AstraZeneca has agreed to pay $520 million to settle charges that it illegally marketed the anti-psychotic drug Seroquel, the U.S. Department of Justice and the U.S. Department of Health and Human Services announced today.
The Wilmington, Del.-based pharmaceutical company was accused of promoting the drug’s use for multiple illnesses never approved by the Food and Drug Administration.
The settlement is the largest ever by a "company in a civil only settlement of off-label marketing claims," according to the DOJ statement.
The DOJ said that by promoting Seroquel for off-label uses, the company caused false payment claims to be submitted to various federal programs including Medicaid and Medicare. The allegations were originally raised in a lawsuit under the whistleblower provisions of the False Claims Act.
"These were not victimless crimes – illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets," Attorney General Eric Holder Jr. said in prepared remarks.
As part of the settlement, the federal government will receive $302 million and the states and the District of Columbia will receive $218 million.
AstraZeneca also reached a five-year Corporate Integrity Agreement with the HHS Office of Inspector General. Among other provisions, a board of directors committee must annually review the company’s compliance program and certify its effectiveness, as must certain managers.
According to the DOJ, Seroquel was originally approved for the treatment of psychotic disorders in September 1997, followed by short-term treatment of schizophrenia, acute manic episodes associated with bipolar disorder and bipolar depression during the next decade.
However, from January 2001 to September 2006, AstraZeneca allegedly also marketed the drug to psychiatrists and other physicians for aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness. The company allegedly targeted doctors who don’t typically treat schizophrenia or bipolar disorder, promoted the off-label uses in medical education programs, and recruited doctors to serve as the named authors of articles that were ghostwritten by medical literature companies.