Direct-to-Consumer Advertising (DTCA)

History

In the 19th century, promotion of patient medicines in the United States represented the largest print advertising spending by any industry. The federal 1906 Pure Food and Drug Act, passed in response to egregious abuses in the production and representation of food and drugs, was replaced in 1938 by the Food, Drug, and Cosmetic Act (FDCA), which gave the U.S. Food and Drug Administration (FDA) more authority to regulate the labeling of all drugs, then not distinguished as prescription and over-the-counter drugs. The FDCA prohibited “false or misleading labeling.” The U.S. Congress assigned the regulation of drug advertising to the U.S. Federal Trade Commission (FTC). In 1951, the Dunham-Humphrey Act legally defined prescription drugs as distinct from those safe for consumers to purchase over the counter. In 1962, the Kefauver-Harris amendments to the FDCA moved prescription drug advertising regulation to the FDA, where it is currently handled by the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications (DDMAC).

Until the early 1980s, prescription drugs were advertised only to physicians, primarily through detailing (company representatives who visited the physicians), sampling (provision of drug samples to physicians' offices), and professional medical journals. The 1962 amended FDCA required that advertisements not be “false or misleading,” contain what it called a “brief summary” (relating to side effects, contraindications, and drug effectiveness), and have a “fair balance” coverage of risks and benefits. To supply the brief summary, drug advertisements in medical journals simply reprinted [Page 302]the FDA-approved product labeling (package insert), constituting at least an entire page of very technical medical information in very small print. The mandated fair-balance requirement specified that the advertisement present an evenhanded account of all clinically relevant information and that the presentation not focus disproportionately on the benefits. Fair balance is measured not only in the quantity of information on both sides but also in quality (major vs. minor risks) and in presentation (legibility, readership, and size of font).

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