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Otsuka to Pay More Than $4 Million to Resolve Off-Label Marketing Allegations Involving Abilify
Date:3/27/2008

WASHINGTON, March 27 /PRNewswire-USNewswire/ -- Otsuka American Pharmaceutical Inc., the U.S. subsidiary of Japanese pharmaceutical manufacturer Otsuka Pharmaceutical Co., Ltd., has agreed to pay more than $4 million to resolve allegations that it marketed Abilify, an atypical antipsychotic drug, for "off-label" uses, the Justice Department announced today.

Otsuka developed Abilify in Japan and then entered into an agreement with Bristol-Myers Squibb (BMS) to co-promote sales of the drug in the United States. Under the agreement, Otsuka sales representatives worked on sales teams led primarily by BMS sales managers. In September 2007, BMS and the government entered into an agreement resolving allegations that BMS had promoted Abilify for off-label uses.

The Food and Drug Administration (FDA) has approved Abilify to treat adult schizophrenia and bi-polar disorder but has not determined the drug to be safe and effective in the treatment of children and adolescents or in the treatment of geriatric patients suffering from dementia-related psychosis. The FDA has mandated that the package for Abilify carry a "black box" warning concerning its use in the treatment of dementia-related psychosis.

Today's settlement resolves government allegations that, from 2002 through the end of 2005, Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis. Otsuka is alleged to have participated in directing its sales force to call on child psychiatrists and other pediatric specialists, with the sales force then urging those physicians and others providers to prescribe Abilify for pediatric patients. Otsuka sales representatives also participated in a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder. Because of the potential market benefit, the long term care sales force
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SOURCE U.S. Department of Justice
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