Prescription drug advertising has been regulated by the Food and Drug Administration since 1962. In the past decade, pharmaceutical companies have employed new communication mechanisms to reach physicians and, with increasing frequency, consumers. Examples of physician-oriented promotional activities are medical symposia and teleconferences. Consumer-oriented efforts include press conferences, use of celebrity spokespeople, and direct-to-consumer advertising. The Food and Drug Administration has asserted its legal jurisdiction over these nontraditional promotional activities and is regulating them on a case-by-case basis. As nontraditional promotional efforts become more prevalent, the Food and Drug Administration's regulatory framework must be able to meet the challenges of a changing environment.