DES MOINES – Drug manufacturer Bristol-Myers Squibb Company (BMS) will pay $19.5 million dollars to 43 states, including nearly $300,000 to Iowa, in a settlement to resolve allegations the company improperly marketed atypical antipsychotic drug Abilify.
In Iowa, the agreement, through a consent decree in Polk County District Court, resolves a consumer fraud lawsuit by Attorney General Tom Miller. The lawsuit alleges the drugmaker engaged in unfair or deceptive trade practices when it marketed Abilify.
Abilify is the brand name for the prescription drug aripiprazole. Aripiprazole is now available as a generic, but several product formulations are still protected by patent.
In 2002, the U.S. Food and Drug Administration (“FDA”) approved the drug for the treatment of schizophrenia. Since then, the FDA has approved various formulations of Abilify for additional treatment uses.
The lawsuit, however, alleges that BMS promoted Abilify for use in 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 efficacy for those uses. In 2006, the FDA required a so-called “black box” warning on Abilify, which appears on the drug’s label and calls attention to serious or life-threatening risks. The warning stated that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
Additionally, the lawsuit alleges that BMS promoted Abilify for uses in children not approved by the FDA.
Moreover, the petition alleges that the company minimized and misrepresented risks thereby making false and misleading representations about Abilify’s risks.
The petition further alleges that BMS also overstated the findings of scientific studies by not revealing limitations that would materially affect the interpretation of the study results.
As part of the settlement, Bristol-Myers Squibb denies liability or wrongdoing. The agreement places restrictions on the company’s marketing of any formulation containing the active ingredient aripiprazole. The company 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. BMS 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 off-label promotion.
BMS will pay Iowa $296,340, which will go to the state's Consumer Education and Litigation Fund.