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05sep22_fnklstin - Finkelstein 22 Sep 05 Drug Regulation...

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Finkelstein 22 Sep 05 Drug Regulation and the FDA Historical perspective on the FDA (ancient history to 2000; PhD for other part) - set-up - what does it do - what ought to happen - succession of crises (5): bad things have to happen before action Protection from fraud - 19 th century concern re: fraud (adulteration) – multiple acts passed - U.S. Pharmacopeia – sets purity standards o antedates FDA Food and drug safety issues - The Jungle (Upton Sinclair) o advocating need for food regulation o at the time, lots of drugs didn’t work o oral ingestion - 1 st crisis: 1901 tetanus spores, 13 children die 1906: “pure” Food & Drug act - bureau of chemistry: enforcement ability - court test: can’t promote adulterated products o false claims allowed? Obsolescence - science/technology revolutionize everything Changes suggested to authority of FDA - 1937: crisis 2 o sulfanilamide – treat bacterial infections carrier agent: ethylene glycol 1938: Food, Drug, Cosmetic Act - powers of FDA, specifically enforcement - prove safety of product before marketing
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