Update:
As expected, the Department of Justice (DOJ) announced on Thursday that it is asking that the U.S. Supreme Court pause the parts of Judge Matthew Kacsmaryk’s decision that remain in effect after the 5th Circuit Court of Appeals granted only a partial stay.
"The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal. We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care," the brief statement from Attorney General Merrick Garland read.
Statement from Merrick B. Garland on Alliance for Hippocratic Medicine v. FDA Appeals Decision https://t.co/IkBZULyNfD
— Justice Department (@TheJusticeDept) April 13, 2023
As The Hill reported in covering this breaking news, it is Justice Samuel Alito who handles emergency applications from the 5th Circuit.
Original:
The Biden administration acted swiftly against U.S. District Court Judge Matthew Kacsmaryk’s abortion ruling from last Friday finding that the Food and Drug Administration (FDA) violated federal standards when it approved mifepristone to be used as an abortion method in 2000. On Monday, the Department of Justice (DOJ) announced it was appealing to the 5th Circuit Court of Appeals, asking for a "pause," as was Danco Laboratories. Late on Wednesday night, the court decided that it would only grant a stay in part. The decision also explained that "Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges."
While the court put on hold suspending the FDA's original approval of mifepristone from 2000, it upheld critical parts of Judge Kacsmaryk's decision suspending the FDA's changes from 2016. Why the 2000 approval from the FDA remains is a matter of timing. As an NBC report about the decision summarized:
The appeals court concluded that the challengers had waited too long to challenge the 2000 approval in court. But, the court found, the claims against the 2016 revisions and later decisions could be pursued because the government and drug maker Danco Laboratories "have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges."
Changes made in 2016 included approving the abortion pill method, also known as medication abortion or chemical abortion, from seven weeks to 10-weeks. In-person office visits were also reduced to just one visit, non-doctors were allowed to prescribe and administer mifepristone, and the reporting of nonfatal adverse events was eliminated.
In another win for safety regulations and protecting women, regulations known as Risk Evaluation and Mitigation Strategy (REMS) that were permanently suspended by the Biden administration in December of 2021, can also be put on hold. The suspension of REMS meant that women no longer needed an in-person visit to obtain the abortion-causing pills, and could obtain them by mail.
Without an in-person visit, women would not be given an ultrasound to confirm that she met the gestational requirement, or that she was even pregnant at all. An ultrasound is also done to confirm that a woman is not experiencing an ectopic pregnancy, which this method does not treat.
The decision make clear points about the danger of the method. "As a result of FDA’s failure to regulate this potent drug, these doctors have had to devote significant time and resources to caring for women experiencing mifepristone’s harmful effects. This harm is sufficiently concrete," it noted. The decision would later mention that "doctors can also show that these injuries are traceable to FDA regulations and redressable by this court."
This method carries with it four times the complications of surgical abortions. Side effects and risks associated include abdominal pain, nausea, vomiting, diarrhea, weakness, fever/chills, and headaches. The bleeding may last for weeks.
Some studies have found 10 percent of women face incomplete abortions at 9-weeks gestation. This can lead to death from infection if the remaining fetal parts or tissue are not properly removed.
In November of 2021, the Charlotte Lozier (CLI) Institute released a peer reviewed journal that showed emergency room visits went up 507 percent between 2002 and 2015 following this method, and that 60 percent of visits were incorrectly attributed to miscarriages.
The method's side effects are discussed in the decision, which is cited via testimony from doctors, with a mention about ectopic pregnancies are particularly dangerous as well.
Pro-life groups are celebrating the decision. "Corporate abortion has hidden behind talking points for decades, ignoring the risks of deadly Chemical Abortion Pills as they have weaponized and weakened the medical standards to favor abortion industry interests," said Student for Life of America’s Kristan Hawkins. "This ruling demolishes the FDA and abortion lobby's claim that these drugs are safer than Ibuprofen using their own words and warnings. In court, the facts spoke louder than the spin, and the deadly impact on women is finally acknowledged."
Hawkins' group, Students for Life of America (SFLA), has raised awareness about the method through the This Is Chemical Abortion website and has conducted a YouGov-Vinea poll by the Demetree Institute for Pro-Life Advancement which shows strong support for regulations.
SFLA Corporate Counsel Zac Kester also said that the decision "returns the focus of the case to the women exposed to Chemical Abortion Pills," and that the, "The 5th Circuit properly observed how the 2016 reducing of protections along with subsequent FDA action represented a ‘sea change’ in prescribing standards that harms women and is worthy of being stopped at this early phase. This bad policy did not need to remain in place."
Not only is the case being expedited on the appeals court's calendar, but the case is almost certainly going to go to the U.S. Supreme Court, which is comprised of a 6-3 majority for conservatives. In January of 2021, at the behest of the outgoing Trump administration, the Court had decided to keep the REMS, though this was not maintained by the incoming Biden administration.
"5th Circuit" is trending on Twitter about the news, with hand wringing still occurring because of reinstated safety regulations.
Join the conversation as a VIP Member