Missouri receives $383K in pharmaceutical settlement

Seniors with dementia and young children – those were the alleged targets behind a $19.5 million settlement with pharmaceutical company Bristol-Myers Squibb Co. (NYSE: BMY).

Over allegations of illegal off-label marketing of its drug Abilify, the Show-Me State is among 43 states in line for a portion of the money. Missouri is set to receive $383,000. 

Off-label use is the practice of prescribing pharmaceuticals to treat conditions for which they have not been approved by the U.S. Food and Drug Administration, according to a news release from the office of Missouri Attorney General Chris Koster. 

The suit alleged Bristol-Myers Squib promoted the drug Abilify – an atypical antipsychotic drug originally approved by the FDA for the treatment of schizophrenia in 2002 – for use in elderly patients with dementia and Alzheimer’s disease despite the lack of FDA approval.

“Consumers trust that their medication is safe and effective at treating the conditions for which they are prescribed,” Koster said, in the release. “Any pharmaceutical company that prioritizes profits over consumer safety must be held to account for their actions.”

In 2006, Abilify received a black box warning stating elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Additionally, the complaint alleged Bristol-Meyers Squibb promoted Abilify for uses in children not approved by the FDA, according to the release. 

As stated by terms of the settlement, Bristol-Meyers Squibb’s marketing of any formulation containing the active ingredient aripiprazole is restricted. The company also is 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-Meyers Squibb also will 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.

New York City-based Bristol-Meyers Squibb is a global biopharma company focused on discovering innovative medicines for patients with serious diseases, according to its website. The company – which has produced 12 new medicines within the past seven years – reported 2015 net sales of $16.6 billion, and employs 25,000 people worldwide.
 
BMY shares were trading at $57.05 as of 10:31 a.m., compared with a 52-week range of $49.03 to $77.12.

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