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Astrazenecea To Pay Vermont $1.4 Million In Historic Settlement

CONTACT: Wendy Morgan, Assistant Attorney General, (802) 828-5479

March 11, 2011

Vermont will receive approximately $1.4 million as part of a settlement with AstraZeneca Pharmaceuticals, LP, and AstraZeneca LP, Attorney General William H. Sorrell announced today. The total settlement of $68.5 million, paid to thirty-seven states and the District of Columbia, is the largest payment ever for a multistate drug consumer protection settlement. “Pharmaceutical companies must accept that they can only promote drugs for FDA-approved uses,” said Attorney General Sorrell, “to do otherwise puts some of the most vulnerable Vermonters at risk, including children, the elderly, and those suffering from mental illness.”

The settlement is the result of a three-year multistate investigation into AstraZeneca’s sales and marketing practices. It resolves allegations that AstraZeneca promoted its atypical antipsychotic drug, Seroquel, for off-label usage, failed to adequately disclose the drug’s potential side effects to health care providers, and withheld negative information contained in scientific studies concerning the safety and efficacy of Seroquel.

Seroquel was approved by the U.S. Food and Drug Administration for use only by adults (prior to 2009), primarily to treat conditions related to schizophrenia and bipolar mania. While it is legal for physicians to prescribe drugs for off-label uses, it is a violation of federal law and Vermont’s Consumer Fraud Act to market or promote pharmaceuticals for off-label uses.

In a complaint filed today, Vermont alleges that despite the limitations on the FDA’s approval, AstraZeneca promoted Seroquel’s use in children and adolescents before establishing with the FDA that it was safe or effective to do so. AstraZeneca also promoted Seroquel to treat dementia and Alzheimer’s disease in the elderly even though Seroquel has never been approved for that treatment. In addition, AstraZeneca failed to fully disclose information about Seroquel’s side effects and risks, including weight gain, hyperglycemia, diabetes, cardiovascular complications, and an increased risk of mortality in elderly patients with dementia and other severe conditions.

In addition to the monetary component, the settlement prohibits AstraZeneca from promoting Seroquel for off-label uses. The settlement contains additional injunctive relief as well, including requiring AstraZeneca to publicly post its payments to physicians on a website; to have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing; and to have policies that ensure AstraZeneca sales personnel do not promote to individual health care providers who are unlikely to prescribe Seroquel for an FDA-approved use.

This is the third multistate settlement to address off-label marketing of atypical antipsychotics. In September 2009, Vermont received $432,000 as its share of a multistate settlement with Pfizer Inc. relating off-label marketing of Geodon, and in October 2008, Vermont settled with Eli Lilly and Company for $1.5 million relating to its off-label marketing of Zyprexa.

A copy of the complaint can be found here. A copy of the settlement can be found here.

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