New Issues in Drug Advertising and Labeling: The Five Advertising End-Runs

Abstract

Five marketing practices which are often at variance with FDA drug advertising regulations are discussed: 1. Use of industry-sponsored scientific and educational activities, 2. Activities lacking in scientific legitimacy, 3. Use of public relations, 4. Direct-to-consumer promotion of prescription drug products, and 5. Industry activities related to promotional materials subject to Food and Drug Administration preapproval. Areas of FDA concern, industry trends, and regulatory responses are discussed for each of these practices