The Pharmaceutical Research and Manufacturers of America (PhRMA) filed an amicus brief with the U.S. Supreme Court in the U.S. Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine case. Arguing in support of the FDA, the PhRMA brief supports the U.S. Fifth Circuit Court of Appeals’ (Fifth Circuit) decision to leave in place the 2000 FDA approval at issue in the district court. Importantly, the amicus brief also argues the Fifth Circuit should also have left in place the 2016 FDA-approved changes to the relevant risk evaluation and mitigation strategy (REMS).