State joins settlement over Abilify marketing allegations

Connecticut has joined a $19.5-million multistate settlement with drug maker Bristol-Myers Squibb to resolve allegations that the company improperly marketed the atypical antipsychotic drug Abilify, Attorney General George Jepsen and state Department of Consumer Protection (DCP) Commissioner Jonathan A. Harris announced last week.

Abilify is the brand name for the prescription drug aripiprazole, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2002 for the treatment of schizophrenia in adults. The FDA has since approved Abilify in various formulations for several indications, including the treatment of bipolar disorder in certain children and adults, treatment of major depressive disorder in adults, and treatment of schizophrenia in certain children, among others.

The states allege, however, that Bristol-Myers Squibb promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease despite lack of FDA approval for this use and without establishing the drug’s safety. In 2006, the FDA issued a black-box warning for Abilify stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.

The states also allege that Bristol-Myers Squibb marketed Abilify for children suffering from schizophrenia before it was approved by the FDA for children, and that the company minimized and misrepresented the risks associated with taking Abilify.

Connecticut’s share of the settlement funds is $310,133. Of those settlement funds, $15,000 will be deposited in DCP’s Consumer Protection Fund and $15,000 will be deposited in the attorney general’s Consumer Protection Fund; both funds are used by the respective agencies to support investigations, training and consumer outreach efforts. The remaining settlement funds will be deposited in the state’s general fund.

In addition to the monetary payment, Bristol-Myers Squibb faces several restrictions on its marketing of Abilify through the settlement, and the company is prohibited from making false or misleading claims about Abilify, about its safety or efficacy in comparison to other drugs and about the implications of clinical studies related to Abilify.

Assistant Attorneys General Jeremy Pearlman and Lorrie Adeyemi, head of the Consumer Protection Department, assisted the attorney general with this matter.