DECIDED OCTOBER 8, 2020

592 U. S. ____ (2020) · No. 20A34

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FDA v. American College of Obstetricians and Gynecologists

application held in abeyance pending District Court reviewEmergency action
abortion pillmifepristoneFDA drug safetyCOVID-19emergency orders

Per curiam

The Supreme Court neither granted nor denied the government's request to revive the FDA's in-person mifepristone pickup rule during the COVID-19 pandemic, instead sending the matter back to the lower court for a faster look at whether circumstances had changed.

The procedural sidestep drew a sharp dissent arguing the delay was functionally a denial and that the Court was applying starkly different levels of scrutiny to COVID-era restrictions on religious worship versus restrictions on abortion access.

How it got here: A federal district court in Maryland issued a nationwide injunction blocking the FDA's in-person mifepristone rule; the government filed an emergency stay application directly with the Supreme Court.

The Case in Depth

What happened

The FDA has required since 2000 that women pick up the abortion drug mifepristone in person at a clinic, hospital, or medical office as a drug-safety measure. During the COVID-19 pandemic, a federal judge in Maryland issued a nationwide injunction blocking that requirement, concluding that forcing in-person clinic visits during a pandemic placed an undue burden on abortion access. The federal government asked the Supreme Court to pause the injunction while the legal fight continued.

The question before the Court

Should the Supreme Court immediately let the FDA enforce its rule requiring women to pick up the abortion drug mifepristone in person, rather than waiting while a lower court took another look?

The Court's answer

Neither yes nor no — the Court declined to immediately decide whether to let the FDA enforce its in-person mifepristone pickup rule. Instead, it held the government's application in abeyance, reasoning that a fuller record from the district court would better support the Court's review of the matter.

The Court suggested the nationwide injunction might be too sweeping — applying across the entire country and for an indefinite period regardless of how COVID-19 conditions varied from state to state — but it expressly declined to signal any view on the merits. The district court was directed to rule within 40 days on whether to modify, dissolve, or stay the injunction based on any changed circumstances.

Curious how the Court got there? See the step-by-step legal reasoning →

Why it matters

Women seeking medication abortions remained free to receive mifepristone without an in-person clinic visit while the order was in effect. The dissent's argument — that the Court deferred to state officials restricting religious worship while letting a single judge override an FDA drug-safety rule — previewed debates about the Court's consistency in COVID-19-related cases.

What changes now

The case returned to the Maryland district court, which had 40 days to consider whether to dissolve, narrow, or maintain the injunction in light of any changed pandemic circumstances. The Supreme Court's order was explicitly not a ruling on whether the FDA's in-person rule is lawful or whether blocking it during COVID-19 was proper — those questions remained open for future proceedings.

What this does not decide

The Court expressly declined to signal any view on the merits of the district court's injunction. The order did not decide whether the FDA's in-person mifepristone rule is lawful, whether it imposes an undue burden on abortion access, or whether the FDA was right to keep the rule in place during the pandemic.

Concurrences and dissents

Dissent — Justice Alito

Justice Alito argued the Court should have simply granted the stay rather than holding the application in abeyance for weeks more. He contended the delay was functionally identical to denying the stay, since the FDA still could not enforce its rule either way. He also argued the order was inconsistent with prior COVID-19 rulings: the Court had shown sweeping deference to state officials restricting religious worship, yet here it let a single district judge override an FDA drug-safety determination using the pandemic as grounds to expand abortion access.

How the Court got there

The legal reasoning, step by step

  1. The Court was presented with an emergency stay application — a request to pause a lower court's order while an appeal plays out — from the federal government. The government argued the Maryland district court's nationwide injunction blocking the FDA's in-person mifepristone rule was overbroad in both geographic reach and duration.
  2. The Court concluded that a more complete factual record from the district court would help it review the application properly, particularly because COVID-19 conditions had been shifting and varied widely across states — factors that bore directly on whether the nationwide injunction remained appropriate.
  3. Rather than granting or denying the stay outright, the Court chose to hold the application in abeyance — setting it aside temporarily without deciding it — a procedural tool the Court has used in prior cases when the existing record is insufficient for a sound ruling.
  4. The Court directed the district court to act within 40 days on a government motion to dissolve, modify, or stay the injunction, including on the ground that relevant circumstances had changed since the injunction was issued. This created a path to a narrowed or lifted injunction without the Supreme Court having to reach the underlying merits.

Doctrinal impact

Laws and provisions at issue

21 U.S.C. § 355-1(f)(3)(C)

Federal statute authorizing the FDA to require that certain drugs be dispensed only in person at approved medical facilities.

First Amendment

Constitutional protection for free speech and religious practice, cited by the dissent regarding COVID-era restrictions on worship.

Supreme Court Opinion

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FDA v. American College of Obstetricians and Gynecologists | SCOTUS Reporter