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Does the Trickle of cGMP Prosecutions Foreshadow a Flood?
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
Traditionally, cGMP cases were addressed administratively by the Food and Drug Administration (FDA), with the occasional injunction or consent decree following an inspection or warning letter. cGMP violations under the Food, Drug and Cosmetic Act (FDCA) can be criminal when they result in shipping adulterated drugs or devices. The standard, however, is amorphous. For example, for drugs there is adulteration, as defined in 21 U.S.C. ' 351(a)(2)(B): “If the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”
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