WASHINGTON – Johnson & Johnson has agreed to pay more than $2.2 billion to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors and impaired patients, the Department of Justice announced Monday.
The agreement is the third-largest settlement with a drugmaker in U.S. history.
Justice Department officials alleged that J&J used illegal marketing tactics and kickbacks to persuade physicians and pharmacists to prescribe Risperdal and Invega, both anti-psychotic 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 – children, the elderly and those with developmental disabilities, said Zane Memeger, a U.S. attorney in 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.
Monday’s action is the latest example of regulators cracking down on aggressive pharmaceutical marketing tactics of increasing sales by pushing medicines for unapproved, or off-label, uses. While doctors are allowed to prescribe medicines for any use, drugmakers cannot promote them in ways 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, Attorney General Eric Holder said.
J&J said in a statement, This resolution allows us to move forward.
The FDA first approved Risperdal tablets for schizophrenia in 1993, but prosecutors say J&J began promoting the drug for unrelated uses by the end of the decade.
Risperdal then grew to become J&J’s top product by 2005, with sales more than $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 older adults.
Janssen agreed to plead guilty to violating drug marketing laws and will pay $400 million in fines and lost sales.
In a separate civil complaint, the government alleged that J&J and Janssen promoted Risperdal and a similar drug, Invega, to control numerous behavioral problems in seniors, children and mentally impaired adults between 1999 and 2005.
In its most recent quarterly filing, New Brunswick, N.J.-based J&J reported $17.3 billion in cash on hand.