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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 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.
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