AstraZeneca To Pay Georgia Over $11 Million As Part Of $520 Million Nationwide Settlement Resolving Claims of Off-label Drug Marketing
Claims Also Centered On Allegations That AstraZeneca Made Illegal Payments To Doctors and Paid For Physician Travel To Resorts As Part Of Program To Increase Off-label Use of Seroquel
Attorney General Thurbert Baker announced today that Georgia has joined with other states and the federal government and reached an agreement in principle with AstraZeneca Pharmaceuticals LP (“AstraZeneca”), to settle allegations that 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. Georgia will receive $11,121,220.77 in damages and penalties as part of the settlement, of which $4,252,335.03 are state dollars, with the remainder the federal share of Georgia’s Medicaid recovery.
In announcing the settlement, Attorney General Baker stated that, “today’s settlement should mark the end of yet another scheme where highly questionable conduct on the part of a drug manufacturer drives up the number of improper or unnecessary prescriptions, which in turn cost the state’s Medicaid program and Georgia taxpayers millions of dollars.”
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 the sale and use of Seroquel for certain uses that the Food and Drug Administration had not approved. The settlement resolves a government investigation into promotional activities undertaken by AstraZeneca that were directed not only to psychiatrists but also to primary care physicians and other health care professionals for unapproved uses in the treatment of 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 that were not medically accepted indications for which state Medicaid programs would 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.