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Abbott Labs Cops to Illegal Depakote Marketing

Filed May 8th, 2012 Laurie

Abbott Laboratories has pleaded guilty to promoting its anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration, and has agreed to pay $1.5 billion to settle the issue. A criminal fine, a forfeiture of $700 million, and civil settlements with the government totaling $800 million are included in the settlement amount.

During a news conference with the Justice Department, U.S. Attorney Timothy Heaphy said that top levels of Abbott
Laboratories systematically marketed Depakote for purposes other than what federal regulators had allowed. The strategy was not the earmark of rogue sales representatives; Heaphy, who is the U.S. attorney for the western district of Virginia, said the company willfully broke the law between 1998 and at least 2006.

Separately, Virginia Attorney General Ken Cuccinelli announced a $100 million settlement between Abbott and 45 states, including the District of Columbia, over consumer claims that the drug maker had marketed the drug for unapproved purposes.

Depakote is an anti-seizure, mood-stabilizing drug used approved for the treatment of bipolar disorder; Abbott has admitted marketing the drug for the treatment of schizophrenia, agitated dementia, and autism. Doctors can legally prescribe medications for off-label purposes, but it is illegal for pharmaceutical companies to prescribe them for any other uses than the ones they are approved for by the FDA.

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