As a result of the verdict, the Fifth Circuit’s decision to limit FDA regulations that enabled the abortion pill to be mailed and used later in pregnancy would no longer be in force.
The Department of Justice (DOJ) requested an administrative stay as well as a stay pending its Fifth Circuit appeal in its emergency appeal, which was submitted to the Supreme Court on April 14. To give itself more time to make a decision, the Supreme Court last Friday issued a five-day administrative stay, which it then prolonged by an additional two days on Wednesday.
The FDA’s approval of mifepristone, which was scheduled to go into force seven days later, was initially subject to a preliminary injunction imposed by Northern District of Texas Judge Matthew Kacsmaryk on April 7. The FDA was ordered not to revoke permission on the same day a federal court in Washington gave a contrary decision in a case brought by twelve Democratic state attorneys general.
Following the FDA’s prompt appeal, the Fifth Circuit decided on April 12 by a vote of 2-1 to partially accept the FDA’s request for a stay on Kacsmaryk’s ruling. As a result, the FDA’s request for the approval of the abortion pill was no longer completely blocked, but limits on regulations published by the agency after 2016 were still in effect.
After 2016, the FDA removed important protections, permitting the pill to be mailed and extending the earliest time it may be taken during pregnancy to 10 weeks.
Alito refuted claims in his dissent that refusing a stay would suggest an opinion on “whether the FDA acted lawfully in any of its actions regarding mifepristone.”
Instead, he added, “it would just refuse to do something that has not been shown to be necessary to avoid the threat of any real harm during the presumably brief period at issue.” Alito said that the Fifth Circuit’s limited stay would just “restore the circumstances” that prevailed between 2000 and 2016 rather than “removing mifepristone from the market.”
He said, “At this time, the applicants are not entitled to a stay because they have not demonstrated that they are likely to endure irreparable harm in the interim.” He then attacked the FDA’s claim that lower court judgments will result in “chaos” in the regulatory system.
In a brief submitted to the Supreme Court on Tuesday evening, the FDA expressed concern that upholding the lower court rulings would “scramble the regulatory regime governing a drug that FDA determined was safe and effective under the approved conditions and that has been used by more than five million American women over the last two decades.”
On Wednesday, the maker of abortion pills GenBioPro also sued the FDA to stop the agency from carrying out court orders directing it to stop selling mifepristone.
A lot of states have weighed in on the lawsuit, which was filed by the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and several medical professionals.
According to the plaintiffs, the FDA is not authorized to approve mifepristone. According to the complaint, when it authorized the pill in 2000, it did so under fast approval rules that required it to classify pregnancy as a “illness” and the pill as offering “meaningful therapeutic benefit.”
The plaintiffs said that the pill causes substantial health dangers to women and girls, citing research demonstrating that women who get chemical abortions are 50% more likely to visit the emergency department within thirty days than women who undergo surgical abortions.
President Biden stated in a statement that “as a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts.” “I still support FDA’s evidence-based approval of mifepristone, and my Administration will continue to uphold FDA’s independent, expert authority to review, approve, and regulate a broad range of prescription drugs,” the spokesperson said.
The stakes for women in America could not be greater. I’ll keep fighting against political assaults on women’s health, he said.
