June 15, 2010
Jefferson City, Mo. - Attorney General Chris Koster said today his office has reached a settlement with AstraZeneca Pharmaceuticals LP, in which Missouri will receive $8.9 million. The agreement included the federal government and a number of states. The settlement stems from allegations AstraZeneca engaged in an off-label marketing campaign that improperly promoted the antipsychotic drug, Seroquel. AstraZeneca will pay the states and the federal government a total of $520 million in damages and penalties to compensate Medicaid and various federal healthcare programs for harm suffered as a result of this conduct.
"This company unlawfully profited at the expense of taxpayers and people in need of our state's Medicaid services," Koster said. "This settlement will make other companies think twice before resorting to such tactics."
Koster said Seroquel is one of a newer generation of antipsychotic medications (called atypical antipsychotics) used to treat certain psychological disorders. From January 1, 2001, through December 31, 2006, AstraZeneca promoted Seroquel for certain uses the Food and Drug Administration had not approved. The settlement resolves a government investigation into promotional activities undertaken by AstraZeneca that were directed to psychiatrists, primary care physicians, and other health care professionals for unapproved uses to treat medical conditions such as aggression, Alzheimer's disorder, anger management, anxiety, attention deficit hyperactivity disorder, dementia, and sleeplessness.
In implementing its marketing campaign, AstraZeneca was also alleged to have made illegal payments to physicians, paying their way to travel to resort locations to "advise" AstraZeneca about marketing messages for unapproved uses, to serve as authors of articles written by AstraZeneca and its agents, and to conduct studies for unapproved uses of Seroquel. The settlement resolves claims that, as a result of these promotional activities, AstraZeneca caused physicians to prescribe Seroquel for children, adolescents, and dementia patients in long-term care facilities, which are uses for which state Medicaid programs would not approve reimbursement.
As part of the settlement, AstraZeneca will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company's future marketing and sales practices.
This settlement is based on qui tam cases that were filed in the United States District Court for the Eastern District of Pennsylvania by relators - private parties who filed actions under state and federal false claims statutes.