Posted on Leave a comment

Kilmartin: Bristol-Meyers Squib to Pay RI $235K for Alleged False Marketing of Abilify

RI Attorney General Peter F. Neronha.

RIAGPROVIDENCE, R.I. — Rhode Island will receive $235,269 of a $19.5 million dollar, 42-state settlement with Bristol-Myers Squibb for alleged improper marketing of the drug Abilify, approved by the U.S. Food and Drug Administration for treatment of schizophrenia in 2002.

In a complaint filed Thursday in court along with the settlement agreement, Attorney General Kilmartin alleged thatBristol-Myers Squibb engaged in unfair or deceptive trade practices when it marketed Abilify (, promoting it 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 the company  promoted Abilify for uses in children not approved by the FDA, Kilmartin’s office reported. The complaint also alleges that Bristol-Myers Squibb minimized and misrepresented risks, making false and misleading representations about the drug.

The complaint further alleges that Bristol-Myers Squibb 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.

“Bristol-Myers Squibb purposefully did an end run around the FDA approval process in order to enhance profits, while putting vulnerable patients at risk,” said Attorney General Kilmartin.  “This isn’t the first time a pharmaceutical company has put profits ahead of patients, which is why our partnership with attorneys general across the country to investigate this deceptive practice is critical to keeping these companies honest.”

NOW, CHECK OUT THIS:
McKee: All COVID-19 Strategies Needed to Fight Pandemic

The terms of the settlement restrict Bristol-Myers Squibb’s marketing of any formulation containing the active ingredient aripiprazole. The drug manufacturer 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. Bristol-Myers Squibbwill 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.

Rob Borkowski
Author: Rob Borkowski

Rob has worked as reporter and editor for several publications, including The Kent County Daily Times and Coventry Courier, before working for Gatehouse in MA then moving home with Patch Media. Now he's publisher and editor of WarwickPost.com. Contact him at editor@warwickpost.com with tips, press releases, advertising inquiries, and concerns.

This is a test