The Supreme Court extended a hold on a lower-court ruling on mifepristone until Friday, meaning the drug will remain broadly available for now.
On Wednesday afternoon, hours before the stay on the lower-court ruling was expected to be lifted, Justice Samuel Alito extended the pause through Friday evening.
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 weeks to 7 weeks, and reinstating rules around required physician visits.
Importantly, it also would have suspended the approval of generic mifepristone, which accounts for two-thirds of the available supply of the drug.
Those restrictions could still take effect, however, if the Supreme Court allows the stay to expire on Friday.
“There’s a lot at stake for patients, for doctors, and for public health,” Joshua Sharfstein, MD, a former principal deputy commissioner of the FDA, told MedPage Today. “So, the uncertainty is really unfortunate.”
Sharfstein said it’s “a little rattling that this is not an obvious question for the courts. We’re talking about a very safe medicine with the full support of major professional associations. The court should not be spending time to undo something that has been a bedrock of reproductive healthcare.”
Medication abortions account for more than half of all abortions nationwide.
The mifepristone saga has advanced through the courts rapidly, with many twists and turns. The most recent events began on Friday, April 7, when a federal judge in Texas — Matthew Kacsmaryk — issued a ruling ordering the suspension of FDA’s 2000 approval of mifepristone.
Kacsmaryk put a stay — or pause — on his own order for 7 days, until the following Friday.
Late last Wednesday night, before the Texas ruling was slated to take effect, a three-judge panel from the Fifth Circuit Court of Appeals in New Orleans acted to uphold parts of Kacsmaryk’s order, but not all of it.
The Fifth Circuit’s order said that the plaintiffs in the case — the Alliance for Hippocratic Medicine (AHM), and other anti-abortion physicians — 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.
This past Friday, the Department of Justice, acting on behalf of the FDA, and mifepristone maker Danco Laboratories, asked the Supreme Court to halt the Fifth Circuit’s ruling. That same day, the high court paused the lower court ruling while the appeal was decided. That pause has just been extended.
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