(COLUMBUS, Ohio) – Ohio Attorney General Mike DeWine along with 37 other attorneys general today announced a record $68.5 million dollar settlement with AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively "AstraZeneca") to resolve concerns about its off-label marketing of the antipsychotic drug Seroquel.
"This agreement represents the largest monetary settlement ever reached in a multi-state consumer protection pharmaceutical settlement," DeWine said. "It sends the message that pharmaceutical companies must not market their products in a deceptive manner. Consumer safety must come first."
The settlement is the result of a three-year multi-state investigation into AstraZeneca's marketing of Seroquel, specifically marketing for "off-label" uses not approved by the U.S. Food and Drug Administration. Although physicians may 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 at that time was not approved for the treatment of those conditions and AstraZeneca had not established that Seroquel was safe and effective for those 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.
The Ohio Attorney General's complaint, filed in the Franklin County Court of Common Pleas, alleges that AstraZeneca engaged in unfair and deceptive practices when it marketed Seroquel for unapproved or off-label uses and failed to adequately disclose the drug's potential side effects.
Among other provisions, the settlement requires AstraZeneca to:
- Implement policies to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing;
- Implement policies 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 Seroquel's FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only.
AstraZeneca admits no wrongdoing in the settlement but agrees to pay $68.5 million to the states. Ohio's share of the payment is $2,687,973, which will go to the Consumer Protection Enforcement Fund to support the Ohio Attorney General's consumer protection efforts.
Ohio served on the executive committee of the multi-state working group that reached the record settlement. Led by Florida and Illinois, the group also included the attorneys general of Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Idaho, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Media Contacts:
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