Filed on behalf of 7 former FDA Commissioners, this brief emphasizes that Congress granted FDA broad authority to review and approve drugs and that after careful review confirming the safety and effectiveness of mifepristone, the FDA approved the drug in 2000. Further, the brief states that under the proper standard of review, which requires deference to decisions of FDA’s scientific experts, FDA’s decision stands and the district court’s decision does not present any bases for overturning the sound scientific judgement of the FDA. Finally, it emphasizes that allowing the district court’s decision to stand would upend FDA’s approval system and harm patients.
This brief was one of many filed in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.