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cGMP Enforcement and Compliance in the Wake of Rostholder

July 27, 2015

By ERIC SUSSMAN, TERRA REYNOLDS & CHRISTOPHER ALLEN

In recent years, the Department of Justice (“DOJ”) has increasingly pursued pharmaceutical companies for alleged noncompliance with current good manufacturing practices (“cGMP”), and companies have faced criminal and civil penalties in the hundreds of millions of dollars for such violations. While the Fourth Circuit's recent decision in Rostholder casts serious doubts on the government's ability to use cGMP violations as a basis for liability under the False Claims Act, the DOJ’s continued interest in cGMP violations poses risks for the in-house legal and compliance departments of pharmaceutical companies.