Supreme Court rules on FDA’s regulation of abortion drug mifepristone
In a landmark decision, the US Supreme Court has ruled on the Food and Drug Administration (FDA’s) regulation of the abortion drug mifepristone. The case, titled “FDA v. Alliance for Hippocratic Medicine,” was decided on June 13, 2024.
Case background: back in 2000, the FDA approved a new drug application for mifepristone tablets, marketed under the brand name Mifeprex. The drug was approved for use in terminating pregnancies only up to seven weeks of pregnancy. To ensure safe and effective use, the FDA put more restrictions on use and distribution, with patients having to have three in-person visits with the doctor for them to receive the medicine and doctors having to prescribe or supervise the prescription of the drug.
In 2016, the FDA relaxed some of these restrictions, deeming Mifeprex safe to terminate pregnancies up to 10 weeks, allowing healthcare providers, such as nurse practitioners, to prescribe Mifeprex, and approving a dosing regimen that required just one in-person visit to receive the drug. In 2019, the FDA approved an application for generic mifepristone. In 2021, the FDA announced that it would no longer enforce the requirement of the initial in-person doctor’s visit.
In 2002, three pro-life associations filed a petition asking the FDA to rescind its Mifeprex approval, but the agency denied the petition. Then, in 2019, two pro-life medical associations filed petitions asking the FDA to withdraw its 2016 modifications to mifepristone’s conditions of use, but the agency denied that petition too.
The case: in 2022, four pro-life medical associations and several individual doctors sued the FDA in the US District Court for the Northern District of Texas, challenging the lawfulness of the 2000 and 2019 approvals and the 2016 and 2021 drug use-modifying actions. Mifeprex sponsors Danco Laboratories became the defenders of the FDA. The plaintiffs moved for a preliminary injunction that would require the FDA to rescind either the approval of mifepristone or the 2016 and 2021 regulatory actions. The District Court agreed and in effect enjoined the mifepristone approval, thereby ordering the drug off the market.
On appeal, the Fifth Circuit granted the stay in part, with temporarily reinstating Mifeprex’s approval with the requirements of when the drug was first approved.
Danco and the FDA then sought a full stay in the Supreme Court, which stayed the order of the District Court in its entirety
pending the disposition of the appeals by Danco and the FDA in the US Court of Appeals for the Fifth Circuit and the Supreme Court’s ultimate resolution.
The stay by the Supreme Court allowed for Mifeprex and generic mifepristone to remain available as abortion drug as allowed by the relaxed 2016 and 2021 requirements.
“A few months later, the Court of Appeals issued its decision on the merits of the District Court’s order, affirming in part and vacating in part,” reads the opinion of the court as delivered by Supreme Court Associate Justice Brett Kavanaugh. “The Court of Appeals first concluded that the individual doctors and the pro-life medical associations had standing. The Court of Appeals next concluded that plaintiffs were not likely to succeed on their challenge to FDA’s 2000 approval of Mifeprex and 2019 approval of generic mifepristone. So the Court of Appeals vacated the District Court’s order as to those agency actions. But the Court of Appeals agreed with the District Court that plaintiffs were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful.”
In its ruling, the Supreme Court held that the plaintiffs lack Article III standing to challenge the FDA’s actions regarding the regulation of mifepristone.
“The plaintiffs have sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone,” Justice Kavanaugh said. “But under Article III of the Constitution, those kinds of objections alone do not establish a justiciable case or controversy in federal court. Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact. For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions. The plaintiffs may present their
concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the
legislative process. And they may also express their view about abortion and mifepristone to fellow citizens, including in the political and electoral processes.”
“We reverse the judgment of the U. S. Court of Appeals for the Fifth Circuit and remand the case for further proceedings
consistent with this opinion. It is so ordered.”
This decision marks a significant development in the ongoing debate over the regulation of reproductive health drugs in the United States. The full implications of this ruling are yet to be seen, but it is clear that it will have a profound impact on the future of mifepristone regulation.
Following the Supreme Court’s ruling, President Biden posted on X, “…decision does not change the fact that the fight for reproductive freedom continues.”
Read the opinion of the court as delivered by Justice Kavanaugh and concurred by Supreme Court Associate Justice Clarence Thomas here.
Featured photo attribution: Phil Roeder. License: CC BY 2.0
