredesperatetoaccessit,tothepointofbeingsuicidal.Hehopesthatnotonlywillhebeabletomakethedrugaccessibletothosepeople,buthe’llalsobeabletocollectdatafromthem—datathatmighthelpacceleratethedrug’sapprovalprocess.“Wehaveanewsletter[thatissentto]around15,000patients,”saysKim.“NotallofthemwillbeabletogotoMontana,butmanyofthem,Ithink,will.”Hiscompanystillplanstocontinuewithregularclinicaltrialsaswell.Butnotallbiotechcompanieswithearly−stagedrugsfeelcomfortablesubmittinganapplication—atleastnotyet.ThomasJoudinaud,CEOofaFrenchbiotechnologycompanycalledCeresBrainTherapeutics,hasfieldedarequestfromapersonkeentoaccessthecompany’sexperimentaldruginMontana.HesaysthatwhileMontana’ssystemis“veryinterestingandverypragmatic”and“suitableforourdrug,”hewon’tbesubmittinganapplicationforthetimebeing.HeisconcernedthatifanythinggoeswronginMontana,itmayjeopardizethecompany’sstandingwiththeFDA,whichwieldsthepowertoapproveorrejectthesaleofitstreatmentstobroaderpopulations.MartinandothershaveaskedtheFDAforsomekindofassurancethatbiotechcompaniesparticipatinginMontana’sprogramwon’tbepenalizedlateron.Buttheagencyhasn’tprovidedthemwithmorethanarestatementofthefederalRighttoTryAct.“Asamatterofpolicy,theFDAdoesnotcommentonstatelegislation,”anFDAspokespersonwroteinresponsetoarequestforclarificationfromMITTechnologyReview.EveniftheFDAweretoprovidesomekindofassurance,itwouldn’tnecessarilyprotectbiotechcompaniesinthelongterm,cautionsChrisRobertson,aspecialistinhealthlawatBostonUniversity.TheFDA’spositioncouldchangewithanewpresidentialadministration,hesays:“Iwouldn’tbetonanythingthattheFDAissayingtodaybeingapplicablewhentherubberhitstheroadlater.”CompaniesthatwanttostayongoodtermswiththeFDAwouldbesafesttakingtheexpanded−accessroute,saysRobertson.That’sthepathwaytheFDAalreadyusesforpeoplewhoareseriouslyorterminallyill,haverunoutofoptions,andwanttotryexperimentaldrugsthathavenotyetbeenthroughclinicaltrials.TheFDAapprovesover99“TheFDAisn’tabottleneckbutinfactexiststohelpensurethatexpanded−accessprogramsareaboveboardandthatpatientswhoreceive[thedrugs]areabletocontributeknowledgeabout[them],”saysKesselheim.Hesayshedoesn’tthinkthatany“legitimatemanufacturer”shouldfearhavingtogothroughtheFDA’sexpanded−accessprocess,whichtheagencysaystakes“lessthan45minutes”tofillout.ThecostofexperimentingTherearesomekeydifferencesbetweenexpandedaccess,whichallowsseriouslyillpeopletoapplyforaccesstoexperimentaldrugsthatmightnothavebeenthroughanyhumantrials,andMontana’sapproach.Intheory,apersondoesn’tneedtobeseriouslyilltoaccessexperimentaldrugsinMontana.“InMontana,patientsmaybeeligibleforpreventiveorearlier−stageinterventionsiftheyprovideinformedconsentandmeettheprogram’srequirements,sothebreadthofpotentialtherapiesandsituationsismuchbroader,”saysKaeberlein,theMontanaETRBmember,whoisanaffiliateprofessorattheUniversityofWashingtoninSeattle.Kaeberleinalsohighlightsanotherkeydifference,whichiscost.Companiesthatmaketheirtreatmentsavailablethroughexpandedaccessareonlyabletochargeforthecostsofmaking,transporting,andmonitoringthedrug,andtheymustjustifytheeventualpricetotheFDA.InMontana,theycanchargewhateverpricetheywant.StanleyofWinSanTorsaysheplanstosellhisdrugs“atcost.”ButCeres’sJoudinaudsaysthathe’dbemoreinterestedinsellinghisatamarketprice.Whenaskedwhatthatmightbe,hehintedthatthepricesofnewdrugsforrarediseasescanbehigh.Inrecentyears,themedianpriceofsuchdrugswas218,872.
“Instead of simply creating a legal pathway for patients, it also creates a business model that companies may actually be willing to use,” says Kaeberlein.
But the moment when people start spending money on these treatments is already fast approaching. While Montana’s first ETRB prepares to review its first applications, clinics that hope to be part of the program are busy addressing the requirements laid out in the state’s new rules. Treatment rooms are being outfitted. Medical directors are being hired. And experimental treatments should be reaching patients in the coming months.
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