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

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At the conclusion of the week, we will undertake a further examination of the significant decision rendered by a panel of judges from the 5th U.S. Circuit Court of Appeals. This panel determined that the Biden administration’s mail-order drug regimen was unlawful and that the FDA must reinstate essential safeguards on chemical abortion drugs. This is according to Erin Hawley, who represented the Alliance for Hippocratic Medicine. In an article published in World magazine, Hawley stated that while the ruling will not take effect until the Supreme Court decides whether to review the case, the unanimous decision represents a victory for women’s health and the rule of law.

The panel, comprising judges Jennifer Elrod, James Ho and Cory Wilson, upheld certain aspects of a ruling handed down last April by Judge Matthew J. Kacsmaryk, who had suspended the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone on the grounds that the approval was “based on clearly unsound reasoning and studies that did not support its conclusions,” as reported by Pam Belluck and Adam Liptak of the New York Times. However, the decision of the appellate court maintained the approval of the Food and Drug Administration (FDA). Furthermore, the F.D.A. approval of the generic version of the drug, which now accounts for approximately two-thirds of the mifepristone sold in the United States, was also maintained.

Hawley, senior counsel at Alliance Defending Freedom, described the 3-0 decision, as previously mentioned, as a “victory for women’s health and the rule of law.” Given that over half of all abortions in the United States employ the two-drug chemical regimen (also known as “medication abortion”), it is evident why attorneys representing the Justice Department and the drug’s distributor are adamant that the mifepristone/misoprostol combination is “safer than Tylenol.”

This assertion is presented as an unquestionable truth, as though it were universally accepted and therefore unnecessary to provide evidence to support it. Hawley effectively refuted this assertion in both her courtroom presentation and her contributions to popular press publications.

#1. The first item on the agenda is as follows: In his written opinion, Hawley asserts that the court’s action represents a victory for women’s health. The court determined that the so-called abortion pill, a form of chemical abortion, can be dangerous. Indeed, it has caused harm to thousands, if not hundreds of thousands, of women.

It is evident that these findings challenge the assertions made by government lawyers and mifepristone promoters that abortion pills are highly safe, with rates of serious complications being “far less than one percent.” The record examined by the Fifth Circuit reveals a markedly different picture.

The majority opinion of the 5th Circuit, authored by Judge Jennifer Walker Elrod, states:

Of course, not every woman who experiences a complication will go to the emergency room or need surgery and/or other urgent care. But many will. According to the most recent REMS medication guide, in studies conducted in the United States, between 2.9% and 4.6% of women went to the emergency department after taking mifepristone.

It is of the utmost importance to comprehend the rationale behind the assertions made by defenders regarding the prevalence of complications, which are demonstrably inaccurate. The process begins with the establishment of clear 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 Ushma Upadhyay, a researcher at the University of California, San Francisco, is frequently cited as evidence that the rate of serious complications is less than 1%. Indeed, in the January 2015 issue of Obstetrics & Gynecology, Upadhyay published a study titled “Incidence of emergency department visits and complications after abortion,” in which she found that the major complication rate was 0.23%, which is less than a quarter of one percent.

However, this conclusion is contingent upon several questionable methodological decisions that have been employed to refine the data.

Firstly, Upadhyay explicitly delineates the parameters of what may be considered a “serious” or “major” complication. The article asserts that “major complications were defined as serious unexpected adverse events requiring hospital admission, surgery, or blood transfusion.” “Minor complications were defined as all other expected adverse events.”

While this may appear reasonable, it is important to consider the inclusions in Upadhyay’s definition of ‘minor complications’. These include haemorrhage, infection, incomplete or ‘failed’ abortion requiring ‘uterine aspiration’ (i.e. surgical abortion). Even conditions such as uterine perforation were classified as minor.

Secondly, it is important to consider that when Upadhyay included both major and “minor” complications in her calculations, the overall complication rate for chemical abortions was 5.19%, which is considerably higher than the figure of “less than one percent” that was previously advertised.

Having addressed the aforementioned error, Hawley proceeds to inform us of the decision.

restores crucial safeguards to chemical abortion – eliminating the FDA’s unlawful mail-order abortion scheme and ensuring that a doctor actually sees a woman before she receives the dangerous drug. This decision is not only critical to protecting women’s health, it restores the promise of Dobbs that the people’s representatives can pass laws regulating abortion and protecting life.

Furthermore, the gestational limit for the use of the drug was revised, moving from 10 weeks after a woman’s last menstrual period to the original 7 weeks. A series of studies demonstrated that the drug’s efficacy diminished with increasing gestational age, accompanied by an elevated incidence of complications.

Secondly, Hawley asserted that the decision represented a triumph for the rule of law. The court found fault with the FDA for cutting numerous corners when it removed these crucial safeguards from the chemical abortion drug regimen. This was deemed unlawful.

In his summary of the dangerous shortcuts, Judge Elrod identified the following:

These changes include: increasing the maximum gestational age from forty-nine to seventy days; allowing non-physicians to prescribe mifepristone; removing the requirement that misoprostol be administered and followed up in person; removing the requirement for prescribers to report non-fatal adverse events; changing the method of administration of misoprostol from oral to buccal; and changing the dose of mifepristone (600 mg to 200 mg) and misoprostol (400 mcg to 800 mcg). The FDA admits that none of the studies it relied on looked at the effect of implementing all of these changes together. It looked at the changes individually.

Judge Elrod concluded

In relaxing the safety restrictions on mifepristone, 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 these “major” and “interrelated” changes might change the risk profile such that the agency should continue to require reporting of non-fatal adverse events. And it failed to gather evidence to demonstrate that mifepristone could be used safely without being prescribed and dispensed in person. [Underline added].

In conclusion, it is my considered opinion that Hawley’s fine summary paragraph provides the most appropriate conclusion to this discussion.

Women and girls deserve the best our country can give them. It’s time for the federal government – and that includes the FDA – to recognize that their health and well-being are more important than political ideology or filling the coffers of abortion providers and drug companies. It’s time to hold the FDA to the rule of law.


Daniel Miller is responsible for nearly all of National Right to Life News' political writing.

With the election of Donald Trump to the U.S. presidency, Daniel Miller developed a deep obsession with U.S. politics that has never let go of the political scientist. Whether it's the election of Joe Biden, the midterm elections in Congress, the abortion rights debate in the Supreme Court or the mudslinging in the primaries - Daniel Miller is happy to stay up late for you.

Daniel was born and raised in New York. After living in China, working for a news agency and another stint at a major news network, he now lives in Arizona with his two daughters.

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