- Bristol-Myers Squibb is being fined $19.5 million for the "alleged improper marketing and promotion" of its atypical antipsychotic Abilify (aripiprazole) through a multi-state agreement with 42 States and the District of Columbia.
- The complaint included off-label marketing and misrepresenting or minimizing risks, including metabolic and weight gain side effects, as well as misrepresenting data from studies.
- The agreement prohibits Bristol-Myers from taking part in a number of marketing practices, including restricting compensation to healthcare professionals.
The complaint alleges that Bristol-Myers Squibb promoted the drug for off-label uses including in elderly Alzheimer's patients and that the company violated state consumer protection laws by misrepresenting and minimizing risks of the drug including metabolic and weight gain side effects.
"Drug companies should not market their drug for off-label uses or make claims that are not supported by scientific evidence," said New York State Attorney General Eric T. Schneiderman. "Consumers must be able to rely on their doctor’s advice for medication without having to worry about drug companies manipulating their advertising to promote their products at the expense of patients."
The fine will be split between the states, and the consent decree forbids Bristol-Myers from further off-label promotion of Abilify. It will also restricts the use of grants, samples and compensation for healthcare professionals. But this isn't the only fine for Bristol-Myers due to Abilify marketing this year. In July, despite denying wrongdoing, the pharma paid $30 million in a settlement with the California Department of Insurance over claims of illegal marketing and kickbacks for a range of drugs including Abilify.
Abilify was approved in the U.S. for the treatment of schizophrenia in 2002, and since then has been approved as an add-on in depression, for bipolar disorder, and for irritability associated with autism in children and adolescents. It has a boxed warning for increased risk of death in patients with psychosis related to dementia, and suicidal thoughts in children and young people with depression.Abilify's sales have tumbled since generic competition. From a peak of $7.4 billion in 2011, sales fell to $2.3 billion in 2013 and $746 million in 2015.