Published November 05. 2013 4:00AM
Washington - Johnson & Johnson and its subsidiaries have 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 allegations 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 figure includes $1.72 billion in civil settlements with federal and state governments as well as $485 million in criminal fines and forfeited profits.
The agreement is the third-largest U.S. settlement involving a drugmaker, and the latest in a string of legal actions against drug companies that allegedly put profits ahead of patients. In recent years, the government has cracked down on the pharmaceutical industry's aggressive marketing tactics, which include 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, in prepared remarks at a news conference.
J&J said in a statement, "This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients."
In its plea agreement, J&J subsidiary Janssen Pharmaceuticals admitted that it promoted Risperdal to nursing home doctors and nurses to control erratic behavior in seniors with dementia between 2002 and 2003. 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. Antipsychotic drugs are known for their sedative effects and are occasionally used to treat post-traumatic stress and sleep disorders, though those uses have never been approved by the FDA.
Janssen agreed to plead guilty to violating FDA drug marketing laws and will pay $400 million in fines and forfeited sales. The plea is subject to acceptance in U.S. District Court.
In a separate civil complaint, the government alleged that J&J and Janssen also promoted Risperdal and a similar drug Invega, to control numerous behavior problems in seniors, children and the mentally disabled between 1999 and 2005.
Documents filed in the case include numerous objections the government sent to the company or its subsidiaries dating back over a decade. In a 1999 letter, the FDA wrote to J&J's Janssen subsidiary, saying that "disseminating materials that state or imply that Risperdal has been determined to be safe and effective for the elderly population ... are misleading."