On December 8, Attorneys General in 43 states and Washington D.C. reached a settlement agreement with Bristol-Myers Squibb over the misleading marketing of the drug Abilify. The company will pay out $19.5 million because of allegations that it engaged in unfair and deceptive trade practices when it marketed the drug. Complaints in the 43 states and D.C. led to the official charges and settlement and included claims that the company promoted the drug for the elderly, in spite of serious risks, and for unapproved uses in children.
Uses for Abilify
Bristol-Myers Squibb partnered with Otsuka Pharmaceuticals, the company that developed Abilify, to market it to patients and doctors. Abilify is a second generation antipsychotic with the generic name aripiprazole. It has been approved by the U.S. Food and Drug Administration (FDA) to treat serious mental illnesses that include psychotic episodes. These include schizophrenia and bipolar disorder, and other mental illnesses that cause symptoms severe enough to interfere with daily life.
Risks and Black Box Warning
Abilify comes with serious risks for certain patients, including children and the elderly. Specifically, elderly patients with symptoms psychosis related to dementia are at an increased risk of dying from a stroke. Young people, under the age of 24, are put at a greater risk of having suicidal thoughts or taking suicidal thoughts if given Abilify to treat serious depression.
The Charges and Settlement
Abilify has proven to be a top seller for Otsuka and Bristol-Myers Squibb with more than $5 billion in sales in 2014 alone. Part of this success may be due to unethical marketing of the drug, a charge that ultimately led to the $19.5 million settlement. After the FDA announced the special risk that Abilify posed to certain elderly patients, Bristol-Myers Squibb failed to stop marketing to this population. They put elderly patients at risk by continuing to sell the drug to them in spite of known, serious risks.
The company was also accused of deceptive marketing to young people. The drug was promoted for use in children while downplaying the risk of suicide. The company has also been accused of promoting the drug for uses in children that have not been approved and for misrepresenting the risks of Abilify for children.
With the settlement reached, Bristol-Myers Squibb will have to pay $19.5 million which will be split between 43 states and the District of Columbia. The settlement included restrictions on how the drug is marketed in the future. The company has been strictly forbidden from misrepresenting the safety or effectiveness of Abilify when promoting it.
The multi-state settlement is not the first time Bristol-Myers Squibb had to pay for poor marketing choices. In 2007 the U.S. Department of Justice also accused the company of illegally marketing Abilify and forced it to pay a $515 million settlement. Additionally, the company faces multiple individual lawsuits filed by people claiming that Abilify caused them to develop addictive behaviors, particularly compulsive eating and gambling.
The current settlement is not the first one that Bristol-Myers Squibb has had to pay for Abilify and it may not be the last. Evidence is growing that the drug increases the risk of compulsive behaviors and the number of lawsuits over this side effect is also increasing.