Federal Appeals Court Restricts Access to Widely Used Abortion Medication
In a recent ruling, a federal appeals court has announced that it will restrict access to a widely used abortion medication due to concerns over the federal government’s failure to follow proper processes in loosening regulations. The medication in question is mifepristone, which is a key component of a two-drug regimen used in over half of all U.S. abortions. The court found that previous decisions by the Food and Drug Administration (FDA) to allow the drug to be taken later in pregnancy, be mailed directly to patients, and be prescribed by medical professionals other than doctors were not lawful.
The conservative U.S. Court of Appeals for the 5th Circuit, in a three-judge panel, partially upheld a lower-court judge’s ruling in favor of a coalition of anti-abortion challengers. The court’s decision can still be appealed to the Supreme Court. For now, mifepristone will remain available under existing regulations while the litigation continues, in accordance with a Supreme Court ruling earlier this year.
If the appeals court ruling eventually takes effect, it would make obtaining the abortion pill more difficult for patients. Judge Jennifer Walker Elrod wrote in the court’s opinion that the FDA failed to address important concerns about the safety of mifepristone when loosening its restrictions. She stated that the FDA “failed to consider the cumulative effect of removing several important safeguards at the same time.”
The legal battle over mifepristone has intensified since the Supreme Court overturned Roe v. Wade’s grant of a constitutional right to abortion in June 2022, leading several states to further restrict or ban the procedure. The challenge to mifepristone was brought by the Alliance for Hippocratic Medicine, an association of anti-abortion doctors and others. They argued that the FDA did not adequately consider safety concerns when approving and expanding the use of the drug.
U.S. District Judge Matthew Kacsmaryk, a Trump nominee with anti-abortion views, initially sided with the challengers and suspended FDA approval of mifepristone in April. However, his ruling was quickly put on hold to allow for appeals by the government and the drug manufacturer, Danco Laboratories.
The appeals court, including Judges Elrod and Cory T. Wilson, ruled that the challengers had missed the statute of limitations to challenge the FDA’s 2000 approval of mifepristone. However, they did find that the FDA failed to properly vet the medication’s safety when considering its use without in-person administration.
The Justice Department, representing the FDA, and Danco Laboratories highlighted the numerous studies and low incidence of serious side effects associated with mifepristone. They argued that the anti-abortion challengers lacked standing to file a lawsuit and that revoking approval of an already approved medication would have broader negative consequences for medical research and innovation.
During oral arguments in May, all three appeals court judges, who have previously supported abortion restrictions, indicated their willingness to limit access to the medication. Wednesday’s decision largely echoed an earlier review of Judge Kacsmaryk’s opinion, which reversed FDA actions taken since 2016 to relax restrictions on obtaining mifepristone. The Supreme Court temporarily put that decision on hold, preferring to maintain current FDA regulations while the litigation continues.
Judge James C. Ho dissented from part of the court’s today’s opinion. He believes the statute of limitations for challenging the initial approval of mifepristone has not lapsed and disputes the standing of the challengers to contest it. Judge Ho, an outspoken conservative and former clerk to Supreme Court Justice Clarence Thomas, asserts that the FDA’s initial approval should have been invalidated and argues that the agency’s decisions should be subject to review by the courts.
This is a developing story, and updates will be provided as the case progresses.