AstraZeneca to pay US$520m fine for off-label drug marketing
Seroquel marketed for uses not approved by US Food and Drug Administration
AstraZeneca, the Anglo-Swedish pharmaceutical giant, has agreed to pay a US$520m (£340m) fine plus interest to US regulators to settle allegations that the company illegally marketed anti-psychotic drug Seroquel in the US.
The US Justice Department alleged that AstraZeneca marketed Seroquel for uses never approved by the Food and Drug Administration (FDA), such as Alzheimer’s disease, anger management and anxiety. It also contended that the company promoted the unapproved uses by improperly influencing the content of company sponsored medical education programmes.
AstraZeneca denied the allegations but will pay the previously disclosed fine that was taken as a reserve in 2009, along with certain accrued interest.
As part of the settlement, the company has entered into a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services. The corporate integrity agreement will be in effect for five years.
‘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,’ said attorney general Eric Holder.
Under the terms of the settlement, the federal government will receive $302m, and the state Medicaid programmes and the District of Columbia will share up to $218m, depending on the number of states that participate in the settlement.
The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes. As part of the settlement, James Wetta, the whistleblower in that action, will receive more than $45m from the federal share of the civil recovery.
‘When pharmaceutical companies interfere with the FDA's mission to insure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at risk,’ said Michael Levy, US Attorney for the Eastern District of Pennsylvania. ‘People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues.’