The American Medical Association (AMA) recently adopted a new policy supporting a ban on direct-to-consumer pharmaceutical advertising (DTCPA) of prescription drugs and medical devices in an effort to make prescription drugs more affordable.1 Dr. Patrice A. Harris, MD, MA, chair-elect of the AMA Board of Trustees, stated that the vote “reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices.” She added, “[it] also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”1
The United States and New Zealand are the only 2 countries that allow DTCPA that includes product claims.1 There are 3 basic types of DTCPA, all of which are regulated by the US Food and Drug Administration (FDA): (1) help-seeking advertisements, which provide information about a disease but do not recommend specific drugs or devices; (2) reminder advertisements, which mention specific drugs and provide some information (eg, strength, dosage form, price) but do not mention the indication or make efficacy claims; and (3) product claim advertisements, which are the most common type and mention drug names, indications, and efficacy and/or safety data.2
The FDA’s Division of Drug Marketing, Advertising, and Communications is responsible for regulating DTCPA. The FDA has had authority to approve pharmaceutical products in the United States since 1938 and has regulated labeling and advertising of these products since 1962. In 1969, the FDA issued regulations stipulating that drug advertisements should not be false or misleading and should provide information about risks and benefits, facts about the uses of the drug, and a list of all risks in the product’s labeling. At that time, drug advertisements were directed at health care providers—not the general public—and were mainly found in medical journals and other print sources aimed directly as physicians.
When a number of pharmaceutical manufacturers ran direct-to-consumer advertisements in print and broadcast media, the FDA had to consider how to regulate a new area of advertising. In 1985, the FDA issued a notice claiming regulatory jurisdiction over DTCPA. Believing that DTCPA was beneficial to the general health of consumers, the FDA gradually eased its regulations in recognition of the prohibitive time and expense that the older rules required. Advertisers now only had to list major risks rather than all risks and direct consumers to sources of further information.
In 1980, total spending on DTCPA by industry was $12 million; this figure reached $1.2 billion by 1998, topped out at $5 billion in 2006 and 2007, and dropped to $4.5 billion in 2009.2 Today, most DTCPA spending goes toward television commercials, with the average American viewer watching as many as 9 drug advertisements per day; however, spending on Internet advertising is increasing since the return on investment in that medium is greater.