Case: 23-10362 Document: 543-1 Page: 46 Date Filed: 08/16/2023
“major” changes to the mifepristone REMS. When considering the data-collection question, FDA reasoned that non-fatal adverse events did not have to be recorded because the risks associated with mifepristone were well known. FDA Summary Review of 2016 Amendments at 26 (“[A]fter 15 years of reporting serious adverse events, the safety profile for Mifeprex is essentially unchanged.”).
But FDA failed to account for the fact that it was about to significantly loosen mifepristone’s conditions for use. At no point during the decision did the agency acknowledge that the 2016 Amendments might alter the risk profile. And when FDA addressed this subject in its response to the 2019 citizen petition, it just referred back to its statement that the risks were minimal under the 2011 REMS. See 2021 Denial Letter at 20. We conclude that FDA ignored “an important aspect of the problem,” Michigan, 576 U.S. at 752 (quoting State Farm, 463 U.S. at 43), and that its explanation of the basis for the change contains significant “shortcomings.” Sw. Elec. Power Co., 920 F.3d at 1018–19. This also likely violates the APA.
Defendants respond that the change is insignificant because Danco remains obligated to report serious adverse events to FDA. See FDA Br. at 53; Danco Br. 47 (citing 21 C.F.R. §§ 314.80, 314.98). True, Danco is still subject to some reporting requirements, but these are significantly different than the ones that were removed. Before, prescribers were required to report certain adverse events directly to FDA. Given that prescribers interact with the women taking mifepristone, they are well placed to know if a patient actually experiences an adverse event. By contrast, Danco has no direct relationship with Mifeprex patients and little ability to track events. Like any member of the public, Danco can access the FDA Adverse Event Reporting System (FAERS), a voluntary reporting website. But prescribers are not required to log non-fatal adverse events. Indeed, no one is required to report anything on FAERS. Nor are prescribers required to report to Danco. The end result
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