SCOTUS Avoids Merits Ruling That Would Disrupt FDA Drug Reviews

In a critical decision for reproductive rights, the US Supreme Court unanimously rejected a challenge to the Food and Drug Administration’s approval of mifepristone, a drug commonly used in medication abortions and for other pregnancy-related concerns.

The court’s ruling means mifepristone remains legal nationwide, and permits doctors to continue to prescribe it via telehealth. Perhaps more importantly, by deciding the case on procedural grounds, the court has avoided a merits ruling that would have been hugely disruptive for the FDA’s drug regulatory approval process—holding litigants to one of the fundamental precepts of federal court jurisdiction—the limit on courts to decide only “cases or controversies.”

The court found the plaintiffs couldn’t establish Article III standing and didn’t have a legal right to bring suit—reversing the Fifth Circuit’s April 2023 decision that entertained claims by plaintiff organizations alleging their members’ hypothetical future injuries to limit access to mifepristone.

Last week’s decision didn’t reach the merits, focusing exclusively on the plaintiffs’ lack of standing. The court reiterated that standing—the plaintiff’s assertion of an actual injury, caused by defendants, and redressable by the court—remains a fundamental requirement for litigants, and rejected the plaintiffs’ invitation to restrict access to a medication that they themselves do not prescribe.

The FDA first approved mifepristone—one of two medications commonly used in medication abortion—for use in 2000, further expanding access to the medication in 2016 and again in 2021, when it eliminated a previous in-person dispensing requirement and permitted distribution by mail. The FDA’s approach recognized that mifepristone is exceptionally safe, with a safety profile similar to ibuprofen, and an important component of reproductive care.

After the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, mifepristone became even more important as a means of extending care to individuals living in states that banned the medical procedure entirely.

The plaintiffs opposed use of mifepristone by others, and brought their case in hopes the courts would override the FDA’s regulatory judgment and restrict access to the medication to advance their ideological goals. Although the trial court in the Northern District of Texas and the Fifth Circuit Court of Appeals were willing to entertain the plaintiffs’ claims despite their lack of the traditional indicia of standing, the Supreme Court wasn’t.

Our law firm has participated in this case throughout. We represented amici at every level of pleadings on behalf of medical and public health societies urging the court to preserve access to this vital medication. The amici briefs underscore mifepristone’s safety and that the restrictions surrounding its use aren’t medically necessary or scientifically sound.

The court unanimously rejected the plaintiffs’ claim and reiterated that standing remains a constitutional requirement for litigants in US courts. It found the plaintiffs’ standing claims to be “too speculative or too attenuated” to merit relief, and that the lower courts had erred in holding otherwise.

In rejecting the case due to the inadequacy of the plaintiffs standing, the court avoided addressing the merits, but reinforced a core principle of Article III, limiting courts to adjudicating “cases and controversies” presented by litigants with a true stake in the outcome.

Who, precisely, might be considered to have a stake remains an open question, however. Other plaintiffs may emerge to raise the merits arguments that the court didn’t consider here, including the central argument that the Comstock Act imposes a nationwide ban on medication abortion or that the FDA exceeded its remit. The decision explicitly leaves the door open, stating, “it is not clear that no one else would have standing.”

While the decision can be considered a rare victory for reproductive care in this court, because it declined to further restrict mifepristone, it could prove problematic in future cases. The opinion grants unusual credence to the possibility of “conscience injuries,” which opponents of reproductive care may seek to exploit in future cases to attempt to limit access.

Nor does this decision fully do away with this case. In January, the lower court judge permitted three states with Republican leadership to intervene in this litigation, and they can be expected to pursue it.

For now, the regulation of mifepristone by the FDA remains unchanged, and whether it is legal and accessible within any particular state will depend on the severity of that state’s restrictions on reproductive care.

The cases are Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Shannon Rose Selden is partner at Debevoise & Plimpton and counsel to amicus curiae medical and public health societies in this case.

Isabelle Canaan and Hillary Hubley are associates at Debevoise & Plimpton.

Emily Morgan, an associate at Debevoise & Plimpton, contributed to this article.

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