Ropes & Gray Submits Amicus Brief in U.S. Supreme Court Litigation for Association of American Medical Colleges

On January 30, Ropes & Gray filed an amicus brief with the U.S. Supreme Court on behalf of the Association of American Medical Colleges (AAMC) in support of the petitioners in the consolidated appeals U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine. The case involves appeals of a decision by the U.S. Court of Appeals for the Fifth Circuit holding, among other things, that certain FDA actions with respect to the conditions of use of the medication abortion drug mifepristone were likely arbitrary and capricious.

AAMC’s amicus brief addressed the implications of the Fifth Circuit’s decision beyond the particulars of mifepristone. AAMC explained that the case is about judicial deference to an agency’s expert execution of Congressionally directed scientific decision-making review of medical products, not a judicial branch. The brief emphasized that the Fifth Circuit’s decision would jeopardize FDA’s science-driven approval process and the continued availability of approved drugs.

The brief concluded: “The Court should reaffirm faithfulness to the FDA’s evidence-based process, rather than embark on a new path in which individual judges, without access to the scientific resources and expertise of the FDA, are permitted to substitute their own views for those of the experts that Congress has entrusted to protect the public health.”

The amicus brief was authored by Douglas Hallward-Driemeier, partner and head of the Appellate and Supreme Court practice, life sciences regulatory and compliance partner Joshua Oyster, life sciences regulatory and compliance associate Rebecca Williams and litigation & enforcement senior attorney Dee FitzGerald.