On Aug. 9, 1997, the U.S. Food and Drug Administration (FDA) announced a policy that allowed pharmaceutical companies the expansion of direct-to-consumer advertising into broadcast and electronic media. The adequate provision requirement could be fulfilled by referring consumers to a physician, a website, a toll-free telephone number, and a print advertisement. 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.

Direct-to-consumer advertising of prescription drugs is a powerful force in the health care market. Proponents claim that good direct-to-consumer advertising educates and empowers patients in their relationship with their health care providers. Furthermore, they assert that direct-to-consumer advertising provides an opportunity for patients to talk to providers about under-diagnosed and under-treated medical conditions and may lead to improved health outcomes. Opponents of the practice argue that there is an inherent conflict of interest for pharmaceutical companies in advertising products directly to patients and that the decision to advertise is not based on concern for the public health but rather investment return.

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, and 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 discussed above suggest that interest in direct-to-consumer advertising has waned among the public.¹⁵ Secondly, pharmaceutical companies are concerned about ever increasing liability from direct-to-consumer advertising.