1938

Following 106 deaths in 1937 arising from the drug firm S. E. Massengill’s (Tenn.) use of the antifreeze additive ethyl diglycerol as a buffer in a liquid preparation of Elixir Sulfanilamide (Marks, 82; Hager, 209-222; Lesch III, 178-181), Congress passes Federal Food, Drug and Cosmetic Act, authorizing the FDA to review the safety and composition of new drugs: “FDA officials adopted a regulatory policy that seemed – to them – minimally intrusive on the prerogatives of practicing physicians and drug manufacturers. The FDA would contribute to the public good largely by regulating what manufacturers said about drugs, while leaving other efforts to improve the use of drugs to medicine’s scientific and professional authorities” (Marks, 73, 81). FDA early focused attention on sulfanilamide (the first of the sulfonamides, introduced in US in 1936), whose healing potential, esp. in treating pneumococcal pneumonia (but also gonorrhea and cerebrospinal meningitis), was tempered by knowledge of its toxicity (anemias, depressed white-cell counts, etc.). First delineation of prescription-only drugs in 1938 Act in terms of labeling: The 1938 Act permitted companies, at their discretion, to substitute for the information about certain drugs the phrase: “Caution: To be used only by or on the prescription of a physician [or dentist or veterinarian],” but this warning only increased consumer demand and consumers got the drug without prescriptions over-the-counter and also from pharmacists. Additional regulations in 1940 did not help the problem of “fence-straddling” manufacturers and sales by druggists (Rasmussen IV, 110-11). The FDA’s effort at regulation became law in 1951. Temin sees it somewhat differently: Re the warning label, “It allows the drug companies to create a class of drugs that cannot legally be sold without a prescription by putting the appropriate label on them. . . . Far from encouraging self-medication, as [FDA commissioner] Campbell had said the 1938 act would do, this provision sharply curtailed it. Previously, the consumer was allowed to judge for himself whether he wanted to take any drug on the market. Now the drug manufacturers and the FDA would decide for him which drugs he could select on his own. . . . The FDA had appointed doctors as the consumer’s agents in selecting drugs (Temin, 98). . . . The regulation grew out of conditions which existed before the revolution in drug therapy produced by the wonder drugs of the 1940s. The dangerous component of Elixir Sulfanilamide was the solvent, not the sulfa drug. . . . The FDA assumed that adequate directions for self-medication could not be written for some drugs” (99). The codification of the prescription-OTC distinction in 1951 in the Durham-Humphrey amendment to the 1938 bill still prevented FDA from interfering with drug companies’ rights to determine which drugs required prescriptions: “Instead of an administrative decision, which the drug companies could appeal, the FDA would have to sue the companies for misbranding if it disliked their decisions.” Also the law dealt only with drug safety, not efficacy (Temin, 103).