On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen Pharmaceuticals, Inc. (JPI), a Johnson & Johnson company, pled guilty to misbranding the drug Risperdal (risperidone) in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), arising from its off-label marketing of the drug. Under the plea agreement, the Company is required to pay a $400 million criminal fine. It will also be required to pay civil penalties under a separate settlement concerning Risperdal. The cases resulting in these settlements originated from qui tam, or “whitstleblower,” lawsuits filed under the federal False Claims Act. You can read the announcement on the FDA’s website.
Risperdal is an atypical anti-psychotic drug that was approved by the FDA for the treatment of schizophrenia in 2002 and the treatment of acute mania and mixed episodes associated with Bipolar I disorder in 2003. Pursuant to the FDCA, physicians are allowed to prescribe drugs to patients for unapproved uses within the practice of medicine but the marketing or promoting a FDA-approved drug for indications other than those that are contained on the drug’s label, commonly known as off-label marketing, renders the drug misbranded in violation of federal law. In this case, the FDA alleged that, beginning in March 2002, JPI promoted Risperdal to health care providers for the treatment of agitation in elderly dementia patients and certain behavioral challenges in children, two uses for which Risperdal had not been proven safe and effective, and thereby misbranded the drug. Risperdal was not approved for any use in children until 2006 and has never been approved to treat dementia in the elderly.
In sum, in addition to its settlement agreements, JPI is subject to a corporate integrity agreement entered into with the Department of Health and Human Services as a way to prevent future fraud and abuse. If you have any questions about compliance with the FDA provisions involved in these recent settlements or other FDA laws and regulations pertaining to off-label marketing, please contact us at: firstname.lastname@example.org.