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May 1971

internal medicine at large

Arch Intern Med. 1971;127(5):817-828. doi:10.1001/archinte.1971.00310170025004

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Drug efficacy  There are now about 3,500 individual drug products on the American market, and Americans currently receive 2 billion prescriptions for them each year. The rate is expected to reach 3 billion in the next five years—and these figures do not include over-the-counter drugs.Are all these drugs effective? The answer is "no," according to the director of the Bureau of Drugs, Food and Drug Administration, in an address to the American College of Physicians. Henry E. Simmons, MD, MPH, described the FDA's continuing Drug Efficacy Study and its impact on therapeutics in America.The 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetics Act required the FDA to test all drugs for efficacy as well as safety—including some 3,000 products already approved for safety alone since 1938 when the original act was passed. Decisions have been reached on about 2,000 of these drugs, and conclusions about the others

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