Off label marketing fraud occurs when a drug company or medical device manufacturer markets and promotes the use of an FDA-approved controlled substance (a prescription drug) or device for a purpose other than that for which FDA approval was obtained.
The Food and Drug Administration, through the Food and Drug Administration Center for Drug Evaluation and Research (CDER), receives and reviews a company's application for new prescription drugs (a “New Drug Application,” or NDA), based upon extensive research data and clinical trials. The reason for this review and approval by the FDA is to ensure that the new prescription drug is safe and effective for its intended purpose, and that the manufacturer provides appropriate and accurate language describing safe dosage, route of administration, drug storage, and other important information about the drug that relates directly to patient safety. As part of the approval process, the FDA must approve patient inserts and labels for every prescription drug. The approvals constitute the only approved usages for the particular prescription drug, and cannot be substantively changed or altered without FDA approval. Both physicians and patients rely upon the FDA approval process and the purpose and usages for a drug, according to the FDA approved uses.
A physician may lawfully prescribe an FDA-approved prescription drug for a use or treatment other than that for which it was approved by the FDA. However, a drug company is absolutely forbidden from marketing and promoting and therefore may not market and promote a prescription drug for a use other than that for which it was approved via the FDA drug approval process. Similarly, a medical device manufacturer is also forbidden from marketing and promoting and therefore may not market and promote a medical device for a use other than that for which it was approved by the FDA. When this happens, it is referred to as “Off-Label Marketing.”
Due to the enormous profits that drug companies medical device manufacturers can reap when they believe that their FDA-approved drugs or devices are effective for other, unapproved uses, many companies are tempted to engage in off-label marketing, which is illegal and may endanger patient safety.
Many of the very largest False Claims Act cases resolved the last decade concerned off-label marketing violations.
Real World Examples of Recent Off-Label Marketing False Claims Act Cases:
- 2012: Abbott Laboratories, Inc. paid $800 million to settle whistleblower lawsuits alleging that the company marketed the drug Depakote for uses other than those approved by the FDA. Depakote was only approved for treatment of epilepsy, bipolar mania, and migraines. However, Abbott Laboratories promoted the drug to treat both agitation and aggression in dementia patients and schizophrenia. The whistleblowers received $84 million from the federal government as a result of the settlement.
- 2012: GlaxoSmithKline, LLC paid $1.043 billion to settle four whistleblower lawsuits alleging that it engaged in in the off-label marketing of the drugs Paxil, Wellbutrin, Advair, Lamictal, and Zofran. The allegations included that the company marketed Zofran, which the FDA only approved to treat post-operative nausea, for the treatment of morning sickness in pregnant women and that the company improperly marketed the epilepsy drug, Lamictal, for psychiatric and pain treatment.
- 2010: Novartis Pharmaceuticals Corporation paid $237.5 million to settle civil lawsuits alleging that the company engaged in off-label marketing with 6 of its drugs, resulting in the submission of false claims to the government. Specifically, regarding the drug, Trileptal, a drug approved to treat epilepsy, Novartis marketed the drug for both psychiatric and pain treatment, uses not approved by the FDA. The civil lawsuits were brought by former employees of Novartis, and the whistleblowers received over $25 million as their share of the recovery under the False Claims Act.
- 2010: Allegan, Inc. paid $225 million to settle civil lawsuits with federal and state governments in which it was alleged that the company promoted its product, Botox, for uses not approved by the FDA, resulting in false claims submitted to the government. Allergan promoted and marketed Botox's off-label uses in a variety of ways, including conducting workshops teaching physicians and their staffs how to bill for Botox's off-label uses. The civil lawsuits were initiated by five whistleblowers, who shared in $37.8 million awarded to the Relators.