A federal appeals court ruled 2-1 Wednesday that the abortion pill mifepristone (Mifeprex) should remain on the market, although with some restrictions.
“We conclude that the medical organizations and doctors’ claim as to the [drug’s] 2000 approval [not being valid] is likely barred by the statute of limitations,” wrote Judge Jennifer Walker Elrod of the Fifth Circuit Court of Appeals. “This means that, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016.” The ruling also applies to the generic version of the drug, she noted.
The decision, which the judges stayed pending appeal, is the latest twist in a complicated case that began in November 2022, when a group known as the Alliance for Hippocratic Medicine (AHM) and other anti-abortion physicians sued the FDA, arguing that mifepristone was rushed to approval too quickly. On April 7, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas ruled in the alliance’s favor.
Medication abortions account for more than half of all abortions nationwide. Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. While misoprostol alone is safe and effective, it is not as effective as the two-drug regimen. The drugs are also commonly used in managing miscarriages.
In his decision, Kacsmaryk argued that given the ability for women and girls to undergo medication abortion without a physician supervision, those in maternity care deserts may lack access to emergency care. “In sum, there are fewer safety restrictions for women and girls today than ever before. Plaintiffs have good reasons to believe their alleged injuries will continue in the future, and possibly with greater frequency than in the past,” he wrote. His ruling — had it taken effect fully — would have amounted to a nationwide ban that would block access to those seeking medication abortion even in Democratic-led states, where abortion is still broadly legal.
While Kacsmaryk’s case was proceeding, out in the Pacific Northwest, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington issued a competing decision nearly at the same time granting — in part — a preliminary injunction in another case that would prevent the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”
Rice’s decision, unlike Kacsmaryk’s, directed the FDA to make no changes that would reduce access to mifepristone across the 17 states and the District of Columbia, those that filed the lawsuit. The Washington federal judge stopped short of a nationwide injunction, which he deemed “inappropriate” given the potential for competing litigation.
Like Elrod, Kacsmaryk stayed his April decision to allow the government time to appeal, which it did. Then on April 12, before Kacsmaryk’s ruling was slated to take effect, a three-judge panel from the Fifth Circuit Court of Appeals acted to uphold parts of Kacsmaryk’s order, but not all of it.
The Fifth Circuit’s order said that the AHM had not given an adequate rationale for challenging mifepristone’s original FDA approval. However, the judges said the AHM could challenge the FDA’s 2016 risk evaluation and mitigation strategy (REMS) program and subsequent agency actions, including the 2019 approval of GenBioPro’s generic mifepristone, and a 2021 REMS update that made the drug permanently available by mail.
On April 14, mifepristone maker Danco Laboratories and the Department of Justice, acting on behalf of the FDA, asked the Supreme Court to halt the Fifth Circuit’s ruling. A week later, the Supreme Court granted an “emergency stay,” allowing the case to move forward to its current state.
Had the Supreme Court not extended the stay, the Fifth Circuit Court of Appeals’ order would have gone into effect, banning the distribution of medication abortion through the mail, rolling back the gestational age at which an individual can be provided mifepristone, from 10 to 7 weeks, and reinstating rules around required physician visits. Importantly, the Fifth Circuit Court’s order would also have suspended the approval of generic mifepristone, which accounts for two-thirds of the available supply of the drug. Those parts of the decision remain in place under Wednesday’s order, which has been stayed until the Supreme Court decides whether it will take up the case.
Groups on either side of the issue each had a different take on Wednesday’s decision. “The bottom line is that this decision does not change the availability of mifepristone today or in the immediate future,” said Mini Timmaraju, JD, president of NARAL Pro-Choice America, in a statement. “Despite the attempts by right-wing judges and politicians, medication abortion remains available … As this baseless lawsuit makes its way to an extremist Supreme Court, we will continue to fight with our allies to protect and expand access to medication abortion for all.”
The Alliance Defending Freedom, a conservative legal group which is anti-abortion, saw it differently. “The 5th Circuit Court of Appeals has ruled the FDA must do its job and restore crucial safeguards around chemical abortion drugs, including ending illegal mail-order abortions,” the group wrote on X. “It’s a significant victory for the doctors we represent, and for women’s health and safety.”
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