Florida and 42 other states announced Thursday a $19.5 million settlement with Bristol-Myers Squibb Co. related to the alleged improper marketing of the drug Abilify to certain elderly patients and children.
“With this multistate settlement, consumers will be armed with better information about medication that could endanger their health,” Florida Attorney General Pam Bondi said in a statement.
A complaint by Florida officials alleged the company promoted Abilify for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease despite a lack of federal approval for those uses. In 2006, Abilify received a boxed warning that such patients who are treated with antipsychotic drugs have an increased risk of death, state officials said.
In addition, the complaint asserted the company promoted Abilify for uses in children in ways that minimized and misrepresented the antipsychotic drug’s risks.
A settlement agreement requires the company to agree to guidelines for promoting “off-label” uses.
In a statement, Bristol-Myers Squibb said it “denies any wrongdoing, and we are pleased to put this matter behind us so that we can focus on making transformational medicines for patients battling serious diseases.”
The company said it “chose this path to achieve a prompt and full resolution of potential state consumer protection act claims stemming from a multi-state coalition investigation relating to the marketing of Abilify, an atypical antipsychotic medication, which Bristol-Myers Squibb has not marketed since 2013.”
This settlement awaits court approval.