Off-Label Promotion Leads to Criminal Plea, Consent Decree of Permanent Injunction, Disgorgement of Profit

The Food and Drug Administration (FDA) has just concluded a significant enforcement action involving alleged off-label promotion of a prescription drug. On December 21, 2005, the Department of Justice and Eli Lilly and Company (Lilly) announced agreements to resolve an investigation into the marketing and promotion of Evista® (raloxifene hydrochloride).1 Lilly agreed to a criminal fine of $6 million, a civil disgorgement of $24 million, and forfeiture of another $6 million to the government, together with a consent decree of permanent injunction. The government alleged that Lilly had promoted Evista, a drug approved only for the prevention and treatment of osteoporosis, for other uses, including the prevention and reduction in risk of breast cancer and the reduction of risk of cardiovascular disease.2 The actions taken, and the government’s legal rationale, offer several important lessons for pharmaceutical and medical device companies.