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  Vol. 264 No. 18, November 14, 1990 TABLE OF CONTENTS
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The Federal Regulation of Prescription Drug Advertising and Promotion

David A. Kessler, MD, JD; Wayne L. Pines

JAMA. 1990;264(18):2409-2415.


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.

(JAMA. 1990;264:2409-2415)



Author Affiliations

From the Jack D. Weiler Hospital of the Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY (Dr Kessler), and Burson-Marsteller, Washington, DC (Mr Pines). Mr Pines served as Associate Commissioner for Public Affairs at the Food and Drug Administration from 1978 to 1982 and currently advises pharmaceutical clients in his role at Burson-Marsteller.


Footnotes

This article was written, submitted, and accepted for publication before Dr Kessler was nominated to be Commissioner of the Food and Drug Administration.

Reprint requests to the Jack D. Weiler Hospital of the Albert Einstein College of Medicine, 1825 Eastchester Rd, Bronx, NY 10461 (Dr Kessler).



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