5th Circuit Court of Appeals imposes restrictions on abortion pill mifepristone, however drug will stay on the market for now — Part Three

By Dave Andrusko

At the end of the week, we’re taking still another look at this week’s  important decision by a panel of judges from the 5th U.S. Circuit Court of Appeals which “found unlawful the Biden administration’s mail-order drug regimen and held that the FDA must restore important safeguards on chemical abortion drugs,” in the words of Erin Hawley who represented the Alliance for Hippocratic Medicine. In an article she wrote for World magazine, Hawley said, “While the ruling will not go into effect until the Supreme Court decides whether to review the case, the unanimous decision is a victory for women’s health and the rule of law.”

The panel, comprised of Judges Jennifer Elrod, James Ho, and Cory Wilson, upheld portions of a decision rendered last April by Judge Matthew J. Kacsmaryk who had “suspended the FDA’s approval of the abortion drug mifepristone on the grounds that approval was given ‘based on plainly unsound reasoning and studies that did not support its conclusions,‘” reported the Times’s Pam Belluck and Adam Liptak. “But the appeals court decision kept the F.D.A.’s approval in place. It also kept in place a later F.D.A. approval of the generic version of the drug, which now accounts for about two-thirds of the mifepristone sold in the United States” [],

Hawley, senior counsel at Alliance Defending Freedom, called the 3-0 decision, as mentioned above, “a victory for women’s health and the rule of law.” With well over half of the abortions in the United States using the two-drug chemical regime (so- called “medication abortion”), it is easy to see why lawyers for the Justice Department and the drug’s distributor are adamant that the mifepristone/misoprostol combination is “safer than Tylenol.”

This is stated as if it were a truism so universally accepted that it need not even be proven. Hawley demolished this canard both in her presentation in front of the court and in her articles for the popular press.

#1. “First, the court’s action is victory for women’s health,” Hawley writes. “The court concluded that the so-called abortion pill—a form of chemical abortion—can be dangerous. Indeed, it has harmed thousands, if not hundreds of thousands, of women.”

Obviously, this runs counter to claims made by government lawyers and mifepristone promoters that abortion pills are extremely safe, with rates of serious complications “far less than one percent.” The record examined by the Fifth Circuit says something far different.

 From the 5th Circuit majority opinion written by Judge Jennifer Walker Elrod:

To be sure, not every woman who experiences complications will present to the emergency room or require surgery and/or some other form of urgent care. But many will. According to the most updated REMS medication guide, in studies conducted in the United States, between 2.9% and 4.6% of women visited the emergency room after taking mifepristone.

It is imperative we understand why defenders are able to make the kind of obviously wrong claims about the incidence of complications [“less than 1%”] that they do. It begins with definitions. As Randall K. O’Bannon, NRL Director of Education & Research, has written in an important analysis

A 2015 study of emergency room visits by University of California, San Francisco researcher Ushma Upadhyay is one of those often cited as proof that the rate of serious complications is “less than 1%.” Indeed, in “Incidence of emergency department visits and complications after abortion,” from the January 2015 issue of Obstetrics & Gynecology, Upadhyay officially found that “The major complication rate was 0.23%,” less than a quarter of one percent.

But this depends on several questionable moves to finesse the data. 

First, Upadhyay specifically limits what can be counted as a “serious” or “major” complication. “Major complications were defined as serious unexpected adverse events requiring hospital admission, surgery, or blood transfusion,” the article asserts. “Minor complications were all other expected adverse events.”

While this sounds reasonable, consider the things included in Upadhyay’s “minor complications”: hemorrhage, infection, incomplete or “failed” abortion requiring “uterine aspiration” (i.e., surgical abortion). Even things like “uterine perforation” were classified as “minor.”

Second, with this knowledge, consider that when Upadhyay added in and counted both major and “minor” complications, the complication rate for chemical abortions was 5.19% – considerably higher than the “less than one percent” advertised[Underlining added.]

With that error rebutted, Hawley tells us that the decision

restores crucial safety guardrails on chemical abortion—eliminating the FDA’s unlawful mail-order abortion regime and ensuring that a doctor actually sees a woman before she receives the dangerous drug. This decision is not only crucial for protecting women’s health but restores the promise of Dobbs that the people’s representatives may enact laws regulating abortion and protecting life.

It also moved the gestational limit for use of the drug back from 10 weeks after a woman’s last menstrual period to the original 7 weeks.  Studies showed that the drug became less effective and that complications increased the later it was used.

Second, Hawley wrote, the decision was “a victory for the rule of law: The court faulted the FDA for cutting numerous corners when it removed these crucial safeguards from the chemical abortion drug regimen. That is unlawful.”

Judge Elrod summarized the dangerous shortcuts:

Those changes include: increasing the maximum gestational age from forty-nine days to seventy days; allowing non-physicians to prescribe mifepristone; removing the requirement that the administration of misoprostol and the subsequent follow-up appointment be conducted in person; eliminating prescribers’ obligation to report non-fatal adverse events; switching the method of administration for misoprostol from oral to buccal; and changing the dose of mifepristone (600 mg to 200 mg) and misoprostol (400 mcg to 800 mcg). FDA admits that none of the studies it relied on examined the effect of implementing all of those changes together. It studied the amendments individually. 

Judge Elrod concluded

In loosening mifepristone’s safety restrictions, the F.D.A. failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person. [Underlining added.]

I could not do better than to end with Hawley’s fine summary paragraph:

Women and girls deserve the very best our country can give them. It’s high time the federal government—and that includes the FDA—recognizes that their health and wellbeing matters more than a political ideology or padding the coffers of abortion providers and drug manufacturers. It’s time to hold the FDA to the rule of law.