Tuesday, December 1, 2015

Abbott pleads guilty, $1.5 billion fine sets new record - for now

Abbott Laboratories pleaded guilty to a criminal charge and agreed to pay $1.5 billion to federal and state governments for off-label promotion of the drug Depakote.

Abbott pleads guilty, $1.5 billion fine sets new record - for now


The Justice Department, 49 states and the District of Columbia announced that Abbott Laboratories had pleaded guilty to criminal charges and agreed to pay $1.5 billion over allegations that it promoted the anti-seizure drug Depakote for uses unapproved by the U.S. Food and Drug Administration.

For the moment, that is the new record for the largest fine for bad behavior primarily focused on one drug.

The record is likely to surpassed if or when the Justice Department, several states and Johnson & Johnson settle on figures related to allegations of various bad behaviors related to Risperdal. (By the way, in Monday's SEC filing, J&J says it remains confident that the $1.1 billion fine it got in Arkansas will be overturned and it has not set aside money for it.)

Both drugs -- as are several in the high-fine category - are in the category of pharmaceuticals used to treat mental disorders or diseases or conditions.

James M. Cole, Deputy Attorney General, said in a statement that the “settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud. We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

Abbott's Laura J. Schumacher, executive vice president and general counsel, said in a statement, "We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement. The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements."

A link to Justice Department site with numerous court documents is here.

A link to Abbott's statement is here.

Inquirer Staff Writer
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About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com or 215-854-4506.

David Sell Inquirer Staff Writer
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