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Regulatory Focus™ > News Articles > Abbott Hit with $1.5 Billion Fine for Off-Label Marketing

Abbott Hit with $1.5 Billion Fine for Off-Label Marketing

Posted 03 October 2012 | By Alexander Gaffney, RAC 

Life sciences manufacturer Abbott has pleaded guilty to charges of unlawfully promoting its anti-seizure drug Depakote (divalproex sodium) and will pay a total of $1.5 billion in fines and be subject to a five-year probationary period, the Department of Justice (DOJ) announced on 2 October.

Under the settlement, Abbott will pay a $500 million criminal fine, forfeit $198.5 million in earnings and pay $800 million to state and federal government.

The fines and penalties are the result of a probe into Abbott's marketing of Depakote, which the company had promoted for off-label uses not approved by the US Food and Drug Administration (FDA).  Under federal law, physicians may prescribe a drug for unapproved uses, but companies are only allowed to tout the product's FDA-approved uses.

Abbott acknowledged under the settlement that it had improperly marketed the anti-seizure drug for uses including behavioral disturbances and schizophrenia, neither of which are approved by FDA.

DOJ officials said the settlement is the second-largest ever for a single product, exceeded only by Pfizer's $2.3 billion fine for misbranding and improperly promoting its painkiller Bextra. A July 2012 settlement involving multiple drugs manufactured by GlaxoSmithKline totaled more than $3 billion and remains the largest single fine ever levied against a pharmaceutical manufacturer.

Abbott will also be required to enter into a five-year corporate integrity agreement (CIA), which DOJ reports will involve "enhanced accountability, increased transparency and wide-ranging monitoring activities conducted by both internal and independent external reviewers."

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