Oregon Department of Justice

Attorney General Ellen F. Rosenblum

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ATTORNEY GENERAL KROGER ANNOUNCES $68.5 MILLION AGREEMENT WITH PHARMACEUTICAL GIANT

March 10, 2011

AstraZeneca will pay $1.4 million to Oregon under a multistate agreement that resolves unlawful marketing allegations

AstraZeneca will pay $1.4 million to Oregon under a multistate agreement that resolves unlawful marketing allegations

Attorney General John Kroger today announced a $68.5 million agreement with AstraZeneca Pharmaceuticals LP that settles allegations of illegal promotion of the antipsychotic drug Seroquel.

"Promoting drugs for illegal purposes undermines the public safety and trust in an already-broken health care system," said Attorney General Kroger. "The resolution in this case should serve as a strong warning that we will not tolerate companies who attempt to mislead Oregon consumers."

Oregon was among 37 states that participated in the three-year investigation into AstraZeneca's alleged unlawful marketing scheme that promoted Seroquel for unapproved uses and specifically targeted vulnerable pediatric and geriatric populations. Specifically, AstraZeneca allegedly promoted the antipsychotic drug in nursing homes for treating Alzheimer's disease and Dementia, as well as anxiety, depression, sleep disorders and post-traumatic stress disorder. Seroquel was not approved to treat those conditions at the time. 

Although doctors may legally prescribe drugs for off-label purposes, pharmaceutical manufacturers are prohibited from marketing their drugs for uses unapproved by the U.S. Food and Drug Administration. The proscription against off-label pharmaceutical promotion is intended to ensure that drugs are safe and effective for a particular use before they are marketed as such.

The complaint filed today along with the settlement further alleges that AstraZeneca failed to properly disclose the potentially harmful side effects of Seroquel to health care providers and withheld negative findings from scientific studies concerning the safety and efficacy of the drug. Atypical antipsychotic drugs such as Seroquel are known to produce dangerous side effects and can increase the risk of mortality in elderly patients.

In addition to paying $68.5 million, the settlement prohibits AstraZeneca from promoting Seroquel in a false, misleading or deceptive manner, including for off-label uses not approved by the FDA. The company must also adhere to injunctive terms which address specific concerns identified in the investigation.

Under the agreement, AstraZeneca will pay $1.27 million to the Oregon Department of Justice to fund consumer protection efforts. The company will pay an additional $145,000 to the state Public Employees Benefit Board to reimburse for Seroquel purchases associated with the alleged misconduct.

Assistant Attorney in Charge David Hart handled the case for the Oregon Department of Justice.

The Oregon Department of Justice is recognized as a national leader in the fight against health care fraud. In addition to prosecuting criminal health care fraud, the Department of Justice has filed lawsuits against pharmaceutical companies for conducing fraudulent marketing campaigns In the past year alone, the Oregon Department of Justice's Medicaid and Financial Fraud units recovered $33.5 million for Oregon from companies like AstraZeneca, Bayer, GlaxoSmithKline and Omnicare for defrauding Oregon consumers and the state Medicaid program.

Attorney General John Kroger leads the Oregon Department of Justice. The Department's mission is to fight crime and fraud, protect the environment, improve child welfare, promote a positive business climate, and defend the rights of all Oregonians.

Contact:

Tony Green, (503) 378-6002 tony.green@doj.state.or.us |
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