Tennessee Attorney General Herbert H. Slatery III, along with the Tennessee Division of Consumer Affairs and 42 other Attorneys General, announced Monday a $19.5 million settlement with Bristol-Myers Squibb Company. The settlement relates to the drug company’s alleged improper marketing of Abilify, an atypical antipsychotic drug. The complaint, which was filed Monday along with the settlement, alleges BMS engaged in unfair or deceptive trade practices when marketing Abilify.
Abilify is the brand name for the prescription drug aripiprazole.
The drug was originally approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in 2002. However, the complaint alleges that BMS promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease. This was done 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.
“Drug manufacturers are prohibited from promoting their drugs for uses that have not been approved by the FDA,” General Slatery said. “By making false claims and down-playing the risks associated with this drug, the company jeopardized the health of Tennesseans and should be held accountable.”
The states allege BMS also promoted Abilify for uses in children not approved by the FDA. The complaint states that BMS made false and misleading representations about Abilify’s risks and overstated the findings of scientific studies by not revealing limitations that would materially affect the interpretation of the study results.
“We will continue to work with the State Attorney General’s Office and other partnering organizations to protect Tennessee consumers from unfair and deceptive business practices such as this one,” said Director Cynthia Wiel of the Tennessee Division of Consumer Affairs.
As part of the $19.5 million settlement, the state of Tennessee will receive $399,022.
According to the terms of the settlement:
• BMS’ marketing of any formulation containing the active ingredient aripiprazole will be restricted.
• BMS will be prohibited from making false or misleading claims regarding Abilify, its safety, or efficacy in comparison with other drugs, or 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 may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the Tennessee Division of Consumer Affairs at 615-741-4737 or toll-free in Tennessee at 1-800-342-8385.