The conservative U.S. Court of Appeals for the 5th Circuit said the Food and Drug Administration did not follow proper procedures when it began loosening regulations for obtaining the pill, which was first approved more than 20 years ago. The changes made over the last few years included allowing the drug to be taken later in pregnancy, to be mailed directly to patients and to be prescribed by a medical professional other than a doctor.
Medications to terminate pregnancy, which can be taken at home, have increased in importance over the last 18 months, as more than a dozen states severely limited or banned abortions following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization.
The justices agreed to review the case as the broader issue of abortion access remains a divisive issue politically and legally. A pregnant woman in Texas this week lost her legal battle for permission to end her pregnancy this week, after she had left the state to obtain an abortion. Last week, a Kentucky woman went to court asserting the state’s abortion restrictions violate her constitutional right to privacy.
If access to mifepristone was restricted, abortion providers and advocates say, pregnancies could still be terminated using only the second drug in the regimen, misoprostol. But using that drug alone causes more cramping and bleeding, and abortion opponents could move to restrict its use as well if they win limits on the use of mifepristone from the high court.
The court’s decision to review the mifepristone case is not surprising. In April, after a District Court ruling to suspend FDA approval of the drug, the justices said existing rules for prescribing and distributing mifepristone would remain in place nationwide while the litigation continues.
In that order, only Justices Clarence Thomas and Samuel A. Alito Jr. said they would not have granted the Biden administration’s request for a stay of the District Court decision. Critics say the lower court’s ruling undermines the role of federal regulatory agencies.
Solicitor General Elizabeth B. Prelogar told the high court that mifepristone has been safely used by millions of people over more than two decades, and warned that allowing the lower court’s decision to stand would have “damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”
The challenge to mifepristone was initiated 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 — allowing the use of mifepristone through 10 weeks of pregnancy, for instance, instead of seven.
The group filed its lawsuit in Amarillo, Tex., where U.S. District Judge Matthew J. Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge. He sided with the challengers and suspended FDA approval of the medication.
The 5th Circuit reversed that part of Kacsmaryk’s order, but agreed with him in blocking the changes starting in 2016 for how the drug was prescribed and distributed, and at what point in a pregnancy it could be used.
The justices said Wednesday they would not review a separate request to consider a challenge to the FDA’s initial approval of mifepristone in 2000.
This is a developing story. It will be updated.
