Johnson & Johnson has agreed to pay over $2.2 billion to resolve allegations that it marketed two schizophrenia drugs, Risperdal and Invega, for off-label uses. Janssen, a J&J subsidiary pled guilty to marketing Risperdal for off-label purposes. According to the DOJ, J&J marketed Risperdal for symptoms such as anxiety, agitation, depression, hostility and confusion in elderly dementia patients. The FDA had previously raised ethical concerns with such off-label use because of the potential for the drug to be used to sedate patients’ legitimate response to poor conditions. Futhermore, Risperdal is associated with an increased risk of diabetes, a risk that J&J allegedly downplayed. The government also alleged that J&J paid kickbacks to pharmacies and Omnicare, a national nursing home pharmacy, to induce prescriptions for its drugs.

The settlement also resolves allegations that J&J marketed its heart failure drug, Natrecor, for off-label uses. Natrecor was reserved for severe heart failure, but J&J allegedly marketed its use in less-severe cases and encouraged provision of the drug in outpatient clinics.

As part of the settlement, J&J will enter into a Corporate Integrity Agreement with the HHS-OIG. Under the agreement, J&J has agreed to change its pharmaceutical marketing practices to promote greater transparency and implement an executive compensation claw-back provision.

Read the entire press release, “Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations”