The agreement marks the largest consumer protection-based pharmaceutical settlement ever reached. Arizona will receive nearly $2 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.
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.
“Consumers need to be able to trust the health care system, and that includes ensuring that pharmaceutical companies market their products appropriately,” Horne said. “This settlement shows that this office and my colleagues nationwide will not tolerate the improper marketing of medicines that affect peoples’ physical and mental well-being.”
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.
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. As part of this settlement, Arizona will receive $1,964,188.00 in settlement funds from the company to be deposited into the Consumer Fraud Revolving Fund pursuant to A.R.S. § 44-1531.01.
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.