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Az to get nearly $2M from Depakote settlement

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Az to get nearly $2M from Depakote settlement

Pharmaceautical company will pay states $100M under deal

Arizona will receive nearly $2 million of a $100 million, multi-state settlement with Abbott Laboratories over allegations of illegal off-label marketing for the drug Depakote, state Attorney General Tom Horne announced Monday.

In addition, Abbott will pay a $700 million criminal penalty and will plead guilty to one misdemeanor count of violating the Food, Drug and Cosmetic Act for misbranding, the company said in a press release Monday.

The agreement is the largest-ever consumer protection-based settlement with a pharmaceutical company, said Amy Rezzonico, spokeswoman for the Arizona Attorney General's Office.

Depakote is approved by the Food and Drug Administration for the treatment of seizure disorders, bipolar disorder, and migraines. The lawsuit alleged Abbott marketed the medication for schizophrenia, agitated dementia, and autism, which were not FDA-approved.

In the complaint filed Monday with the settlement, Arizona, 43 other states and the District of Columbia alleged unfair and deceptive practices when the company marketed Depakote for those unapproved uses, Rezzonico said.

Abbott agreed to change its marketing of the drug and to no longer promote off-label use. It agreed to pay $100 million in the settlement, of which Arizona will receive $1,964,188 that will be placed in the state's Consumer Fraud Revolving Fund, Rezzonico said.

“Consumers need to be able to trust the health care system, and that includes ensuring that pharmaceutical companies market their products appropriately,” Horne said in a press release. “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.”

Under the settlement, Abbott will be:

  • 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.

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 continuing medical education,
  • Disclosure of payments to physicians, and
  • Register and disclose clinical trials.

Other than Arizona, Attorneys General of the District of Columbia and the following states also participated in Monday’s settlement:  Alabama, Alaska, 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.

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