43-state settlement resolves allegations of improper marketing of Abilify
Jefferson City, Mo. – Attorney General Chris Koster announced today that Missouri will receive $383,000 as part of a 43-state $19.5 million settlement with Brisol-Myers Squibb Company (“BMS”) over allegations of illegal off-label marketing of its drug Abilify. Off-label use is the practice of prescribing pharmaceuticals to treat conditions for which they have not been approved by the Federal Drug Administration (FDA).
Abilify (aripiprazole) is an atypical antipsychotic drug originally approved by the FDA for the treatment of schizophrenia in 2002. Since then, the FDA has approved various formulations of Abilify for several indications. The Attorney General’s complaint, however, alleged that BMS promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease despite the lack of FDA approval for these uses and without first establishing the drug’s safety and efficacy for those uses. In 2006, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Additionally, the complaint alleged that BMS promoted Abilify for uses in children not approved by the FDA.
BMS’ marketing of any formulation containing the active ingredient aripiprazole will be restricted by the terms of the settlement. BMS will be prohibited from making false or misleading claims about Abilify, about its safety or efficacy in comparison with other drugs, and about the implications of clinical studies relating to the drug. BMS will also be subject to limitations on financial incentives to sales representatives and health care providers, dissemination of information that may promote off-label use of Abilify, and other practices affecting off-label promotion.
“Consumers trust that their medication is safe and effective at treating the conditions for which they are prescribed,” Koster said. “Any pharmaceutical company that prioritizes profits over consumer safety must be held to account for their actions.”