Mifepristone will remain available for now under existing regulations while the litigation continues, in accordance with a Supreme Court ruling this spring. Wednesday’s decision, which only partially upheld a lower-court judge’s ruling in favor of a coalition of anti-abortion challengers, can be appealed to the Supreme Court.
If the appeals court ruling eventually takes effect, the abortion pill would still be available in the United States, but it would be more difficult for patients to get it.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote in Wednesday’s opinion. “It failed to consider the cumulative effect of removing several important safeguards at the same time.”
Mifepristone is part of a two-drug regimen used in more than half of U.S. abortions and first approved for use in this country more than 20 years ago. The legal battle over the medication has intensified since the Supreme Court overturned Roe v. Wade’s grant of a constitutional right to abortion in June 2022, a decision that spurred multiple states to further limit or ban the procedure.
The challenge to mifepristone was brought by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others. The group asserted that the FDA did not sufficiently consider safety concerns when it approved the drug in 2000 or when it removed some restrictions years later — extending the approved use of mifepristone, for instance, through 10 weeks of pregnancy instead of seven.
The challengers had argued that the abortion pill should never have been approved and should be removed entirely from the market. They filed their lawsuit in Amarillo, Tex., where U.S. District Judge Matthew Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge.
Kacsmaryk sided with the challengers and issued an unprecedented ruling in April, for the first time suspending FDA approval of a human drug over objections from the agency. His ruling embraced language used by antiabortion activists, referring to abortion providers as “abortionists” and to fetuses and embryos as “unborn humans.”
It was quickly put on hold so the federal government and the drug manufacturer could appeal.
Two of the three judges on the appeals court — Elrod and Cory T. Wilson — did not go as far as Kacsmaryk in their opinion Wednesday. They ruled that too much time has lapsed for the challengers to mount a court challenge to the FDA’s 2000 approval of mifepristone. Because that statute of limitations has passed, the judges did not address whether the FDA followed proper protocol when it originally approved the drug.
They did rule, however, that the agency years later did not properly vet whether the medication would still be safe if it is not administered in-person.
The Justice Department, representing the FDA, and the drug manufacturer Danco Laboratories, have emphasized the FDA’s reliance on dozens of studies involving thousands of patients to approve the medication, which has been used by more than 5 million women. Serious side effects occur in fewer than 1 percent of patients.
Lawyers defending the drug said the antiabortion challengers had no legal right — or standing — to file the lawsuit because they were not directly harmed by the FDA’s approval of the abortion pill. They also argued that allowing a court to revoke approval of an approved medication would jeopardize access to non-abortion drugs and more broadly harm medical research and innovation.
At oral argument in May, all three appeals court judges, who have previously supported abortion restrictions, seemed prepared to limit access to the medication.
Wednesday’s decision essentially echoed an earlier, initial review of Kacsmaryk’s opinion, in which a separate three-judge panel of the 5th Circuit declined to suspend approval of mifepristone but reversed actions taken by the FDA since 2016 to loosen restrictions on how to obtain the medication.
The Supreme Court temporarily put that appeals court decision on hold, opting to leave the current FDA regulations for mifepristone in place while the litigation continues.
Judge James C. Ho dissented from part of Wednesday’s opinion, saying said he believes that the statute of limitations for challenging the initial approval of mifepristone has not lapsed and the challengers have standing to contest it. Ho, an outspoken conservative and former clerk to Supreme Court Justice Clarence Thomas, wrote that he would have invalidated the FDA’s initial approval and believes the agency’s decisions are subject to review by the courts, just like decisions made by any other agency.
“The scientists at the FDA deserve our respect and our gratitude, but not our blind deference,” Ho said.
This is a developing story. It will be updated.
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