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naraburns  nihil supernum  1yr ago (text post)   34986 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?

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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