history and evolution of drug regulation

History and Evolution of Drug Regulationin charge of development, testing, and monitoring of new drugskeep tabs on 95000 business1 trillion woth of goodsreactive rather than proactivetypically as result of major crisespatchwork solutionsresolved the issue at hand but left other unresolved issuesbeginningmostt drugs imported this timestates exercised principal control over domestically produced and distributed food and drugscontrol was markedly inconsistent from state to statePatent medicinesmiracle elixirscure aches, pains, rheumatism, gout and cancersyrupcalm colicky babies and tonics for adultslisterineprevent TBcrisis: adulterated and imported drugs 1848mesican war of 1848yellow feverquinine claimed ineffective because adulteratednot provedharmed pharm/doc repnew york and phil coll of pharm passed law to congressDrug Importation Act of 1848all medications inspected by US CUSTOMSowners or consignees recieved right to demand independent analystic esxaminationsrecognized U.S. PHARMACOPEIA NGO that sets state-of-the-art standards to ansure quality of medicinesFDAoldest reg dedicated to consumer prooriginated as single chemist in bureau of chemistry (USDA)2009-11500 chemists,aksdjflkjsdhfljsdfhcrisis: death of children in 1901tetanus constaminated serum of horse used to produce diphtheria antitoxin(horse produced antibodies)tetanus contaminated smallpox vaccineattributed to failure of proper procedures and testing by local officialsBiologics Control Act 1902biologics (antibodies, hard to characterize chemically)required fed gov o issue premarket approval for biolodic drinspects establishments of manufacturelicense these place annuallyFirst Clinical Trialsin effort to inderstand preservative effectstrial design: 10 days of baseline, increasing levels therafterseven prevalnt preservatives usedborax/boric acisroachessalicylic acid/salicylatesfacewashacne caused by bacterium, affective antibenzoic acid and benzoatesaboveSubtopic 2sulphur dioxide and sulphiteswine presSubtopic 2Subtopic 3formaldehydeenbalmingcarcinogenicSubtopic 6copper sulfateused in agr to kill microbes potassium nitrate (saltpeter)component of firework) yellowthe poison squadno animal safety studiesno carcinogenic, mutagenic, or teratogenic studiesno institutional review board oversightno informed consent forms for participantsno contorls, i.e. untreated group for comparisonof 7 preservatives studies, 4 are now bannedboraxsal acidformalcoper sulfatethe muckrakers 1906harvey wileyinv food predFood and Drug Act (Wiley Act)june 30 1906first fed lw to regulate food and drugsprohibits interstate comerce in misrandedcharged buraeu of chemistryrequired proper labelingalcohol, morphine, heroin, and cocaine11 totalsamuel hopkins adamsquestioning dangers of patent medicines)uptonsinclairquestion meat industry, wrote The Jungle, precipating force behind comprehensive food and drug lawcrisis: Elixir Sulfanilamidein tablet and powder form to treat streptococcal infectionshad highly toxic variant of antifreezepeople diedFederal Food Drug and Cosmetic act 1938 (passed wiley act)required manufacturers to show new drug was saferequired safe tolerancesdrug must be given under direction of medical expert???crisis: contaminated antibioticphenoarbital antibioticled to good manufacturing practicesclinincal trials1941 wwIpublic health service actcrisis thalidomide babies 1962sedative to control prgnant nausuealed to baby deformitesthese babies diednot approved in use merrell co, fda pharm kelsey disapprovedkafacuve arris ammednemtnrequired drug manudacturs to notify fda before testing in humansprove effective and safesend adverse action reportsfair packaging and labeling act of 1966consumer products to be labeledidentity,quantity, name od bussiness, place of manufacture1970 first for contrapSubtopic 2crisis: tylenon adulterated subst with cyanise, no safety seals in packageingFederal Anti tampering Act of 1982crime to tamper with packaged consumer productsreuiwred on OTC drugsdistinctive by designprominet, identified on label, provide visible evidence if tamperingotc sante TEP adulteratedGO THROUGH ALL AOTHER ACTSCrisis: Pst market drug safety actrezulin, antiporozasx, only of adults
29 2 2