One objective of the food and drug act is to prevent the marketing of worthless and unsafe drugs. Examples of drugs without proven therapeutic value are purported cancer cures like krebiozen and laetrile. However, drugs being promoted for nonscientific uses include more than these well-recognized examples. Prior to the 1962 Kefauver-Harris amendments to the FDCA, reputable pharmaceutical manufacturers promoted many drugs based on evidence of effectiveness that could not withstand scientific review. After the 1962 amendment, the FDA contracted with the National Academy of Sciences/ National Research Council (NAS/NRC) to review the scientific evidence supporting the efficacy of drugs marketed between 1938 and 1962. Approximately 360 prescription drugs (about 7% of the drugs reviewed) were rated as lacking substantial evidence of effectiveness by the NAS/NRC review and were removed from the market. Of 16,000 therapeutic claims made for these products, 66% lacked a substantial scientific basis. Products of many major U.S. pharmaceutical manufacturers were included. Often the removals involved considerable controversy, including appeals to the U.S. Supreme Court.29
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