Janssen Pharmaceuticals, a unit of Johnson & Johnson, has been under investigation since 2004 regarding the company’s promotion of the popular antipsychotic drug, Risperdal. A disclosure of progress in the investigation was recently announced via J&J’s quarterly filing, in which the company stated it has agreed in principle to plead guilty to a misdemeanor criminal charge as part of a settlement with federal prosecutors. In fact, J&J indicated that a final settlement could be reached by the end of the year. However, while Janssen’s off-label marketing practices for Risperdal are the target of the investigation, several other issues also remain in the spotlight.

At the moment, it is unclear how much of a penalty J&J will pay, but the Wall Street Journal reported that federal prosecutors are seeking approximately $1 billion. J&J announced that it has allotted funds to cover the financial component of the criminal settlement but did not disclose the actual amount on reserve. Additionally, the company is currently working to negotiate a settlement over the civil investigations associated with the marketing of Risperdal, but the company said a settlement may not be reached on those claims.

Risperdal is approved to treat schizophrenia and bipolar disorder. Prior to the drug’s patent expiring, it had been a blockbuster product for pharmaceutical giant, Johnson & Johnson, with more than $2.2 billion in U.S. sales reported in 2007.


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