AG Beemer Announces $19.5 Million Settlement With Maker of Antipsychotic Drug

Joanne Bauer

Joanne Bauer

Published December 9, 2016 5:21 am
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HARRISBURG, Pa. — Attorney General Bruce R. Beemer yesterday announced the filing of a $19.5 million settlement with a major biopharmaceutical company related to the company’s alleged improper marketing of Abilify, an antipsychotic drug.

The settlement with Bristol-Myers Squibb Company was joined by 42 other Attorneys General. Pennsylvania’s share of the settlement is approximately $745,000. Part of that money will go toward future consumer protection efforts.

“This investigation showed the company made misrepresentations that provided health care providers and patients with misleading information about the approved uses of this drug,” Attorney General Beemer said. “This settlement implements a number of meaningful reforms that will protect consumers while preventing this conduct from occurring in the future.”

According to the settlement and a complaint filed today, Bristol-Myers Squibb Company, often referred to as BMS, engaged in unfair and deceptive trade practices in its marketing of Abilify, which is the brand name for the prescription drug aripiprazole. The drug was originally approved in 2002 by the U.S. Food and Drug Administration for the treatment of schizophrenia.

Since then, the FDA has approved various formulations of Abilify for several indications. However, the complaint 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, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Additionally, the complaint alleges that BMS promoted Abilify for uses in children not approved by the FDA.

Moreover, the complaint alleges that BMS minimized and misrepresented risks thereby making false and misleading representations about Abilify’s risks. The complaint 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. The active ingredient in Abilify, aripiprazole, is now available as a generic, but several product formulations are still protected by patent.

BMS’ marketing of any formulation containing the active ingredient aripiprazole will be restricted by the terms of the settlement. BMS 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.

The Attorneys General from Maryland and Kentucky led the negotiation of the settlement. Attorneys from the Pennsylvania Office of Attorney General were part of the executive committee that worked on the settlement. The settlement and complaint were filed in the Dauphin County Court of Common Pleas.

The other participating Attorneys General are from Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

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