Drug Price Competition and Patent Term Restoration Act of 1984.docx

Drug Price Competition and Patent Term Restoration Act of 1984.docx

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DrugPriceCompetitionandPatentTermRestorationActof1984（Hatch-WaxmanAmendments）

Statementof

DanielE.Troy

ChiefCounsel

U.S.FoodandDrugAdministration

before

theSenateCommitteeontheJudiciary

AUGUST1,2003

INTRODUCTION

Mr.ChairmanandMembersoftheSubcommittee,IamDanielE.Troy,ChiefCounselfortheUnitedStatesFoodandDrugAdministration（FDAortheAgency）.IamjoinedbyGaryBuehler,R.Ph.,Director,OfficeofGenericDrugs,CenterforDrugEvaluationandResearch.

IampleasedtobewithyoutodaytodiscussFDA'simplementationoftheDrugPriceCompetitionandPatentTermRestorationActof1984,commonlyknownastheHatch-WaxmanAmendmentsandrecentCongressionalactiononamendmentstoHatch-Waxman.

ThistestimonywilldiscussanumberofissuesthataffectthetimelyintroductionofgenericdrugsintotheU.S.marketplace.Itwillfocusinparticularonwhethercertain"later-listed"patentsorinappropriatepatentsubmissionsbythesponsorsofinnovatordrugproductshaveresultedinthedelayofgenericdrugapprovals.OnJune18,2003,FDApublisheditsfinalruleintendedtospeedaccesstoandincreasetheavailabilityofgenericdrugsbylimitingtheuseof30-monthstaysbybrand-namedrugsponsorsandbyclarifyingthetypesofpatentsthatmustandmustnotbesubmittedtoFDAforlistingintheOrangeBook.

TheHatch-WaxmanAmendmentswereintendedtobalancetwoimportantpublicpolicygoals.First,Congresswantedtoensurethatbrand-name（alsoknownasinnovator）drugmanufacturerswouldhavemeaningfulpatentprotectionandaperiodofmarketingexclusivitytoenablethemtorecouptheirinvestmentsinthedevelopmentofvaluablenewdrugs.Second,Congresssoughttoensurethat,oncethestatutorypatentprotectionandmarketingexclusivityforthesenewdrugshasexpired,consumerswouldbenefitfromtherapidavailabilityoflowerpricedgenericversionsofinnovatordrugs.

Sinceitsenactmentin1984,Hatch-Waxmanhasgovernedthegenericdrugapprovalprocess.Ingeneral,thelawhasbeenworkingwell.Since1984,over10,000genericdrugshaveenteredthemarket,andgenericsnowaccountforcloseto50percentofprescriptionsfilled.Attentionhasrecentlyfocusedontwokeyprovisionsofthelawthatallowfor180daysofmarketingexclusivitytocertaingenericdrugapplicants,andforthe30-monthstayongenericapprovals.Bothoftheseprovisionsarediscussedindetailbelow.

FDA'sobjectiveistoenhancetheabilityofinnovators,genericfirmsandtheAgencytoachievethegoalsembodiedinHatch-Waxman.WhilethenewrulewillimproveFDA'simplementationofthelaw,thisisonlyonepartofasetofFDAinitiativesthatwillreducedrugcostsbyencouraginginnovationandspeedingupthedrugdevelopmentandapprovalprocess,whilemaintainingFDA'shighstandardsforsafetyandeffectiveness.Ourreformsinthegenericapprovalprocesswillgenerallyshavemonthsoffthetimetoavailabilityofgenericdrugsacrosstheboard.Similarly,newpathwaysforapprovinginhaledandtopicalgenericdrugswillpotentiallyaffectmanyproducts.Thisbroadimprovementintheavailability,ofbothnewdrugsandgenericdrugs,willhaveapositiveimpactonallpatients,notjustthoseaffectedbyimperfectionsintheoperationofHatch-Waxman.

STATUTORYPROVISIONS

TheHatch-WaxmanAmendmentsamendedtheFederalFood,Drug,andCosmeticAct（FD&CAct）andcreatedastatutorygenericdrugapprovalprocesswithsection505（j）.Section505（j）establishedtheabbreviatednewdrugapplication（ANDA）approvalprocess,whichpermitsgenericversionsofpreviouslyapprovedinnovatordrugstobeapprovedwithoutsubmittingafullnewdrugapplication（NDA）.AnANDAreferstothepreviouslyapprovedNDA（the"listeddrug"）andreliesontheAgency,sfindingofsafetyandeffectivenessforthelisteddrugproduct.

ThetimingofanANDAapprovaldependsinpartonpatentprotectionsfortheinnovatordrug.Innovatordrugapplicantsmustinclude,inanNDA,informationaboutpatentsrelatingtothedrugproductthatisthesubjectoftheNDA.FDAisrequiredtopublishthepatentinformationsubmittedoncethedrugisapproved.ThestatuteestablishesaprocessthatrequiresthatANDAapplicantscertifytothepatentslisted,providenoticetotheNDAholderandpatentowner,and,ifpatentinfringementlitigationisfiled,itimposesa30~monthstayontheapprovalofanANDA.TheHatch-WaxmanAmendmentsalsocreatedaperiodofmarketexclusivityforcertaingenericapplicants.

“ORANGEBOOK”LISTINGS

OnlycertaintypesofpatentinformationcanbesubmittedtoFDA.FDApublishespatentinformationonapproveddrugproductsintheAgency'spublicationApprovedDrugProductswithTherapeuticEquivalenceEvaluations,alsoknownasthe"OrangeBook."TheOrangeBookisavailableonFDA'swebsiteandisupdatedeveryfewweeks.