Abstract
AbstractPharmaceutical manufacturers continue to battle with the Food and Drug Administration (FDA) over compliance with current Good Manufacturing Practice regulations (cGMP), which outline the requirements that drug manufacturers must follow for the manufacture, processing, packing, and holding of a drug. Pharmaceutical manufacturers have already been the target of successful Federal False Claims Act (FCA) prosecutions, mostly due to pricing and kickback issues raised in qui tam lawsuits. Qui tam lawsuits are brought under the FCA by private citizens who sue on behalf of the United States (US). In exchange for their efforts, the US law provides that the private citizen is entitled, generally, to 15 to 30 % of the recovery generated by the qui tam lawsuit.Kenneth J. Nolan, a top qui tam attorney says that in the last several years, total payouts by manufacturers to settle qui tam lawsuits have amounted to over USD 2.0 billion. Copyright © 2004 John Wiley & Sons, Ltd.
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