FEDERAL CRIMINAL LAW FDA Attorney 》》 FDA Lawyer 联邦刑法FDA律师》》FDA律师.ppt

fdac 1 federalcivilandcriminallaws howtheyimpactbiomedicalcompaniesandtheiremployees fdac 2 preparedby michaela swit esq lawofficesofmichaela swit539samuelct suite229encinitas ca92024760 815 4762fax 760 454 2979mswit for sdranracreviewcourseoct 23 2003 fdac 3 introduction thisoutlinepresents ina userfriendly format howthecivilandcriminallawsofthefederal i e theunitedstates governmentimpactabiomedicalcompanyanditsemployees itreviewsthedifferenttypesofviolationsthatcanoccur andthepenaltiesandothercollateralconsequencesofthoseviolations or why crime doesn tpay fdac 4 thefederalfood drug andcosmeticact fdca themainlawthatappliestobiomedicalcompanies howthefdcaworks fdcacreatesrequirementsyoumustmeet ifyoudon tmeettherequirements eitherbydoingthewrongthingorfailingtodotherightthing youcommita prohibitedact any person thatcommitsa prohibitedact canbechargedwithacrimeunderthefdca fdac 5 thefdcaisa strictliability criminallaw nointentorknowledge ofthecrimeortheactthat thecrime isneededforapersontobeaccusedofacrimeforviolatingthefdca instead ifaviolationofthefdcaoccurs andapersonwasinapositiontopreventtheviolation thenthepersonmaybechargedwithacrime u s v park supremecourtcase 1975 fdac 6 whatfdcarequiresofaregulatedcompanyanditsemployees threebasics makeandsellproductsthatare approved cleared orotherwiselawfullymarketeddonotmakeorsellproductsthatare adulterated donotmakeorsellproductsthatare misbranded fdac 7 violatingfdca srequirementsmayleadtocriminalcharges generalrule 1 ifyoudoanythinginvolvingthesaleofanunapproved misbrandedoradulterateddrugordevice youhavecommittedaprohibitedact under 301ofthefdca generalrule 2 ifyoudoaprohibitedact youcanbechargedwithacrimeunderthefdca fdac 8 examplesof prohibitedacts underfdca 301 sellinganadulteratedormisbrandeddrugin interstatecommerce i e acrossstatelines receivinganadulteratedormisbrandeddrugafteritwasshipped sellingadrugrequiringanndawithouthavinganeffectiveapproval fdac 9 prohibitedacts underfdca 301 cont d refusingtopermitfdatoinspectyourplant counterfeitingadrug fdac 10 fda sthreepowersunderfdcaifapersondoesa prohibitedact criminalprosecutionofindividualsorcompanies seizureofviolativegoods injunctionordersagainstpersonsorcompaniesdoingtheprohibitedacts fdac 11 seizurefdca 304 civilactioninremon libel ofinformationinu s districtcourtaffectedpersoncanfilea claim andshowwhygoodsareokafterentryofdecree canbe destroyed sold ifok orreconditioned fdac 12 injunctionfdca 302 civilactionagainstpersonorcorporationcourthasauthoritytorestrainviolationand incertaincircumstances mayorderarecalldisgorgement abbottlabs scheringthecostsarerising now 500mmaninjunctionactionmayleadto orariseoutof consentorders fdac 13 schering ploughconsentdecree may2002 500mmfine subjecttocourtapproval representsdisgorgementofprofitsfromadulteratedproductsresultof13fdainspectionsat4facilitiesinnjandprsince1998fineincludes 471 500paymenttocovercostsofpastfdainspections fdac 14 schering ploughconsentdecree may2002 125rx otcdrugsmadeattheseplants representing90 ofs p sproductspermanentinjunctionrequiresprocedurestoassurecgmpcompliance suspendedmanufacturingof73productsintensiveinternalauditrequiredfor5years withincreasedfdainspectionaswell fdac 15 afourthfda power force apersontodoa recall recallsare voluntary requestsbyadrugcompanytosendbackdrugsthatviolatethelawdevices fdadoeshavepowertoorderarecall 518 e rarelydone requiresafindingthatadevicewouldcause serious adversehealthconsequencesordeath see21cfrpart7 generalinfoonrecalls fdac 16 recalls but fdahaswaysto make youdoarecallthreatensprosecution injunctionorseizurethreatensoractuallyspreadsbadpublicityaboutpersonwhodidthe prohibitedact fdca 705 fdac 17 fda snon judicialenforcementtools warningletterscivilpenalties devices noticesofviolation inspectionsapplicationintegrityprogramgenericdrugenforcementactof1992powers e g debarment publicity fdac 18 the 305 hearingfdca 305 youdon twanttogeta 305notice ifyoudo behappy yougettoargueyourcasebeforefdatakesofficialcriminalreferralfairlyinformalprocesshasbeensuccessfulinavoidingcharges fdac 19 warningletters procedure seeregulatoryproceduresmanual rpm chapter8mayissuedirectlyfromdistrictofficeothersrequirefdahqsign offpublicdocuments yourcompetitorswillread andcirculate them fdac 20 noticesofviolation mostfrequentlyusedonthedrugside nowrequireclearanceviafdaofficeofchiefcounsel maychangeback notquiteawarningletter butshouldbetakenseriously fdac 21 applicationintegrityprogram aip spawnedbythegenericdrugscandal56fed reg 46191 sept 10 1991seecompliancepolicyguide cpg 7150 09 www fda gov ora ora home page html triggers actionssubvertingfdaprocess examples fraudinapplicationsorotherfalsificationsbriberyorgratuitiesproblem bars youfromapprovals fdac 22 applicationintegrityprogram aip con d correctiveactionplan whatyouneedtodoiffallunderaip cooperatewithfdaandotherfederalinvestigatorsidentifyallwrongdoersandremovethemfromauthority fdac 23 applicationintegrityprogram aip con d conductaninternalreviewwithoutsideconsultantstouncoverallotherwrongdoingwrittenactionplan proceduresandcontrolstoprecludeinfutureethicsprogramsfdaverification reinspection fdac 24 criminalprosecutionfdca 303 process fdadistrictoffice fdacenteroc fdagc justicedepartment ofc ofcivillitigation u s attorney grandjury iffelonysought indictment felonyinformation misdemeanororforpleaagreements fdac 25 theparkcase strictliabilityinaction question isitfairtochargeapersonwithacrimeiftheydidnotknowaboutaviolationordidnotintendtoviolatethelaw mr park presidentofacmemarkets acmehadawarehouseinbaltimore whichfdainspectorsfoundtobefilthy thus acmeandmr parkwerechargedwithadulteratingfood alsoaprohibitedactunder 301offdca fdac 26 theparkcase cont d u s supremecourt ifapersonisinapositiontostopaviolationofthefdcafromoccurring buttheviolationhappensanyway thenthatperson whetheranindividualsuchasmr parkoracompany canbechargedwithacrimeunderthefdca fdac 27 theparkcase cont d reason apersonwhovoluntarilytakesajobinanindustryregulatedbythefdcahasahigherduty toprotectthepublichealth thusissubjecttothe strictliability standardoffdca fdac 28 theparkcase cont d exceptiontostrictliability ifitwas objectivelyimpossible fortheresponsibleperson suchasmr park topreventtheviolation thennotacrimeunderfdca objectiveimpossibility mayrequire accordingtoonecourt thatapersonshowthattheyexercisedextraordinarycaretopreventtheviolation butitstillhappened fdac 29 impactoftheparkcaseonadrugordevicecompany companyexecutiveshaveaduty totrytofindviolationsofthelaw and topreventviolationsfromoccurringinthefirstplace companyemployeesarebasically partners withtheexecutivesbecause ifyouviolatethefdca yourbosscouldbechargedwithacrime fdac 30 otherfederalcrimesandthebiomedicalindustry falsestatements tomakeastatement oralorwritten tothefederalgovernmentthatisfalse e g falsedatasubmittedtofdainananda youcan tlietounclesam fdac 31 otherfederalcrimesandthebiomedicalindustry conspiracy happenswhenyouplanwithanotherpersontodoacrimeandoneofyoutakesoneaction calledan overtact tocarryoutthatplannote itisstillacrimeevenifyoustoptheplanbeforethecrimehappensifyouoryourco conspiratordidtheone overtact fdac 32 otherfederalcrimesandthebiomedicalindustry bribery togivemoneyoranythingelseofvalueinreturnforagovernmentofficialtakingcomeactionforyou fdac 33 otherfederalcrimesandthebiomedicalindustry gratuity sameasbribery butyoudon taskthegovernmentofficialtodoanything stillwrongbecauseofficialsshouldbefairtoallandmoneymayinfluencethemtofavoryou perjury lyingwhileunderoath whetherincourttestimonyorinaswornaffidavit fdac 34 otherfederalcrimesandthebiomedicalindustry obstructionofjustice interferingwithagovernmentofficial slawfulperformanceoftheirduties e g notlettinganfdainspectorintoseearoomtheyaskstoseethattheyhavearighttosee fdac 35 otherfederalcrimesandthebiomedicalindustry wirefraud touseatelephone telegraph orotherformofelectroniccommunication e g e mail todoacrime mailfraud tousethemailstodoacrime aidingandabetting occurswhenyoudon tdothecrimeitself butyouhelpsomeoneelsedoit fdac 36 criminalpenalties or doescrimepay prisonorjail felonies uptofive 5 yearsinprisonforeachviolation misdemeanors uptoone 1 yearinjailforeachviolation fdac 37 criminalpenalties or doescrimepay fines amountdependsontheperson whetheranindividualorcompany theclassofcrime felonyv misdemeanor andifthecrimeresultedinadeath fdac 38 criminalpenalties or doescrimepay finesindividual misdemeanor 100 000perviolationmisdemeanorresultingindeathorfelony 250 000perviolationcompany misdemeanor 100 000perviolationmisdemeanorresultingindeathorfelony 500 000perviolation fdac 39 criminalpenalties or doescrimepay problemsforindividualsifconvicted loserighttovote loserighttorunforpublicoffice damagetoreputation fdac 40 criminalpenalties or doescrimepay problemsforindividualsifconvicted cont d canbedeportedifnotau s citizen financialruin loseyourjob fdac 41 criminalpenalties or doescrimepay problemsforcompaniescausedbycriminalconvictions shareholderssuethecompany itsofficersanddirectors othercompaniesmaysuethecompany e g mylanlabssuedparandothers federalgovernmentmaysuspendor debar companyfromsellingtogovernment fdac 42 criminalpenalties or doescrimepay problemsforcompaniescausedbycriminalconvictions cont d fdamayrefusetoapproveapplicationsunderaipmaylosestatelicensescustomersabandonyoudecreasedsalesmayforcelay offsofemployees fdac 43 criminalpenalties or doescrimepay problemsforcompaniescausedbycriminalconvictions cont d quitam actionsunderthefalseclaimsact e g lifescancase whistleblower cases leadingtocivildamagesandmayalsospawnacriminalprosecution fdac 44 criminalpenalties or doescrimepay problemsforcompaniescausedbycriminalconvictions con d financingdisappears banksmayrefusetolendmoneymayviolatelendingagreements realestatemortgagesorleasesacriminalinvestigationcancausegreatdisruptiontonormalbusinessactivities fdac 45 criminalpenalties or doescrimepay problemsforcompaniescausedbycriminalconvictions con d highcostinmoneyofaninvestigation lostsalesstockpricefallsattorney sfeesandcostscostsofcomplyingwithrequestsbygovernmentfordocuments fdac 46 fdaactivity enforcementstatisticsfiscalyear2002prosecution 0 civilmoneypenalty 1seizures 13consentdecreesofpermanentinjunctions filed 15convictions oci 317warningletters 755fda483sissued7 180recalls 5 025inspections 18 572importrefusals 32 654assetforfeitures oci 18 300 000finesandrestitution oci 24 027 549 doesnotincludeofficeofcriminalinvestigationsdata fdac 47 fdaactivity prosecutions fdac 48 fdaactivity oci fdac 49 fdaactivity injunctions fdac 50 fdaactivity seizures fdac 51 fdaactivity recalls bycenter fdac 52 fdaactivity warningletters bycenter fdac 53 fdaactivity warningletters byyear fdac 54 fdaactivity inspections fdac 55 fdaactivity devices fdac 56 fdaactivity devices fdac 57 fdaactivity drugs fdac 58 fdaactivity drugs fdac 59 fdaactivity biologics fdac 60 fdaactivity biologics fdac 61 sourceoffdastatisticsslides fda theenforcementstory http www fda gov ora about enf story default htm fdac 62 partingthoughts thesearepicturesyoudonotwanttosee inyournewspaper onyourlocalnews ontheinternet orinfdaregulatorylawyers presentationsforyearstocome fdac 63 ex imcloneceoexitsfederalcourtafterbeingchargedwithninefelonycounts fdac 64 ex imcloneceoexitsfederalcourtafterenteringguiltyplea fdac 65 thenextpicture dr wakshalinprisongarb pledguiltyoct 15 2002tosixcounts including bankfraud securitiesfraud aka insidertrading conspiracytoobstructjustice and perjuryfaces upto65yearsinprison millionsinfines fdac 66 thanks tomonikachas formerlyofparpharmaceutical sregulatoryaffairsdepartment fordrawingtheillustrationsinthisoutline tomichellevi a formerlyofparpharmaceutical sm i s department forgettingmonika sdrawingsimportedintothesoftwareprogramsotheycouldbeprinted fdac 67 theend fdac 68 questions call e mail faxorwrite michaela swit esq lawofficesofmichaela swit539samuelct suite229encinitas california92024760 815 4762 760 454 2979 fax mswit fdac 69 aboutthespeaker michaela swithasextensiveexperienceinallaspectsoffdaregulationwithaparticularemphasisondrugsandmedicaldeviceregulation inadditiontohisregulatorylawexperience mr switalsoservedforthreeandahalfyea