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Janssen to pay nearly $1.7 billion to settle misbranded Risperdal case
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The US Department of Justice announced a guilty plea agreement with Janssen Pharmaceuticals and a $400 million criminal fine for introducing risperidone — a misbranded schizophrenia drug — into interstate commerce, according to a press release on behalf of the FDA.
Risperidone (Risperdal) was approved to treat schizophrenia in 2002 and for the short-term treatment of mania and mixed episodes associated with bipolar 1 disorder in 2003. In March 2002, however, Janssen, a Johnson & Johnson company, began marketing the drug as a safe and effective treatment for agitation associated with dementia in the elderly — an indication and subpopulation the drug was not approved to treat.
"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," according to the press release. "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 misbranded, and introduction of that misbranded drug into interstate commerce is a violation of the law."
Janssen also is required to pay $1.25 billion as part of a separate civil settlement for the same drug. Combined, the criminal plea and civil settlement agreement related to the drug totals more than $1.67 billion, according to the press release.
"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," FDA Commissioner Margaret A. Hamburg, MD, said in the press release. "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. [This] announcement demonstrates that pharmaceutical manufacturers that ignore the FDA's regulatory authority do so at their own peril."
Risperdal also was marketed in children with behavioral challenges, despite known health risks to children and adolescents, according to the press release.
As part of a corporate integrity agreement with the US Department of Health and Human Services' Office of the Inspector General, Janssen and Johnson & Johnson will yield to strict requirements designed to increase accountability and transparency and prevent future fraud and abuse.
For more information:
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html.
Perspective
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Jan Fawcett, MD
Physicians make decisions to treat with medication based on deciding that the risks of not treating are greater than treating with an available medication that has the best probability of a therapeutic effect. If the risk of not treating an agitated, demented patient is determined to be greater (eg, severe agitation may lead to death, interference with other needed medical treatment, or injury to the patient) than the risks of the treatment, the physician may prescribe the treatment off-label (not approved by the FDA for this indication) despite risks of the treatment. In order to make this risk-benefit decision with as much accuracy as possible, the clinician must have adequate information about the risks of the available treatment. If this information is inaccurate, the accuracy of this important calculation may well be flawed. Any distortion or obfuscation of risk information is very dangerous when these decisions have to be made.
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