Off-Label Promotion

This is a term used to describe the act of marketing a drug for an unapproved use. Off-label promotion can be a felony or a criminal misdemeanor offense, depending on the case. Pharmaceutical companies are required to limit their promotion of drugs to only those uses permitted by the Food & Drug Administration (FDA). Off-label marketing occurs when a company attempts to circumvent the often costly and time-consuming FDA testing procedures by obtaining approval for a drug and then promoting the same drug for purposes other than those initially approved by the FDA.