Can someone summarize the ruling in Texas Mifepristone ruling?
<p>I started reading the ruling in <a href="https://int.nyt.com/data/documenttools/court-decision-invalidating-approval-of-mifepristone/0bb045930a649567/full.pdf" rel="nofollow noreferrer">Alliance for Hippocratic Medicine v. FDA</a>, but it's 60 pages long and full of the expected legalese.</p>
<p>Can someone summarize the argument of the plaintiffs and the legal basis of the judge's ruling in plain language? How can a judge with no medical background invalidate the FDA's approval of a drug?</p>

<p>Some interesting reasoning about standing aside (which antivaxxers etc. will love though, because it stipulates that the FDA refusing to collect <em>all</em> side effects statistics [even starting 16 years later] gives standing to sue on the original approval), the Texas' judge estimation of success on the merits is essentially relying on the finding that &quot;Pregnancy is not an illness&quot; (p. 40) and essentially repeated on p. 44 as &quot;Chemical Abortion Drugs do not provide a Meaningful Therapeutic Benefit&quot;, so that in the Judge's estimation drugs for terminating pregnancy can be held to a [much] higher safety standard than the FDA decided by itself. This ultimately phrased as (p. 57):</p>
<blockquote>
<p>The Court does not second-guess FDA's decision-making lightly. But here, FDA
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.</p>
</blockquote>
<p>It's followed by another finding that there was likely political interference by the Clinton administration with the FDA's decision.</p>
<p>This a rather partial summary since the order involves several FDA decisions, the details of which which I'm glossing over here (like the fact that the decision to not collect all side effects stats for mifepristone is rather more recent, being taken in 2016--but nonetheless the judge found that consequently the original 2000 decision was reopened as well, and can the object of the suit too.)</p>

<h2>This is an order for a preliminary injunction</h2>
<p>It requires the FDA to temporarily suspend its approval of the drug until the case is resolved on its merits; nothing of substance has been decided yet.</p>
<p>The judgement is well laid out and easy to follow with headings telling us what each part is about. It starts with background facts and the legal issues to be decided are in the first paragraph on page 6. The judgement then goes onto issues of standing (the plaintiffs have standing), if the action is too early or too late (no), if the plaintiffs are likely to succeed on the merits (yes), if there is a substantial risk of harm (yes), if an injunction would serve the public interest (yes), if what the plaintiffs asked for is the appropriate solution (no), therefore the injunction is granted (in part).</p>
<p>I can’t see anything that indicates bias. I can see a judge that is pissed off that the FDA apparently failed in its statutory duty to respond to complaints in the time the law requires. That was, rightly, held against the FDA in their arguments that the proceedings were time barred - you can’t delay a process by your own inaction and then say “you can’t sue me because you’re too late.”</p>

<p>Contrary to how much of the media has been been presenting it, the judge was not ruling on the medical safety or effectiveness of the drug. There were 2 main issues that the plaintiffs claimed:</p>
<ul>
<li>The FDA did not follow the proper processes when they approved the drug and subsequently relaxed the conditions for dispensing it (increasing the availability from the first 7 weeks of pregnancy to the first 10 weeks).</li>
<li>They violated the <a href="https://en.wikipedia.org/wiki/Comstock_laws" rel="nofollow noreferrer">Comstock Act</a> when they approved sending abortion pills by mail.</li>
</ul>
<p>KFF.org has a summary of this decision, as well as the contrary ruling in Washington state, <a href="https://www.kff.org/policy-watch/q-a-implications-of-two-conflicting-federal-court-rulings-on-the-availability-of-medication-abortion-and-the-fdas-authority-to-regulate-drugs/" rel="nofollow noreferrer">here</a>.</p>
<p>Yesterday (April 14, 2023), the Texas ruling was put on temporary hold by US Supreme Court Justice Samuel Alito. One of the contentious issues is whether the plaintiffs have standing to make this complaint.</p>

texas federal-courts abortion