Vermont Business Magazine Vermont will receive over $220,000 from a settlement entered into by Attorney General William H Sorrell and 42 other Attorneys General with Bristol-Myers Squibb Company (“BMS”). The settlement relates to the drug company’s alleged improper marketing of Abilify. The total settlement amount is $19.5 million. Abilify is the brand name for the prescription drug aripiprazole.
Abilify was originally approved by the US Food and Drug Administration (“FDA”) for the treatment of schizophrenia in 2002. The Complaint filed by the Attorney General’s Office alleges that while Abilify was subsequently approved for the treatment of additional conditions, BMS 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, the FDA required that BMS place a “black box warning” on Abilify stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. The Complaint also alleges that BMS promoted Abilify for uses in children that were not approved by the FDA, and that BMS made deceptive statements when it minimized and misrepresented Abilify’s risks. The Complaint further alleges that BMS overstated the findings of certain scientific Abilify studies when it failed to reveal limitations that would materially affect the interpretation of the study results.
Attorney General Sorrell said, “Making false or misleading claims about the safety and efficacy of a drug, or its risks, is intolerable. Consumers whose health is already compromised should never be subjected to untruths about the medications prescribed for them.”
The active ingredient in Abilify, aripiprazole, is now available as a generic drug, but several product formulations are still protected by BMS’s patent. BMS’s marketing of any formulation containing the active ingredient aripiprazole will be restricted by the terms of the settlement which, among other things, precludes deceptive statements about Abilify’s safety or efficacy in comparison with other drugs, and about the implications of clinical studies related to the drug. The settlement also subjects BMS to limitations on financial incentives paid to sales representatives and health care providers, the dissemination of information that may promote off-label use of Abilify, and other practices affecting off-label promotion.
Vermont AG: Dec 8, 2016