Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
November 7, 2013
United States Attorney
Eastern District of Pennsylvania
Contact: Patty Hartman
PHILADELPHIA - Janssen Pharmaceuticals, Inc. (Janssen), a subsidiary of health care giant Johnson & Johnson (J&J), pleaded guilty today to a one count information charging Janssen with introducing a misbranded drug, Risperdal, into interstate commerce. U.S. District Court Judge Timothy J. Savage sentenced the company, ordering payment of a $344 million fine and forfeiture of $66 million.
Risperdal, an atypical anti-psychotic drug, was originally approved only to treat the management of the manifestations of psychotic disorders. On March 3, 2002, the approved use was narrowed to treatment of schizophrenia only. Janssen introduced Risperdal for a new, unapproved use, rendering the product misbranded. In a plea agreement resolving these charges, Janssen admits that between March 3, 2002, and December 31, 2003, it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated disturbances exhibited by elderly, non-schizophrenic dementia patients, uses not approved as safe and effective by the Food and Drug Administration (FDA).
The Federal Food, Drug and Cosmetic Act (FDCA) requires a pharmaceutical company to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or "off-label" uses. A manufacturer's promotional activities of a drug for a use not approved by the FDA are evidence of its intent to distribute the drug for a new, unapproved use, also known as "misbranding."
The case was investigated by the Health and Human Services-Office of Inspector General, the Food and Drug Administration's Office of Criminal Investigations, and the Defense Criminal Investigative Service of the Department of Defense.
The criminal case was prosecuted by Assistant U.S. Attorneys Albert Glenn and Scott Cullen.