Settlement Awarded Over Seroquel

‘Off-Label Marketing’

HARTFORD — Attorney General Richard Blumenthal and Department of Social Services (DSS) Commissioner Michael P. Starkowski announced that Connecticut will receive $3.15 million under an agreement in principle with AstraZeneca Pharmaceuticals LP for alleged off-label marketing of Seroquel, and antipsychotic drug, for uses unapproved by the US Food and Drug Administration (FDA).

AstraZeneca will pay the states and the federal government a total of $520 million in damages and penalties to compensate Medicaid and various federal health care programs harmed by the company’s conduct.

Seroquel is an antipsychotic medication used to treat certain psychological disorders, including schizophrenia and bipolar disorder. From January 1, 2001, through December 31, 2006, AstraZeneca allegedly promoted Seroquel to psychiatrists, primary care physicians, and other health care professionals for unapproved uses to treat aggression, Alzheimer’s disorder, anger management, anxiety, attention deficit hyperactivity disorder, dementia, and sleeplessness.

AstraZeneca also allegedly made illegal payments to physicians, including paid trips to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses, to serve as authors of articles written by AstraZeneca agents, and to conduct studies for unapproved uses of Seroquel.

The settlement resolves claims that AstraZeneca’s conduct induced physicians to prescribe Seroquel for children, adolescents, and dementia patients in long-term care facilities.

As part of the agreement, AstraZeneca will enter into a Corporate Integrity Agreement with the US Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.

Mr Blumenthal said, “More than the millions returned to Connecticut taxpayers, this settlement stops AstraZeneca’s practice of putting profits over patients. My office will continue to work with state and federal authorities to stop a systemic drug industry culture of illegal off-label marketing that flouts FDA safety measures and endangers patients — particularly children. This settlement provides millions of dollars back to Connecticut taxpayers who paid for improper drug dispensation — but also provides sustained scrutiny by federal authorities over AstraZeneca’s practices going forward.”

Commissioner Starkowski said, “The penalty of $3.15 million could not come at a better time to help offset Connecticut’s Medicaid expenditures. The cost of pharmaceuticals is a major part of our Medicaid budget – over $325 million a year. Unfortunately, continuing vigilance by the federal and state governments is necessary to root out fraudulent practices by some parts of the industry.”