AstraZeneca LP and AstraZeneca Pharmaceuticals LP have agreed to pay $520 million to resolve allegations the anti-psychotic drug Seroquel was illegally marketed for unapproved uses.

AstraZeneca was accused of "off-label" marketing between January 2001 through December 2006, in promoting Seroquel to psychiatrists and physicians for uses including aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness, uses the U.S. Food & Drug Administration had not approved as safe and effective. The U.S. Department of Justice (DOJ) said that AstraZeneca had promoted the off-label use through company-sponsored continuing medical education programs, and encouraged doctors to give promotional speaking programs and to conduct studies on the drug.

The Federal government will receive $301,907,007 under the civil settlement, and State Medicaid programs and the District of Columbia will share up to $218,092,993, depending upon how many States participate in the settlement. The original action against AstraZeneca was brought through a qui tam (whistleblower) action under Federal and State False Claim Acts. Under the agreement AstraZeneca denies the allegations but enters into a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services, which will be in effect for five years.

In March 2006, AstraZeneca brought some conduct to the attention of the government and then cooperated in the investigation of the allegations, the DOJ said.

"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 in a press release. "This Administration is committed to recovering taxpayer money lost to health care fraud, whether it's by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation's biggest companies."

Adapted in part from press releases from the DOJ and AstraZeneca.

Links: http://www.justice.gov/opa/pr/2010/April/10-civ-487.html

http://www.astrazeneca.com/media/latest-press-releases/SEROQUEL-US-Marketing-Agreement?itemId=9289780

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