SEATTLE – Attorneys general announced today the largest multistate, consumer protection settlement with a pharmaceutical company in history. AstraZeneca Pharmaceuticals LP will pay a record $68.5 million to settle allegations of improper marketing of the antipsychotic drug Seroquel.
“The makers of Seroquel illegally marketed their drug as an appropriate treatment for a variety of unapproved conditions in children and elderly patients, even though antipsychotic drugs can produce dangerous side effects,” Washington Attorney General Rob McKenna said.
Following a three-year investigation, Washington Attorney General’s Office filed its version of the settlement and complaint today in King County Superior Court. The documents allege that U.K.-based AstraZeneca engaged in unfair and deceptive practices when it marketed Seroquel for unapproved or off-label uses, failed to adequately disclose the drug’s potential side effects to health care providers, and withheld negative information contained in scientific studies concerning the drug’s safety and efficacy.
Senior Counsel Bob Lipson handled the case for the Washington Attorney General’s Consumer Protection Division.
Washington will receive more than $1.6 million from the settlement. A small portion will be used to recover the state’s costs for the investigation and litigation. The court agreement permits the remaining funds to be distributed by the Attorney General’s Office to support programs that promote mental health or address the proper use of prescription drugs. The agreement does not provide for restitution for individual consumers.
Although a physician is allowed to prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from marketing their products to treat conditions other than those approved by the U.S. Food and Drug Administration. The states claim AstraZeneca unlawfully marketed Seroquel as an appropriate treatment for some children and nursing home residents and to treat conditions including Alzheimer’s Disease, dementia, anxiety, depression, sleep disorders, and post-traumatic stress disorder. At the time, AstraZeneca had not established that Seroquel was safe and effective for these uses.
Atypical antipsychotics, including Seroquel, can produce dangerous side effects, including hyperglycemia, diabetes, cardiovascular complications and an increased risk of mortality in elderly patients with dementia.
AstraZeneca agreed not to promote Seroquel in a false, misleading or deceptive manner, including for unapproved uses. Along with other prohibitions and requirements, the agreement specifically requires AstraZeneca to:
- Publicly post its payments to physicians on a Web site;
- Ensure marketing and sales personnel don’t receive financial incentives for off-label marketing;
- Ensure sales personnel don’t promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use; and
- Cite Seroquel’s FDA-approved indications when referencing selected symptoms.
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, Maine, 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.
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