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White House Rejects Calls To Ignore Abortion Pill Ruling, As FDA Seeks Emergency Stay From 5th Circuit

White House Rejects Calls To Ignore Abortion Pill Ruling, As FDA Seeks Emergency Stay From 5th Circuit

“more than five million Americans have chosen to end their pregnancies using mifepristone. Today, more than half of women who terminate their pregnancies rely on that drug.”

On April 7, FDA Approval Of Abortion Pill Mifepristone Was Revoked by a federal judge Matthew Kacsmaryk in Texas, with a 7-day stay for the FDA and other litigants to seek a further stay pending appeal in the 5th Circuit. Top Democrats such as Senator Ron Wyden and Representative AOC called on the Biden administration to “ignore” the ruling.

Today the White House press secretary said the Biden administration rejected calls to ignore the ruling:

“We are going to always follow the law, always,” White House press secretary Karine Jean-Pierre said Monday. “That doesn’t mean that we’re not going to fight.”

Today the FDA filed an Emergency Motion for a Stay Pending Appeal, pointing out not only the contested legal issues, but also the widespread use of mifepristone, which has been used in 5 million abortions (emphasis added):

More than two decades ago, the Food and Drug Administration (FDA) determined that mifepristone is safe and effective to terminate early pregnancies. FDA has consistently adhered to that judgment across five presidential administrations. During that time, more than five million Americans have chosen to end their pregnancies using mifepristone. Today, more than half of women who terminate their pregnancies rely on that drug. When mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen.

Rather than preserving the status quo, as preliminary relief is meant to do, the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety….

The district court’s extraordinary and unprecedented order should be stayed pending appeal. Plaintiffs lack standing to challenge FDA’s approval of a drug they neither take nor prescribe; their challenge to FDA actions dating back to 2000 is manifestly untimely; and they have provided no basis for second-guessing FDA’s scientific judgment….

The court’s sweeping nationwide relief was especially unwarranted given the balance of harms: If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity. This harm would be felt throughout the country, given that mifepristone has lawful uses in every State….

Danco Laboratories, which is a distributor of mifepristone and is an intervenor in the case, also filed a similar motion for a stay. The Court has ordered the plaintiffs to respond to both motions by midnight on April 11.

Alliance Defending Freedom, which represents the plaintiffs in this and many other abortion pill cases issued the following statement on the stay motion, attributed to Senior Counsel Erin Hawley:

“By illegally approving dangerous chemical abortion drugs, and imposing its mail-order abortion regime, the FDA put women in harm’s way, and the agency should be held accountable for its reckless actions. Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life. The district court’s ruling last week was a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women and girls. ADF remains committed to their protection.”

As mentioned in the earlier post, separately a Federal Judge in Washington State issued an injunction preventing the FDA from changing its protocols with regard to mifepristone. I did not see that as a direct conflict, though others 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.

The FDA has filed a Motion for Clarification in that case:

On April 7, 2023, this Court declined to preliminarily enjoin FDA from enforcing or applying any requirement of mifepristone’s REMS. Order at 26-27. But the Court preliminarily enjoined the agency 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 [(REMS)] under 21 U.S.C. § 355-1 in Plaintiff States.” Order at 30.

Shortly before this Court entered its order, the United States District Court for the Northern District of Texas entered an order invoking 5 U.S.C. § 705 to stay the approval of the new drug application and abbreviated new drug application for mifepristone…. But if the Texas district court’s order takes effect, the order would—of its own force and without any further action by FDA—stay the effectiveness of FDA’s prior approvals of mifepristone nationwide….

The result of that order appears to be in significant tension with this Court’s order prohibiting FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in Plaintiff States. Order at 30. The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart. To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.

I don’t expect it to get to any real conflict between the two district courts anytime soon. I expect the 5th Circuit to issue a stay pending appeal, and if it doesn’t do so, for the Supreme Court to do so, for the reasons I said before:

I don’t expect this ruling to go into effect in a few days – it’s highly likely that either the 5th Circuit or the Supreme Court will stay the ruling pending the normal appellate process. The ruling upsets a 23-year-old FDA approval for a drug that now is widely used, on an issue that already has resulted in an unprecedented leak of a draft opinion, an assassination attempt againat Justice Kavanaugh, and protests at the homes of conservative Supreme Court Justice. Don’t think that isn’t weighing on them.

The pressure on SCOTUS is tactical, as witnessed by Democrats’ Forever War On Justice Clarence Thomas Ramps Up.


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Mifepristone Does not = Motrin…

some of the “pregnancy tissue”, classy, they won’t say fetus, baby, it’s just tissue, is left in your uterus

pass large clots (bigger than a lemon) for more than 2 hours
blood clots in your uterus

( now THAT is impressive )

I had no idea what was coming. No idea. The cramping was deep and very painful. I’ve had three children since then, and it felt like labor”, says Elizabeth a victim of the misinformation of the effects resulting from the abortion pill. Elizabeth was told that her pregnancy was not viable after a nurse showed her a still-shot image (not a live image) of her baby on an ultrasound machine. This caused her to believe that her baby lacked mobility along with any signs of growth and development.
“There was my baby, in a toilet. This wasn’t fetal tissue [as she was told it would be]. This was a formed, recognizable, undeniable baby. My baby, says Tammi.
“OB-GYN, Donna Harrison, [compares] the process (which is four times more likely to require medical intervention afterward), to ‘almost patient abandonment.’”

The executive Ignoring a court?

Does it matter anymore?

    The_Mew_Cat in reply to | April 11, 2023 at 12:48 pm

    It’s happened before. See President Jackson, Andrew.

    No, you idiot. The article and headline say the exact opposite. The White House rejects calls for it to ignore the court. The administration has announced that it will obey the law no matter what. It is of course appealing the decision, as is not only its right but as the court itself gave it seven days to do! And of course it’s asking the appeals court for a stay, as is right and proper and expected. But your silly and false predictions that it would ignore the court are once again proved to be utterly invented. You cannot cite even one instance of the government defying a court order, and you will not find one because it does not happen.

Biden’s DOJ is now involved, on behalf of the FDA, HHS and other parties. Not a legal expert but why is the DOJ involved, these other parties should have their own legal representation for matters like this

“they have provided no basis for second-guessing FDA’s scientific judgment….”
Two words: baby formula.

    MosesZD in reply to henrybowman. | April 11, 2023 at 9:04 am

    That wasn’t a FDA problem. That was an Abbot Labs problem. So maybe you should point your fingers at Abbot Labs, because they’re the ones who recalled their baby formula and closed their plant.

    That was because someone at the plant went whistle-blower because it was unsanitary and Abbot didn’t care (ironically, it’s unsanitary food production in the free market that caused the Government to make the FDA) until the FDA showed up at their door to get answers to the questions posed by the 34-page whistleblower report.

    What was happening at the plant was the falsification of test results, unsanitary handling practices (even to the basics of not washing hands after you go to the bathroom!) and a number of other problems including dangerous bacterial growths in the processing equipment that wasn’t being properly sterilized.

    But ‘the gubmit’, right? And, of course, ‘Muh free markets which are magic and pure…’

    You people crack me up. We have the FDA because you can’t trust these big corporations. And while there is certain amount of institutional capture going on with the FDA thanks to Reagan, it’s still better than trusting the free-market fantasy that no company would take such risks as to lose customers. Because they do!

    People die, even here in the US, because some big corporations take short-cuts and play roulette with your life. And rarely do they end up in jail, like the head of Peanut Corporation of America whose practices caused a massive salmonella outbreak that poisoned over 700 people, of which 9 died.

    That bastard got 25 years. Mostly, though, it’s a slap on the wrist.

      cyrano in reply to MosesZD. | April 11, 2023 at 11:25 am

      You got your details wrong. FDA shut down Abbot for an unrelated “hot” test. Samples gathered weren’t necessarily from production product though collected at the sight.

      The whistleblower didn’t know what they were talking about.

      Every plant has some sort of flagged item when they are forensically inspected.

      The FDA was warned that shutting down Abbot would cause problems but they ignored it.

      The CDC analyzed clinical samples from two of the infants and did not find a genetic match to the environmental strains found at the plant. It also said the bacteria from the patient samples were not closely related to one another.

        henrybowman in reply to cyrano. | April 12, 2023 at 2:25 am

        And then they dragged their asses about letting Abbot re-open the plant, even though the sound of hungry babies was heard throughout the land.
        Fuckin’ A “the gubmit.”

There is a factual disagreement here. If the FDA properly approved this drug, if it is safe and effective for over-the-counter use, let them show the data. It should be readily available.

    CommoChief in reply to Valerie. | April 11, 2023 at 8:58 am

    The FDA approved it using data from clinical conditions where the patients were monitored during use and had easy access to follow up care. The real-world application doesn’t follow that model as folks can take it without being supervised by a physician. Data from European Nations shows about 20% ish have serious complications requiring follow up medical care. The FDA has avoided gathering any US data or producing follow up studies since approval.

      MosesZD in reply to CommoChief. | April 11, 2023 at 9:21 am

      Bullshit. It’s 2% not 20%. And that’s for ALL TYPES of abortions. The majority of those are classified as MINOR,

      People like you do more harm than good with your repeating of this laughable bullshit. Especially when it comes time to vote.

      Classic liberals like myself, the people who swing elections as opposed to the lever-pullers on the left and right are not all stupid and gullible. The irony is, we’re statistically more likely to vote for Republicans, until you do stupid shit like this and then we’re like ‘fuck, you getting government in our lives and we don’t like that’ so we’ll vote to protect our social freedoms.

        The_Mew_Cat in reply to MosesZD. | April 11, 2023 at 1:01 pm

        Social freedoms. That is what it is always all about, and always has been. The US has historically swung back and forth between very libertine and very restrictive eras. That pattern continues to this day, and one of the legacies of a restrictive era, the Comstock Act, does outlaw mail and common carrier delivery of abortion pills. Getting that law repealed in Congress should be a priority of the Democrats. Why isn’t it? Why don’t they attach a repeal to a debt ceiling raise or some other must pass legislation?

        CommoChief in reply to MosesZD. | April 11, 2023 at 5:36 pm


        Slow your roll there guy. If you have links to the data showing 2% v 20% please post it so we can take a look. I am more than happy not be convinced.

        In the meantime ‘classic liberals’ like yourself have done far more damage to the Nation by failing to use the levers of power in your hands; Academia, media, SR Fed govt bureaucracy to stop the woke insanity and lefty totalitarians before they became such an onslaught.

        FWIW I am small l libertarian so don’t project your billy bob cosplay onto me thanks. The fact is there are some problems with FDA approval of Mifepristone. It was fast tracked by Clinton. There was not testing on under 18 (aka minor children) and the approval was for supervised use and in person dispensing. Those are very different conditions than the use today and no studies that I am aware of have been acknowledged by FDA as the basis to allow this drug to be mailed directly to consumer for unsupervised use. If you have better info then please provide it before calling ‘bullshit’ and making unsupported attacks.

        henrybowman in reply to MosesZD. | April 12, 2023 at 2:43 am

        “Bullshit. It’s 2% not 20%. And that’s for ALL TYPES of abortions.”

        Looks a lot like 20% to me.
        And quite clearly marked medical (medicinal) vs. surgical.
        And it wasn’t published by an activist judge.

      henrybowman in reply to CommoChief. | April 12, 2023 at 2:31 am

      Isn’t this the point where somebody always posts a European movie scene about somebody getting on and off a train? The failure of familiar traditions causes me anxiety.

    MosesZD in reply to Valerie. | April 11, 2023 at 9:14 am

    They have. It’s in the medical literature. So, maybe, before you raise idiotic rhetorical questions, you should understand that there are, LITERALLY, well over 100 studies published.

    This is nothing more than an activist judge (a Trump appointee) playing political games.

    Worse, the clowns that brought this suit are also going against HIV prevention drugs because HIV is most prevalent in the people they hate – gays & IV drug users. They also go against safe and effective vaccines.

    Those ignorant pricks would rather you die from AIDs, or your children die from deadly childhood diseases, than keep their arrogant, prick noses out of your fucking business. When you actually look at what they are, they are not heroes, they’re the baddies.

Pro-Abortion = Pro-Murder.

E Howard Hunt | April 11, 2023 at 9:55 am

They should be provided with safe access to coat hangers while the courts thrash this out.

There are multiple issues in this case
— the standing of the plaintiffs
— the legality of the drug’s approval
— the legality of recent actions, namely allowing it to be mailed in direct violation of the Comstock Act.

Of all these issues, I think the Administration is likely to ultimately lose on the Comstock Act question, because the text of that law is clear, and was reactivated by Dobbs. The reactivation of the Comstock Act is a really big deal and will have a huge effect on 2024,