According to a press announcement released by the U.S. Food and Drug Administration (FDA) on November 4, 2013, Janssen Pharmaceuticals, Inc., a Johnson and Johnson subsidiary, pleaded guilty to misbranding its schizophrenia drug, Risperdal.
As part of the plea agreement, Janssen Pharmaceuticals (and Johnson and Johnson) will pay more than $1.6 billion to resolve allegations relating to Risperdal, a medication approved by the FDA in 2002 to schizophrenia and in 2003 for short-term treatment of acute mania and mixed episodes associated with bipolar disorder. The U.S. government charged that, from March 3, 2002 through December 31, 2003, Janssen Pharmaceuticals introduced Risperdal to interstate commerce for indications not approved as safe and effective by the FDA. For most of the time period mentioned, Risperdal was only approved to treat schizophrenia.
The criminal information filed in the Eastern District of Pennsylvania alleges that Janssen’s ElderCare sales force promoted Risperdal to physicians by urging them to prescribe Risperdal to treat anxiety, agitation, depression, hostility, and confusion in elderly dementia patients. The U.S. Department of Justice action also alleges that Janssen Pharmaceuticals were aware of the serious health risks posed by Risperdal to the elderly. These health risks include increased risk of stroke; however, the company downplayed those risks and manipulated study data to support a perception of decreased stroke risk from using the drug. Janssen Pharmaceuticals also marketed Risperdal for use in children with behavior changes, despite repeated warnings from the FDA advising the company that promoting its use in children was problematic. Risperdal was not approved for use in children until late in 2006. Sales reps were encouraged to reach out and “sell” the drug to physicians treating elderly dementia patients as well as child psychiatrists and mental health facilities that primarily treated children and adolescents.
The resolution includes criminal fines and forfeiture totaling $400 million and $1.25 billion under a separate civil settlement concerning Risperdal. This resolution is one of the largest in U.S. history. The actions taken by Janssen Pharmaceuticals put the public’s health at risk. In promoting the drug for off-label uses without regard to the health and safety of patients, the company has, “damaged the public trust,” says Attorney General Eric Holder. Johnson and Johnson and Janssen Pharmaceuticals also signed a five-year corporate integrity agreement with the U.S. Department of Health and Human Services’ Office of the Inspector General. Johnson and Johnson and Janssen Pharmaceuticals will submit to stringent requirements designed to increase accountability and transparency and to prevent future fraud and abuse.
Sources:
FDA New Release November 4, 2013
U.S. Department of Justice Office of Public Affairs Release November 4, 2013
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