The agreement was reached Thursday with attorneys general representing 43 other states and the District of Columbia.
Abilify is the brand name for the prescription drug aripiprazole, an antipsychotic drug. It was originally approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in 2002, and later approved for other uses.
In their lawsuit, the states allege that Bristol-Myers improperly promoted Abilify for use in elderly patients who had symptoms of dementia and Alzheimer’s disease, without FDA approval for these uses and without first establishing the drug’s safety and effectiveness for these uses.
“Drug companies should not market their drug for off-label uses or make claims that are not supported by scientific evidence,” said New York Attorney General Eric Schneiderman. “Consumers must be able to rely on their doctor’s advice for medication without having to worry about drug companies manipulating their advertising to promote their products at the expense of patients.”
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 wasn’t stopped.
Other allegations in the lawsuit include that Bristol-Myers promoted Abilify for uses in children not approved by the FDA, that the company minimized and misrepresented risks associated with the drug, and that it overstated the findings of scientific studies on Abilify.
The active ingredient in Abilify, aripiprazole, is now available as a generic, but several products are still protected by patent.
Under the terms of the settlement, Bristol-Myers’ marketing of any product containing the active ingredient aripiprazole will be restricted. It will be prohibited from making false or misleading claims about Abilify, about its safety or effectiveness in comparison with other drugs, and about clinical studies.
The company will also limit 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.
<div style="width: 100%; margin: auto; text-align: center;">Copyright 2016, Rita R. Robison, Consumer Specialist</div>