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The Federal Prosecutor As Regulator

Business Crimes Bulletin

In the May 2013 issue of the Law Journal Newsletter’s Business Crimes Bulletin, Post & Schell White Collar Principal Ron 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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About the Author

Ronald H. Levine is Chair of Post & Schell's Internal Investigations & White Collar Defense Group and former Criminal Division Chief at the U.S. Attorney’s Office in Philadelphia. He counsels and defends corporations, as well as directors, executives, professionals and others, confronting potential allegations of fraud or other misconduct at all stages of the government enforcement cycle.

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