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Does the Trickle of cGMP Prosecutions Foreshadow a Flood?

By Joseph F. Savage, Jr. and Christopher J. Somma

By at least 2004, qui tam relators were filing False Claims Act (FCA) cases alleging that violations of current good manufacturing practices (cGMP) by companies selling federally reimbursed products led to false reimbursement claims. Two of these cases led to corporate prosecutions. Other cases were declined by the Department of Justice (DOJ). Significant uncertainty remains, but apparently, under particular circumstances, cGMP allegations will now be a top prosecution priority.'

The Traditional Approach ' and Then, SB Pharmaceutical

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