1. in charge of development, testing, and monitoring of new drugs
2. keep tabs on 95000 business
   1. 1 trillion woth of goods
3. reactive rather than proactive
   1. typically as result of major crises
4. patchwork solutions
   1. resolved the issue at hand but left other unresolved issues
5. beginning
   1. mostt drugs imported this time
   2. states exercised principal control over domestically produced and distributed food and drugs
   3. control was markedly inconsistent from state to state
   4. Patent medicines
      1. miracle elixirs
         1. cure aches, pains, rheumatism, gout and cancer
      2. syrup
         1. calm colicky babies and tonics for adults
      3. listerine
         1. prevent TB
   5. crisis: adulterated and imported drugs 1848
      1. mesican war of 1848
         1. yellow fever
            1. quinine claimed ineffective because adulterated
            2. not proved
         2. harmed pharm/doc rep
         3. new york and phil coll of pharm passed law to congress
            1. Drug Importation Act of 1848
            2. all medications inspected by US CUSTOMS
            3. owners or consignees recieved right to demand independent analystic esxaminations
            4. recognized U.S. PHARMACOPEIA NGO that sets state-of-the-art standards to ansure quality of medicines
   6. FDA
      1. oldest reg dedicated to consumer pro
      2. originated as single chemist in bureau of chemistry (USDA)
      3. 2009-11500 chemists,aksdjflkjsdhfljsdfh
   7. crisis: death of children in 1901
      1. tetanus constaminated serum of horse used to produce diphtheria antitoxin
         1. (horse produced antibodies)
      2. tetanus contaminated smallpox vaccine
      3. attributed to failure of proper procedures and testing by local officials
      4. Biologics Control Act 1902
         1. biologics (antibodies, hard to characterize chemically)
         2. required fed gov o issue premarket approval for biolodic dr
         3. inspects establishments of manufacture
         4. license these place annually
   8. First Clinical Trials
      1. in effort to inderstand preservative effects
         1. trial design: 10 days of baseline, increasing levels therafter
         2. seven prevalnt preservatives used
            1. borax/boric acis
            2. roaches
            3. salicylic acid/salicylates
            4. facewash
            5. acne caused by bacterium, affective anti
            6. benzoic acid and benzoates
            7. above
            8. Subtopic 2
            9. sulphur dioxide and sulphites
            10. wine pres
            11. Subtopic 2
            12. Subtopic 3
            13. formaldehyde
            14. enbalming
            15. carcinogenic
            16. Subtopic 6
            17. copper sulfate
            18. used in agr to kill microbes
            19. potassium nitrate (saltpeter)
            20. component of firework) yellow
         3. the poison squad
            1. no animal safety studies
            2. no carcinogenic, mutagenic, or teratogenic studies
            3. no institutional review board oversight
            4. no informed consent forms for participants
            5. no contorls, i.e. untreated group for comparison
            6. of 7 preservatives studies, 4 are now banned
            7. borax
            8. sal acid
            9. formal
            10. coper sulfate
         4. the muckrakers 1906
            1. harvey wiley
            2. inv food pred
            3. Food and Drug Act (Wiley Act)
            4. june 30 1906
            5. first fed lw to regulate food and drugs
            6. prohibits interstate comerce in misranded
            7. charged buraeu of chemistry
            8. required proper labeling
            9. alcohol, morphine, heroin, and cocaine
            10. 11 total
            11. samuel hopkins adams
            12. questioning dangers of patent medicines)
            13. uptonsinclair
            14. question meat industry, wrote The Jungle, precipating force behind comprehensive food and drug law
   9. crisis: Elixir Sulfanilamide
      1. in tablet and powder form to treat streptococcal infections
      2. had highly toxic variant of antifreeze
      3. people died
   10. Federal Food Drug and Cosmetic act 1938 (passed wiley act)
       1. required manufacturers to show new drug was safe
       2. required safe tolerances
       3. drug must be given under direction of medical expert
       4. ???
   11. crisis: contaminated antibiotic
       1. phenoarbital antibiotic
       2. led to good manufacturing practices
       3. clinincal trials
       4. 1941 wwI
   12. public health service act
   13. crisis thalidomide babies 1962
       1. sedative to control prgnant nausuea
          1. led to baby deformites
             1. these babies died
       2. not approved in use merrell co, fda pharm kelsey disapproved
   14. kafacuve arris ammednemtn
       1. required drug manudacturs to notify fda before testing in humans
       2. prove effective and safe
       3. send adverse action reports
   15. fair packaging and labeling act of 1966
       1. consumer products to be labeled
          1. identity,quantity, name od bussiness, place of manufacture
          2. 1970 first for contrap
       2. Subtopic 2
   16. crisis: tylenon adulterated subst with cyanise, no safety seals in packageing
       1. Federal Anti tampering Act of 1982
          1. crime to tamper with packaged consumer products
          2. reuiwred on OTC drugs
             1. distinctive by design
             2. prominet, identified on label, provide visible evidence if tampering
          3. otc sante TEP adulterated
6. GO THROUGH ALL AOTHER ACTS
   1. Crisis: Pst market drug safety act
      1. rezulin,
      2. antiporozasx, only of adults