U.S. Postal Service Office of Inspector General special agents joined other federal investigators in a U.S. Department of Justice (DOJ) investigation of Abbott Laboratories’ “off-label” marketing of the drug Depakote, a Food and Drug Administration (FDA) approved drug for the treatment of bipolar (manic depression) symptoms. Although FDA regulations permit physicians and other healthcare practitioners to prescribe approved medications for other than their approved indications, it is illegal for pharmaceutical companies to promote a drug for any other purpose without formal FDA approval, a practice known as “off-label” marketing.
From March 2008 through June 2011, investigators from multiple agencies, including the Postal Service’s OIG, conducted numerous interviews and document reviews relating to alleged off-label marketing practices. This work led to a negotiated settlement with the Office of the United States Attorney in May 2012 in which Abbott Laboratories Inc. pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability. Abbott pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved.
On October 2, 2012, Abbott Laboratories Inc. was sentenced in U.S. District Court for the Western District of Virginia to pay a criminal fine in the amount of $500 million (the second-largest criminal fine for a single drug), plus a forfeiture of $198.5 million, and $1.5 million to the Virginia Medicaid Fraud Control Unit. Abbott also entered into a civil settlement agreement under which it agreed to pay $800 million to the federal government and the states to resolve claims that its unlawful marketing and illegal remuneration practices caused false claims to be submitted to government healthcare programs.
As a result of the conviction, the Postal Service received $40 million of the criminal fine and $1.1 million of the civil fine for its investigative efforts.