The pharmaceutical industry, which researches, develops, produces, and markets prescription drugs in the United States, is the most heavily regulated of all industries when it comes to the advertising and promotion of its products. Through its Drug Marketing, Advertising, and Communications Divisions, the Food and Drug Administration (FDA) regulates all advertising and promotional activities for prescription drugs, including statements made to physicians and pharmacists by pharmaceutical sales representatives. Advertising of over-the-counter (OTC) drugs, which is not regulated by the FDA, is under the jurisdiction of the Federal Trade Commission (FTC).

Before a new prescription drug is approved for marketing, the FDA and the pharmaceutical company must agree on the "full prescribing information" that will accompany the product and that must be included in all ads, brochures, promotional pieces, and samples. This full prescribing information must include, in the correct order...