Otsuka pays $4m penalty for off-label marketing

Otsuka American Pharmaceutical is to pay more than $4m to resolve allegations that it marketed Abilify, an atypical antipsychotic drug, for ‘off-label’ uses, according to the Justice Department.

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 US.

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 in the treatment of children or geriatric patients. 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 directed its sales force to call on child psychiatrists and pediatric specialists, urging those physicians to prescribe Abilify for pediatric patients and off-label for the treatment of dementia-related psychosis.