Tennessee, along with 44 other states and the District of Columbia, has joined a $100 million multistate agreement with Abbott Laboratories over allegations of illegal off-label marketing of its Depakote drug, Attorney General Bob Cooper along with Commerce and Insurance’s (TDCI) Consumer Affairs Director Gary Cordell, announced Monday.

The agreement marks the largest consumer protection-based pharmaceutical agreement ever reached.  Tennessee will receive $1.95 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.

“We are pleased to announce the resolution of this investigation into the off-label promotion of this drug,” Attorney General Cooper said.  “We hope other companies will think twice before promoting drugs for uses that have not been approved.”

In a complaint filed Monday along with the 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.

Under the agreement, 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,
• Disclose payments to physicians, and
• Register and disclose clinical trials.

The State’s Complaint and Agreed Final Judgment may be viewed by going online to www.tn.gov/attorneygeneral and clicking on “Filings of Interest.”

Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at 615 741-4737 or toll-free in Tennessee at 800 342-8385.