J&J Settles Criminal Charges over Risperdal Marketing

Johnson & Johnson announced this week that the company has reached an agreement with federal prosecutors to settle a misdemeanor criminal charge over its marketing practices for the antipsychotic drug, Risperdal. The agreement in principle on the criminal charge is “pursuant to a single misdemeanor violation of the Food, Drug and Cosmetic Act,” and includes allegations that J&J marketed Risperdal for unapproved uses and even downplayed the risks associated with using the drug.

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 the company has on reserve. J&J is also in negotiations to settle civil claims against its Janssen Pharmaceuticals unit regarding the marketing of Risperdal, as well as the drug Invega (paliperidone).

Risperdal is approved to treat schizophrenia and bipolar disorder. Prior to the drug’s patent expiring, Risperdal 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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