In a succinct one-page order, the Supreme Court this morning consented to a review of a ruling by the U.S. Court of Appeals for the 5th Circuit that significantly restricted but did not entirely eliminate access to mifepristone. Mifepristone is one of two drugs utilized 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 manufacturer of the drug mifepristone, requesting that the Supreme Court overturn an appellate ruling that would prohibit the drug’s delivery through the mail and impose other restrictions, even in states where abortion remains legal,” Mark Sherman reported for the Associated Press. The restrictions include a reduction in the time period during which mifepristone can be used in pregnancy, from the current 10 weeks to seven weeks.
In a parallel development, the Supreme Court declined to hear an appeal by the Alliance for Hippocratic Medicine, which had challenged the FDA’s original approval of the drug in 2000. The justices’ decision not to accept the petition for review was the sole instance of denial of review noted on the one-page list of orders. This suggests that the justices wished to make it clear that they would not consider the FDA’s initial approval of the drug in 2000. This is 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. Additionally, Judge Kacsmaryk suspended subsequent modifications, including the authorization for the drug to be utilized through the 10th week of pregnancy, rather than the 7th, and the allowance for healthcare providers who are not physicians to prescribe the drug. Judge Kacsmaryk’s suspension of the FDA’s approval of mifepristone.
The 5th Circuit Court of Appeals reversed a portion of Kacsmaryk’s order, but concurred with him in preventing the implementation of the revised prescription and distribution guidelines, as well as the expanded gestational period for which the drug could be utilized, as reported by Ann E. Marimow for the Washington Post.
The original 2000 requirements that the drug be used only up to seven weeks of pregnancy, including three physician visits, were left in place. The ability for the drug to be mailed or dispensed by pharmacies was removed. The ability for non-physicians to administer the drug was prevented, and the reporting requirements for non-fatal adverse events were reinstated.
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.
