Astra Zeneca agreed to pay $520 million to settle charges it illegally marketed the anti-psychotic drug Seroquel. The wrongdoing was originally revealed by a whistleblower under The False Claims Act. The company was accused of promoting the drug’s use for multiple illnesses never approved by the Food and Drug Administration. 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.
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.