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Mifepristone was not given special treatment by the FDA

Yesterday a friend asked if I wanted to comment on National Review's editorial about the national abortion pill ban.¹ I didn't, really. NR is, obviously, institutionally anti-abortion, and I didn't have much interest in reading a bunch of pro-life boilerplate for the thousandth time in my life.²

But eventually my curiosity got the best of me, and I have two comments. First, kudos to NR for acknowledging that the bulk of the ban was wrongly decided "given that the six-year statute of limitations passed between the FDA’s belated 2016 ruling on that approval and the filing of suit." This is true. Mifepristone foes like to point out that the FDA waited 14 years to rule on a legal challenge filed in 2002, but that doesn't matter anymore. The FDA re-issued and updated their rules in March 2016 and the lawsuit challenging them was filed in November 2022. This was the first time the original approval of mifepristone was challenged, and by then the statute of limitations had expired. This should have gotten most of the lawsuit thrown out immediately.³

Most partisans these days are unwilling to acknowledge any interpretation of the law that works against them, so due credit here.

But I also have a second comment. I am (already!) sick and tired of reading stuff like this:

From the beginning, the pill was given favored regulatory treatment, with accelerated approval under Subpart H, a program designed for emergency AIDS drugs. Utilizing this fast-track approval process required the FDA to characterize pregnancy, preposterously, as a “serious or life-threatening illness.”

This just isn't true. Mifepristone was approved under normal procedures. Subpart H was used only to accelerate rules that limited how it could be used. KFF explains:

In the case of mifepristone, Subpart H was originally used to restrict the dispensing to prescribers who agreed to dispense it in certain health care settings, by or under the supervision of a qualified physician who attested to the ability to accurately date pregnancies and diagnose ectopic pregnancies.

This whole thing reminds me of the conservative myth that Obamacare was "rammed through" under reconciliation rules. It wasn't. Obamacare was passed under regular order. After that, a small "sidecar" of mostly minor revisions was passed under reconciliation, but that's all. Nonetheless, the conservative myth persists.

Subpart H "acceleration" looks like it's going down the same path. It's quickly congealing into accepted wisdom even though it's simply not true that mifepristone got any special treatment by the FDA. It's safe, reliable, and legal, and there's no reason it shouldn't have been initially approved and shouldn't now be widely available.

¹Which has since been partly stayed.

²I imagine the editors of NR feel the same about reading anything I write on the subject, and I don't blame them.

³In addition to a few minor things, there's a different part of the lawsuit that challenges the FDA's 2021 ruling that made mifepristone available by mail. These items are not affected by the statute of limitations. However, the basic approval of mifepristone is.

9 thoughts on “Mifepristone was not given special treatment by the FDA

  1. KJK

    A note to anyone who thinks that there is reasonable abortion compromise with these MAGA / Christian Talban motherfuckers: Just like the Terminator, they will not stop until abortion is made illegal in the entire US. They will use any means available to them because they are utterly ruthless in this pursuit.

    If anyone votes for any GOP candidate at any level of government, you deserve what you get.

    1. Doctor Jay

      Yep. They think "you don't vote on right and wrong", and they are the ones who know right from wrong better than anyone else. They know the heart of God. Their sense of a righteous crusade excuses all manner of wrongdoing. You know "God's Law is higher than Man's Law". That kind of stuff.

      I mean, Socrates put a dagger into that attitude. And they killed him for it.

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  2. Jasper_in_Boston

    This whole thing reminds me of the conservative myth that Obamacare was "rammed through" under reconciliation rules. It wasn't. Obamacare was passed under regular order.

    True, but also, so what if Obamacare had been passed under "reconciliation rules"? Reconciliation rules is just another way of saying: as stipulated in the Constitution.

    It is so-called "regular order" that is highly irregular: there's not a peep in the Constitution about a supermajority requirement. This extra-constitutional bullshit custom was mostly developed by those forces keen on protecting slavery.

    1. royko

      Absolutely. What happened is the exact opposite of what they claim -- each chamber passed its own version, and the minor differences normally would have been ironed out in reconciliation. But Democrats lost the Kennedy's Senate seat in a special election, so they no longer had the votes to overcome a filibuster. So the House had to adopt the Senate's (already passed) version. Conservatives seem to think once Democrats lost the seat, the original vote on the bill should have been somehow rescinded, which is not how legislatures work, nor should they.

      But, as you point out, the bill passed the Senate with 60!!! votes. Even after losing that seat, the bill had the support of 59/100 Senators. The idea that the Senate needs 60 votes to legislate is idiotic and not part of the Constitution (which very specifically lays out circumstances where a supermajority should be required.) The idea that anything with 60 (or even 59) out of 100 Senators supporting is "jammed through" because it didn't have a Republican vote is also stupid. The Republicans only had 40/41 votes at that time because as a party they were unpopular and did not reflect the will of the people.

  3. pjcamp1905

    None of this matters. Nobody in this case had standing to bring it. You have to have real, concrete and particularized harm to you personally to have standing. The harms asserted in this case are purely speculation about things that might happen sometime, someday in the future. Nothing past that point should even have been heard. If Democrats take back the House, impeaching this judge should be at the top of the agenda. He simply ignores the law as well as binding precedent.

    1. royko

      Yup, I was going to bring this up. Most of the case passed the statute of limitations, and nobody bringing the case has standing. Sometimes, even though the standing principle is important, I think it is used to dodge issues. But here, if Mifepristone is a truly harmful drug, they should be able to find someone who was actually harmed by Mifepristone to bring the case. That they can't is a testament to its safety.

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