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Attorney General's News Release

May 7, 2012

Attorney General Koster says Missouri to receive $1.9 million in pharmaceutical settlement

Jefferson City, Mo. – Attorney General Chris Koster said today that Missouri will receive $1.9 million as part of a 45-state settlement with Abbott Laboratories over allegations of illegal off-label marketing of its drug Depakote. Off-label use is the practice of prescribing pharmaceuticals to treat conditions for which they have not been approved by the Federal Drug Administration (FDA).

Koster said Abbott engaged in illegal marketing of the drug by:

  • Promoting Depakote for off-label uses even though Abbott did not have substantial evidence that the drug was effective for the other uses, as required by federal law;
  • Instructing its sales representatives to distribute studies that found Depakote to be effective for these off-label uses when the studies were not reliable;
  • Marketing Depakote for certain conditions without clear clinical trial evidence to support the effectiveness of the drug for the conditions;
  • Failing to disclose well-conducted, well-designed clinical trials that found Depakote ineffective for some of the conditions for which it was marketed.

Depakote is approved for treatment of seizure disorders, mania associated with bipolar disorder, and prevention of migraines, but Abbott marketed the drug for treating other conditions, including schizophrenia, agitated dementia and autism.

As a result of the states’ investigation, Abbott has agreed to significantly change how it markets Depakote and has agreed to cease promoting off-label uses. The company also will pay $100 million nationally, including $1.9 that will go to Missouri. Koster said this is the largest consumer protection-based pharmaceutical settlement ever reached.

“Consumers trust that their medication is safe and effective at treating the conditions for which they are prescribed,” Koster said. “This settlement should send a strong signal to all pharmaceutical companies that Missouri will take action against this deceptive marketing.”

In addition to the fines and penalties, Abbott is prohibited under the settlement from making false or misleading claims about Depakote or promoting the drug for off-label use.

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