AstraZeneca is still denying allegations that it actively marketed the antipsychotic drug Seroquel for off-label indications but will pay $520 million to resolve the civil suit brought about by federal and state entities. The monetary settlement, confirmed by the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT), will be split between the federal government and the state Medicaid programs and District of Columbia, with the government receiving just shy of $302 million.
As part of the final agreement the firm has also entered into a five-year corporate integrity agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services. The CIA will include an annual review of AstraZeneca’s compliance program.
Seroquel is AstraZeneca’s second best-selling pharmaceutical and made sales of $4.87 billion in 2009, up 12% on 2008. The drug was first granted FDA approval in 1997 for the treatment of manifestations of psychotic disorders. Three years later FDA proposed narrowing the approval to the short-term treatment of schizophrenia only. In January 2004, U.S. approval was also given for the short-term treatment of acute manic episodes associated with bipolar disorder. Finally in 2006, the drug was sanctioned by FDA for the treatment of bipolar depression.
The government’s investigation was brought about as a result of a whistleblower lawsuit. The resulting allegations stated that between 2001 and 2006 AstraZeneca promoted Seroquel to psychiatrists and other physicians for disorders not covered by FDA approval. These off-label indications spanned a broad range of conditions including aggression, Alzheimer disease, anger management, anxiety, ADHD, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness. Moreover, it is claimed, AstraZeneca promoted Seroquel to physicians who don’t normally treat patients with schizophrenia and bipolar disorder, the two approved disorders for the drug.
The firm was also accused of “improperly and unduly” influencing company-sponsored continuing medical education programs and violating the federal Anti-kickback Statute. This violation included the payment of doctors to advise AstraZeneca about marketing messages for unapproved uses of Seroquel, give promotional lectures to other healthcare professionals, or serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. As a result of such false marketing, AstraZeneca was alleged to have effectively caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare, and Tricare as well as to the Department of Veterans Affairs, the Federal Employee Health Benefits Program, and the Bureau of Prisons.
“People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors’ judgement has not been affected by misinformation from a pharmaceutical company trying to boost revenues,” comments Michael L. Levy, U.S. attorney for the Eastern District of Pennsylvania.