摘要：Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. We reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA. This advertising has some benefits, but significant risks are evident as well, magnified by the prominence of DTCA in population-level health communications. To minimize potential harm and maximize the benefits of DTCA for population health, the quality and quantity of information should be improved to enable consumers to better self-identify whether treatment is indicated, more realistically appraise the benefits, and better attend to the risks associated with prescription drugs. We propose guidelines for improving the utility of prescription drug advertising. THE FOOD AND DRUG ADMIN istration (FDA) acquired jurisdiction over direct-to-consumer advertising (DTCA) of prescription drugs in 1962. For the next 35 years, television advertising was limited by a requirement that advertisements briefly summarize potential adverse reactions and contraindications to drugs. But in 1997 the FDA issued guidance specifying that “adequate provision” of information about drug risks and benefits could be made by referring consumers to a toll-free telephone number, a concurrent print ad, a Web site, or a physician, making it easier to advertise on television. The pharmaceutical industry dramatically increased its DTCA spending ($4.9 billion in 2007 1 ) and shifted the majority of its budget from print to broadcast media. 2 , 3 The United States is alone in permitting DTCA, with the single exception of New Zealand. Regulation of DTCA recognizes that prescription drugs differ from other consumer commodities because of their inherent risks. Commercial speech is nevertheless subject to significant protection under US law, leading legal scholars to conclude that a complete ban of DTCA is unlikely to withstand litigation testing its constitutionality. 4 – 6 Policymakers revisited the issue of DTCA in 2004, after the voluntary market withdrawal of Vioxx (rofecoxib; Merck & Co., Whitehouse Station, NJ), and again during the reauthorization of the FDA in 2007. Signs point to renewed interest in DTCA regulations in 2009. 2 – 7 But legislators have struggled to reach consensus about the appropriate role of DTCA in the health care system. This polarized policy debate begs the question of which views have empirical support. In effect, DTCA amounts to a large and expensive uncontrolled experiment in population health. We identified the major claims made by proponents and opponents of DTCA and reviewed findings from relevant empirical studies, with a focus on peer-reviewed literature. We then formulated options for legislators to consider in balancing the constitutional protection of commercial speech with the need to protect the public's health.
