Otsuka to pay $4M for off-label promotion
Pharma Compliance Alert, April 2, 2008
Off-label promotion of Abilify will cost Otsuka American Pharmaceutical Inc. more than $4 million, according to a Department of Justice (DOJ) press release.
Otsuka, which developed Abilify in Japan, entered into an agreement with Bristol-Myers Squibb to co-promote the drug in the U.S. Abilify is approved to treat adult schizophrenia and bipolar disorder. However, the DOJ alleges Otsuka knowingly promoted the sale and use of Abilify for pediatric use and to treat dementia-related psychosis from 2002 through 2005.
Otsuka allegedly had its sales representatives call on child psychiatrists and allegedly created a specialized long-term care sales force that called almost exclusively on nursing homes.
In addition to the $4 million settlement, Oksuta entered into a corporate integrity agreement. In September 2007, Bristol-Myers Squibb settled allegations it promoted Abilify for off-label uses.
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