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Michelle M. Mello, JD, PhD; Meredith Rosenthal, PhD; Peter J. Neumann, ScD

JAMA. 2003;289:477-481.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

During the last several years, the marketing of prescription drugs has undergone substantial change, facilitated by changes in the regulatory environment governing direct-to-consumer advertising (DTCA). Since the release in 1997 of new draft guidance by the Food and Drug Administration (FDA),¹ consumer-oriented drug marketing has become pervasive, particularly in broadcast media. Ninety-one percent of US individuals report having seen consumer-oriented drug advertisements, and the pharmaceutical industry spent nearly $2.5 billion on DTCA in 2000.²

Health services researchers are hard at work trying to understand the impact of DTCA on the marketplace, the patient-physician relationship, and public health. Meanwhile, the courts and the FDA are reviewing the existing legal structures to determine whether they require modification in light of the upsurge in DTCA.³ Historically, under a common-law doctrine called the learned intermediary rule (LIR), manufacturers have only been required . . . [Full Text of this Article]

A Sea Change in the Law

Author Affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Mass.

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