A pharmaceutical drug achieves an approved indication for pediatric patients only after undergoing clinical trials in children, and the FDA’s strictest review of data to assess the safety and effectiveness of the drug in children.
Over the years, some manufacturers have omitted this cost (and, in some cases, a sure denial), by promoting their drugs off-label for pediatric populations.
Once armed with abstracts and other materials, and educated on pediatric talking points, some sales forces have unofficially been directed to call on pediatric healthcare providers. To provide comfort to uneasy sales reps, managers have assured them that pediatric sales calls are permitted so long as they don’t open with the pediatric talking points.
These directives are simply wrong and illegal. By specifically targeting providers who treat populations, the drug manufacturers are intending to push their drugs outside of their labels, in violation of the criminal provisions of the federal Food, Drug & Cosmetic Act. Moreover, when such promotions cause providers to prescribe the drugs for children by government healthcare dollars, the manufacturer are also running afoul of the False Claims Act.
While the False Claims Act offers substantial rewards to whistleblower sales force members who successfully expose off-label pediatric promotions, the greatest reward might be knowing that they have the ability to stop promotions that risk the lives of our nation’s youngest citizens.
More information for whistleblowers is located at the Nolan Auerbach & White website.