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naraburns  nihil supernum  1yr ago (text post)   35348 thread views

Culture War Roundup for the week of April 3, 2023

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I can't seem to find a discussion on this yet, and I'm very curious to hear this site's interpretation of events. Yesterday, judge Matthew Kacsmaryk ruled that the FDA should rescind it's approval for a commonly-used pill for abortions, mifepristone. The narrative I'm reading in mainstream media frames this decision as so cartoonishly insane that I'm struggling to see how it can be accurate. However, I'm also struggling to see where exactly the narrative is misleading.

First, the civics-101 explanation of how an agency like the FDA or the Fed should work is that certain regulatory problems are too technical and change too quickly based on new science for lawmakers to deal with them directly. Therefore, Congress delegates its power to a group of skilled experts who can react to the cutting edge of research and make reasonably policy. Of course, this is the civics-101 explanation and reality is presumably much more complicated, but the point is that laypeople who don't really understand the subject matter, like judges or members of Congress, should not be the ones making the final decision on technical questions.

Kacsmaryk's decision is framed as exactly this happening---the FDA made a complicated judgement about the safety of mifepristone based on their expertise and a non-expert judge decided to invalidate it based on their personal disagreements with the technical science. Articles emphasize quotes from the judgement where he explicitly disagrees with the FDA's interpretation of studies: "“Here, F.D.A. acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.", etc. Unfortunately, the actual decision (Edit: better link from ToaKraka) is very long with most of the pages being about legal details like establishing standing, making it hard to find the true reasoning behind it (though props to NYT for emphasizing the primary source so prominently, beat my expectations for news sources).

There has to be more going on here than a random judge deciding that they are more qualified to decide technical medical questions than actual experts; as a general rule, political opponents aren't ever this insane. What are the details I'm not understanding in the decision that make this more reasonable?

What are the details I'm not understanding in the decision that make this more reasonable?

The reasonable interpretation of his court decision is that he has taken umbradge at the FDA's choice to use an expedited approval process where the typical use of the pill does not meet the criteria for expedited approval. That is, most of the problem he is pointing out is not with the underlying science and cost-benefit analysis of the FDA, but rather is a procedural problem.

Just to clarify this interpretation, do you think the judge would accept if a new non-expedited/properly-justified expedited approval process happened over the next few months that reapproved the drug (this isn't rhetorical)? There might be some important legal reason I don't understand for why if there was in fact incorrect procedure the first time around, the agency shouldn't be allowed to redo things in the proper way.

Also, under this interpretation, what was the point of all the language in the opinion specifically disagreeing with the underlying science and cost-benefit analysis? Was it not actually doing that?

It certainly depends on your conflict/mistake theory thesis of the world. The opinion, as written, is mistake theory. The rest is just showing how badly the FDA made a mistake.

If you are pure conflict, there is no reason to respect this if you are an abortion enthusiast.

But if you're pure conflict, there's also no reason to believe the FDAs own decision was apolitical.

I recently read most of the decision after this came up in another forum. The most convincing part of the argument I found was:

  • mifepristone can lead to severe complications if used at too high a gestational age, or in the case of ectopic pregnancy

  • if delivered in the mail, there is often no ultrasound, so the gestational age or the presence of ectopic pregnancy is not checked

  • potential users can include people who don't check this themselves, and then sometimes die or experience severe adverse effects

  • while the data shows this is rare, it's undercounted because the FDA removed reporting requirement for non-fatal adverse effects, and also when the women go into emergency services the side effects are misdiagnosed as side effects from miscarriages instead of from mifepristone (because the doctor doesn't know they've taken it).

  • this implies the need to ban sending the drug through the mail, or to impose an ultrasound requirement to check for the dangerous conditions

The judge goes further and tries to ban mifepristone entirely.

There is some mention of strange bureaucratic interpretations:

the American Medical Association explained that “[Mifepristone] poses a severe risk to patients unless the drug is administered as part of a complete treatment plan under the supervision of a physician”). Thus, to satisfy Subpart H, FDA deemed pregnancy a “serious or life-threatening illness[]” and concluded that mifepristone “provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.”

Whether this is true or not I don't know.

There's some heavy shenanigans about the Comstock Act, which prevents sending abortifacients through the mail, which was rendered null and void by Griswold v. Connecticut but not overturned and so still shambles on, offering a zombie-like ability to infect any cases about sending abortifacients through the mail.

Congress does not (and cannot) fully delegate carte blanche authority to administrative agencies. Any delegation is limited and often governed by things like the APA.

Under the APA, decisions of agencies are reviewed under the arbitrary and capricious standard. I haven’t reviewed this case (and I don’t practice in the FDA area so not sure the particulars there). But courts can look at the record and if it is clear the agency clearly just ignored data or otherwise fucked up, the court can say set aside the agency decision. That is, delegations are still subject to checks and balances.

Haven’t read this case so have zero opinion.

There has to be more going on here than a random judge deciding that they are more qualified to decide technical medical questions than actual experts; as a general rule, political opponents aren't ever this insane. What are the details I'm not understanding in the decision that make this more reasonable?

This is a commendable attitude but in this case it is leading you astray. Kacsmaryk granted relief to Plaintiff's who (1) lack standing and (2) even if they had standing their claims are statutorily time-barred and (3) even if they weren't time barred are barred by lack of exhaustion of administrative remedies. You don't have to take my word for it either. Indeed, the lead plaintiff in this case (the Alliance for Hippocratic Medicine) was formed three months after Dobbs was decided last year and incorporated in Amarillo Texas specifically so they could file this suit and be assured that Matthew Kacsmaryk is the judge who would hear it.

Pretty unfortunate timing of this top level post. The one just below it, shows the partisanship of allegedly purely fact-based federal agencies. So I would support more oversight and protection against human rights violations, in this case right to life, that are perpetrated under the guise of science.

You understand that if this drug is banned, women who suffer miscarriages have to carry the dead fetus and risk sepsis (whereas before they could take the pill to pass the tissue) correct?

  • -13

Definitely not the case. This is a chance for you to ask where you heard that, why they're lying to you, and what else you might have believed from them.

I’m no doctor, but a brief search online shows that doctors routinely prescribe mifepristone for miscarriages. Maybe there are alternatives that are just as good, but I presume doctors aren’t using their second choice.

You need to bring more evidence to this disagreement. As it is, this comment is bad.

What is the evidence that they are repeating a lie?

That is not true. The judge rescinded approval of the abortifacient part of the drug course, not the labor-inducing part.

So I would support more oversight and protection against human rights violations, in this case right to life, that are perpetrated under the guise of science.

The FDA was only in charge of saying whether the drug itself is safe and effective (or safe enough technically I suppose) though. Whether the drug SHOULD be used is outside the FDA's purview. The FDA isn't committing the (proposed) humans rights violations itself.

You could outlaw most abortion and still have the FDA sign off on the drug as safe but it only to be legal to use for cases where the legislature thinks it needs to happen (incest/rape etc.).

The science says this drug ends pregnancies X% of the time with A B and C side effects Z% of the time when taken in Y dosages under Z circumstances. Whether ending a pregnancy should happen is not something the FDA has any say in. So that isn't a human right violation perpetrated under the guise of science.

The FDA says you CAN use this to terminate a pregnancy. But they can't tell you if terminating the pregnancy is legal or moral. Assuming abortion is a human rights violation and is allowed then that would be the fault of the state and federal legislatures for not outlawing it rather than the FDA, surely? Or arguably the fact that enough people don't agree that it is a human rights violation so as to elect politicians who would carry out that agenda.

Otherwise the ATF is on the hook for any human rights violations carried out by firearms they have deemed legal under the relevant statutes as well. Which doesn't seem to make a lot of sense.

Otherwise the ATF is on the hook for any human rights violations carried out by firearms they have deemed legal under the relevant statutes as well. Which doesn't seem to make a lot of sense.

Don't give them ideas...

That does raise a question, though, is it really necessary to strike at mifeprestone specifically, then? Roe already is striking at the sort of higher echelons of law on this issue. I guess the 2022 midterms did show that there still isn't quite enough pressure all around to just formally illegalize abortion, but still.

Its always better to have multiple angles of attack practically i would say. Especially if the public doesn't seem to be entirely onboard. Banning abortion isn't popular but if you feel its murdering millions of babies then morally you probably should not let that stop you. Same with the getting rid of gas cars or whatever to prevent the (putative) end of the human race.

the actual decision

Better link

Unfortunately, the actual decision is very long and full of legal details about things like establishing standing

Standing is important, though.

Anyway, it may be easier to understand the decision if you have a table of contents open in another window.

  • Background
  • Legal Standard
  • Analysis
    • A. Plaintiffs Have Standing
      • 1. Plaintiff Medical Associations Have Associational Standing
      • 2. Plaintiff Medical Associations Have Organizational Standing
      • 3. Plaintiffs' Alleged Injuries are Concrete and Redressable
      • 4. Plaintiffs Are Within the "Zone of Interests"
    • B. Plaintiffs' Claims Are Reviewable
      • 1. FDA "Reopened" Its Decision in 2016 and 2021
      • 2. FDA's April 2021 Decision on In-Person Dispensing Requirements Is Not "Committed to Agency Discretion by Law"
      • 3. Plaintiffs' Failure to Exhaust Certain Claims Is Excusable
        • a. Contrary to Public Policy
        • b. Individual Injustice and Irreparable Injury
        • c. Administrative Procedures Are Inadequate
        • d. Exhaustion Would Be Futile
        • e. The Comstock Act Was Raised with Sufficient Clarity
    • C. Plaintiffs' Challenges to FDA's 2021 Actions Have a Substantial Likelihood of Success on the Merits
      • 1. The Comstock Act Prohibits the Mailing of Chemical-Abortion Drugs
      • 2. FDA's 2021 Actions Violate the Administrative Procedure Act
    • D. Plaintiffs' Challenges to FDA's Pre-2021 Actions Have a Substantial Likelihood of Success on the Merits
      • 1. FDA's 2000 Approval Violated Subpart H
        • a. Pregnancy Is Not an "Illness"
        • b. Defendants Are Not Entitled to Auer Deference
        • c. Chemical-Abortion Drugs Do Not Provide a "Meaningful Therapeutic Benefit"
        • d. Defendants' Misapplication of Subpart H Has Not Been Cured by Congress
      • 2. FDA's Pre-2021 Actions Were Arbitrary and Capricious
        • a. The 2000 Approval
        • b. The 2016 Changes
        • c. The 2019 Generic Approval
    • E. There Is a Substantial Threat of Irreparable Harm
    • F. Preliminary Injunction Would Serve the Public Interest
    • G. A Stay under Section 705 of the APA Is More Appropriate Than Ordering Withdrawal or Suspension of FDA's Approval
  • Conclusion

And here's an article from a law professor who criticizes both this decision and an almost-simultaneous decision in the other direction from a different district court.

Thanks for the links! It's surprisingly hard to find primary sources about current events these days since for whatever reason search engines decided five years ago to heavily prioritize low-quality news articles instead. I really hate this---you have to basically be in the field and know the name of the database/repository where things are held, otherwise you're doomed. That's why I'm so happy when the news articles actually provide the source, even though they also didn't give a link to the official court-decision repository that I'm sure exists somewhere.

the official court-decision repository that I'm sure exists somewhere

The official PACER repository is paywalled (though downloading a document costs only a few cents). The links that I provided are to the unofficial RECAP repository.

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