Johnson & Johnson (NYSE:JNJ) is poised to pay more than $1 billion to the federal government and several states as part of an agreement to end a civil investigation over its marketing of antipsychotic drug Risperdal, according to a report by Bloomberg.
The New Brunswick, New Jersey company reached the deal with the U.S. attorney in Philadelphia last week, Bloomberg reported.
Risperdal had been a blockbuster drug for 14 years since it was approved by the U.S. Food and Drug Administration in 1993 for the treatment of psychotic disorders such as schizophrenia. It produced annual sales of up to $4.5 billion.
J&J subsidiary Janssen allegedly sought to sell Risperdal for then-unapproved, off-label uses, such as bipolar disorder, dementia, mood and anxiety disorders, according to Bloomberg, citing documents from a Louisiana lawsuit. Although the FDA later approved Risperdal for the treatment of bipolar disorder and symptoms of autism in children and teens, it did not approve it to treat dementia, according to Bloomberg.
Although SEC documents in May said the company had set aside funds to cover Risperdal marketing litigation, the amount was not disclosed.
Off-label marketing is a contentious issue in the pharmaceutical industry. Some legal minds argue it is a first amendment issue while others stress the need to adhere to the FDA’s parameters.
