FDA v. American College of Obstetricians and Gynecologists
The Court reinstated the FDA's rule requiring women to pick up the abortion pill mifepristone in person at a clinic, blocking a lower-court order that had suspended the requirement during the COVID-19 pandemic.
The ruling is temporary and does not decide whether the FDA's mifepristone rule is constitutional — Chief Justice Roberts wrote separately to emphasize that courts should defer to public health agencies' judgments, not substitute their own.
How it got here: A federal district court blocked the FDA's in-person mifepristone pickup rule; the Fourth Circuit denied a stay of that order; the government applied to the Supreme Court for emergency relief.
The Case in Depth
What happened
The FDA has long required patients to pick up the abortion pill mifepristone in person at a hospital, clinic, or medical office — one of the only drugs with such a restriction — even though patients can consult a doctor remotely and take the medication unsupervised at home. A coalition of medical organizations and reproductive health advocates sued to suspend that in-person pickup rule during the COVID-19 pandemic, and a federal district court agreed, blocking the requirement for the pandemic's duration.
The question before the Court
During the COVID-19 pandemic, could a federal judge order the FDA to stop requiring women to pick up the abortion pill mifepristone in person at a clinic?
The Court's answer
Yes — the Court put the FDA's in-person mifepristone pickup requirement back into effect while the government's appeal was pending. The unsigned majority order granted the stay without extended explanation. Chief Justice Roberts wrote separately to supply the key principle: when courts evaluate government responses to a public health crisis, they owe substantial deference to agencies like the FDA, which have the expertise and political accountability to make those calls. Under that framework, the district court overstepped by directing the FDA to change its established dispensing rules based on the court's own pandemic risk assessment.
The order is explicitly temporary. It does not resolve whether the in-person requirement violates abortion rights under normal or pandemic conditions — that question remains for the lower courts to decide on the merits.
Curious how the Court got there? See the step-by-step legal reasoning →
Why it matters
While the case continued in lower courts, women seeking early medication abortions had to keep making in-person trips to pick up mifepristone — even though they could consult their doctor by phone or video and take the pill at home. Justice Sotomayor's dissent highlighted that this disproportionately burdened low-income women and women of color who face higher COVID-19 risks and longer travel distances to clinics.
What changes now
The FDA's in-person mifepristone pickup rule was back in force while the appeal continued in the Fourth Circuit. The stay would terminate automatically if the government did not seek the Court's full review after the Fourth Circuit ruled, or upon the Court's final judgment if it did grant review. The underlying constitutional question — whether the rule imposes an unlawful burden on abortion access — was left entirely unresolved.
What this does not decide
This order does not decide whether the FDA's mifepristone in-person requirement is constitutional, either generally or during a pandemic. Chief Justice Roberts stated explicitly that the question before the Court was only whether the district court properly second-guessed the FDA — not whether the rule itself violates abortion rights.
Concurrences and dissents
Concurrence — Justice Roberts
The Chief Justice agreed with reinstating the FDA's requirement but wrote to explain his reasoning. He framed the question narrowly: not whether mifepristone's in-person rule is unconstitutional in general, but whether a district court was justified in overriding the FDA's specific pandemic judgment. Citing his earlier COVID-19 church-capacity concurrence, he concluded that courts owe strong deference to agencies with public health expertise, and that the district court had no sufficient basis to compel the FDA to change its established drug dispensing rules.
Dissent — Justice Sotomayor
Sotomayor (joined by Kagan) would have denied the stay. She argued that requiring women to travel in person to pick up mifepristone during the pandemic — when counseling could happen remotely and the drug is taken at home — imposed an unconstitutional undue burden, especially for low-income women and women of color facing greater COVID-19 risks and longer travel to clinics. She also argued the government failed to identify any concrete harm from the six months the injunction had already been in place, and that Roberts' deference rationale was inapplicable because the FDA offered no reasoned explanation for refusing to waive the in-person rule the way it had waived similar requirements for other drugs.
How the Court got there
The legal reasoning, step by step
- An emergency stay is extraordinary relief, requiring the applicant to show both that the lower court was likely wrong and that it will suffer irreparable harm without a pause. The Court weighed these factors here, though the per curiam order did not detail the analysis.
- Chief Justice Roberts, concurring, identified the controlling principle: in cases involving government pandemic responses, courts owe significant deference to politically accountable agencies with specialized public health expertise. He drew on the same reasoning he applied in an earlier COVID-19 church-capacity case.
- Applying that deference standard, Roberts concluded the district court exceeded its proper role. The FDA had made an ongoing judgment that in-person pickup was still required for mifepristone during the pandemic, and a single district court's contrary assessment of public health risk was not a sufficient basis to override that agency decision.
- The dissent countered by applying the undue burden standard from Planned Parenthood v. Casey (1992) — the constitutional test asking whether a regulation places a 'substantial obstacle' in the path of a woman seeking an abortion. Sotomayor argued the in-person rule easily failed that test given clinic closures, COVID exposure risks, the ten-week window for medication abortion, and the FDA's own decision to waive similar in-person requirements for other drugs, including opioids.
- The dissent also argued the government never demonstrated concrete irreparable harm: the in-person requirement had already been suspended for six months under the injunction with no identified adverse outcomes, and the FDA's stated safety rationales were undercut by its own telemedicine accommodations for other prescriptions.