Appeals court rules that abortion pill can stay on the market, but limits access
The FDA approved mifepristone under the brand-name Mifeprex in 2000, and an abortion-drug regimen that has seen few deaths and a low rate of adverse events in more than two decades of use. (Photo by Peter Dazeley/Getty Images)
An appeals court in New Orleans late Wednesday partly blocked a judge’s order that would have overturned federal approval of the abortion pill — which means the pill remains available across the nation for now.
But the 5th Circuit Court of Appeals also let part of the Texas judge’s order stand. The effect of the appeals court decision appears to be that while the case is on appeal, the abortion medication mifepristone is approved for use in pregnancies up to seven weeks, not 10 weeks, and it can’t be dispensed through the mail.
U.S. District Court Judge Matthew Kacsmaryk, in the Northern District of Texas, had ruled Friday, April 7, to overturn the U.S. Food and Drug Administration’s 2000 approval of the abortion drug mifepristone.
Kacsmaryk put a seven-day delay in his ruling and the U.S. Justice Department filed an appeal to the 5th Circuit Court of Appeals and asked the court to put the Texas ruling on hold. The manufacturer, Danco Laboratories, also appealed.
In the 42-page ruling in the 5th Circuit, a panel of three judges wrote, “At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.” They granted a stay, or pause, of that part of the Texas decision.
But they said the arguments of anti-abortion groups are more likely to succeed in connection with the actions taken by the FDA in 2016 and later to make the abortion pill more widely available.
The 2016 changes by the FDA increased maximum gestational age to 70 days when the pill could be used; reduced required in-person office visits to one; allowed non-doctors to prescribe and administer mifepristone; and eliminated reporting of non-fatal adverse events, according to the appeals court ruling.
In 2021, the FDA announced “enforcement discretion” to allow mifepristone to be dispensed through the mail during the COVID-19 pandemic. Earlier this year the FDA permanently removed the in-person dispensing requirement, the court said.
The lawsuit, brought by the anti-abortion Alliance for Hippocratic Medicine and others against the FDA, will continue through the appeals process and is expected to wind up at the U.S. Supreme Court.
The three-judge appeals court panel in New Orleans that issued Wednesday night’s order was made up of Judge Catharina Haynes, appointed by former President George W. Bush; Judge Kurt D. Engelhardt, appointed by former President Donald Trump; and Judge Andrew W. Oldham, also appointed by Trump.
It was not immediately clear how the 5th Circuit ruling would affect — or not affect — a separate ruling from U.S. District Court for the Eastern District of Washington Judge Thomas Rice.
Rice on Friday, just minutes after the Texas order, barred the FDA from changing “the status quo and rights as it relates to the availability of Mifepristone” in the 17 states and District of Columbia that filed a lawsuit about the pharmaceutical in his court.
The U.S. Justice Department has asked Rice to clarify his ruling, saying it “appears to be in significant tension” with the Texas opinion.
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