Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech

Abstract

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use.