Janssen Pharmaceuticals fined $1.6 billion for misbranding By By Tim Sandle Nov 12, 2013 in Business Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., has been fined $1.6 billion for its role is selling a misbranded drug. The drug in question is Risperdal (risperidone). The fine against Janssen was issued by the The fine relates to Janssen’s sales representatives allegedly promoting the drug Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. This was an ‘off label’ recommendation, for which there was insufficient approved evidence. The company also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents. FDA Commissioner Margaret A. Hamburg, M.D. is quoted by The news relating to Janssen Pharmaceuticals follows on from the record fine of $2.2 billion handed out to Johnson and Johnson (as reported on the Digital Journal last week). Janssen is a subsidiary of the J&J pharma giant.The fine against Janssen was issued by the U.S. Justice Department , following a case brought by the U.S. Food and Drug Adminsitration (FDA).The fine relates to Janssen’s sales representatives allegedly promoting the drug Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. This was an ‘off label’ recommendation, for which there was insufficient approved evidence.The company also marketed Risperdal for use in children with behavior challenges, despite known health risks to children and adolescents.FDA Commissioner Margaret A. Hamburg, M.D. is quoted by Controlled Environments as saying: “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications. The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective. Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.” More about janssen pharmaceuticals, Johnson and Johnson, Pharmaceuticals, Fine, Penalty More news from janssen pharmaceutic... Johnson and Johnson Pharmaceuticals Fine Penalty Drugs Medicine