Byline 1/19/2010, Legal Times
DOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case
If you are working in a senior legal, compliance or risk-management leadership role inside an FDA-regulated company, and unless you’ve been living under a rock, you are aware that the Obama Administration, the Department of Justice and the Food and Drug Administration are on the offensive against companies that don’t maintain effective compliance programs and stay in compliance with a multitude of requirements and expectations. The January 19 article above provides some insight into how the Department of Justice is approaching companies that are not in compliance with the law — any law. This is the latest in a recent series of actions by DOJ against companies it suspects of either intentional, or grossly negligent non-compliance.
While this hasn’t occurred — yet — what you should be asking in your executive corporate compliance role is: could my company right now, be the subject of a sting operation for FCPA, False Claims Act, Medicare/Medicaid reimbursement, or other FDA regulatory enforcement action. If you become the target of such a sting, retain counsel. However, if you want to prevent or minimize gross non-compliance with laws, call us to discuss how robust compliance systems, processes, training, cultural change, and other programs can minimize your risks to the greatest extent possible.