391m) fine to settle allegations it had marketed the antipsychotic drug quetiapine fumarate (Seroquel) for unapproved off label uses, the US Department of Justice announced on 27 April. The drug was a bestseller for AstraZeneca in 2009, with sales of $4.9bn. Eric Holder, the US attorney general, took the unusual step of announcing the settlement at a news conference. He said that illegal acts by drug companies and false claims for government health programmes "can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets."
The Justice Department said that by promoting off label uses, AstraZeneca caused "false claims for payment to be submitted to federal insurance programmes including Medicaid, Medicare," and other government programmes.
The federal government will receive about $302 000 in the settlement and Medicaid programmes for the poor in the states and the District of Columbia [Washington, DC] will share about $218 000.
AstraZeneca denied wrongdoing but signed the civil settlement with the Department of Justice and other federal agencies and whistleblowers. The company also entered into a corporate integrity agreement with the US Department of Health and Human Services that will be in effect for five years.
The integrity agreement calls for annual reviews within the company to certify that its departments are compliant with the integrity agreement.
AstraZeneca must also send doctors a letter telling them about the settlement. It must post on its website payments to doctors such as honoraria, travel, or hotels.
Quetiapine is approved in the United States only for the treatment of psychotic disorders and short term treatment of schizophrenia and manic episodes of bipolar disorder.
AstraZeneca was charged with off label promotion of the drug to psychiatrists and general physicians for aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress dissorder, and sleeplessness.
The Department of Justice said AstraZeneca promoted the off label uses by "improperly and unduly influencing the content of, and speakers in, company sponsored medical educational programmes. The company also engaged doctors to give promotional speaker programmes on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel." The Justice Department said that was a violation of a federal anti-kickback law.
The lawsuit against AstraZeneca was triggered by a whistleblower lawsuit filed by James Wetta. He will receive more than $45m from the federal government’s share of the fine. The Wall Street Journal and other reports say that Wetta previously helped the government investigate illegal drug marketing practices.
Cite this as: BMJ 2010;340:c2380
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