Pharmaceutical giant Johnson & Johnson (J&J) announced November 4 that it will plead guilty to a single misdemeanor charge that it misbranded the atypical antipsychotic drug Risperdal for uses not approved as safe and effective by the Food and Drug Administration (FDA).
A part of one of the largest health care fraud settlements in U.S. history, the pharmaceutical company has agreed to pay $2.2 billion to resolve criminal and civil investigations, the U.S. Department of Justice announced.
Risperdal (risperidone)—a dopaminergic antagonist—was FDA approved to treat schizophrenia in 1993 and approved in 2003 to treat mixed episodes associated with bipolar I disorder. A complaint filed by the U.S. Court for the Eastern District of Pennsylvania alleged that Janssen Pharmaceuticals, a J&J subsidiary and Risperdal’s developer, began to market the drug from 1999 through 2005 to remedy agitation associated with dementia in the elderly and psychiatric disorders in children—indicating to physicians and other prescribers that Risperdal was safe and effective for these unapproved indications and populations.
According to the FDA, J&J received several warnings regarding its misleading marketing tactics targeted to physicians and consumers. After a whistleblower complaint was filed, the FDA Office of Criminal Investigations initiated a probe concerning J&J’s alleged misconduct.
“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 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…. Pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”
The Department of Justice further alleged that J&J was aware that Risperdal posed serious health risks, including increased risks for the onset of diabetes, breast development in boys, and strokes in elderly patients.
During the investigation, a physician who worked on a J&J study claimed that the company was “purposely withholding the findings” that showed that Risperdal increased risk for stroke in elderly patients after the company combined negative data with other studies to make it appear that there was an overall lower risk for adverse events. In addition, the company promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes),” ignoring data that indicated otherwise.
As a result of its practices and misconduct, the company has agreed to submit to stringent requirements under a corporate integrity agreement with Department of Health and Human Services Office of the Inspector General. The agreement is designed to increase accountability and transparency and prevent future fraud.
Psychiatric News contacted J&J to ask how the company plans to regain trust among clinicians and consumers. Michael Ullmann, J&J vice president and general counsel, replied in a statement saying, “This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world. We remain committed to working with the U.S. Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards.”
Though J&J acknowledged that it improperly marketed Risperdal to older adults for unapproved uses, the pharmaceutical firm admitted to no wrongdoing for accusations that it promoted drug use in children and the developmentally disabled and that it provided kickbacks to doctors and pharmacists in exchange for writing more prescriptions.
The agreement will also resolve similar misbranding accusations for the company’s heart failure drug, Natrecor, and newer antipsychotic drug, Invega. ■