|May 7, 2012
Contact: Whitney Ray
Phone: (850) 245-0150
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TALLAHASSEE, Fla.–Attorney General Pam Bondi today joined 44 other states and the District of Columbia in announcing a $100 million settlement with Abbott Laboratories over allegations of illegal off-label marketing of Depakote. Florida will receive nearly $5 million, and the Illinois-based Abbott will be restricted from marketing the drug for off-label uses not approved by the U.S. Food and Drug Administration. The $5 million will go toward future consumer protection efforts.
“Marketing off-label uses for pharmaceutical drugs is dangerous, and this settlement holds Abbott accountable and protects consumers,” stated Attorney General Pam Bondi.
In a complaint filed today along with the settlement agreement, the states alleged Abbott engaged in unfair and deceptive practices when it marketed Depakote for off-label uses. Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder and prophylaxis of migraines, but the attorneys general alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.
As a result of the states’ investigation, Abbott has agreed to significantly change how it markets Depakote and to cease promoting off-label uses. The company also will 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 CME,
· Disclosure of payments to physicians, and
· Register and disclose clinical trials.
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.