An Unprecedented Settlement For FDCA Violation

Law360, New York (May 22, 2012, 6:14 PM EDT) -- On May 7, 2012, the U.S. Department of Justice (DOJ) announced that Abbott Laboratories pleaded guilty to a misdemeanor under the Food, Drug and Cosmetic Act and agreed to pay $1.5 billion to resolve criminal and civil liability relating to allegations of off-label promotion of the prescription drug Depakote.

Abbott also entered into a five-year Corporate Integrity Agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG).

These components of Abbott’s settlement have become relatively standard in DOJ...
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