North Carolina to Receive Part of Bristol-Myers Squibb Settlement for Unfair Drug Marketing
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North Carolina to Receive Part of Bristol-Myers Squibb Settlement for Unfair Drug Marketing

Drug manufacturer allegedly engaged in off-label marketing of antipsychotic drug

December 8, 2016

Drug manufacturer Bristol-Myers Squibb (BMS) must pay $19.5 million to North Carolina and other states as a result of marketing the drug Abilify for uses that were not approved for it, says Attorney General Roy Cooper.

Together with 42 other attorneys general, Cooper reached a settlement with the company to resolve claims that it marketed atypical antipsychotic medication Abilify using unfair and deceptive practices. Under the terms of the settlement, BMS will pay $19.5 million to 43 states, $663,302 of which is to go to North Carolina.

"Misleading drug marketing is unfair to patients and their doctors, especially when it pitches a treatment that may not be safe and effective," Cooper said. "We're holding drug companies accountable when their marketing crosses the line."

Abilify is the brand name for prescription medication aripiprazole, which was originally approved by the Food and Drug Administration (FDA) back in 2002 for the treatment of schizophrenia. The agency has since approved the drug to treat other conditions.

Although physicians can prescribe medications for off-label uses—uses not approved by the FDA—drug manufacturers are barred from marketing their products for such uses. According to the attorneys general, BMS marketed Abilify to treat elderly patients who have symptoms of dementia and Alzheimer's disease without obtaining FDA approval and without first establishing the safety and efficacy of the medication for those uses. Abilify received a "black box" warning in 2006 stating that elderly patients who had psychosis related to dementia and who were treated using antipsychotic drugs had a greater risk of death.

Cooper and the other attorneys general also contended that the company promoted the drug for non-FDA-approved uses in children, minimized and misrepresented the risks of the drug, and overstated the findings made about it in scientific studies.

The terms of the settlement bar BMS from making false or misleading claims about Abilify, its safety or effectiveness when compared with other medications, and about clinical studies' implications for the drug. The company will also be subject to limits on financial incentives for sales representatives and healthcare providers, the dissemination of information that might promote off-label use of the drug, and other practices that affect off-label promotion. The terms will apply to the company's marketing of any formulation that contains the active ingredient.