Law Commons^™

The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh

Faculty Publications

This article addresses the question as to whether a federal court has the authority to compel a pharmaceutical company to disgorge profits obtained from an alleged violation of the FDCA, specifically the failure of a pharmaceutical company to comply with current good manufacturing practices (GMPs). Section II of this article summarizes the article to which we are responding. In all fairness, it did not purport to be a full-blown defense, and we expect the agency's comprehensive defense of disgorgement would be considerably more detailed. Section III turns to the Sixth Circuit case on which FDA rests its argument for disgorgement, …