A container holding boxes of Mifepristone, the primary medication in a medical abortion, are prepared for patients at Alamo Women’s Clinic in Carbondale, Illinois, April 20, 2023.
Evelyn Hockstein | Reuters
A federal appeals court on Wednesday imposed restrictions on the abortion pill mifepristone, though the ruling is not going to have a direct impact on the medication’s availability.
The U.S. Court of Appeals for the fifth Circuit ruled that several decisions the Food and Drug Administration took to make mifepristone more broadly available to women didn’t take safety concerns into consideration.
The ruling is paused from taking effect until the Supreme Court decides in regards to the case. The high court imposed the pause in April upon request from the Biden administration after lower courts had ruled against the pill within the spring.
If the Supreme Court upholds Wednesday’s ruling, women would now not have the opportunity to acquire the abortion pill through telemedicine appointments and by mail. Patients would must receive a prescription from a health care provider and have three follow-up appointments in person.
The restrictions would also shorten the time period when women can take the pill to 49 days into their pregnancy, down from 70 days.
“In loosening mifepristone’s safety restrictions, FDA failed to handle several necessary concerns about whether the drug can be protected for the ladies who use it,” Judge Jennifer Walker Elrod wrote for the court Wednesday. “It failed to think about the cumulative effect of removing several necessary safeguards at the identical time.”
The appeals court left the FDA’s underlying 2000 approval of mifepristone and its 2019 authorization of a generic type of the drug in place.
In a dissenting opinion, Judge James Ho arguedthe appeals court must also have rolled back the FDA’s original approval of mifepristone, an motion that may remove the medication from the U.S. market.
The American College of Obstetricians and Gynecologists criticized the appeals court decision as “judicial activism.” The medical association said mifepristone is “demonstrably protected and effective” for its FDA-approved use as much as 10 weeks of pregnancy.
Mifepristone, used together with one other drug called misoprostol, is probably the most common method to terminate a pregnancy within the U.S.
The case ended up within the fifth Circuit on appeal after U.S Judge Matthew Kacsmaryk of the Northern District of Texas issued a much wider ruling in April that suspended the FDA approval of mifepristone.
The three-judge panel on the fifth Circuit heard oral arguments in May from the FDA, mifepristone distributor Danco Laboratories and a bunch of anti-abortion doctors called the Alliance for Hippocratic Medicine.
The appeals court judges were all appointed by Republican presidents. Elrod was appointed by George W. Bush. Ho and Judge Cory Wilson were appointed by Donald Trump.
The FDA and Danco argued throughout the May hearing that the lawsuit in search of to drag mifepristone from the U.S. market is unprecedented, has no basis in science and can jeopardize women’s health.
The panel of judges pushed back hard on those arguments.
The judges questioned whether allowing women to receive mifepristone by mail without having to see a health care provider would lead to more patients in search of emergency care. Ho took issue with the characterization of the case as unprecedented.
“I do not understand this theme — the FDA can do no incorrect. That is essentially the narrative you all are putting forth — no one should ever query the FDA,” Ho said throughout the hearing.
“We’re allowed to take a look at the FDA similar to we’re allowed to take a look at any agency, that is the role of the courts,” Ho said.
Correction: Justice Samuel Alito dissented from the Supreme Court emergency decision on April 21 that kept mifepristone broadly available. A previous version of this story misstated his position.