On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator’s action in the Southern District of Florida, arguing that “[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.” Specifically, requesting “that the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,” also known as “fraud on the FDA.”
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