Published April 13, 2023
In a 42-page opinion issued late last night (in Alliance for Hippocratic Medicine v. FDA), a Fifth Circuit motions panel granted in part the FDA’s motion for a stay pending appeal of federal district judge Matthew Kacsmaryk’s order last week that would block the FDA’s approval of the abortion drug mifepristone. Specifically, the panel stays the district court’s order with respect to the FDA’s approval in 2000 of the marketing of mifepristone, but it leaves in place the district court’s order with respect to the FDA’s removal in 2016 of four of the original safety restrictions that accompanied its approval (the FDA’s “2016 Major REMS Changes”).
In short, the FDA’s approval of mifepristone will stay in effect during the pendency of the Fifth Circuit appeal under the approved conditions of use that applied from 2000 to 2016. The FDA will not be able to implement during the pendency of the appeal the four changes that it made in 2016: “(1) increasing the maximum gestational age at which a woman can use the drug from 49 to 70 days; (2) reducing the number of required in-person office visits from three to one; (3) allowing non-doctors to prescribe and administer the chemical abortions drugs; and (4) eliminating the requirement for prescribers to report non-fatal adverse events from chemical abortion.”
Judge Kurt Englehardt and Judge Andrew Oldham signed on to the panel’s per curiam opinion. The third member of the panel, Judge Catharina Haynes, “would grant an administrative stay for a brief period of time and defer the question of the stay pending appeal to the oral argument merits panel which receives this case.”
In its tentative analysis “based on our necessarily abbreviated review,” the panel agrees with Judge Kacsmaryk on some major points even as it respectfully disagrees (“close call”) on others. Here is a quick summary:
Standing (pp. 10-23): “[I]t appears that the individual plaintiffs and doctors in plaintiff associations have standing to challenge FDA’s actions.” The emergency-room doctors “have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects” and have suffered “enormous stress and pressure” as a result. They “also face an injury from the irreconcilable choice between performing their jobs and abiding by their consciences.”
“Plaintiff associations have also suffered independent injuries because FDA’s actions have frustrated their organizational efforts to educate their members and the public on the effects of mifepristone.”
Timeliness (pp. 23-30): “Though admittedly a close question, we ultimately agree with [the FDA] at this preliminary juncture” that plaintiffs’ challenges to the FDA’s approval of mifepristone in 2000 are time-barred and that the doctrines of reopening and equitable tolling do not apply. The panel emphasized that the reopening question was a “close call” and that “plaintiffs could very well prevail on this reopening claim.”
Exhaustion (pp. 31-33): The FDA is wrong to contend that plaintiffs failed to exhaust their claims before the FDA.
Arbitrary and capricious (pp. 33-35): The FDA has failed to carry its burden of showing at this stage that its actions with respect to the 2016 Major REMS Changes were not arbitrary and capricious. The FDA failed to examine the relevant data when it made the changes. It instead “eliminated REMS safeguards based on studies that included those very safeguards” (emphasis in original):
Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures. That was obviously arbitrary and capricious in State Farm [1983 Supreme Court case]. And so too here.
The FDA also eliminated the requirement that non-fatal adverse events must be reported to the FDA and then “declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe’”:
This ostrich’s-head-in-the-sand approach is deeply troubling…. It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.
Other stay factors (pp. 36-40): The FDA and Danco make no argument why blocking the 2016 Major REMS Changes would irreparably harm anyone.
Comstock Act (pp. 40-42): The Comstock Act undermines the FDA’s showing on these other stay factors: “if the Comstock Act is construed in-line with its literal terms, then Danco cannot say it is irreparably harmed by the district court’s order, because Danco has no interest in continuing to violate the law, which (under a plain view of the Act) it does every time it ships mifepristone.”
The FDA argues that the Comstock Act “does not mean what it says it means.” The Comstock Act provisions specify a mens rea (mental state) of “knowingly.” Contrary to the Office of Legal Counsel’s opinion, the “plain text” of the provisions does not require that a user of the mails or common interstate carriage intend that an abortion actually occur.” The panel observes that OLC’s “thorough exploration of this topic” consists of nothing more than “a variety of aging out-of-circuit opinions and a single footnote within one Supreme Court dissent [that] favor the [FDA’s] position.”
I will address in a separate post the much broader significance of the Fifth Circuit’s disparagement of OLC’s opinion on the Comstock Act.