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Off-Label Marketing of Drugs and Medical Devices
Policing the marketing of drugs and devices was once primarily the preserve of the Food and Drug Administration (FDA), which focused on misleading labels and outright quackery. No longer. Nowadays, many federal investigations, worked jointly by the FDA, Department of Justice (DOJ) and Health and Human Services (HHS), are fueled by the enormous financial recoveries that can be won from manufacturers accused of illegally promoting FDA-approved drugs or devices, bearing an FDA-approved label, for uses not approved by the FDA ('off-label' uses).
For example, Warner-Lambert pleaded guilty, paid $430 million, and entered into a 'Corporate Integrity Agreement' to resolve civil and criminal charges over off-label promotion of the drug Neurontin'. Other reported settlements relate at least in part to off-label allegations: Genentech ($50 million); Lilly ($36 million); Serono ($704 million); Schering-Plough ($435 million); Intermune ($36 million) and, more recently, Purdue Frederick ($470 million).
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