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Four takeaways from Wednesday’s argument over the abortion drug mifepristone

by | May 18, 2023

By Dave Andrusko

Actually listening to the back and forth of yesterday’s 5th US Circuit of Appeals hearing on what to do with mifepristone, the first of the two drugs that make up the chemical abortion regime, is very much worth an hour or two of your time.

The three judge panel (described as “conservative,” “very conservative.” “highly conservative,”  or even “extremely conservative”) peppered lawyers from  all sides with questions that pointed to two options: uphold the trial judge Matthew Kacsmaryk’s conclusion to suspend mifepristone, or reverse actions taken by the FDA since 2016 that have greatly increased the dangers to women.

Here are four takeaways.

#1. The panel was not going to roll over and blindly accept what the FDA said as if it were gospel. We had barely gotten started when Circuit Judge James Ho “showed his hostility to the idea of giving the FDA deference.”

Department of Justice [DOJ] attorney Sarah Harrington started out saying that Judge Kacsmaryk’s opinion was “unprecedented.”

Judge Ho interrupted to say “I’m just wondering why not just focus on facts of the case rather than have this sort of ‘FDA can do no wrong’ theme?” Later he said “We are allowed to look at FDA just like any other agency. That’s the role of the courts.”

#2. Much of the nearly two hours was taken up with the government’s position that the litigants lacked
“standing”—that the challengers failed to show they “are at imminent risk of suffering the kinds of concrete, direct harms due to the FDA’s actions that make it appropriate for a court to intervene,” according to CNN’s Tierney Sneed.

For example, the language in the declarations “lacked the needed level of detail, Ellsworth argued, and were ‘generalized statements.’ The judges pushed back aggressively on her and Harrington’s claims about the declarations’ ambiguity, with Ho repeatedly reading from the declarations themselves.”

Suffice it to say “the judges questioned the reasoning, siding with the anti-abortion groups’ argument that physicians have been forced to provide an abortion, as well as care for patients who have had complications from the procedure,” as summarized by Axios’s Oriana González.

#3. Which is lifted directly from the story appearing in POLITICO written by Alice Miranda Ollstein and Josh Gerstein: Is pregnancy an “illness”?

Multiple judges fixated Wednesday on the FDA’s initial approval of mifepristone falling under a regulatory category technically reserved for drugs that treat serious illnesses, asking DOJ and Danco attorneys if that’s how they view pregnancy.

“When we celebrated Mother’s Day, were we celebrating illness?” Judge James Ho quipped.

Hawley also hammered the point in her turn at the lectern, accusing the agency of “labeling pregnancy an illness.”

Ellsworth explained that the FDA uses the words “illness,” “disease” and “condition” interchangeably and uses that same regulatory pathway for many things that aren’t technically illnesses, including high and low blood pressure, acne and infertility.

My take on that is Ellsworth response was (to be generous) weak. And

#4. Complications, complications, and complications. The DOJ and Danco Laboratories (which manufactures mifepristone) insisted that complication rate for women who take mifepristone is miniscule—less than one percent.

Dr. Randall O’Bannon, director of Education & Research, has cited studies proving that the percentage is much, much higher. See here.

He told me “But the coup de grace is probably just exactly what the Alliance for Hippocratic Medicine attorney Erin Hawley cited — the FDA itself, pointing to Table 2 of the 2023 label itself, which showed ER Visits to be between 2.9%-4.6%.”

We’ll have more tomorrow. You can listen here.

Categories: Judicial
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