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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, and explains why the case does not support disgorgement for distribution of drugs manufactured in a facility that is not fully GMP- compliant. Section IV returns to "first principles" and demonstrates that neither the text nor the legislative history of the FDCA supports a statutory disgorgement remedy. Section V explains that, while a court may fashion equitable remedies to effect the purposes of a remedial statute, courts have in fact been cautious about ordering any nonstatutory remedy in cases arising under the FDCA, in part because the statute already contains an elaborate remedial scheme. It further explains that the limited jurisprudence permitting equitable disgorgement in lawsuits brought under remedial statutes cannot logically be applied to GMP violations. We conclude that FDA has, without congressional approval or judicial review, forced several companies to agree to a remedy that Congress never intended and that a court would not order.



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