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Off-Label Promotion of Drugs and Medical Devices

By Michael Kendall and Nicole Colby Longton
June 29, 2009

A spate of billion- and hundred-million-dollar settlements with the Department of Justice (DOJ) illustrates how the investigation of off-label promotions of drugs and devices has emerged as a predominant theory in pharmaceutical and medical-device prosecutions. Up to 60% of all prescription drug use in the United States is off-label, and the regulatory and medical issues are exceedingly complicated. The application of off-label regulations, therefore, has significant impact in these cases that generate enormous criminal and civil monetary penalties and can lead to misdemeanor convictions of corporate executives on a strict-liability theory.

Typically, prosecutors seek to punish off-label promotion with civil penalties under the False Claims Act predicated on billings to Medicare and Medicaid and criminal prosecution under the Food, Drug, and Cosmetic Act. Federal prosecutors have entered into criminal and civil settlements that included off-label allegations with Pfizer, Eli Lilly, Serono, Astra Zeneca, Cephalon, Bristol-Myers Squibb, and Schering Plough, among others. Several device manufacturers have entered into off-label settlements too. The DOJ has made off-label investigations a continuing priority, which means off-label cases will be among the largest cases the Department prosecutes over the next several years.

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