Mifepristone, the FDA, and the unborn child

Mifepristone, the FDA, and the unborn child
By Terry A. Hurlbut
Yesterday two consolidated cases – the Mifepristone Cases – came to oral argument before the Supreme Court. At issue is whether the Food and Drug Administration acted properly in first approving mifepristone – the current chemical abortifacient of choice – and whether the FDA still acted properly in removing at least three safeguards regarding its use. It has turned into an issue of whether anyone has any oversight whatsoever over the FDA for its decisions. But it also illustrates the current obstacle toward a goal of forbidding abortion in the United States today. The courts of this land – except in certain “red States” – simply will not allow anyone to argue for the forgotten entity in the abortion debate – the unborn child.
What is mifepristone?
Mifepristone is the generic name for 11β-[p-(Dimethylamino)phenyl]-17α-(1-propynyl)estra-4,9-dien-17β-ol-3-one. Before the assignment of that generic name, it carried three other development names, most notably RU-486. (The “RU” in this case stood for Roussel-UCLAF, a French drug maker now long since bought out. The company that now makes the only variant available in the United States is Danco Laboratories.
Mifeprisone is an antiprogestogen and an antiglucocorticoid. As an antiprogestogen, it causes the lining of the womb to become inhospitable to an implanted unborn child. The child, starved for oxygen, dies. Then the patient takes a prostaglandin analogue, called misoprostol, to expel what’s left. (Internists also use the drug to treat certain cases of Cushing’s Syndrome.)
In June 2022, the Supreme Court vacated the blanket prohibition against State regulation, or bans, of abortion. Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022).
https://rumble.com/v19sqbz-roe-v.-wade-has-fallen-has-fallen.html?mref=4teej&mc=88ce6
In December of that year, the FDA removed all existing restrictions on the use of mifepristone, which originally required a physician visit. Now, patients would be able to order it through the mail. The Justice Department then declared that no State may ban mifepristone. And though sending mifepristone through the mail violates the Comstock Act (18 U.S.C. section 1461), the Justice Department refuses to prosecute.
https://rumble.com/v25xq08-abortion-pills-by-mail-not-so-fast.html?mref=4teej&mc=88ce6
The Alliance for Hippocratic Medicine sued the FDA, alleging violation of the Administrative Procedures Act. That case came before Judge Matthew Kacsmaryk in Amarillo, Texas. (See docket page.) Danco Laboratories later petitioned for acceptance as an intervenor in the case.
Not without side effect
In the last action on mifepristone, the Fifth Circuit Court of Appeals has upheld an injunction against the FDA’s removal of certain restrictions that prevented the sending of the drug through the mail. (See Docket Page here.) The Fifth Circuit could not support enjoining the original approval, because the statute of limitations has run out.
While the oral arguments were taking place, Commentator Elijah Schaffer released this video describing the key issues the Alliance for Hippocratic Medicine is raising: the complications that occur to women taking it.
https://rumble.com/v4lp2sc-beyond-the-headlines-a-landmark-case-on-abortion-goes-before-the-supreme-co.html?mref=4teej&mc=88ce6
The New York Times admits that mifepristone now accounts for more than two thirds of abortions in America today. The problem is that in 2.9 to 4.6 percent of uses, the women involved land in the emergency room. Obstetricians on call to these emergency rooms face a dilemma. They do not want to perform abortions, and hospital superintendents must respect that. But often a patient bleeding from a mifepristone complication requires completion of the abortion to save her life. The doctor does not have time to decide why the patient is even before him. So he must treat the patient, no matter how she got there. No one seriously suggests that this doctor withhold care.
Thus the Alliance relies on the statements of two of these doctors (one from Indiana, the other from Texas) that they face crises of conscience virtually every night they spend on-call.
The arguments for mifepristone
The two cases (now consolidated) before the Supreme Court have Docket Numbers 23-235 and 23-236. Transcript and audio recording are available at the Court’s site. Yesterday’s argument session lasted for slightly more than an hour and a half.
Solicitor General Elizabeth Prelogar argued that the Alliance has no standing, because no physician can definitely show that he or she will face that moral dilemma. Several Justices asked her, if the Alliance had no standing, who would? Her answer: no one, because she also said the courts ought never “second-guess… the agency’s expert judgments.” Furthermore, she said allowing this injunction would “inflict grave harm on women across the nation.” Why? Because:
Some women could be forced to undergo more invasive surgical abortions. Others might not be able to access the drug at all.
Justice Alito especially found Prelogar’s argument, that no one had standing to challenge the FDA, hard to swallow. Naturally, the Solicitor General chose to evade the question.
Jessica Ellsworth, lawyer for Danco Laboratories, made much the same arguments. Her position seemed only slightly less tenable for a big reason: the Comstock Act. That Act forbids the sending through the mails of anything for “immoral purposes,” the then-current euphemism for abortion. Justice Thomas especially made the point that Danco likely stands in violation. Ms. Ellsworth answered that the law has seen no enforcement action for “nearly a hundred years.”
Both lawyers made the astounding claim that the FDA had absolute authority to approve or disapprove of a drug. No court, they said, could gainsay the FDA on any ground whatsoever.
The argument against it
Erin M. Hawley, arguing for the Alliance, asserted her organization’s standing, and raised the most important argument. Which is that the FDA violated the Administrative Procedures Act in clearing the sending of mifepristone through the mail. She also presented the figures that 2.9 to 4.6 percent of women who take it, require an emergency room visit.
Sadly, the questioning by Justice Thomas and especially Chief Justice Roberts suggests that the weight of precedent stands against them. To her credit, she pressed on, reiterating that a doctor doesn’t have time to screen out a case violating his or her conscience.
Justice Ketanji Brown Jackson was the most consistent defender of the FDA and Danco, in her questioning of all three. Clearly she sought to get the Court to leave mifepristone alone. So also did Justices Kagan and Sotomayor, though they seemed less comfortable with General Prelogar’s arguments than did Jackson.
The strongest arguments seem to be the ones that matter the least. A 2.9 to 4.6 percent severe complication rate does not seem “infinitesimally rare.” Yet that is what General Prelogar called it – though she didn’t say the rate out loud; Ms. Hawley did.
Then we have the party no one will acknowledge: the unborn child. A woman who suffers such a complication, and lives to tell about it, is far more likely to change her lifestyle so she would never have to go through that again. But a cold, hardened sex addict with no feelings for unborn children, will not.
Analysis
Your correspondent is not a lawyer, but he did train as a physician. The physician’s observation is that any drug having a frequency of severe side effect comparable to that of mifepristone, would not long remain on the market. The only reason mifepristone does remain, is that the current Commissioner of Food and Drugs wants to preserve abortion access. As such this person displays all the ideological corruption of the current administration. This administration, furthermore, will not enforce the Comstock Act, for the same reason they will not enforce the immigration laws. The reason is: those laws run counter to their ideological agenda. The Resident does not even hold himself subject to the directive to “take care that the laws be faithfully executed.” (Article II Section 3.)
Solicitor General Prelogar offers a totally specious argument to allege “grave harm on women.” No, General Prelogar, no woman would be forced to obtain a surgical abortion. No woman is forced to obtain an abortion at all – at least, not by any current laws. Sadly, before the Court even gets to that point, it must conclude that a party before it has standing.
In that regard, General Prelogar offers an argument even more dangerous, considering its wider implications. Lay aside that she forgets that courts may at any time appoint expert Special Masters. She asserted that the FDA is accountable only to the President. If that’s true, Congress needs to correct that legislative error forthwith. But at least one Justice doubts that.
The forgotten individual
But this case illustrates yet again the most tragic flaw in American constitutional and case law. No one speaks for the unborn, either individually or as a class. Beyond an FDA that holds itself accountable only to Presidents, and that cheerfully sets its own rules aside to preserve “access to abortion,” is that significant proportion of women who actually want it. These are the women who practice abortion tourism, and who may or may not risk arrest by ordering mifepristone or other abortifacients through the mail.
https://rumble.com/v420ufb-abortion-need-for-a-great-awakening.html?mref=4teej&mc=88ce6
The most exquisite irony of yesterday’s events was Justice Jackson, a Black woman, arguing for access to a procedure originally designed to wipe out her race. New York State Attorney General Letitia James doesn’t understand that any better, it seems. She was demonstrating in front of the Supreme Courthouse for continued access to this drug.
https://twitter.com/NewYorkStateAG/status/1772682644913799268
Some will say that this desire for abortion is self-correcting and self-terminating. Few indeed of the women who seek abortion will settle down with children of their own. (If they can have children; have one abortion too many, and a woman loses that option.) Those who do have children, will raise them to value life and deprecate “sexual freedom.” That might have produced the Dobbs result, but even that is not 100 percent effective.
Only a Second Great Awakening can avail to stop spectacles like lawless administrations, and the continued abortion curse.
https://rumble.com/v4hb3b6-a-great-awakening-for-america.html?mref=4teej&mc=88ce6
Link to:
Docket pages for Alliance for Hippocratic Medicine v. FDA:
District Court:
https://www.courtlistener.com/docket/65768749/alliance-for-hippocratic-medicine-v-us-food-and-drug-administration/
Appeals Court:
https://www.courtlistener.com/docket/67164167/alliance-hippocratic-medicine-v-fda/
Supreme Court:
https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/23-235.html
https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/23-236.html

Elijah Schaffer’s commentary:
https://rumble.com/v4lp2sc-beyond-the-headlines-a-landmark-case-on-abortion-goes-before-the-supreme-co.html?mref=4teej&mc=88ce6

Oral argument transcript and audio download:
https://www.supremecourt.gov/oral_arguments/argument_transcripts/2023/22-235_q8l1.pdf
https://www.supremecourt.gov/media/audio/mp3files/23-235.mp3

Tish James’ post:
https://twitter.com/NewYorkStateAG/status/1772682644913799268

Previous videos:
https://rumble.com/v19sqbz-roe-v.-wade-has-fallen-has-fallen.html?mref=4teej&mc=88ce6
https://rumble.com/v25xq08-abortion-pills-by-mail-not-so-fast.html?mref=4teej&mc=88ce6
https://rumble.com/v420ufb-abortion-need-for-a-great-awakening.html?mref=4teej&mc=88ce6
https://rumble.com/v4hb3b6-a-great-awakening-for-america.html?mref=4teej&mc=88ce6

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