Over the last several years, we have written extensively about the ongoing government prosecution of pharmaceutical and medical device manufacturers involved in off-label promotion, misbranding, and other illegal marketing and promotional activities. Much of the focus and resources of the federal government, including the US Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the Office of the Inspector General (OIG) for HHS have been devoted to investigating and prosecuting such large-scale cases, including the largest in history—a $3 billion fine against GlaxoSmithKline.
While the ongoing prosecution of these cases into the future likely will remain stable despite the U.S. Second Circuit’s decision in United States v. Caronia, DOJ recently announced in late January of this year, that compliance with current good manufacturing practices (cGMPs) will be one of the agency's “top areas of focus” in the coming year, “opening up new areas of uncertainty for those involved in compliance and regulatory activities for the pharmaceutical industry,” writes RAPS.
cGMP regulations are designed to assure that drugs meet safety, identity, and strength requirements and that they meet the quality and purity characteristics which they are represented to possess.
- See more at: http://www.policymed.com/2013/02/doj-to-target-pharma-and-device-current-good-management-practices-cgmps-violations.html#sthash.j9xBJxUa.dpuf
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