Janssen Pharmaceuticals fined US$1.6bn for misbranding
Johnson & Johnson subsidiary also filed false claims for its schizophrenia drug Risperdal
Janssen Pharmaceuticals (JPI) of Titusville, NJ, US, has been fined US$1.6bn for its role in selling a misbranded drug for the treatment of schizophrenia.
The US Department of Justice, on behalf of the US Food and Drug Administration (FDA), has announced a guilty plea agreement with the firm and a $400m criminal fine for introducing schizophrenia drug Risperdal (risperidone) into interstate commerce.
JPI must also pay $1.25bn under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67bn.
'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,' said FDA Commissioner Margaret Hamburg. '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.'
Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril
The FDA approved Risperdal in 2002 for the treatment of schizophrenia and in 2003 for the short-term treatment of acute mania and for mixed episodes associated with Bipolar 1 Disorder. But in March 2002 Janssen began to market the drug for the treatment of agitation associated with dementia in the elderly, representing that Risperdal was safe and effective for this unapproved indication and sub-population.
The US Department of Justice action also alleges that JPI and Johnson & Johnson were aware that Risperdal posed serious health risks for the elderly, including increased risk of stroke, but that the companies downplayed those risks by combining negative data with other studies to support a perception of decreased risk from using the drug.
JPI had received repeated warnings from the FDA regarding its misleading marketing messages targeted at general practitioners. After a whistle blower complaint was filed, the FDA Office of Criminal Investigations initiated a criminal investigation into JPI’s conduct.
JPI also marketed Risperdal for use in children with behaviour challenges, despite known health risks to children and adolescents. Until late in 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly advised the company that promoting its use in children could be evidence of a violation of the law.
