Tags: Abbott | Seizure | Drug | labs

Abbott Labs to Pay $1.5B for Misbranding Anti-Seizure Drug

Monday, 07 May 2012 02:22 PM

Abbott Laboratories has pleaded guilty and agreed to pay $1.5 billion over allegations that it promoted the anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration.

Deputy Attorney General James Cole said Monday the settlement reflects the determination by government "to hold accountable those who commit fraud."

At a news conference at the Justice Department, U.S. Attorney Timothy Heaphy said that the top levels of Abbott carried out a strategy of systematically marketing the drug for purposes other than what federal regulators had intended.

The misconduct was not the product of "some rogue sales representatives," said Heaphy, the U.S. attorney for the western district of Virginia.

The case includes a criminal fine and forfeiture of $700 million and civil settlements with the federal government and states totaling $800 million.

In Richmond, Virginia Attorney General Ken Cuccinelli announced the state portion of the settlement between the company and 45 states and the District of Columbia.

Depakote is an anti-seizure and mood-stabilizing drug prescribed for bipolar disorder. However, the federal and state governments alleged that Abbott Laboratories marketed the drug for unapproved uses, including treatment of schizophrenia, agitated dementia and autism.

Under the settlement, Illinois-based Abbott also will be restricted from marketing the drug for off-label uses not approved by the Food and Drug Administration.

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2012-22-07
Monday, 07 May 2012 02:22 PM
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