Publications

Off-label promotions of drugs by pharmaceutical companies continue to be a concern of the United States Food and Drug Administration (FDA) and United States Department of Justice (DOJ). In January 2009, Pfizer’s US $2.3 billion settlement and Eli Lilly’s US $1.42 billion settlement in connection with off-label promotions have been two of the largest payouts to date.

While doctors are free to prescribe drugs for any treatment, pharmaceutical companies are prohibited from promoting drugs for any purposes not approved by the FDA. Each drug’s label must contain “adequate directions for use,” meaning that the label must describe the uses for which the drug manufacturer received the FDA’s approval. Any promotion of a drug for a use that is not indicated on its labeling is an “off-label promotion.”