1951

Durham Humphrey Amendments to FDCA of 1938 created a statutory definition of prescription drugs; primary purpose was to avoid patient self-diagnosis and self-administration of complex and potentially harmful drugs (Donohue, 667). It used the language of the FDA’s 1944 prescription regulations: A drug could be dispensed “only upon a written prescription” if “because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, [it] is not safe for use except under the supervision of a practitioner licensed by law . . .” But the initiative remained with the drug companies [not the FDA], who would decide which of their products met the statutory criterion” (Marks IV, 112). “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). “In the Cold War era, the regulated [drug] industry imparted ideological significance to the prescription drug regulations in a successful campaign to maximize the industry’s control over prescription labeling. . . . The industry’s success in Congress depended on the powerful appeal of antistatist and anticommunist rhetoric in postwar America” (Marks IV, 113).