Regulatory Focus™ > News Articles > J&J Faces Larger Fine as DOJ Rejects $1B Risperdal Settlement

J&J Faces Larger Fine as DOJ Rejects $1B Risperdal Settlement

Posted 13 March 2012 | By Alexander Gaffney, RAC 

Johnson & Johnson's tentative $1 billion settlement with the US Department of Justice over allegations of improper marketing of its schizophrenia drug Risperdal was rejected on 12 March by federal prosecutors, reports The Wall Street Journal.

Sources close to the matter told Bloomberg News federal prosecutors are demanding an additional $800 million to resolve the civil claims in the government's lawsuit.

The charges originate from a US investigation into whether Johnson & Johnson subsidiary Janssen marketed Risperdal for off-label uses.

The 1993 approval for Risperdal was for a narrow range of psychotic disorders, and the US government alleges Janssen sought to increase its profitability to marketing it as a treatment for numerous other unapproved uses including bipolar disorder and dementia.

Read more:

Wall Street Journal - J&J's Drug Settlement for $1 Billion Is Rejected

Bloomberg - J&J Said to Face Demand to Lift Risperdal Settlement Offer by $800 Million

Philly Pharma - Tougher Justice

Pharmalot - Feds Reject Deal With J&J Over Risperdal Marketing

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