制药工业应用

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1、Finkelstein22Sep05DrugRegulationandtheFDAHistoricalperspectiveontheFDA(ancienthistoryto2000;PhDforotherpart)-set-up-whatdoesitdo-whatoughttohappen-successionofcrises(5):badthingshavetohappenbeforeactionProtectionfromfraud-19thcenturyconcernre:fraud(adulterati

2、on)–multipleactspassed-U.S.Pharmacopeia–setspuritystandardsoantedatesFDAFoodanddrugsafetyissues-TheJungle(UptonSinclair)oadvocatingneedforfoodregulationoatthetime,lotsofdrugsdidn’tworkooralingestion-1stcrisis:1901tetanusspores,13childrendie1906:“pure”Food&Dru

3、gact-bureauofchemistry:enforcementability-courttest:can’tpromoteadulteratedproductsofalseclaimsallowed?Obsolescence-science/technologyrevolutionizeeverythingChangessuggestedtoauthorityofFDA-1937:crisis2osulfanilamide–treatbacterialinfections°carrieragent:ethy

4、leneglycol1938:Food,Drug,CosmeticAct-powersofFDA,specificallyenforcement-provesafetyofproductbeforemarketingonodossier;sendlettertoFDAw/intent°noresponsere:prevention,freetogo°revolutionaryatthetime-authoritytoinspectfactoriesFinkelstein22Sep05Refinements-195

5、0:can’tgetapprovalforonethingandmarketforanother-1951:needprescription-1950s:disdainfordrugindustry(marketpower;monopolistic)odrugsweren’tanygoodin1950soindustry:targetforpoliticians1960s:thalidomidedisaster(3rdcrisis)-before6monthswereup:FDAneededmoretime-su

6、ccessivedelaysÆsideeffectsknownoPhocomelia:birthdefect:noarmsorlegs-Dr.Kelsey:diedlate1990s;folkhero-reasonfordelays:slowvs.concerned-nospecificrequirementsforsubmissiontoFDA-thalidomideisbackPre-marketreviewandapprovalofnewdrugs-safety,workedornot-efficacyvs

7、effectivenessoclinicaltrialsoidealizedsettingsprotocolorealworld:tougherstandard-clinicaltrialsvs.panelofexpertsre:approval-implicationoflawrequiredreviewofdrugsonmarketbefore1962oonlyahandfulofathousanddrugswereeffective-FDA:authoritytoinspectmanufacturingpr

8、actice-burdenforindustry?otime,cost,etc.ocomparedtoEurope,U.S.wouldshow“druglag”ocostburden:onlybigcompaniescansurvive°predictionoccurredbutdidn’tlastoBoston:centerforcomplaint;frustrated