By Dave Andrusko
As we near the end of 2023, pro-lifers are fixing their attention on the Supreme Court. On December 13, the justices agreed to hear the pro-abortion Biden Administration defend the new REMS put in place last January. These changes remove the required in-person visit to pick up the pills, thus authorizing mail order, but still keep certain provider certification qualifications and impose a certain set of requirements for pharmacy certification.
But note, the justices chose to hear the more limited 5th Circuit Court of Appeals’ decision, not that of the trial Judge Matthew J. Kacsmaryk.
The original lawsuit was brought by the Alliance Defending Freedom on behalf of pro-life medical organizations and four doctors who say they have treated women with mifepristone. Judge Matthew J. Kacsmaryk held “that both the initial approval of the pills in 2000 as well as more recent FDA decisions allowing them to be prescribed via telemedicine, sent by mail and dispensed at retail pharmacies, are unlawful,” Politico’s Alice Miranda Ollstein wrote.
Judge Kacsmaryk stayed his decision to allow an appeal which came in short order. The case moved to the Fifth Circuit, an appellate court that oversees district courts in several states, including Texas.
“In August 2023, that court ruled that the statute of limitations on challenging mifepristone’s FDA approval had passed,” Rachael Robertson reported for MedPage. “However, mifepristone was ruled back to pre-2016 restrictions.”
“The upshot,” Ryan Bangert wrote, “is that the Fifth Circuit’s decision will, if allowed to stand, reinstitute the same prescribing rules in place throughout all but the final year of the Obama administration.”
Very much worth noting were the comments of Judge Ho, who was part of the 5th circuit court of appeals panel. He wrote
By the applicant’s own admission, the FDA used an unlawful procedure when it approved mifepristone. And the agency’s later regulations are likewise invalid—both under the APA as the majority outlines, and under the Comstock Act as well. In sum, the regulations are “not in accordance with law” and therefore must be set aside. Accordingly, we should affirm.
His biting conclusion?
Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect. None of us are. We all make mistakes. And the F.D.A. has made plenty.
[For more on the 5th Circuit’s decision, see here]
Robertson’s account was typical of the way the case has been reported. In addition to minimizing the weight of the plaintiffs’ argument, trotting out the pro-abortion-to-the-hilt Medical Establishment, interviewing only one pro-abortion law professor, there was not a whisper of one of the key complaints brought by the AHM and the physician plaintiffs, that challenged the soundbite that says “safer than Tylenol”: it isn’t safe for women!
Christina Francis is chair of the board of the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG). She has written extensively about the real danger—that posed by mifepristone/misoprostol. One example:
One of the largest studies to date, which analyzed high-quality registry data obtained from nearly 50,000 women in Finland, found that the overall incidence of immediate adverse events is four-fold higher for medical abortions than for surgical abortions. The same study showed that nearly 7% of women will need surgical intervention — a significant number when you consider there are nearly 900,000 abortions per year in the U.S., 40% of which are medication abortions.
Dr. Randall K. O’Bannon, NRL Director of Education & Research, also noted,
Other studies, even some by abortion advocates, have found something similar — that chemical abortions have a much higher failure rate, that more of these women have complications, that more women show up in the emergency room needing surgical treatment for bleeding, to deal with “retained products of conception” — than what Dr. Rebecca Miller reports here.
[Dr. Miller is a fellow with Physicians for Reproductive Health.]
A lot is riding on this case. We will keep you up to date throughout the new year.