Case: 23-10362 Document: 543-1 Page: 51 Date Filed: 08/16/2023
ments and the FAERS submission process harm medical practices by taking away significant time from a doctor to treat and meet with patients.
Dr. Harrison Declaration ¶¶ 33–34; see also Dr. Frost-Clark Declaration ¶ 23 (“I have not reported adverse events that I have witnessed as a result of chemical abortions because the process is so cumbersome.”). One doctor testified that it can take hours to report an adverse event to FAERS:
[T]he process of reporting to [FAERS] is also cumbersome. The actual form to be filled out is not easy to find online—requiring several steps to get it. It once took me two hours to get the website to accept submission of the form, taking me away from the care of my other patients. The minimum amount of time I have spent reporting a mifepristone complication to the FAERS is thirty minutes—valuable time that should be spent in patient care.
Dr. Francis Declaration ¶ 18. FDA’s decision to rely so heavily on data from FAERS “runs counter to” the critical limitations associated with that data. State Farm, 463 U.S. at 43; Sw. Elec. Power Co., 920 F.3d at 1018–19.
FDA responds that it also considered adverse-event data submitted by Danco, but Danco’s data was exactly the same as the data FDA obtained from FAERS. FDA acknowledged as much in its letter denying the 2019 citizen petition. 2021 Denial Letter at 27. (“The information provided by the Applicants included the same cases identified in FAERS….”). If anything, the fact that Danco submitted identical data tends to confirm the assertion that FDA lacked sufficient information; it shows that neither FDA nor Danco had the means to collect data directly from prescribers.
The second defect in the Non-Enforcement Decision is that it relied on various literature relating to remote prescription of mifepristone—despite FDA’s admission that the literature did not affirmatively support its position. Danco insists that the studies “all … supported the conclusion that mife-
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