December 8, 2016
Carson City, NV – Today, Nevada Attorney General Adam Paul Laxalt, along with attorneys general representing 42 other states and the District of Columbia, announced a $19.5 million dollar settlement with Bristol-Myers Squibb Company (BMS) related to the drug company’s alleged improper marketing of Abilify. Abilify is the brand name for the prescription drug aripiprazole, and is an atypical antipsychotic drug. The settlement resolved allegations that BMS engaged in unfair or deceptive trade practices while marketing the drug.
Abilify was originally approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in 2002. Since then, the FDA has approved various formulations of Abilify for several uses. In their complaint, the States allege that BMS improperly promoted Abilify for use in elderly patients who exhibited symptoms consistent with dementia and Alzheimer’s disease without FDA approval for these uses and without first establishing the drug’s safety and efficacy for these uses. Despite receiving a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death, the promotion of Abilify to elderly patients was not halted.
“Pharmaceutical companies have a responsibility to accurately promote their medications, and should not mislead consumers in a way that could jeopardize their health and well-being,” said Laxalt.
Other allegations contained in the complaint include that BMS promoted Abilify for uses in children not approved by the FDA, that BMS minimized and misrepresented risks associated with the drug, and that BMS overstated the findings of scientific studies regarding Abilify.
The active ingredient in Abilify, aripiprazole, is now available as a generic, but several product formulations are still protected by patent. Under 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 about Abilify, about its safety or efficacy in comparison with other drugs, and about the implications of clinical studies relating to the drug. The company 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 offlabel promotion.
In addition to Nevada, other states who participated in this settlement include: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin. The District of Columbia also participated in this settlement.
Chief Deputy Attorney General JoAnn Gibbs and Deputy Attorney General Laura Tucker represented Nevada in this matter.
As a result of this settlement, Nevada will receive $289,456. The settlement judgment is attached.