TALLAHASSEE, Fla. – Attorney General Pam Bondi joined 42 other attorneys general Thursday to announce a $19.5 million settlement reached with Bristol-Myers Squibb Company.
The settlement relates to the drug company’s alleged improper marketing of Abilify, an atypical antipsychotic drug.
A complaint filed in court along with the settlement agreement alleges that BMS engaged in unfair or deceptive trade practices when marketing Abilify.
“With this multistate settlement, consumers will be armed with better information about medication that could endanger their health,” Bondi said.
Abilify is the brand name for the prescription drug aripiprazole. In 2002, the U.S. Food and Drug Administration originally approved the drug for treating schizophrenia. In 2006, Abilify received a boxed warning that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Since then, the FDA has approved various formulations of Abilify for several indications.
According to the multistate complaint, BMS allegedly promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease despite FDA’s lack of approval for these uses. Additionally, the complaint alleges that BMS promoted Abilify for uses in children beyond the drug’s indications and minimized and misrepresented the antipsychotic drug’s risks.
As part of the settlement, BMS is prohibited from making false or misleading claims about Abilify, its safety or efficacy in comparison with other drugs and the implications of clinical studies relating to the drug. Additionally, BMS will 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.