PIERRE, S.D. – Attorney General Marty Jackley 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 its Depakote drug.
The agreement marks the largest consumer protection-based pharmaceutical settlement ever reached. South Dakota will receive $1,103,843 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.
“Consumers put their trust in drug manufacturers advertising, and these misleading advertisements put consumers’ health at risk,” said Jackley. “Today’s settlement sends a message that pharmaceutical companies will be held responsible for deceptive practices.”
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. 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.
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,
- Disclosure of payments to physicians, and
- Register and disclose clinical trials.