By Peter Pinedo
Washington D.C., Apr 11, 2023 / 13:15 pm
Texas judge Matthew Kacsmaryk suspended the FDA’s approval of the abortion drug mifepristone Friday on the grounds that approval was given “based on plainly unsound reasoning and studies that did not support its conclusions.”
Though Kacsmaryk’s decision is set to take effect this Saturday, the Biden administration has appealed the ruling to the 5th Circuit Appellate Court in an effort to leave the FDA’s abortion pill approval in place.
Kascmaryk’s ruling, made in the Alliance for Hippocratic Medicine’s suit against the Food and Drug Administration (AHM v. FDA), set off a firestorm of controversy as the latest battle in the abortion fight.
Just hours after the Texas decision, Thomas Rice, another federal judge in Washington state, issued a contradictory ruling, prohibiting the FDA from removing its mifepristone approval in states where abortion drugs are legal.
At issue in both cases is the FDA’s broad approval of mifepristone, the first drug used in a chemical abortion that kills an unborn baby by cutting off the nutrients necessary for it to continue developing.
Given that chemical abortions now account for over half of all U.S. abortions, these rulings carry significant implications for the entire country, including states where abortion remains legally protected.
“This is a pretty unprecedented situation,” Andrea Picciotti, a legal analyst for EWTN, told CNA, adding that “right now the ball is in the 5th Circuit’s hands.”
What’s happening now?
On Monday, the Biden Department of Justice filed an emergency appeal to the 5th Circuit Court of Appeals to stop the Texas judge’s ruling from taking effect.
The DOJ also asked the Washington court to issue a clarification on how its decision affects the Texas ruling. For the time being, the Washington ruling will allow the Biden administration and FDA to argue that it is receiving contradictory guidance from the judiciary.
Health and Human Services Secretary Xavier Becerra slammed Kacsmaryk’s ruling in a Sunday CNN interview, saying, “one judge, in one court, in one state, turned upside down the FDA’s approval process for safe and effective medications, we have to go to court and seek an appeal.”
“We want the courts to overturn this reckless decision,” Becerra said, adding that “everything is on the table,” including instructing the FDA to simply ignore Kacsmaryk’s ruling.
As president, Joe Biden has vowed to broaden access to abortion drugs. In January, he issued a memorandum directing federal agencies to promote wider abortion pill access.
The FDA and mifepristone manufacturer Danco Laboratories have also appealed the decision.
Though the Biden administration is painting Kacsmaryk’s decision as an example of judicial overreach, Picciotti told CNA that his “order was very thorough, very measured and does show a lot of the administrative sleight of hands that were done by the FDA over the years.”
According to Picciotti, the 5th Circuit will most likely at least rule on whether to freeze Kacsmaryk’s decision this week.
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Whichever way the 5th Circuit rules, with the Supreme Court set to go into recess toward the end of June and the DOJ requesting emergency review, Picciotti believes the issue will end up in the nation’s highest court very soon.
Are abortion pills illegal?
By issuing a “stay,” Kacsmaryk’s ruling will block the FDA’s abortion pill approval as unlawful. Kacsmaryk set the decision to take effect on Saturday, April 15, meaning the pills remain legal for now.
Without FDA approval, the legal distribution of mifepristone will be forced to come to a halt across the country. Yet, a lot can change before Saturday.
The Biden DOJ is asking the 5th Circuit Court to freeze the Texas ruling from going into effect until the court is finished reviewing and issues its final opinion. The DOJ has asked the court to freeze Kacsmaryk’s ruling by noon Thursday, “to enable the government to seek relief in the Supreme Court if necessary.”
With all this in flux, it is currently unclear whether abortion pills will be allowed to remain on shelves after Saturday.
Notably, some Democratic leaders, such as the governors in California, Washington, and Massachusetts, are not waiting for a final result and have begun stockpiling years’ worth of abortion pill supplies.
Are abortion drugs safe for women?
The Biden administration continues to maintain that significant FDA research has proven mifepristone to be safe and effective. Yet, according to Mariah Buzza, assistant director of health policy at Christ Medicus Foundation, FDA research is lacking due to the administration’s 2016 decision to remove the requirement for physicians to report nonfatal adverse effects after taking mifepristone.
“Women have been left misinformed, blatantly lied to, and at great risk of harm with mifepristone on the market,” Buzza said. “Through my work and scholarship on women’s health and wellness, I have become painfully aware of the negative impact of mifepristone. While the scope of impact is underreported due to inadequacies with the FDA’s Adverse Event Reporting System, it is known that at least two women have bled to death from undiagnosed ectopic pregnancies after taking these drugs.”
“Because the FDA removed the requirement for confirmation of a uterine pregnancy before administration of mifepristone, we know that women who take this drug are at risk for fatal bleeding if certain pregnancy complications do exist,” Buzza said.
Dr. Ingrid Skop, an OB-GYN and vice president of the Charlotte Lozier Institute, told CNA that “from the beginning,” the FDA has inappropriately classified mifepristone as a treatment for a life-threatening illness, “when the vast majority of the time, pregnancy is not a life-threatening illness.”
“It saddens me when we see politicians vow that they will break the law in order to pursue a pro-abortion agenda,” Skop told CNA. “These pills are dangerous for women; I have seen this over and over, approximately 1 out of 20 women will require surgery often in emergent circumstances … Continuing to prioritize distributing these dangerous drugs, particularly if it’s illegal, just shows a blatant disregard for the rule of law and also a blatant disregard for the health and safety of women.”
