WASHINGTON (AP) — Johnson & Johnson has agreed to pay over $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 announced on Monday.
The agreement is the third-largest settlement with a drugmaker in U.S. history, and the latest in a string of actions against drug companies allegedly putting profits ahead of patients.
Justice Department 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 — children, the elderly and those with developmental disabilities,” said Zane Memeger, U.S. 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.
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, drugmakers cannot promote them in any way that is 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 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 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 agreed to plead guilty to violating drug marketing laws and will pay $400 million in fines and forfeited 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 the mentally disabled between 1999 and 2005.
Documents filed in the case show the government raised objections about the company’s marketing approach for years. In a 1999 letter, the FDA warned Janssen that “disseminating materials that state or imply that Risperdal has been determined to be safe and effective for the elderly population” would be “misleading.”