Article: "The Federal Prosecutor As Regulator: Good Manufacturing Practices and The False Claims Act"
May 29, 2013
In the May 2013 issue of the Law Journal Newsletter's Business Crimes Bulletin, Post & Schell Principal Ron H. Levine explores the potential expansion of False Claims Act actions against medical device and pharmaceutical manufacturers for alleged violations of the FDA's current good manufacturing practices (cGMP) regulations.
Levine discusses the GSK case, provides recommendations for compliance going forward, and concludes that:
"Absent evidence of gross dereliction in the quality area that results in a product entering the stream of commerce that is both adulterated and worthless, resulting in serious risk to the public, targeting alleged cGMP violations for FCA recovery arguably is bad public policy, and unfair. Hopefully, there is ongoing debate within the DOJ and FDA about the legal and policy implications of quasi-criminalizing, under the FCA, alleged violations of broad and loosely defined cGMP regulations. "
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