WASHINGTON — Johnson & Johnson has agreed to pay about $2.2 billion to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors, and disabled patients, the Department of Justice said Monday.
The agreement is the third-largest settlement with a drug maker in US history and the latest in a string of actions against drug companies allegedly putting profits ahead of patients.
Officials alleged that J&J used illegal marketing tactics and kickbacks to persuade physicians and pharmacists to prescribe Risperdal and Invega, both antipsychotic drugs, and Natrecor, which is used to treat heart failure.
‘‘J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society,’’ said Zane Memeger, US attorney for the Eastern District of Pennsylvania.
The settlement amount includes $1.72 billion in civil payments to federal and state governments as well as $485 million in criminal fines and forfeited profits. According to the office of Massachusetts Attorney General Martha Coakley, the state will get $39 million from the Department of Justice settlement, as well as $23.1 million more in related settlements.
Monday’s action is the latest example of regulators cracking down on aggressive pharmaceutical marketing tactics, namely trying to increase sales by pushing medicines for unapproved, or ‘‘off-label,’’ uses. While doctors are allowed to prescribe medicines for any use, drug makers cannot promote them in any way not approved by FDA.
‘‘Every time pharmaceutical companies engage in this type of conduct, they corrupt medical decisions by health care providers, jeopardize the public health, and take money out of taxpayers’ pockets,’’ said Attorney General Eric Holder.
J&J said in a statement, ‘‘This resolution allows us to move forward.’’
The FDA approved Risperdal tablets for schizophrenia in 1993, but prosecutors say J&J began promoting the drug for unrelated uses. Risperdal grew to become J&J’s top product by 2005, with sales over $3.5 billion.
In its plea agreement, J&J subsidiary Janssen Pharmaceuticals admitted to promoting Risperdal as a way to control erratic behavior in seniors with dementia. Today that use is explicitly barred in the drug’s warning label because it can increase the risk of stroke and death in elderly patients. Janssen will plead guilty to violating drug marketing laws and pay $400 million in fines and forfeited sales.
In a separate civil complaint, the government alleged J&J and Janssen promoted Risperdal and a similar drug, Invega, to control numerous behavioral problems in seniors, children, and the mentally disabled from 1999 to 2005. Despite repeated government warnings, the company’s marketing plan targeted nursing homes and the drug maker paid kickbacks to the nation’s largest nursing home pharmacy, Omnicare, the government said.