Drug Acts 6.20

Drug Acts 6.20 - Major Moments in Federal Drug Legislation...

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Major Moments in Federal Drug Legislation Legislation for Safety and Effectiveness o 1938 Federal Food, Drugs, and Cosmetics Act 1 st major legislation; pushed through by crisis 1937 at least 100 Sulfur-related deaths. The act pushed for the requirement of warning labels, directions, and list of ingredients. 1951 Amendment—What is a drug? Who is in charge? 3 ways to define: o Is drug habit forming? o Is drug safe/toxic under some testing? o Is drug not shown to be totally safe? If it falls into any of these categories, it should be a prescription— not OTC. o 1951 Durham-Humphrey Act Safety o 1962 Kefauver Amendment Tennessee Senator concerned about cost of prescription drugs and effectiveness and safety. Thalidomide—used for nausea. William S. Merro—already used in Europe for 4 years. Medical officers declared it unsafe, but the company was pressured. o Given out only by doctors for trial until 1961 after thousands of congenital abnormality cases after using the drug in Europe. o Given to 20,000 Americans, resulting in a small number of birth defects. Should have been properly tested. o Fueled the support of the public and legislators. Strengthened government involvement with prescription drugs. Prohibition o 1914 Harrison Narcotics Act Control of heroin, opiates, cocaine—substances made into prescription drugs but can be administered by a physician. The effect was that law makers interpreted this to mean that it’s not
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This note was uploaded on 10/30/2011 for the course SOCIOLOGY 4465 taught by Professor Becker during the Summer '11 term at LSU.

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Drug Acts 6.20 - Major Moments in Federal Drug Legislation...

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