The U.S. Department of Justice announced today a whopping $400 million criminal fine in addition to a $1.25 billion civil settlement against Janssen Pharmaceuticals of Titusville, N.J. for introducing a misbranded drug, Risperdal (risperidone). Janssen Pharmaceuticals is a Johnson & Johnson company.
The settlement was made on behalf of the U.S. Food and Drug Administration (FDA).
The combined criminal plea and civil settlement agreement related to Risperdal totals $1,673,024 billion.
“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 A. Hamburg, M.D.
“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.”
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 Janssen began in March 2002 to market the drug for the treatment of agitation associated with dementia in the elderly. The company told doctors that Risperdal was safe and effective for this unapproved indication and population.
The FDA maintains that physicians may, within the practice of medicine, use a drug to treat patients for symptoms or diseases even when the drug is not FDA-approved for such uses.
However, if a pharmaceutical manufacturer intends its drug to be used for a new use, not approved by the FDA, and introduces the drug into interstate commerce for that use, the drug is then considered “misbranded.” Introduction of that misbranded drug into interstate commerce is a violation of the law.
The U.S. Department of Justice action also alleges that Janssen and Johnson & Johnson were aware that Risperdal posed serious health risks for the elderly, including increased risk of stroke.
The companies, according to the government’s allegations, downplayed those risks by combining negative data with other studies in order to support a perception of decreased risk from using the drug.
Janssen had received repeated warnings from the FDA regarding its misleading marketing messages targeted to physicians. After a whistle blower complaint was filed, the FDA Office of Criminal Investigations initiated a criminal investigation into Janssen’s conduct.
“Our investigators devoted considerable time and resources to this case, to help ensure that pharmaceutical companies do not mislead healthcare providers and the general public about the safety and efficacy of their medicines,” said John Roth, director of the FDA’s Office of Criminal Investigations. “We stand ready to take similar action in the future, if warranted, to protect public health.”
Janssen also marketed Risperdal for use in children with behavior 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 was problematic and could be evidence of a violation of the law.
Janssen and Johnson & Johnson will also submit to stringent requirements under a corporate integrity agreement with the U.S. Department of Health and Human Services’ Office of the Inspector General. The agreement is designed to increase accountability and transparency and prevent future fraud and abuse.
Additional charges related to JPI’s healthcare fraud and other Federal agencies can be found here. The U.S. District Court for the Eastern District of Pennsylvania oversaw the agreement.