Case: 23-10362 Document: 543-1 Page: 52 Date Filed: 08/16/2023
pristone would still be safe and effective even with a relaxed in-person dispensing requirement,” Danco Br. at 48, but that is not what FDA said in 2021. On the contrary, FDA candidly acknowledged that the literature was only “not inconsistent with [its] conclusion.” 2021 Denial Letter at 28. In other words, the studies neither confirmed nor rejected the idea that mifepristone would be safe if the in-person dispensing requirement were removed. In discussing the various studies, FDA recognized many significant limitations:
We note that the ability to generalize the results of these studies to the United States population is hampered by differences between the studies with regard to pre-abortion care (e.g., telemedicine versus in-person). In addition, the usefulness of the studies is limited in some instances by small sample sizes and lack of follow-up information on outcomes with regard to both safety and efficacy.
There are also factors which complicate the analysis of the dispensing element alone. Some of these factors are: (1) only a few studies have evaluated alternatives for in-person dispensing of mifepristone in isolation (for example, most studies on mail dispensing of mifepristone also include telemedicine consultation); and (2) because most serious adverse events with medical abortion are infrequent, further evaluation of changes in dispensing would require studies with larger numbers of participants. We did not find any large clinical studies that were designed to collect safety outcomes in healthcare systems similar to the United States.
Id. Given those limitations, FDA concluded that the studies were “not adequate on their own to establish the safety of the model of dispensing mifepristone by mail.” Id. at 35.
Especially in light of the unreliability of the adverse-event data, it was not reasonable for FDA to depend on the published literature to support its
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