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December 8, 2016


Attorney General Madigan & 42 Other Attorneys General Reach Settlement Over Drug Company’s Unapproved Marketing to Older Patients

Chicago —Attorney General Lisa Madigan, along with 42 other Attorneys General, today announced a $19.5 million settlement with Bristol-Myers Squibb Company (BMS) over unfair and deceptive marketing of its drug Abilify for unapproved uses in older patients.

Madigan and the attorneys general alleged that BMS marketed Abilify, which is used to treat schizophrenia, to older patients with symptoms of dementia and Alzheimer’s disease, which were not approved uses by the U.S. Food and Drug Administration (FDA). In a complaint filed today along with the settlement, the attorneys general alleged that in 2006, Abilify received a FDA warning stating that older patients with dementia-related psychosis who were treated with antipsychotic drugs, such as Abilify, have an increased risk of death. The complaint alleged that BMS minimized and misrepresented the risks of using Abilify for these unapproved uses. The complaint also alleges BMS overstated the findings of scientific studies in favor of increased use of Abilify.

“This is another example of a big pharmaceutical company ignoring serious health concerns to boost its profits,” Madigan said. “BMS’ practices potentially harmed older patients in order to increase the company’s bottom line.”

Under the settlement, BMS’ marketing of any drugs containing aripiprazole will be restricted. BMS will be prohibited from making false or misleading claims about Abilify, including its safety or efficacy in comparison with other drugs and the implications of clinical studies relating to the drug. The settlement will also limit BMS financial incentives to sales representatives and health care providers and the dissemination of information that may promote off-label use of Abilify and other practices affecting off-label promotion. Illinois will receive more than $500,000 from the settlement.

In addition to Illinois, the following states and the District of Columbia joined the settlement: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.

The settlement was handled by Assistant Attorney General Paige Boggs in Madigan’s Consumer Protection Bureau.


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