Review
Direct-to-Consumer Advertising of Pharmaceuticals

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Abstract

Since the US Food and Drug Administration (FDA) released new guidelines on broadcast direct-to-consumer advertising in 1997, the prevalence of direct-to-consumer advertising of prescription drugs has increased exponentially. The impact on providers, patients, and the health care system is varied and dynamic, and the rapid changes in the last several years have markedly altered the health care landscape. To continue providing optimal medical care, physicians and other health care providers must be able to manage this influence on their practice, and a more thorough understanding of this phenomenon is an integral step toward this goal. This review will summarize the history of direct-to-consumer drug advertisements and the current regulations governing them. It will summarize the evidence concerning the impact of direct-to-consumer advertising on the public, providers, and the health care system, and conclude with observations regarding the future of direct-to-consumer advertising.

Section snippets

Background

Direct-to-consumer advertising is not a new phenomenon. The first recorded advertisement of a pharmaceutical product occurred in the early 18th century, and the practice became widespread in the 19th and early 20th centuries.3 Partially as a response to the proliferation of these advertisements, the United States Congress undertook a series of legislative steps to regulate drug advertisements. One of the first steps was the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938 that established

Prevalence of Direct-to-Consumer Advertising

The FDA divides direct-to-consumer advertising into 3 categories (Table 2).5 Reminder advertisements contain the name of a drug only and are designed to reinforce brand recognition; Help-seeking advertisements contain information about a disease or condition without mentioning a particular treatment; and Product-claim advertisements contain specific efficacy and safety information about a specific drug. The latter are regulated by the FDA, which requires that the advertisements present a fair

Direct-to-Consumer Advertising and the Public

With such significant expenditure, there is little surprise that direct-to-consumer advertising reaches a wide audience in the United States. In 2004, Brownfield et al reported that during a 1-week period in Atlanta, the 3 major networks broadcast 907 advertisements for over-the-counter medications and 428 advertisement for prescription drugs.13 Sixty percent of all direct-to-consumer advertising in this study occurred during news programs and soap operas, arguably targeting older adults and

Direct-to-Consumer Advertising and the Physician-Patient Relationship

Of significant concern to the medical community is the criticism that direct-to-consumer advertising undermines the physician-patient relationship.19 In studying this issue, the 2002 FDA survey showed mixed results. For example, 73% of patients did not believe direct-to-consumer advertising minimized the role of physicians in making product decisions. In fact, 43% felt direct-to-consumer advertising helped them have better discussions with their doctor (down from 62% in 1999). However, 10% of

Direct-to-Consumer Advertising and Physician Behavior

Physicians are more likely to prescribe a medication when they believe that the patient has an expectation to receive that medication.20, 21 By stimulating consumer demand, pharmaceutical companies hope to increase physician prescriptions for a particular product. About half of physicians in the FDA survey reported some pressure to prescribe as a result of direct-to-consumer advertising, with primary care physicians again more likely than specialists to report pressure. Approximately 73% of

Direct-to-Consumer Advertising and Public Health

The findings by Kravitz et al illustrate the difficulty in deciphering the effect of direct-to-consumer advertising on the public health system. The effect of increasing prescriptions is dependent on the condition for which the drug is prescribed; that is, when an indication is appropriate and the condition being treated is under-diagnosed, direct-to-consumer advertising may improve overall health. However, when an indication for therapy is inappropriate and a condition is over-diagnosed,

The Future

The health care market in the United States is a dynamic system. Direct-to-consumer advertising emerged from relative obscurity in 1997 to become a potent force shaping the future of health care. The United States and New Zealand are the only countries in the world at present to allow it. Several factors may alter the course ahead. First and foremost, for direct-to-consumer advertising to be effective in creating interest in a product, consumers have to be willing to pay attention. FDA data

Conclusions

Pharmaceutical companies continue to increase funding for direct-to-consumer advertising. Evidence discussed above suggests that direct-to-consumer advertising stimulates patient demand for pharmaceuticals, may influence physician prescribing habits, and likely increases drug spending. Consumers are aware of these advertisements, and discussions about them are becoming part of the routine provider-patient relationship. As the phenomenon of direct-to-consumer advertising evolves and the

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