In the past several years, the Department of Justice (DOJ) has brought a series of cases in which pharmaceutical companies have entered corporate guilty pleas and reached civil settlements with the government for off-label marketing of drugs and biologics, resulting in some of the largest corporate fines and civil penalties in history.
Recently, federal officials have stated their intention to seek prosecution of not just companies engaged in off-label promotion but also individuals responsible for such activity. Both the commissioner of the Food and Drug Administration (FDA) and a senior DOJ official have declared that the prosecution of individuals is a priority of this administration.1
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