In a significant ruling for reproductive rights, the US Supreme Court has unanimously rejected a challenge to the FDA’s approval of mifepristone, a drug widely used in medication abortions and for other pregnancy-related conditions. The decision, which can be read here, ensures that mifepristone remains legal nationwide, allowing doctors to continue prescribing it via telehealth.
Notably, the court avoided issuing a merits ruling that could have disrupted the FDA’s drug regulatory approval process. Instead, it decided the case on procedural grounds, holding that the plaintiffs lacked Article III standing. This adherence to the fundamental precept of limiting courts to deciding only “cases or controversies” of actual legal standing helps sustain the integrity of the FDA’s review process.
The lower courts, including the Fifth Circuit, had entertained claims by plaintiff organizations based on hypothetical future injuries. However, the Supreme Court’s decision overturned this, reinforcing that plaintiffs must illustrate an actual injury, caused by defendants, and redressable by the court. The full Fifth Circuit’s April 2023 decision can be accessed here.
Although the ruling did not delve into the merits of the case, it underscored the constitutional requirement for standing, thereby avoiding a potentially disruptive outcome for the FDA approval process. The Court’s decision leaves open the possibility that other plaintiffs with more direct stakes might challenge the regulatory framework in the future, as noted in their statement: “it is not clear that no one else would have standing.”
For now, the regulation of mifepristone by the FDA remains unchanged. The future legality and accessibility of the medication will depend significantly on state-level restrictions on reproductive care. The decision also allows for continued involvement of states with differing approaches to reproductive rights, as indicated by the lower court’s earlier ruling permitting intervention by three Republican-led states.
Legal professionals and corporate counsels should closely monitor ongoing and future litigation, as the principles outlined in this ruling may have broader implications for federal regulatory authority and the standards for legal standing.
The cases discussed are Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.