AstraZeneca confirms $520 million deal for US off-label marketing of Seroquel, as HHS details action; Court approves suits against Merck & Co over Vio

28 April 2010

Following rumors reported yesterday as a result of a Wall Street Journal article, Anglo-Swedish drug major AstraZeneca late on Tuesday confirmed that the company has finalised a previously announced agreement in principle with federal and state entities in the USA to resolve civil allegations relating to the company's past marketing and promotion of its atypical antipsychotic, Seroquel (quetiapine).

Under the terms of the agreement, AstraZeneca denies the allegations but will pay a previously disclosed $520 million that was taken as a reserve in 2009, along with certain accrued interest. As part of the settlement, AstraZeneca has entered into a corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services, which will be in effect for five years.

The DHHS and the Departments of Justice and Health and Human Services' Health Care Fraud Enforcement Action Team separately confirmed the agreement, with Attorney General Eric Holder stating: "Over the past 15 months, [Health] Secretary [Kathleen] Sebelius and I have made it a top priority of both our Departments to crack down on health care fraud, which we know costs taxpayers billions of dollars each year. Through our Health Care Fraud Prevention and Enforcement Action Team, or HEAT, we have brought the full resources of the federal government to bear against individuals and corporations who illegally divert taxpayer resources for their own gain.'

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