Johnson & Johnson has agreed to pay the U.S. and most states $1 billion to resolve a civil investigation into the sales and marketing practices of the antipsychotic drug Risperdal. U.S. officials have been investigating the company since 2004, over allegations that J&J was marketing the drug for unapproved uses, Bloomberg reported.
Risperdal was approved in 1993 by the FDA as a treatment for psychotic disorders including schizophrenia; however, the government claims that the drug company’s Janssen unit marketed the drug as a treatment for dementia, mood and anxiety disorders, bipolar disorder and more. Janssen has been sued by 12 states over the marketing of Risperdal.
The FDA ordered Janssen to stop making false and misleading claims about Risperdal in 1994, 1999, and 2004. The drug was not approved as a treatment for bipolar disorder until 2003 and as an autism therapy for children and teens until 2006. The drug has never been approved as a treatment for dementia.
J&J spokesperson Teresa Mueller said in an email that “Janssen is prepared to vigorously defend itself against these claims….We are committed to ethical business practices and have policies in place to ensure that our products are only promoted for their FDA-approved indication.”