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9 Cards in this Set
- Front
- Back
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1906 Pure Food and Drug Act
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Prohibited the interstate commerce of adultered (not pure) food and drugs
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1911 Shirley Amendments
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Prohibited false and misleading claims for drug products
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1938 Federal Food, Drug, and Cosmetic Act
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Scientific proof of safety before a drug could be marketed (sulfonilamide disaster)
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1951 Durham-Hunphrey Amendment
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Created two classes of products prescription and OTC; created "legend drugs"
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1962 Harris-Kefauver Amendments
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Scientific proof of efficacy (effectiveness)
DESI drugs - drugs marketed between 1938 - 1962 were studied to determine their effectiveness (about 3000) and were classified as either effective, probably effective, possibly effective, or in effective |
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1983 Orphan Drug Act
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Gave economic and tax incentives for pharmaceutical manufacturers to develop drugs for rare disease such as:
1) diseases which effect less than 200,000 patients in the US 2) diseases with more than 200,000 patients in which the cost of development will never be recouped |
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1984 Drug Price Competition and Patent Restoration Act
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Created the ANDA for generic drugs (prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval
Orange Book: shows bioequivalence for generics (AA and AB are equivalent, but anything starting with a "B" is not equivalent) |
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Prescription Drug Marketing Act of 1984
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This act
1) regulated samples 2) banned re-importing drugs from other countries 3) regulated who hospitals can sell to |
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1994 Dietary Supplement Health and Education Act
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Made herbals officially dietary supplements and mandated they contain the disclaimer, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
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