The U.S. Supreme Court on Friday temporarily blocked a federal court’s ruling that suspended the FDA’s approval of the abortion pill.
Justice Alito issued the administrative stay of U.S. District Judge Kacsmaryk’s ruling dealing with the circulation of mifepristone, one of two drugs commonly involved in a chemical abortion regime. Mifepristone, a progesterone blocker, kills the unborn baby by depriving it of nutrients, and misoprostol causes uterine contractions to empty the uterus. Over half of all abortions in the U.S. are done using the two-drug combination.
The stay applies until 11:59 p.m. ET on Wednesday. Any response to the application must be filed on or before Tuesday, April 18, 2023 by 12 p.m., the order states.
After Kacsmaryk’s order, the Department of Justice appealed the decision in the case, which has now been escalated to the Supreme Court. His injunction overturned the FDA’s approval of mifepristone in 2000, stopping short of completely withdrawing or suspending the agency’s approval of the drug over the objections of pro-life groups. On the heels of that ruling came a contradictory one from a Washington State federal judge.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the 67-page opinion. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”
The case stems from a lawsuit filed in November by Alliance Defending Freedom on behalf of the Alliance for Hippocratic Medicine, an organization of pro-life medical groups, as well as four pro-life doctors. The lawsuit argued that the FDA failed to conduct a thorough safety assessment of the drug before it granted approval nearly a quarter century ago. The FDA eliminated existing safeguards and made the drug more accessible when it should have increased oversight of the drugs, the plaintiffs allege.
ADF also say that the FDA improperly invoked a certain regulation, called Subpart H, to justify its approval of mifepristone. Subpart H allows for expedited approval of potentially dangerous drugs that can be used to treat “serious or life-threatening illnesses” or that provide a “meaningful therapeutic advantage over existing treatment.” ADF rebutted that pregnancy is not an illness to be remedied but a “normal physiological state that many females experience one or more times during their childbearing years.” The abortion pill poses a greater health risk to the mother than surgical abortion, the ADF attorneys also contend.