Supreme Court Unanimously Preserves Access To Mifepristone

Sheppard Mullin Richter & Hampton


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In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration's regulatory approval of mifepristone, ensuring continued access to the widely-used abortion...
United States Food, Drugs, Healthcare, Life Sciences
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In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration's ("FDA's") regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across the country. Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine et al., No. 23-235 and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al., No. 23-236. The Court ultimately decided the case on procedural grounds, holding that the plaintiffs lacked standing to bring suit.

The Court did not reach the merits of the plaintiffs' claims, but decidedly rejected their "attenuated" theory of standing as being outside the framework of Article III – the "bedrock" of disputes. While courts often decide cases on procedural grounds as a way to sidestep the need to weigh in on substantive and often contentious issues, the Court's procedural ruling here was based on a straight-forward application of the legal doctrine that ensures only legitimate cases and controversies are adjudicated.

This decision is the culmination of a protracted legal battle that originated in Texas involving the FDA's approval and regulation of medication abortion (summarized in our prior posts available here and here). This case was the first dispute the Court heard in the wake of its landmark Dobbs decision that overturned Roe v. Wade and Planned Parenthood v. Casey, and resurrected in their place a patchwork of state laws regarding abortion.

Two weeks shy of the second anniversary of Dobbs, the Supreme Court was asked to weigh in on plaintiffs' claims that the FDA acted unlawfully in taking certain actions in 2016 and 2021 to expand access to mifepristone. The FDA argued the plaintiffs' lawsuit should be dismissed on the basis that the plaintiffs, as medical associations and individual doctors who do not prescribe, manufacture, sell, advertise, or use mifepristone (or a competing drug), lacked standing to challenge the FDA's regulations. The Supreme Court agreed with the FDA, finding that the plaintiffs failed to demonstrate an injury in fact that was caused or likely to be caused by the FDA's actions.

The plaintiffs presented multiple theories as to why they might have Article III standing, but the Court rejected each of them as too speculative and attenuated. In writing for the majority, Justice Kavanaugh stated that "[a]llowing doctors or other healthcare providers to challenge general safety regulations as unlawfully lax would be an unprecedented and limitless approach and would allow doctors to sue in federal court to challenge almost any policy affecting public health." The Court thus declined to "invent a new doctrine of doctor standing," noting that "there would be no principled way to cabin such a sweeping doctrinal change to doctors or other healthcare providers," and refusing to "start the Federal Judiciary down [an] uncharted path" that "would seemingly not end until virtually every citizen had standing to challenge virtually every government action that they do not like – an approach to standing that this Court has consistently rejected as flatly inconsistent with Article III."

While this decision does not preclude other plaintiffs from pursuing their own challenges to the availability of mifepristone (or other FDA-approved drugs), it is clear that "sincere legal, moral, ideological, and policy objections" alone do not confer standing and the traditionally high bar to establish standing must still be met. Amid shifting judicial interpretations regarding both the FDA's authority and when viewed in the broader context of reproductive rights, the Court's adherence to the gatekeeping principles of Article III standing provide a measure of stability and order.

Though the Supreme Court declined to reach the merits of this case, the fact that it left an administrative agency's decision-making authority untouched, even implicitly, is notable given that agency deference is at the heart of a number of cases currently being considered by courts, including the Supreme Court. These cases could result in the Chevron doctrine being overturned, which would upend 40 years of foundational administrative law and create additional uncertainty in the judicial process.

While the Court's decision marks the close of this particular legal battle, the disputes regarding abortion—and agency authority—are far from over.

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