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.
Intentional off-label promotion or marketing is scrutinized closely. Intention, awareness, and knowledge play heavily into the severity of an alleged criminal offense or violation. If it is alleged that off-label promotion resulted in harm to a patient or group of patients, prosecutors could seek severe penalties. Purported acts of off-label violations can be subjective and open to interpretation.
If you are facing charges of off-label marketing, you will need a dedicated, experienced team of white collar defense attorneys to advocate for your best interests. At the Blanch Law Firm, our team of attorneys includes former prosecutors and corporate attorneys who possess many years of defense experience. Call 212-736-3900 or Email our firm today for a free confidential consultation.