“Drug companies should remember that states are watching their marketing practices just as closely as the federal authorities with the consumers’ best interests in mind,” stated Francine A. Giani, Executive Director of the Utah Department of Commerce.
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 states alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.
“We would like to recognize and thank Jeff Buckner; our Division’s Assistant Attorney General, for his dedication and hard work in getting Utah signed on to this landmark case, “said Traci Gundersen, Director, Division of Consumer Protection.
As a result of the states’ investigation, Abbott has agreed to significantly change how it markets Depakote and to cease promoting off-label uses. As part of this settlement, Utah will receive nearly $1,000,000 in settlement funds from the company to benefit consumer education and enforcement. 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.
The State of Utah, 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, Vermont, Virginia, Washington, West Virginia and Wisconsin.