Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/20

23-10362

We disagree because FDA’s own documents show that mifepristone bears no resemblance to ibuprofen. In the 2000 Approval, FDA imposed a “Black Box” warning on mifepristone. FDA requires “Black Box” warnings when a drug “may lead to death or serious injury.” 21 C.F.R. § 201.57(c)(1). In its 2000 Approval, FDA conditioned its approval of mifepristone on the inclusion of this “Black Box” warning:

FDA Add. 182. The 2016 Major REMS Changes relaxed many of the requirements for marketing and using mifepristone. But it retained this “Black Box” warning:

20