OIG Exclusion and FDA Debarment – New Use of Old Tools

In the September/October 2010 edition of the Food and Drug Law Institute’s Update publication, HP&M attorney Jennifer B. Davis authored an article, titled “New Use of Old Tools: Career-Ending OIG Exclusion and FDA Debarment.”  The article focuses on the Department of Health and Human Service’s Office of Inspector General’s exclusion authority and FDA’s debarment authority – particularly now that the government has vowed to wield more aggressively these authorities in conjunction with misdemeanor prosecutions – and their potentially career-crippling effect.  The article discusses what the “exclusion” and “debarment” tools are and the implications for pharmaceutical managers and executives who, although perhaps not personally at fault or even aware of criminal acts, may nevertheless be targeted and prosecuted on grounds that they are “responsible” or “accountable” for what happened.