Scott S. Liebman, Principal of Porzio, Bromberg & Newman and Vice President of Porzio Life Sciences, LLC is quoted in the article "In Notable Shift, DOJ to Treat Manufacturing Regulations as 'Top Area of Focus' in 2013" in a Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article.

 

Mr. Liebman commented on how a focus on current good manufacturing practices (CGMPs) would mark a dramatic change in practice for the US Department of Justice (DOJ) and how “this is out of their normal zone of activity."

 

Particularly in light of Maame Ewusi-Mensah Frimpong’s, deputy assistant attorney general for DOJ's Consumer Protection Branch, advice to break down barriers between segments, Mr. Liebman advised that “companies would do well to do a better job at breaking down regulatory and compliance silos to make sure people are more broadly educated about both CGMP and Prescription Drug Marketing Act (PMDA) requirements to be able to handle DOJ's increased scope of interest.”

 

Mr. Liebman said he believes "the consequences are going to be different" for companies found to have severely violated CGMP regulations relative to those that have severely violated branding or advertising regulations. "They could be more painful," he added.