The Evolving Role of FDA in Prescription Drug Promotion

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.