Healthy Skepticism Library item: 4071

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kessler DA, Pines WL.
The federal regulation of prescription drug advertising and promotion.
JAMA 1990 Nov 14; 264:(18):2409-15

Abstract:

Prescription drug advertising has been regulated by the Food and Drug Administration since 1962. In the past decade, pharmaceutical companies have employed new communication mechanisms to reach physicians and, with increasing frequency, consumers. Examples of physician-oriented promotional activities are medical symposia and teleconferences. Consumer-oriented efforts include press conferences, use of celebrity spokespeople, and direct-to-consumer advertising. The Food and Drug Administration has asserted its legal jurisdiction over these nontraditional promotional activities and is regulating them on a case-by-case basis. As nontraditional promotional efforts become more prevalent, the Food and Drug Administration’s regulatory framework must be able to meet the challenges of a changing environment.

KIE: 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.

Keywords:
*analysis/United States/labeling/Food and Drug Administration/FDA/regulation of promotion/direct-to-consumer advertising/press conferences and releases/sponsored symposia & conferences/promotional literature/ATTITUDES REGARDING PROMOTION: REGULATORS AND GOVERNMENT/PROMOTION DISGUISED: CONFERENCES AND MEETINGS/PROMOTION DISGUISED: PRESS CONFERENCES AND PRESS COVERAGE/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION Advertising/legislation & jurisprudence* Drug Industry/legislation & jurisprudence* Drug Labeling/legislation & jurisprudence Drugs, Investigational*/standards Federal Government Government Regulation* Information Dissemination Public Relations United States United States Food and Drug Administration