Anglo-Swedish pharmaceutical company AstraZeneca agreed yesterday to pay $520 million plus interest to the US government to resolve allegations that it illegally marketed its block-buster anti-psychotic drug Seroquel for uses not approved as safe and effective by the US regulator.
Seroquel is AstraZeneca's schizophrenia and bipolar blockbuster drug that has been ranked as the fifth best-selling drug in the world by drug-data tracker IMS Health and had sales of $4.9 billion last year.
The US Food and Drug Administration (FDA) had approved Seroquel for the treatment of schizophrenia and bipolar depression but the US federal agencies allege that the London-based AstraZeneca had aggressively promoted the drug to psychiatrists and other physicians for unapproved uses like for the treatment of Alzheimer, aggression, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder and sleeplessness.
The US Department of Justice (DoJ) said that AstraZeneca targeted its illegal marketing of Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, paediatric and adolescent physicians, and in long-term care facilities and prisons.
The federal agencies also said AstraZeneca violated the federal anti-kickback laws by offering and paying illegal remuneration to doctors for writing articles on the unapproved uses of Seroquel.
They alleged that AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" and to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel.