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FDA Approval Of Abortion Pill Mifepristone Is Revoked By Federal Judge

FDA Approval Of Abortion Pill Mifepristone Is Revoked By Federal Judge

A Texas Federal Judge ruled FDA approval was improper, staying his injunction for 7 days to give the government time for an emergency appeal. At the same time, a Federal Judge in Washington State issue a seemingly (but not actually) conflicting ruling.

There were two important and seemingly (but not actually) conflicting federal district court rulings regarding the abortion pill Mifepristone, which obtained FDA approval 23 years ago. In a Texas case, the court ruled that the FDA approval was improper and revoked, with his ruling stayed for 7 days to give time for an emergency appeal. In Washington State, a district court judge prohibited the FDA from changing its protocols as to Mifepristone, but limited his ruling to 17 blue state plaintiffs, and in any event prohibiting the FDA from taking action does not preempt the revocation of approval by the Texas federal court.

MORE TO FOLLOW

Ed Whelan provides a handy ‘guide’ to the Texas decision:

Plaintiff medical associations have standing, both associational (pp. 7-11) and organizational (pp. 11-13), allege injuries that are concreted and redressable (pp. 13-17), and are within the statutory zone of interests (pp. 16-18). Their claims are reviewable and are not untimely or unexhausted (pp. 18-31).

Plaintiffs are likely to succeed on their challenges to the FDA’s 2021 actions (pp. 32-39). Federal law prohibits the mailing of abortion drugs (pp. 32-38), and the FDA’s actions violate administrative law (pp. 38-39).

Plaintiffs are likely to succeed on their challenges to the FDA’s pre-2021 actions (pp. 39-60). The FDA’s 2000 approval violated Subpart H (pp. 39-48), and its pre-2021 actions were arbitrary and capricious (pp. 49-60).

Plaintiffs face a substantial threat of irreparable harm (pp. 61-63), and a preliminary injunction would serve the public interest (pp. 63-65).

An APA stay of the FDA approval is more appropriate than ordering withdrawal or suspension of the approval (pp. 65-66).

In describing the two rulings, the NY Times notes that the Texas Judge was a Trump appointee, but neglects to mention which president nominated the Washington State judge (care to guess?*):

The order by Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade, is an initial ruling in a case that could result in the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.

The lawsuit, filed by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of mifepristone, the first pill in the two-drug medication abortion regimen.

The lawsuit in Washington State was filed against the F.D.A. by a dozen Democratic attorneys general. In a preliminary injunction in that case, Judge Thomas O. Rice blocked the agency from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”

I don’t see the rulings as inconsistent, though some disagree. The Washington State order prohibits the FDA from taking any steps with regard to the drug, but the Texas ruling revokes approval ab initio, so there’s nothing for the FDA to do.

2. Pursuant to Federal Rule of Civil Procedure 65(a), Defendants and their officers, agents, servants, employees, attorneys, and any person in active concert or participation, are PRELIMINARILY ENJOINED from: “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”

The reaction is as you would expect:

(*Obama)

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Comments

It would be nice if conservatives stopped shooting themselves in the foot by reminding voters of an emotional issue that is not even in the same ball park as the border, crime, education, inflation, etc as to the future of our country. I would like a little more focus on winning key elections and a little less on giving birth to more Democrats. Think about it … absent Roe v Wade, Hillary would have easily won the 2016 election (because Blacks would have been a bigger percentage of the population).

    SDN in reply to jb4. | April 8, 2023 at 7:30 am

    Killing the “right” children because of worldly advantage? William Roper has descendants, I see.

    “It profiteth a man not to trade his soul for the whole world….. but for Wales?”

      cheeflo in reply to SDN. | April 8, 2023 at 10:52 am

      William Roper was Sir Thomas More‘s son-in-law. Do you mean Richard Rich?

      henrybowman in reply to SDN. | April 8, 2023 at 1:17 pm

      We’re not killing anybody. They’re choosing to kill themselves. Regularly I rue the insanity of caring more for the welfare of their children than they do.

The d/prog activists and the Biden admin got too cute. In Dec of ’21 the FDA decided that Mifepristone would now be permanently allowed to be dispensed without in person pick-up. They had ‘temporarily’ relaxed the prior requirement for in person pick-up during Covid.

Then in the summer of ’22 the US Postal Service acquiesced to the activists and refused to actively inspect shipments from known suppliers to States which bar in some manner the drug being sent by mail. Some States require physician to dispense, some don’t allow minor children to act w/o Parental consent and so on. The AG Garland backed them up declaring that States ‘couldn’t defy the FDA’ which is absurd; the States have legitimate ‘Police’ interests in the healthcare of their Citizens which the Federal govt lacks. See Covid mandates.

So b/c the d/prog and the Biden admin put their eggs in one basket just to stick Red States in the eye and today
a Federal Judge broke the basket. Had they simply allowed Federalism to work instead of attempting to jam a ‘fix’ for Dobbs through the backdoor they wouldn’t be in this situation. Instead of effing Red States they seem to have effed themselves and their baby killing cause.

during the first 63 days of pregnancy. It is also effective in the second trimester of pregnancy.

There’s the problem.

Bodily sovereignty until ex-utero viability, Planned Parenthood #CecileTheClinicalCannibal, or a sanctuary State with a compelling cause (e.g. carbon credits). Women and girls, second… third, and baby, maybe #SS BLM. Social science is the last bastion of religious [ethical] zealotry. That said, human rites are a wicked solution to a hard problem: keep women affordable, available, and taxable, and the “burden” of evidence aborted, perhaps cannibalized, then her carbon sequestered in darkness.

Six weeks, 42 days, to baby meets granny in biological and legal state. Net Zero abortions following conception is a goal we should all strive for.

    healthguyfsu in reply to n.n. | April 8, 2023 at 1:06 am

    When you speak in incoherent terms like this it does no one any good. People who might agree with you don’t totally understand you, and people who disagree with you will easily ignore you.

    Also, you shouldn’t use terms like “Net Zero Abortions following conception” because your opposition will use that to say you don’t care about the life of the mother. There is such a thing as an ectopic pregnancy that needs to be aborted (because it has zero chance of viability and a very high chance of killing or harming the mother). Some of these form in the uterine tube instead of the uterus itself and a few have even formed in the body cavity outside of the reproductive tract. Progressives love to use exceptions to prove the norm, so you should qualify your responses with those to head off the distractions they will use.

      KEYoder in reply to healthguyfsu. | April 8, 2023 at 11:51 am

      A minor nitpick, but my understanding is that ectopic pregnancies are never viable (and will kill the woman if nothing is done), so terminating them was not in the past considered an abortion. Am I wrong?

        n.n in reply to KEYoder. | April 8, 2023 at 1:24 pm

        Ectopic pregnancies are nearly always fatal and endanger the mother’s life. The medical doctor with a life bias acts to care for all lives in his care, but not if it endangers the mother’s life, where it is, in fact, her choice.

    diver64 in reply to n.n. | April 8, 2023 at 6:20 am

    I have no idea what you are saying in the above post. It is gibberish, can you clarify your point?

    artichoke in reply to n.n. | April 9, 2023 at 12:40 am

    Let me try to put it plainly.

    1. This abortion pill can go past viability. Aborting a baby that would be saved in a hospital. That introduces very hard additional questions. (I thought it was just a “mornig after” pill. I guess that was the propaganda. This lets you have full do-it-yourself abortions.

    2. Keeping women available and cheap i.e. if they can fuck and then abort, they’re more likely to open their legs. Baby quickly killed, carbon footprint solved!

    3. Eventually the woman runs out of time and dies too, and it’s as if she had never lived, carbon footprint solved totally!

    I can’t argue with any of these points. They’re no more cynical than is appropriate in this bitter circumstance.

Juris Doctor | April 7, 2023 at 9:35 pm

Texas case will be thrown out for lack of article III standing. The judge’s theory of standing is preposterous on its face.

    diver64 in reply to Juris Doctor. | April 8, 2023 at 6:22 am

    I am not sure what you mean. Can you explain how a Federal Judge cannot rule that a Federal Law has been violated or that Doctors who are licensed by States have no standing over something in their States?

      Joe-dallas in reply to diver64. | April 8, 2023 at 9:42 am

      I am very definitely pro – life.

      That being said, there are a lot of procedural issues including lack of standing that the plaintiffs have in this case. Volokh conspiracy has had lots of articles on the legal procedural issues with this case.

Mifepristone (Mifeprex)

Perhaps a bleach alternative to remove anthropogenic carbon clusters.

Deprecating, devaluing, trafficking, genderfying, and endangering girls and women. This is a revisitation of the witch hunts, warlock trials, and baby-cues of ancient ethical religions and the modern family of Roe’s regrets. Women and girls, men and boys, and “our Posterity” deserve human rights and humane treatment, not human rites and wicked solutions.

    Arminius in reply to n.n. | April 10, 2023 at 1:56 am

    First of all, an ectopic pregnancy is simply any pregnancy when the embryo (not the correct scientific term but autocorrect has its own ideas) implants anywhere it doesn’t belong. Sometimes that might even be outside the uterine wall in the abdomen. But usually it’s a tubal pregnancy so I’ll deal with that.

    “Doing nothing,” a.k.a. “expectant management,” is a viable first option. In 90% of cases by the time a tubal pregnancy is detected the embryo is already dead and the situation may resolve on its own. Any doctor might choose this option whether a devout Catholic or an atheist.

    If it doesn’t resolve itself that leaves 3 other options; 2 surgical and 1 chemical. I’ll discuss each in light of Catholic medical ethics to demonstrate treating an ectopic pregnancy (or miscarriage) is NEVER considered an abortion.

    One surgical technique is salpingectomy; removing all or part of the fallopian tube. This is never considered an abortion as the primary purpose is to remove the damaged tissue.

    Another surgical technique is salpingostomy; cutting the fallopian tube open, removing the embryo along with (hopefully) the damaged tissue, then stitching the tube closed. There are 2 problems with this. First, some but not all Catholic ethicists consider this a direct abortion. Second, while a doctor may have removed all the tissue damaged by the developing embryo this technique itself damages the tissue due to the scar from the incision. The scar tissue itself increases the odds that more ectopic pregnancies may ensue (essentially it can cause what amounts to a blockage).

    Finally a doctor can use the drug methotrexate. This prevents any more cell division in the embryo which also of course kills the embryo. Some but not all Catholic medical ethicists consider this a direct abortion. Also it doesn’t do anything about the damage the embryo has already done to the tube.

    Church authorities haven’t weighed in on the ethical issues so its up to each doctor’s conscience. But the bottom line is that for most Catholic doctors expectant management or if necessary a salpingectomy are the preferred ethical and medical choices. Again, damaged fallopian tube tissue increases the odds of further ectopic (tubal) pregnancies. Naturally it’s really up to the woman.

    A brief mention of miscarriages. If a woman miscarried but none or not all fetal and other pregnancy tissue is is naturally eliminated a Catholic hospital has no moral objections to performing a dilation & curettage. D&Cs are often associated with abortions but these are two entirely different procedures. The purpose of an abortion is to kill a healthy fetus in the womb. In the case of miscarriage the fetus is already dead of natural causes.

    The bottom line is before Roe v. Wade a woman could have received treatment for ectopic pregnancies or miscarriages in every state when abortion was illegal in almost every state. The abortion fanatics are simply lying when they claim outlawing abortion means women will die of untreated ectopic pregnancies or miscarriages. Which is why I approached this from the standpoint of Catholic medical ethics. A woman couldn’t get an abortion in a Catholic hospital before Roe, while Roe was in effect, or now with Roe’s demise. But a woman would have received state-of-the-art treatment for ectopic pregnancies/miscarriages 75 years ago and still will today.

RepublicanRJL | April 8, 2023 at 6:21 am

If you engage in sex, the risk is a possible outcome of a child so be ready to accept it as much as one would accept the risk of an accident when driving a car.

Yes, they aren’t the same but you get the idea. Just be ready to accept the outcome. That’s what a civilized society should do.

I’d be tickled if all abortions were illegal.

    The difference between the two bits you cite is that, while an accident might be inevitable when driving, it’s not the purpose of the automobile or the act of driving.
    A child is the goal of sex. It might not be what you’re looking for in the moment, but it is the goal of all the bits and pieces operating in the sexual act. The bodies fit the way they do so that sperm can be delivered to the ovum in a moderately efficient manner to fertilize that egg and make a baby. And the fact nature so often overcomes our attempts to subvert that act is proof of the act’s purpose.

    And this is true regardless of whether you’re an evolutionist or a Christian (and most other religions). Only progressivism denies it, all to effect their utopia of pleasure without consequence.

I simply do not understand why people are so adamant about being able to murdering their very own unborn child. So much for the concept of love.

    n.n in reply to Cleetus. | April 8, 2023 at 1:27 pm

    Whereas medical care with a life bias is performed to care for all human lives, human rites are performed for social, redistributive, clinical, political, criminal, and fair weather progress.

Most folks don’t know, but coming out of law school Ron Wyden flunked the bar exam 3 times and never did pass it, so his legal acumen is dubious on that basis.

It is complete bullshit that a single judge in Texas just effectively banned the abortion pill nationwide – including in pro-choice
states like my own.

Yet the endless Hawaiian judges issued edicts affecting President Trumps attempts to finish the Wall throughout his Presidency

    n.n in reply to gonzotx. | April 8, 2023 at 1:30 pm

    Not just securing the border, also political congruence (“=”), transgender conversion, immigration reform, redistributive change, diversity, etc.,

The Washington ruling is so thin on true legal analysis that the next step down would be a press release. That’s why they didn’t do a nationwide injunction, to minimize risk of fast competing overturn.

The Texas ruling is more substantive, but fails statute of limitations and standings issues I believe. As such, it will likely be overturned.

I welcome the war on indiscriminate abortion being raised on the right as we fight to save the unborn, but picking the right battles and tactical wins like just rolling back the mail order access that might be winnable on appeal would be more desirable tactically.

The battle won’t be won in a day or a single court case, but a long term – forever actually – battle culturally, legally, educationally, emotionally.

The road to Roe vs Wade being overturned was not a single event but decades of work, intermediate rulings, getting judges appointed …

… and life affirming activists like Lisa Rose keeping the pressure up on the broader landscape.

Politics is downstream from culture.

Quoting a bunch of horrified lefties hardly passes as analysis.

From the right, J Adler at Volokh/ Reason argues that plaintiffs in both cases lack standing and have failed to exhaust administrative remedies. Texas also founders on a statue of limitation problem – folks had six years to appeal an FDA decision made in 2000. Plaintiffs argue that each subsequent modification of the rules restarts the clock, but Adler sort of LOLs at that.

https://reason.com/volokh/2023/04/08/two-wrong-mifepristone-court-rulings-in-one-day/

As a bonus, a former Scalia clerk (Adam Unikowsky) firmly rejects the Texas case:

“Cutting to the chase: the plaintiffs’ legal theory is remarkably weak. Basic principles of administrative law, having nothing to do with abortion, squarely foreclose the plaintiffs’ claims.”.

https://adamunikowsky.substack.com/p/mifepristone-and-the-rule-of-law

I am a big and long-time fan of Prof. Jacobson and I know Easter weekend is a tough time to pull together some research but I’d rather learn his opinion than AOC’s.

[MY opinion? Who am I? But my understanding (also Kavanaugh’s, IIRC) is that overturning Roe would return abortion to the laboratory of the states, NOT empower lawless Texas judges issuing nation-wide rulings. YMMV.]

Quoting a bunch of horrified lefties hardly passes as analysis.

From the right, J Adler at Volokh/ Reason argues that plaintiffs in both cases lack standing and have failed to exhaust administrative remedies. Texas also founders on a statue of limitation problem – folks had six years to appeal an FDA decision made in 2000. Plaintiffs argue that each subsequent modification of the rules restarts the clock, but Adler sort of LOLs at that.

As a bonus, a former Scalia clerk (Adam Unikowsky) firmly rejects the Texas case:

“Cutting to the chase: the plaintiffs’ legal theory is remarkably weak. Basic principles of administrative law, having nothing to do with abortion, squarely foreclose the plaintiffs’ claims.”.

I am a big and long-time fan of Prof. Jacobson and I know Easter weekend is a tough time to pull together some research but I’d rather learn his opinion than AOC’s.

[MY opinion? Who am I? But my understanding (also Kavanaugh’s, IIRC) is that overturning Roe would return abortion to the laboratory of the states, NOT empower lawless Texas judges issuing nation-wide rulings. YMMV.]

    txvet2 in reply to TomMaguire. | April 8, 2023 at 8:38 pm

    “”From the right, J Adler at Volokh/ Reason””

    I’ll leave the legal aspects of all of this to the lawyers, but Volokh/Reason is Libertarian – hardly from the right – and ergo likely tending to be biased in favor of abortion. I don’t know anything about Adler, except for his choice of forum, so I’ll take his analysis with a grain of salt.

Republicans must never want to win another consequential election. Just this week they’ve expelled black members (but not the white member) out of the Tennessee legislature, tried to restrict access to an FDA approved drug in use by women for over 20 years, and lost an incredibly important state Supreme Court seat in Wisconsin by nominating an election denying misogynist. Yeah, that’s the way to win elections. /s

Close The Fed | April 8, 2023 at 12:19 pm

I haven’t read any statutory or case law on this, but one thing is certain, if Roe v. Wade hadn’t been adopted, then some accomodation of different states’ laws on abortion would have been factored in to any FDA decision on abortion pills. In 2000 there certainly was no factoring in of any differences.

I don’t care about standing, as a lawyer. I still don’t care about statutes of limitation here. What I care about is taking a bulldozer to lawitis that uses words and pieces of paper to protect people actively killing unborn children. If the situation were an active shooter in a mall killing people, we would stop the killing first, and then ask what legal steps we should take. Same thing here.

    Close The Fed in reply to Close The Fed. | April 8, 2023 at 12:20 pm

    *Law-itis. Misspelled it!

    That’s it, late-term abortion is illegal outside of sanctuary States. That, and endangering women and girls who have been taught, preached that they can procure “burden” relief without present and progressive consequences.

Can someone point out a succinct explanation of how the Texas plaintiffs have standing to challenge the FDA’s approval a drug? And why, after 23 years, the action would not be time-barred?

FrankJNatoli | April 8, 2023 at 2:52 pm

Funny thing about Mifepristone a/k/a Roussel Uclaf 486.
The Krauts in a Kraut lab of the French drug company Roussel Uclaf were working on a drug to control menstrual cramping, and developed RU-486.
It was a failure controlling menstrual cramping, but it became clear it was useful as a “day after” abortion pill.
Given the history of Mengele et al, the Kraut lab dropped the research, but the Frogs picked it up and marketed it internationally.
How about that?
Krauts with a conscience, Frogs not so much.
Apologies to CommoChief for more whining.

I read the Texas case.

A very compelling argument against the FDA, is the failure to require adverse reactions to be reported.

The failure to track adverse reactions makes it impossible for the MD to explain the procedure’s risks.

This reminds me of the 1980’s when it was forbidden to say homosexual men were more at risk then the general public for aids.

    Yes, they sequestered thousands of trans/homosexual males during the AIDS transdemic in order to celebrate social progress. They have done the same with women and girls with abortion carried out through medical or surgical corruption to keep them affordable, available, and taxable, and the “burden” of evidence disposed (e.g. sanctuary States) with a measure of privacy. Beyond six weeks, they willingly and with malice aforethought, have normalized homicide, bastardized science, and endangered women and girls.