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Drug Misbranding Redefined
The cornerstone of many U.S. Food and Drug Administration (FDA) enforcement actions against pharmaceuticals manufacturers in recent years has been the charge that they and their represetatives have “misbranded” their pharmaceutical products by promoting them for uses not approved by the FDA. The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. ' 331(a), prohibits misbranding of a drug product, yet does not define promotion of off-label drug prescription or use as such “misbranding.” It is federal enforcement agents who came up with the argument that off-label promotion of a pharmaceutical product equaled “misbranding,” and that argument has been very successful.
Although doctors have always been permitted to prescribe medications for uses not officially endorsed by the FDA, manufacturers and their salespeople who actively encouraged such conduct could find themselves the subjects of federal civil and criminal actions. And the consequences are not insignificant. Huge fines have been imposed and settlements obtained, including the October 2012 fine assessed against Abbott Laboratories for marketing Depakote as a treatment for schizophrenics and dementia patients, even though those uses are not FDA-approved. Abbot was ordered to pay what the Department of Justice (DOJ) described as the “second-largest criminal fine for a single drug.” That fine was $500 million, plus a forfeiture of nearly $200 million; this in addition to payment to the Virginia Medicaid Fraud Control Unit of $1.5 million, and an $800 million settlement with federal and state governments for causing false claims to be filed with those entities.
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