J&J hit with $2.2 billion fine
pharmafile | November 5, 2013 | News story | Sales and Marketing | J&J, JJ, Janssen, Risperdal, antipsychotic, fine
Johnson & Johnson has admitted promoting its big-selling antipsychotic drug Risperdal off-label, costing the firm $2.2 billion in fines.
The US Department of Justice has announced that J&J’s pharma unit Janssen has pleaded guilty and is to face criminal fines totalling $485 million, and civil settlements with the federal government and states totalling $1.72 billion.
The Department found that from 1999 through 2005, J&J and its subsidiary Janssen promoted Risperdal for unapproved uses, including controlling aggression and anxiety in elderly dementia patients and treating behavioural disturbances in children and in individuals with disabilities.
Under FDA regulations doctors may prescribe drugs for unapproved – or off-label -use, but pharma are not allowed to do this as it encourages uptake of its medicines for unapproved and untested conditions.
“The conduct at issue in this case jeopardised the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder.
“This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of healthcare fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
In addition to imposing substantial financial sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General.
This agreement is designed to increase accountability and transparency and prevent future fraud and abuse, the Department said in a statement.
Johnson & Johnson said that the settlement of “the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations”.
Ben Adams
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