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MADISON - In the largest ever multi-state consumer protection-based pharmaceutical settlement Wisconsin Attorney General J.B. Van Hollen announced today that he, along with 37 other Attorneys General, reached a record $68.5 million dollar settlement with AstraZeneca Pharmaceuticals LP arising from alleged improper marketing of the antipsychotic drug Seroquel.
The complaint, filed today along with the Consent Judgment, alleges that AstraZeneca engaged in misrepresentations and deception when it marketed Seroquel for unapproved or off-label uses, failed to 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.
Following a 3 year investigation, AstraZeneca agreed not to promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses, which are not approved by the U.S. Food and Drug Administration. In addition to the $68.5 million payment, the terms of the settlement include injunctive provisions which address specific concerns identified in the investigation. Along with other prohibitions and requirements, the agreement specifically requires AstraZeneca to:
Although a physician is allowed to prescribe drugs for off-label uses, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. As alleged, AstraZeneca unlawfully marketed Seroquel for a number of off-label uses, including for use in pediatric and geriatric populations, specifically in nursing homes for Alzheimer's Disease and Dementia, as well as for 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 and effective for these uses.
Atypical antipsychotics, including Seroquel, can produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia and other severe conditions.
“Wisconsin law is very clear that false and deceptive marketing in the sale of pharmaceuticals is unlawful,” Van Hollen said. “Where aggressive pharmaceutical marketing misrepresents the risks and efficacy of a drug, consumers can be driven to – and doctors encouraged to prescribe – medication that is ineffective or dangerous.”
The Attorneys General from Florida and Illinois led the investigation into AstraZeneca's marketing and promotional practices. The Attorneys General of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, 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.
Assistant Attorney General Lara Sutherlin handled the case for the State of Wisconsin.
A copy of the complaint is available below: