By Dave Andrusko
In a brief one-page order, the Supreme Court this morning agreed to review a ruling by the U.S. Court of Appeals for the 5th Circuit that sharply curbed but did not eliminate access to mifepristone. Mifepristone is one of the two drugs used in “medication” abortions which now account for over half of all abortions performed in the United States.
“The justices will hear appeals from the Biden administration and the maker of the drug mifepristone asking the high court to reverse an appellate ruling that would cut off access to the drug through the mail and impose other restrictions, even in states where abortion remains legal,” Mark Sherman reported for the Associated Press. “The restrictions include shortening from the current 10 weeks to seven weeks the time during which mifepristone can be used in pregnancy.”
At the same time, the justices declined an appeal by the Alliance for Hippocratic Medicine that challenged the FDA’s original approval of the drug in 2000. “The justices’ decision not to take up the challengers’ petition for review was the only denial of review noted on the one-page list of orders, suggesting that the justices wanted to make clear now that they would not weigh in on the FDA’s initial approval of the drug in 2000,” according to Amy Howe.
In his April 7, 2023 ruling for the challengers, Judge Matthew Kacsmaryk accepted their argument that the FDA had fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses. Judge Kacsmaryk also suspended later changes “such as allowing the drug to be used through the 10th week of pregnancy, rather than the 7th, and allowing health-care providers who are not physicians to prescribe the drug,” Howe reported. Judge Kacsmaryk’s suspended FDA approval of mifepristone.
“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,” reported Ann E. Marimow for the Washington Post.
It left in place the original 2000 requirements that the drug be used only up to 7 weeks of pregnancy, including three physician visits, removes the ability for the drug to be mailed or dispensed by pharmacies, prevents non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.
Howe added additional details:
The Biden administration and the drug manufacturer Danco came to the Supreme Court this spring, asking the justices to intervene to maintain the status quo until the dispute is resolved. The justices granted that request, allowing the drug to remain widely available for now.
The Biden administration and Danco came to the Supreme Court in September, asking the justices to weigh in on the propriety of the FDA’s decisions in 2016 and 2021 to make mifepristone more widely available, as well as whether the challengers have a legal right to bring their case at all. The doctors and medical groups asked the justices to take up their challenge to the FDA’s initial approval of mifepristone in 2000.