ABSTRACT

INTRODUCTION The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are the two governing U.S. regulatory agencies that affect the marketing and promotion of health-care industry products. The FDA primarily impacts the marketing and promotion practices of the prescription pharmaceutical, biological, medical device, and animal drug industries. The FTC primarily affects nonprescription/ over-the-counter (OTC) pharmaceuticals, nutritional and cosmetic marketing, and promotional practices. A following chapter in this book will discuss the current responsibilities of the FTC and the health-care industries it regulates. Although, recent legislation not currently in effect, the Non-Prescription Drug Modernization Act (November 2007) has been proposed to allow FDA to regulate OTC drug advertising, this chapter will discuss the relationship of the FDA and the health-care industries it currently regulates, with a focus on prescription drug marketing and promotion.