Abilify Drugmaker Reaches $19.5M Federal Settlement
MANHATTAN (CN) — Bristol-Myers Squibb reached a $19.5 million settlement Thursday on its off-label promotion of Abilify, an anti-psychotic that was originally designed to treat schizophrenia.
Among the improper uses for which Bristol-Myers Squibb promoted Abilify was in pediatrics and for elderly patients with symptoms consistent with dementia and Alzheimer’s disease.
For the last 10 years, however, Abilify has been the subject of a “black box” warning that says elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
Bristol-Myers Squibb’s settlement is with the District of Columbia and 42 states, including New York, which filed a suit on the issue this morning in Manhattan Supreme Court.
New York Attorney General Eric Schneiderman noted in a statement that the drugmaker violated state consumer-protection laws by “misrepresenting and minimizing risks of the drug including metabolic and weight gain side effects and by misrepresenting the findings of scientific studies.”
Just $788,774 of the settlement will go to New York.
Abilify (aripiprazole) is second-generation antipsychotic drug, available only by prescription and commonly referred to as an “atypical antipsychotic.”
Though Abilify was originally approved in 2002 for the treatment of schizophrenia in 2002, the U.S. Food and Drug Administration has approved various formulations of Abilify for other indications since thn.
Thursday settlement prohibits Bristol-Myers Squibb from “promoting Abilify for off-label uses; making false or misleading claims about Abilify; compensating health care providers for merely attending a promotional activity for Abilify; promoting Abilify by highlighting selected symptoms instead of diagnoses without reference to the FDA-approved indications; using medical education grants … to promote Abilify; rewarding health care providers with grants based on their prescribing habits; providing samples of Abilify to health care providers whose clinical practices are inconsistent with Abilify’s FDA-approved label.”
Sharing in the settlement with New York and D.C. are Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.