In recent years, a number of drug companies have settled False Claims Act cases, alleging that the companies off-label marketed their products to children. Oftentimes, the offending marketing materials did not specifically mention the use of the products in the pediatric population. However, the companies still ran afoul of the FCA, for their marketing efforts aggressively targeted pediatric specialists.
These successful actions dispelled the misconception that off-label marketing only occurs when marketing materials explicitly promote an unapproved use.
When a drug company details pediatricians or it corrals pediatricians into a room to tout the benefits of its drugs, it is implicitly stating that its products are approved for the doctors’ patient population. If, however, the products have not been approved for use in children and the company fails to share this information with the audience, there is likely a violation of the False Claims Act. In other words, half truths are considered “false” when it comes to off-label marketing.
For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, P.A.