Recently the U.S. Court of Appeals for the Fourth Circuit affirmed the district court’s dismissal of the relator’s False Claims Act (FCA) complaint against Omnicare in United States ex rel. Rostholder v. Omnicare, Inc., a decision having significant repercussions for the pharmaceutical industry and broader FCA jurisprudence. The Fourth Circuit rejected plaintiff’s claim that Omnicare violated the FCA when it sought reimbursement for drugs that it allegedly packaged in violation of the Food and Drug Administration's (FDA) Current Good Manufacturing Practices regulations (cGMP). The decision has several potentially far-reaching impacts, including signaling careful future court reviews of statutes and regulations when relators attempt to use violations of those statutes and regulations to make out an FCA claim, and confirming that once a drug has been approved by the FDA and qualifies for reimbursement under the Medicare and Medicaid statutes, the submission of a reimbursement request for that drug cannot constitute a false claim under the FCA solely due to being processed in violation of the cGMPs.
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