The modern history of United States drug regulation began with the Food, Drug and Cosmetic Act of 1938, which superseded the 1906 Pure Food and Drug Act. The 1938 act was viewed as a means of preventing the marketing of untested, potentially harmful drugs. An obscure provision of the 1938 act was destined to be the starting point for some of the most potent controls the Food and Drug Administration (FDA) now exercises in the drug field. This provision allowed the prescription drug to come under special control by requiring that it carry the legend "Caution—to be used only by or on the prescription of a physician."
A major defect of the generally strong 1938 law was its inadequate control of advertising. Regulations now require that the "labeling on or within the package from which the drug is to be dispensed" contain adequate information for the drug's use; this requirement explains the existence of the package insert. If the pharmaceutical manufacturer makes claims for its product beyond those contained in an approved package insert, the FDA may institute legal action against the deviations in advertising.
The 1938 act required manufacturers to submit a New Drug Application (NDA) to the FDA for its approval before the company was permitted to market a new drug. Efficacy (proof of effectiveness) became a requirement in 1962 with the Kefauver-Harris drug amendments. These amendments established a requirement that drugs show "substantial evidence" of efficacy before receiving NDA approval. Substantial evidence was defined in the amendments as evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug, on the basis of which such experts could fairly and responsibly conclude that the drug would have the claimed effect under the conditions of use named on the label.
Drug regulation in the United States is continuing to evolve rapidly, both in promulgation of specific regulations and in the way regulations are implemented (Table 1.1). The abolition of patent medicines is an outstanding example, as is control over the accuracy of claims made for drugs. Since the 1962 amendments, the advertising of prescription drugs in the United States has been increasingly controlled—to a greater extent than in most other countries. All new drugs introduced since 1962 have some proof of efficacy. This is not to say that misleading drug advertisements no longer exist; manufacturers still occasionally make unsubstantiated claims.
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