A lawsuit and settlement agreement, filed this month, alleges Bristol-Myers Squibb engaged in unfair and deceptive trade practices when it marketed Abilify. Those practices included a minimization and misrepresentation of the drug’s risks, while overstating proof as to its success in treating dementia and Alzheimer’s disease in elderly patients.
West Virginia’s share of the settlement will exceed $253,500.
“No company should be allowed to misrepresent the product it sells,” Morrisey said in a statement. “My office takes any such complaint very seriously so as to ensure a vigorous investigation and appropriate resolution.”
Abilify is the brand name for the prescription drug aripiprazole. The active ingredient is now available as a generic, but several product formulations still are protected by patent.
The settlement restricts future marketing of Abilify. It prohibits Bristol-Myers Squibb from making false or misleading claims about Abilify, its safety, its effectiveness in comparison with other drugs and the implications of clinical studies. It also limits 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.
The U.S. Food and Drug Administration originally approved Abilify for treatment of schizophrenia in 2002. The lawsuit, however, alleges Bristol-Myers Squibb promoted Abilify for use in children, in addition to 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 effectiveness for those uses.
Abilify received a “black box” warning in 2006, which stated elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
West Virginia joined the Maryland- and Kentucky-led coalition, along with Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.