Case: 23-10362 Document: 543-1 Page: 74 Date Filed: 08/16/2023
The 2021 Mail-Order Decision worked an even greater “sea change” to the “basic regulatory scheme.” NRDC, 571 F.3d at 1266. From the get-go, the FDA’s approval of mifepristone was explicitly premised on in-person dispensing. The initial 2000 approval required “[p]rovision of [the] drug through a direct, confidential physician distribution system that ensures only qualified physicians will receive the drug for patient dispensing.” FDA Approval Memorandum to Population Council at 6. See also id. at 4 (“[T]he drug will be distributed directly to physicians. It will not be available from pharmacies.”). The agency viewed this as necessary to “address[] the issue of physical security of the drug.” Id.
So “[t]he in-person dispensing requirement … was critical to FDA’s initial approval of mifepristone in 2000, which relied on the in-person dispensing requirement to dismiss concerns about provider qualifications, improper use, illicit distribution, and detection of adverse events.” Alliance for Hippocratic Medicine v. FDA, 2023 WL 2913725, at *14 (5th Cir. Apr. 12, 2023). “[T]he in-person dispensing requirement was FDA’s primary tool for ensuring the safe distribution and use of mifepristone.” Id. at *15.
“[T]his change eliminates a major safeguard against complications and adverse effects arising from improper mifepristone use.” Id. It “significantly alters the stakes of judicial review,” triggering reopening. NRDC, 571 F.3d at 1266 (quoting Sierra Club, 551 F.3d at 1025).
C.
The FDA counters that the 2016 and 2021 revisions could not have significantly altered the stakes of judicial review or made the regulatory scheme worth challenging in a way it wasn’t before. After all, the FDA says, Plaintiffs already challenged the original 2000 approval in their 2002 petition.
But not all of the Plaintiffs here participated in the 2002 petition. For those Plaintiffs, the FDA’s current regime is clearly “worth challenging,”
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