The Supreme Court has scheduled oral arguments in a challenge to regulations governing the use of the abortion pill mifepristone.
The highly anticipated hearing will take place on March 26, the court announced on Jan. 29. The court granted the petition for certiorari, or review, in the case on Dec. 13, 2023.
The Supreme Court will consider whether the U.S. Food and Drug Administration (FDA) followed federal law when it relaxed restrictions in 2016 and 2021 on the pill.
A medication abortion generally involves the use of mifepristone, which blocks progesterone, a hormone, and misoprostol, which induces contractions. Misoprostol, which is widely available because it has many medical uses, isn’t at issue in the current litigation.
Advocates for mifepristone say the current system by which the drug is provided is safe, while opponents say it puts women at risk by ignoring 2016 and 2021 safety protocols that used to be in place.
The Biden administration and pro-abortion groups worry that the Supreme Court’s eventual decision in the case could affect the availability of the drug.
At issue in the extensively litigated case are the FDA’s decision in 2016 to loosen prescription rules around mifepristone, and then in 2021 to allow prescriptions to be sent by mail without the patient first visiting a physician in person.
The case is actually two cases that have been consolidated—FDA v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM. Danco makes mifepristone, which is also known as mifeprex and RU-486.
The case is the Supreme Court’s most important abortion-related case since its June 2022 decision in Dobbs v. Jackson Women’s Health Organization, which determined that there was no right to abortion in the U.S. Constitution.
That ruling overturned Roe v. Wade (1973) and returned the regulation of abortion to the states.
In a virtual repeat of 2022 and the Dobbs case, the decision is expected by June, at which point it could become a political issue in the November elections. Commentators say that if the court reimposes the old mifepristone restrictions, voters will likely blame Republicans and that Democrats will benefit politically.
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, an appointee of President Donald Trump, ruled in April 2023 that the FDA was wrong to approve mifepristone for public use in 2000 and that the agency had deliberately dragged out judicial review of the drug for years.
The judge also found that the FDA had improperly lifted restrictions related to accessing the drug.
Judge Kacsmaryk issued a preliminary nationwide injunction retroactively staying the FDA’s approval. He wrote that the FDA hadn’t properly assessed the risks posed by the drug before approving it, buckling under political pressure to get it on the market.
In this case, the FDA “acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions,” he wrote.
“There is also evidence indicating FDA faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
The FDA’s failure to impose restrictions on the use of the drug “resulted in many deaths and many more severe or life-threatening adverse reactions,” he wrote.
The regulations have changed over the years.
Getting It By Mail
In 2019, the FDA approved a generic version of the drug. In 2021, the agency allowed patients to receive the drug by mail instead of having to pick it up in person from a specially certified health care provider.The U.S. Department of Justice (DOJ) appealed Judge Kacsmaryk’s decision, but the conservative-leaning U.S. Court of Appeals for the Fifth Circuit refused to block most of the order.
The Fifth Circuit held that the FDA’s actions in 2016 and 2021 were probably unlawful—a finding the FDA and Danco asked the Supreme Court to review.
In August 2023, the Fifth Circuit upheld the district judge’s restrictions on the abortion pill, holding that the FDA failed to give proper consideration to public safety concerns when approving it.
The Fifth Circuit observed that the AHM and the other plaintiffs argued they had “associational standing” because the various organizations involved in the lawsuit have members who “are likely to sustain injuries as a result of FDA’s actions.”
The court found the plaintiffs “made a ‘clear showing’ that their members face injury with sufficient likelihood to support entering a preliminary injunction.”
The DOJ appealed to the Supreme Court, which in April 2023 blocked the injunction over the original approval of the drug in 2000, allowing mifepristone to remain on the market. Conservative Justices Clarence Thomas and Samuel Alito voted against lifting the injunction.
In September 2023, U.S. Solicitor General Elizabeth Prelogar urged the Supreme Court to act, saying that the Fifth Circuit’s ruling was the first time that a court had second-guessed the FDA’s “expert judgment” in approving medication.
If the ruling remains intact, it “would impose grave harms on the government, mifepristone’s sponsors, women seeking medication abortions, and the public,” she said at the time.
Ms. Prelogar followed up with a new filing on Jan. 23, in which she argued that the district court’s injunction would cause “disruptive nationwide relief that threatens profound harms to the government, the healthcare system, patients, and the public.”
Moreover, the FDA’s action in 2016 was supported by “an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world,” she wrote.
“The loss of access to mifepristone would be damaging for women and healthcare providers around the nation.”
