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naraburns  nihil supernum  1yr ago (text post)   35021 thread views

Culture War Roundup for the week of April 3, 2023

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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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