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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).

9 minute read June 28, 2007 at 08:11 AM
By
Ronald H. Levine
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.

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