Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
November 4, 2013
Media Inquiries: Christopher Kelly
Consumer Inquiries: 888-INFO-FDA
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion.
Additional charges related to JPI's healthcare fraud and other Federal agencies can be found at http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html. The U.S. District Court for the Eastern District of Pennsylvania oversaw the agreement.
"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 JPI began in March 2002 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 subpopulation.
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 misbranded, and introduction of that misbranded drug into interstate commerce is a violation of the law.
The U.S. 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 in order 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 to physicians. After a whistle blower complaint was filed, the FDA Office of Criminal Investigations initiated a criminal investigation into JPI'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."
JPI 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.
JPI 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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.