As physician reimbursement decreases, physicians are increasingly looking to other means to replace lost income and control more of the healthcare dollar. From television infomercials to highway billboards, physicians are entering the world of marketing to build and sustain a medical practice.
Part of the marketing by physicians involves describing the nature and benefits of off-label use of medical devices and drugs. But physicians need to be wary of the many restrictions surrounding off-label marketing. While these restrictions generally apply to manufacturers, it is important for physicians to understand the extent of these restrictions and how they may apply to them. The extent to which the prohibition against off-label marketing applies to physicians is ambiguous. This article explores the ways in which physicians may engage in off-label marketing of drugs and devices, while noting the restrictions that may apply to such practices.
FDA Regulations Governing Manufacturers
Regulation of off-label marketing of drugs and medical devices is focused on governing the actions and behavior of those in the manufacturing process. The Food and Drug Administration’s (FDA’s) enforcement actions are premised on the theory that a drug or device is illegally “misbranded” under the federal Food, Drug, and Cosmetic Act1 (FDCA) if it is marketed for a use inconsistent with the direction on its label.2 Under 21 C.F.R. §§ 201.128 and 801.4, the “intended use” (or “on-label” use) is determined by the intent of those who are legally responsible for the labeling of the drug or device. Consequently, enforcement actions against off-label marketing have focused on manufacturers—those who are engaged in the “labeling” of drugs and devices.
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