Attorney General Announces AstraZeneca Settlement

March 14, 2011



AUGUSTA ?Maine Attorney General William Schneider, along with 37 other attorneys general, reached a record $68.5 million settlement with AstraZeneca Pharmaceuticals LP (AstraZeneca), resolving allegations of improper marketing of the antipsychotic drug, Seroquel. It is the largest multi-state consumer protection-based pharmaceutical marketing settlement. Maine will receive $969,000 as a result of the settlement, which includes proceeds to fund prescription drug abuse prevention, victim aid and public protection programs.

The complaint, filed along with the settlement agreement, alleges that AstraZeneca engaged in unfair and deceptive practices when it marketed Seroquel for uses that had not been approved by the U.S. Food & Drug Administration (FDA), failed to adequately disclose the drug?s potential side effects to health care providers and withheld negative information about Seroquel?s safety and efficacy.

?Misleading marketing by pharmaceutical companies puts consumers at risk,? Attorney General Schneider said. ?This settlement will contribute to the safe and effective use of prescription medications here in Maine.?

In addition to the $68.5 million payment, the agreement includes provisions that address specific concerns identified in the investigation, which began three years ago. Along with other prohibitions and requirements, the agreement specifically requires AstraZeneca to:

? Publicly post its payments to physicians on a website;
? Take actions to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing; ? Take actions to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use; and ? Cite to Seroquel?s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only.

Although physicians may prescribe drugs for off-label uses, pharmaceutical manufacturers are prohibited from marketing their products for such uses. As alleged in the complaint, AstraZeneca unlawfully marketed Seroquel for unapproved uses in children and the elderly, and for Alzheimer?s disease and dementia, anxiety, depression, sleep disorders and post traumatic stress disorder. AstraZeneca promoted Seroquel for such uses even though Seroquel was not, at the time it was marketed, approved for the treatment of these conditions and AstraZeneca had not established that Seroquel was safe or effective for these uses.

Atypical antipsychotics, including Seroquel, can produce dangerous side effects such as weight gain, hyperglycemia, diabetes, cardiovascular complications, increased risk of mortality in elderly patients with dementia and other severe conditions.

In addition to Maine, the Attorneys General of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

CONTACT: Brenda Kielty (207)626-8577