I. Introduction
Current Good Manufacturing Practices (''cGMP'') may mark the next frontier in health care fraud enforcement. While pharmaceutical and medical device manufacturers have faced scrutiny from the Department of Justice (''DOJ'') for decades,1 those enforcement activities have largely focused on off-label marketing and enforcement of the Anti-Kickback Statute, areas in which most in-house legal and compliance departments are, by now, quite familiar. But many companies view cGMP issues through a regulatory prism, treating them simply as technical, operational concerns that pose relatively little risk of civil liability, let alone federal criminal enforcement. Given DOJ's increased focus on cGMP violations as a potential basis for criminal and civil liability, companies should rethink that approach and refocus their attention and legal resources on cGMP before serious problems arise.
In fiscal year 2013, the federal government recovered approximately $4.3 billion dollars in criminal fines and civil settlements related to health care fraud, a substantial portion of which came from pharmaceutical and medical device companies.
Please click hear to read the full text of this article
Originally published in Bloomberg BNA's Pharmaceutical Law & Industry Report, 10/17/2014
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
