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May 7, 2012

Miller, State Attorneys General Reach $100 Million Settlement over Off-Label Marketing of Prescription Drug Depakote

Iowa share is more than $1.4 million in 45-state consumer protection prescription drug settlement

(DES MOINES, Iowa)  Attorney General Tom Miller 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.  Iowa will receive more than $1.4 million for its share of the settlement.

Under this consumer protection-based pharmaceutical settlement, 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.

“Off-label prescription drug promotion is a serious problem,” Miller said. “When a pharmaceutical manufacturer markets prescription drugs for unapproved uses, it can create potentially serious risks and consequences to patients.  It also circumvents the government’s ability to ensure that prescription drugs are marketed and used for what they were intended, tested and approved.”

In a petition 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, but the attorneys general alleged Abbott marketed the drug for treating unapproved uses, including schizophrenia, agitated dementia and autism.

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.

Iowa’s share of the settlement is $1,448,141, which the state will use for future consumer education and litigation.

Attorneys general of the following states and the District of Columbia joined Miller in today’s settlement:  Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, 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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