The thalidomide tragedy resurrected Kefauver's bill to enhance drug regulation that had stalled in Congress, and the Kefauver-Harris Amendment became law on 10 October 1962. Manufacturers henceforth had to prove to FDA that their drugs were effective as well as safe before they could go on the US market. The FDA received authority to regulate advertising of prescription drugs and to establish good manufacturing practices. The law required that all drugs introduced between 1938 and 1962 had to be effective. An FDA - National Academy of Sciences collaborative study showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began ten years later. COUNT 9
QSN1 When did the Kefauver-Harris Amendment become a law? ANS1 10 October 1962 QSN2 What did this new law require? ANS2 all drugs introduced between 1938 and 1962 had to be effective QSN3 What did the National Academy of Science's study discover? ANS3 nearly 40 percent of these products were not effective QSN4 How long after the National Academy of Science's study did a study on over the counter drugs occur? ANS4 ten years later QSN5 What brought up enhancement of drug regulations? ANS5 The thalidomide tragedy QSN6 When did the Kefauver-Harris Amendment became law? ANS6 10 October 1962 QSN7 What federal agency regulated the advertising of prescription drugs? ANS7 FDA QSN8 Drugs made between which years had to be tested before going to market? ANS8 1938 and 1962 QSN9 What percentage of drugs were shown to be ineffective after an FDA study? ANS9 40 percent