The Federal Regulation of Prescription Drug Advertising and Promotion
Kessler, David A.
Pines, Wayne L.
JAMA. 1990 Nov 14; 264(18): 2409-2415.
Prescription drug advertising in the United States is regulated by the federal Food and Drug Administration (FDA). Kessler and Pines review the FDA's actions under the Food, Drug, and Cosmetic Act in regulating traditional forms of drug advertising. They describe the nontraditional forms of advertising that the pharmaceutical industry has begun to use within the last decade to reach physicians and consumers. On a case-by-case basis, the FDA is asserting its jurisdiction over promotional activities such as industry-sponsored medical symposia and teleconferences, press conferences, celebrity spokespersons, and direct-to-consumer advertising. Kessler and Pines conclude that the FDA's regulatory framework must evolve along with advertising techniques; it should focus on public health issues raised by pharmaceutical advertising and on the content of the information being conveyed. (KIE abstract)
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A Decade of Controversy: Balancing Policy With Evidence in the Regulation of Prescription Drug Advertising Frosch, Dominick L.; Grande, David; Tarn, Derjung M.; Kravitz, Richard L. (2010-01)Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. We reviewed empirical evidence addressing the claims ...