Healthy Skepticism Library item: 4384

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

Morris LA, Griffin JP.
The evolving role of FDA in prescription drug promotion
Journal of Drug Issues 1992; 22:245-256

Abstract:

This article reviews the contemporary rise of pharmaceutical promotion and FDA’s current regulatory policies. Four trends are identified that have spurred a vast increase in the amount and diversification of promotional messages and methods (i.e., evolving technology, new audiences, more sophisticated marketing strategies, and increasingly competitive environments). FDA’s surveillance and enforcement activities are discussed. A case history regarding Syntex’s promotion of Naprosyn and FDA’s reaction is discussed to illustrate how the industry may use a coordinated marketing campaign to violatively promote its products and how FDA enforces the drug advertising law and regulations.

Keywords:
*analysis/United States/Food and Drug Administration/FDA/regulation of promotion/Syntex/Naprosyn/direct-to-consumer advertising/DTCA/print advertisements/broadcast advertisements/conference speakers/sponsored symposia & conferences/promotion costs and volume/press conferences and releases/generics /ATTITUDES REGARDING PROMOTION: REGULATORS AND GOVERNMENT/ETHICAL ISSUES IN PROMOTION: PAYMENT FOR MEALS, ACCOMODATION, TRAVEL, ENTERTAINMENT/PROMOTION DISGUISED: COMPANY SPONSORED SPEAKING TOURS AND CONFERENCE SPEAKERS/PROMOTION DISGUISED: CONFERENCES AND MEETINGS/PROMOTION DISGUISED: PHYSICIAN EDUCATION MATERIAL AND GUIDELINES/PROMOTION DISGUISED: PRESS CONFERENCES AND PRESS COVERAGE/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION