NC to share in $19.5 million settlement for unfair drug marketing, AG Cooper says

RALEIGH, NC (December 8, 2016)…Drug maker Bristol-Myers Squibb will pay $19.5 million to North Carolina and other states for marketing the drug Abilify for unapproved uses, Attorney General Roy Cooper said Thursday.

Bristol-Myers Squibb allegedly engaged in off-label marketing of antipsychotic drug…

Cooper, along with 42 other Attorneys General, reached a settlement with Bristol-Myers Squibb Company (BMS) to resolve allegations that the drug company used unfair and deceptive practices to market Abilify, an atypical antipsychotic drug. Under the settlement, BMS will pay $19.5 million to 43 states, including $663,302 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 the prescription drug aripiprazole. The drug was originally approved by the U.S. Food and Drug Administration (FDA) in 2002 to treat schizophrenia and has since been approved by the FDA to treat other conditions.

Physicians are allowed to prescribe drugs for off-label uses, uses which are not approved by the FDA, but drug makers are prohibited from marketing their products for off-label uses. The attorneys general allege that BMS promoted Abilify for elderly patients with symptoms of dementia and Alzheimer’s disease without getting FDA approval and without first establishing that the drug is safe and effective 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.

In addition, Cooper and the other attorneys general contend that that BMS promoted Abilify for uses in children not approved by the FDA, minimized and misrepresented the drug’s risks, and overstated the findings of scientific studies about it.

Under the settlement, BMS 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. BMS will also 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. The terms of the settlement apply to BMS’ marketing of any formulation containing the active ingredient.