The federal regulation of prescription drug advertising and promotion
D. A. Kessler and W. L. Pines
Jack D. Weiler Hospital, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY 10461.
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.
