The U.S. Department of Justice and the U.S. Food and Drug Administration (FDA) today announced that Janssen Pharmaceuticals has plead guilty over the misbranding of the drug Risperdal. Janssen and its company, Johnson & Johnson, will pay a total of $2.2 billion to settle the matter.
Around $485 million of the amount will be paid in the form of a criminal fines and forfeitures, while the other $1.72 billion is part of civil case settlement with the U.S. federal and several state governments. In addition, the company will also have to comply with a corporate integrity agreement put together by the U.S. Department of Health and Human Services' Office of the Inspector General.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Eric Holder, U.S. Attorney General. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The drug in question, Risperdal, has been approved by the FDA for the treatment of schizophrenia and the short-term treatment of manic episodes in those with Bipolar Disorder. Janssen has admitted to marketing the drug to doctors for the treatment of agitation associated with elderly dementia - a use for which Risperdal is not FDA approved.
The Justice Department claims that both Janssen and Johnson & Johnson downplayed the increased risk of stroke that the drug could cause in elderly patients and that they paid kickbacks to doctors who prescribed Risperdal. The companies had received multiple warnings about their marketing of Risperdal.
The criminal investigation into Janssen's Risperdal marketing practices began after a whistle-blower complaint was filed with the FDA.
“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 Dr. Margaret Hamburg, FDA Commissioner. “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.”