which exposed the unhealthy conditions of the meat packing industry. Similarly, the sulfanilamide syrup tragedy in 1938 in which almost 100 children died due to an untested ingredient influenced Congress to pass the Food, Drug and Cosmetic Act which gave FDA authority over product safety. In 1962, the event that affected Congress and salvaged the Kefauver legislation was the thalidomide disaster. A sedative developed by a small German manufacturer had been widely sold overseas since 1957, but had not been approved for marketing in the U.S. When it was discovered that thousands of European children had been born with deformed limbs because their pregnant mothers had taken the drug, a wave of revulsion and concern about drugs swept the world. Opposition to increasing the powers of the FDA—the agency that had fortuitously prevented the product from being used in the United States—evaporated, and in the face of this drug-induced calamity, the Kefauver-Harris Amendments passed 78 to 0 in the Senate and 347 to 0 in the House of Representatives. The Kefauver-Harris Amendments greatly extended FDA's oversight of pharmaceutical advertising, giving the regulatory agency responsibility to judge the truthfulness and scientific accuracy of promotional messages, and also requiring advertisers to provide information on side effects, precautions, and contraindications in conjunction with product claims. A "fair balance" presentation was required—effectiveness contrasted to precautionary information—and to emphatically achieve this end, advertisements had also to include a "brief summary" of the product's package insert. The regulatory mechanics FDA imposed to achieve "fair balance" and "brief summary" markedly altered Rx advertising in the 1960's and continue to determine its content today. New Regulations Over Pharmaceutical Advertising The power to decide on regulations governing prescription drug advertising had been delegated to the FDA and the agency issued rules which, at first, appeared unworkable to the industry. The complicated regulations with such subjective and undefined standards as "fair balance," "significant information," "reliable studies" and "brief summary" were confusing and threatening. After all, a product could be seized for advertising violations and
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