Johnson & Johnson is set to pay $2.2 billion to put an end to criminal and civil fines for marketing drugs Risperdal, Invega and Natrecor for uses that were not previously approved for, the U.S. Justice Department said Monday.
According to the Associated Press, the charges include paying kickbacks to physicians and pharmacies to recommend and prescribe Risperdal and Invega, both antipsychotic drugs, and Natrecor, which is used to treat heart failure. The settlement is one of the largest of its kind, the DOJ said.
Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc promoted Risperdal for unapproved uses from 1999 to 2005, including controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities.
"The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust," said Atty. Gen. Eric H. Holder Jr. in a statement.
"Today we reached closure on complex legal matters spanning almost a decade," said Michael Ullmann, vice president and general counsel for Johnson & Johnson. "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."
The company will also be subjected to requirements under a so-called Corporate Integrity Agreement with the Department of Health and Human Services offices. The agreement is intended to increase accountability, transparency and to prevent future fraud and abuse.
