Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration's ("FDA") underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk's blanket suspension of the drug's approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court's ruling to invalidate the FDA's modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court's stay implemented earlier this year.
In reaching its decision, the Fifth Circuit found that Alliance for Hippocratic Medicine ("Plaintiffs") satisfied the injury requirement to establish standing. The panel reasoned that the injury prong is satisfied because the doctors are forced to provide a treatment that conflicts with their moral beliefs, treating Mifepristone patients diverts time, resources, and energy away from other patients, and Mifepristone patients involve greater risks of complications than the average patient.
However, the panel ruled that Plaintiffs' challenge to FDA's initial approval in 2000 is likely time-barred by the six-year statute of limitations. Moreover, the panel rejected Plaintiffs' argument that the later modifications to the drug protocol invoked the "reopening doctrine"—a D.C. Circuit-created exception that restarts the time for seeking review when an "agency has undertaken a serious, substantive reconsidering of the existing rule."1 Here, the majority panel stated that nothing in the amendments shows that the FDA undertook a serious and substantial reconsideration of its approval nor did the amendments alter the FDA's basic assumption that Mifepristone is safe and effective.
The Fifth Circuit allowed the claims challenging the 2016 and 2021 amendments and ruled that these amendments should be set aside as arbitrary and capricious under the Administrative Procedure Act ("APA"). The panel stated that in failing to consider the cumulative effects of the amendments on the overall safety of the drug, the FDA departed from its rulemaking authority and violated the APA.
Judge Jennifer Walker Elrod wrote the majority opinion. Judge James Ho wrote separately, agreeing with the majority to set aside the 2016 and 2021 REMS modifications. However, Judge Ho stated that he would also invalidate the initial approval of Mifepristone as well. In his concurrence, Judge Ho also introduced another theory through which the Plaintiffs can establish Article III standing: a showing of aesthetic injury. While the concept of aesthetic injury has typically been applied in cases seeking to protect plants and wildlife, Judge Ho sought to expand the theory to abortion cases. According to Judge Ho, "[d]octors delight in working with their unborn patients—and experience an aesthetic injury when they are aborted."
Wednesday's decision is merely the latest development in a series of abortion-related rulings following the Dobbs decision issued by the Supreme Court one year ago. The ultimate fate of Mifepristone access will likely be decided by the Supreme Court, as the panel's split decision leaves in place a patchwork of state laws concerning reproductive healthcare. Given that an appeal is likely, the Supreme Court could decide yet another monumental case impacting reproductive healthcare and individual freedoms within the next couple years, despite the high court's contention that the Dobbs decision would end the abortion debate at the federal level.
Sheppard Mullin's Women in Healthcare Leadership Collaborative ("WHLC") continues to closely monitor the docket and will provide updates as the case progresses.
Footnote
1. Texas v. Biden, 20 F.4th 928, 951 (5th Cir. 2021), rev'd on other grounds sub nom. Biden v. Texas, 142 S. Ct. 2528 (2022).
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