Attorney General Bill Sorrell announced Monday that Vermont will receive over $1.7 million in settlement of its consumer protection and Medicaid program claims against Abbott Laboratories over allegations of illegal off-label marketing of its Depakote drug.
The Consumer Protection Settlement
Thesettlement agreementmarks the largest consumer protection-based pharmaceutical settlement ever reached. In addition to the $1,074,000 consumer protection payment to Vermont, the Illinois-based Abbott will be restricted from marketing the drug for off-label uses not approved by the US Food and Drug Administration. 45 states and the District of Columbia participated in the settlement that totaled $100 million.
â Illegal promotion of drugs for off-label use is extremely dangerous,’Attorney General Sorrell said. â It is imperative that we protect consumers from drug companies that use these tactics to sell their drugs."
In acomplaintfiled 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. 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 Medicaid Fraud Settlement
Vermont will receive approximately $693,000 under the agreement with Abbott. The settlement resolves allegations that, from 1998 to 2008, Abbott promoted the sale of seizure drug Depakote for uses that were not approved by the FDA, including the treatment of dementia in nursing home patients and psychiatric conditions in children. The agreement also resolves allegations that Abbott paid kickbacks to doctors, in the form of speaker programs and continuing medical education events, to induce them to prescribe Depakote for these same off-label conditions. As a result of this settlement, Abbott will pay damages equal to double the amount that Vermont and other states paid for Depakote prescriptions. Abbott has also pled guilty to a criminal misdemeanor violation of the Food, Drug, and Cosmetic Act and will pay a criminal fine. Further, Abbott will enter into a Corporate Integrity Agreement with the federal government to closely monitor the companyâ s future marketing and sales practices.
Vermont AG 5.7.2012