California Attorney General Kamala D. Harris announced that California, along with 42 other states and the District of Columbia, has reached a $19.5 million agreement with biopharmaceutical company Bristol-Myers Squibb over allegations that the company illegally marketed the popular atypical antipsychotic drug Abilify. Harris secured $1.3 million of the overall settlement for California.
In 2009, California and other states launched a multistate consumer protection investigation of Otsuka America Pharmaceutical, Inc., which manufactures Abilify, and Bristol-Myers Squibb, which is largely responsible for promoting Abilify.
Abilify is approved to treat schizophrenia, bipolar disorder, major depressive disorder and Tourette’s disorder in adults and children, but Bristol-Myers Squibb (BMS) allegedly prescribed its block-buster drug to treat elderly patients with dementia and for unapproved uses on children.
The Abilify complaint claims BMS promoted the drug off-label (not FDA approved) starting in 2002 for use in the elderly with symptoms consistent with dementia and Alzheimer’s disease. The drug had no clinical trials to establish its safety and efficacy for those uses. In 2006 a black box warning was added to the label, stating that that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
Since its FDA approval in 2002, Abilify was given to more than 24 million patients. It brought in more than $6.4 billion in revenues for Bristol Myers and the manufacturers – Otsuka America Pharmaceutical Inc., and Otsuka Pharmaceutical Co. Ltd. (In April 2015 the FDA approved the first generic versions of Abilify, generic aripiprazole).
The complaint alleges Bristol-Myers Squibb 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.
The complaint also alleges the company promoted Abilify for use by children, which was not approved by the FDA.
The complaint also alleges Bristol-Myers Squibb minimized and misrepresented risks, thereby making false and misleading representations about Abilify’s risks.
The complaint alleges the company overstated the findings of scientific studies by not revealing limitations that would affect the interpretation of study results.
Bristol-Myers Squibb’s marketing of any formulation containing the active ingredient aripiprazole will be restricted by the terms of the settlement.
The company 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.
The company 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.