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Attorney General Cuccinelli announces $100 million settlement with Abbott Laboratories
~Illegal off-label marketing of anti-seizure drug Depakote resulted in
largest consumer protection pharmaceutical settlement ever reached~
RICHMOND (May 7, 2012) – Today, Attorney General Ken Cuccinelli was joined by 44 states and the District of Columbia in announcing a $100 million settlement with Abbott Laboratories for the illegal off-label marketing of its drug Depakote. This agreement marks the largest consumer protection-based pharmaceutical settlement ever reached.
Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder, and prophylaxis of migraines. However, the attorneys general alleged Abbott marketed the drug for unapproved uses, including treatment of schizophrenia, agitated dementia, and autism.
Under the terms of the settlement, the Commonwealth of Virginia will receive more than $2 million. Funds received in this settlement will help fund future consumer protection enforcement matters.
Abbott Laboratories, based in Illinois, will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration (FDA). The company will also pay $100 million nationally.
Under the settlement, Abbott Laboratories is:
- prohibited from making false or misleading claims about Depakote,
- prohibited from promoting Depakote for off-label uses,
- and required to ensure financial incentives on sales do not promote off-label uses of Depakote.
In addition, for a five-year period Abbott must:
- limit the creation and use of responses to requests by physicians for non-promotional information about off-label uses of Depakote,
- limit dissemination of reprints of clinical studies relating to off-label uses of Depakote,
- limit use of grants and Continuing Medical Education activities regarding Depakote,
- disclose payments to physicians,
- and register and disclose clinical trials.
“My office is committed to enforcing Virginia’s consumer protection laws,” said Cuccinelli. “The laws are designed to benefit both consumers and honest businesses, and to ensure that customers have full and accurate information in the marketplace. This settlement sends a clear message to companies that are willing to cut corners to make a dollar: this type of activity will not be tolerated in Virginia. It will also ensure that pharmaceutical companies do not illegally market their drugs for uses not approved by the FDA.”
Attorneys general of the District of Columbia and the following states participated in today’s settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin.
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