WASHINGTON – AstraZeneca will pay $520 million to resolve allegations that it marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration.

Such unapproved uses are known as “off-label” uses because they aren't included in the drug’s FDA-approved product label. AstraZeneca allegedly illegally marketed Seroquel between January 2001 and December 2006, promoting it to psychiatrists and other physicians.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs – including Medicaid, Medicare and TRICARE – and the Department of Veterans Affairs, Federal Employee Health Benefits Program and Bureau of Prisons.

“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by healthcare providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General Eric Holder.

According to the FDA, the Department of Justice and the Health and Human Services Department's Healthcare Fraud Enforcement Action Team (HEAT), the federal government will receive $301,907,007 from the civil settlement, and state Medicaid programs and the District of Columbia will share up to $218,092,993.

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.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also allegedly paid doctors to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other healthcare professionals about unapproved and unaccepted uses of Seroquel.

As part of the settlement, AstraZeneca has entered into a Corporate Integrity Agreement, which allows a committee to annually review the company’s compliance program and certify its effectiveness. The company must also ensure that certain managers annually certify that their departments or functional areas are compliant, that doctors are notified of the settlement, and that information about payments to doctors, such as honoraria, travel or lodging, is posted on the company's Web site.