Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/21

 https://perma.cc/R56J-BHW4.

Ibuprofen’s label, which FDA helpfully provided in its stay addendum, obviously bears no resemblance to the “Black Box” warning on mifepristone’s label. FDA Add. 465–68. To the contrary, FDA has a special regulation regarding ibuprofen so all manufacturers of that over-the-counter medicine include the same information on their labels. See 21 C.F.R. § 201.326. It says nothing about REMS, surgery, emergencies, Emergency Rooms, or death.

In sum, applicants’ own documents—from the “Patient Agreement Form” to the “Black Box” warning that have accompanied mifepristone