Case: 23-10362 Document: 543-1 Page: 48 Date Filed: 08/16/2023
time, but FDA concluded that there did not “appear to be a difference in adverse events when in-person dispensing was and was not enforced.” Id.
Second, FDA considered published literature relating to remote prescription of mifepristone. It determined that those studies were “not inconsistent with our conclusion that … mifepristone will remain safe and efficacy will be maintained if the in-person dispensing requirement is removed from the Mifepristone REMS Program.” Id. at 28. Based on these sources, FDA concluded that “mifepristone will remain safe and effective if the in-person dispensing requirement is removed.” Id. at 35.
1. Mootness
Defendants first raise a threshold question: whether the Medical Organizations and Doctors’ challenge to the 2021 non-enforcement policy is moot. They contend that the 2023 modification of mifepristone’s REMS supersedes the 2021 policy, and also that the prior policy was tied to the Government’s COVID-19 public health emergency, which has since expired. For these reasons, FDA and Danco say, there is no longer a live dispute as to the 2021 Non-Enforcement Decision.
Neither reason is availing. First, FDA is incorrect to say that it tied its December 2021 decision not to enforce the in-person dispensing requirement to the COVID-19 pandemic. True, FDA cited the pandemic as a justification for taking the initial action. FDA Letter of April 2021 at 2 (“[FDA] intends to exercise enforcement discretion during the COVID-19 [pandemic] with respect to the in-person dispensing requirement of the Mifepristone REMS Program….”). But when FDA “directed mifepristone’s sponsors to submit a proposed REMS modification,” several months later, it did so without regard to pandemic conditions. FDA Br. at 11; see 2021 Denial Letter at 6, 25–26. FDA simply did not tether its action in December of 2021 to the continued existence of the public health emergency.
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