Said Attorney General Merrick B. Garland, quoted in
"Judge Invalidates F.D.A. Approval of the Abortion Pill Mifepristone/The Texas judge’s ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available" (NYT).
The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication....
In the 67-page Texas ruling, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the anti-abortion groups and repeatedly used the language of abortion opponents, calling medication abortion “chemical abortion” and referring to a fetus as an “unborn human” or “unborn child.”...
Legal experts said that the ruling appeared to be the first time that a court had acted to order that a drug be removed from the market over the objection of the F.D.A....
Posts
45 comments:
Daily becomes more obvious that judges we currently have are no better than politicians. Of course that has always been the case. Ann probably knows better than any of us how many decisions have been based on personal preference rather than law - no matter how pretty the opinions.
Legislating from the bench, which I recall people objecting to on this blog this week ;)
Don't worry, Biden will soon put it in the drinking water.
"I mean in history, Patty. Before they changed the water."
OMG, he called "medical abortion" "chemical abortion"! Both correct terms by some definitions. But with different emotional valences.
After the last 3 Years I think that everyone should be skeptical about whatever the FDA has said about anything. Ever.
Well, why are we surprised? The accurate label for this drug would simply state, “causes death.” That begs the question of “when does ‘life’ begin,” but it would frame things as the Texas court seems to want.
Isn’t it cute how the NYT cites “the FDA’s expert judgement”.
It’s almost like the last three years never happened.
during the first 63 days of pregnancy. It is also effective in the second trimester of pregnancy.
Mifepristone (Mifeprex)
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.
What is a fetus if not an unborn human? I suppose there are horse fetuses and rabbit fetuses and other fetuses, but I'm pretty sure the fetuses in question are human fetuses so that would make them unborn humans. But I guess the author's point is that based on the language the judge used you can infer the judge's personal feelings about abortion, kind of like you can infer the author's personal feelings about abortion by using the term anti-abortion groups, medication abortion, and of course referring to an unborn human as a fetus. I bet the author is such an abortion extremist that the author even opposes common-sense abortion control we see in Europe and other parts of the world where abortion is limited after 14 or 15 weeks.
The homicide pill. That said, six weeks to baby... fetal-baby meets granny in biological and legal state. The government, abortion industrial complex, and social activists including feminists, masculinists, and liberal religious/ethical sects, should be denied the opportunity to exploit and endanger women and girls for social, redistributive, clinical, political, criminal, and fair weather progress.
Cards on the table - I'm pro-life. A new human being is created at conception. However, I also believe that allowing for a "morning after" pill is an acceptable compromise. (I have reasons, based in science, morality, and philosophy, but I'm not going to review these now - they are extensive.)
RU-486 is not a "morning after" pill. It is clearly a chemical abortion. I think abortion advocates, who have constantly shown that they are willing to sacrifice women's lives and health in their pursuit of abortion at all times, even after birth, are more than willing to overlook the harm caused by RU-486. I do not think the Biden administration will look to the science on this issue. Nor will the abortion advocates. They are the ones who are politicizing this issue.
No one believes the FDA has expert judgment anymore.
And Dobbs would not have been possible without the government shutting down society and ordering people to get vaccinated or lose their job.
And no one thinks Merrick Garland us anything but a bitter left wing errand boy.
Long ago I represented my company in a suit involving a petroleum spill at one of our properties, caused by the fuel truck driver who went inside the building while refilling a tank. We excavated until we couldn't detect any more petroleum, set up a rudimentary venting system, took samples at the perimeter to demonstrate to regulators that we got it all, and then sued the trucking company to recoup the costs of the action.
The trucking company naturally claimed that the soil contamination preceded the spill, and brought in an expert to do a profile of the volatile organics to argue that it was "old." We brought in our own expert to argue that VOC profiling was inexact and the nature of the spilled petroleum and the site conditions meant that few light organics would show up anyway.
The judge ruled in our favor, yay us, but in all honesty he could have ruled the other way just as reasonably. In this case, the facts could have supported either conclusion.
My point being, what are the facts of this case? Are there health risks to this drug that are being ignored and/or not communicated clearly to patients, or aren't there? The judge's personal leanings on abortion are less important than whether the ruling is correct on the facts.
I am pro-life personally but grudgingly willing to accept Euro-style laws on abortion - I believe that every abortion ends a human life, but I acknowledge that it is going to take place no matter how vociferous my side of the issue is, so I'd rather have the best limits the bulk of Americans will accept than none at all. This pill falls under that rubric for me - if its proponents are being complete and truthful in communicating its risks to the pregnant girls and women to whom they're administering it. We have 20 years of data now; surely we can discover the truth?
Washington state judge that sided (as always) with Planned Parenthood seems par for the course.
Who is Thomas Rice, the Washington judge who ruled mifepristone is safe?
read it, and weep
SAFE and effective? For whom, you effete little twit? It kills unborn babies?
Oh, I see. It's safe for women. Pretty soon, feminist baby killers may have to choose sides. They may be eaten by the trannies who will take over their sports, locker rooms, prisons, bathrooms, etc. That won't be safe for women, but who will be their allies? Their protectors?
Of course, the feminist "leaders" like black leaders are hos for the regime. They will let the sisters twist in the wind. Riley Gaines will not.
Another day, another mifepristone of justice ...
If any form of abortion should be legal, it should be the morning after pill.
remember how, two days ago, AOC said that SHE would impeach Justice Thomas.. Singlehandedly?
Well, She's BACK!
https://www.msn.com/en-us/news/politics/watch-aoc-lashes-out-at-abortion-pill-decision-%E2%80%94-says-biden-should-ignore-this-ruling/ar-AA19CEAa
I believe that the Biden administration should ignore this ruling. I think that we — *I* have the legitimacy, and Not the courts.. I am the person that decides right and wrong.
COOPER: But is that — do we want to live in a world where the government can decide to ignore a Federal Court ruling?
OCASIO-CORTEZ: Well, no, of course. I mean, I do
I have no information with which to agree or disagree with the judge's ruling. However:
1. It is not beyond imagining that the Clinton-administration's FDA might have bent the rules, put a thumb on the scales, to favor a quick-and-easy abortion drug. Abortion drugs put the abortion process largely out of the public view, certainly something politically advantageous to the pro-abortion crowd. Whether they did or not is for determination in the judicial review process, which is part of the law. The FDA does not have unfettered discretion; they are subject to review.
2. The "fetus" vs. "unborn child" language controversy is overblown. When an eager expectant mother talks about her pregnancy, she likely doesn't call it a fetus, though it is one. Both seem correct to me, and if you object to calling it an unborn child, that suggests to me that you're reluctant to acknowledge what an abortion is.
3. "Medication abortion" vs. "chemical abortion." What do we call the substances used to carry out a death sentence in a "lethal injection" procedure? Is that "medication"? It's not intended to make the recipient healthier, it's intended to make them dead. Same as to an abortion drug, with respect to the fetus/baby. (This sort of euphemism is all too common, like calling healthy breast removal "gender-affirming care.")
4. Abortion advocates want to conceal the hard facts, that they are killing a human life, so they use terms like medication and fetus. Abortion opponents want to emphasize those same facts. As long as those linguistic preferences don't get in the way of finding the truth (whether these drugs are safe for the pregnant woman?), let's just respect the speech and expression rights of whoever has something to say about it, including this judge.
"Judge Invalidates F.D.A. Approval of the Abortion Pill Mifepristone/The Texas judge’s ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available"
Doesn't work that way, chum.
When one Seattle judge issued a nationwide injunction against Trump's "Muslim ban", the fact that a different judge in Maryland upheld Trump's actions meant nothing.
Nationwide injunction trumps.
People with functioning trains warned you about all this in 2017 - 2020, but you shit for brains insisted on doing it your way.
Enjoy!
Hey Dems - You liked this sh*t when it was a Hawaiian judge issuing national injunctions to block Trump's legitimate moves on immigration enforcement, etc., right?
Well, did you really believe that the other side would use the same tactics?
Their arrogance is eclipsed only by their shortsightedness.
Claim based on "expert"
Dont trust the rest of the sentence
The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication....
Apparently true, since the NYT isn't trying to argue otherwise
In the 67-page Texas ruling, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the anti-abortion groups and repeatedly used the language of abortion opponents
How many rulings forcing schools / States to let boys trans-play as girls "appeared to agree with virtually all of the claims made by the" pro-trans groups, and "repeatedly used the language of" the pro-trans reality deniers.
You know, like calling a male "she"?
calling medication abortion “chemical abortion”
A "medication" is a "chemical", so by definition all "medication abortions" are "chemical abortions"
referring to a fetus as an “unborn human” or “unborn child.”.
He or she is a human fetus. if she were a cow fetus, it wouldn't be an issue.
The pro-abortion side calls human unborn children "fetuses", and tries to dehumanize and etherize them by dropping the "human" part.
To call the "human fetus" just a "fetus", the way the NYT does, is to engage in propaganda.
To complain that the judge is using technically correct language that just isn't their preferred propaganda takes a special degree of arrogance and stupidity
The FDA inappropriately approving a drug/therapy/vaccine for political purposes? Shocker!
The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000
Perfectly true.
and that it has since ignored safety risks of the medication
Which are what, precisely? I have no trouble believing that FDA approved the drug with inadequate testing for political reasons, nor do I have any trouble believing that the FDA and the entire medical community would suppress entries of bad reactions into the FDA Adverse Event Reporting System (FAERS). But if, after 2 decades, there isn’t a whole lot of data recorded about adverse effects, then the FDA was right (for the wrong — political — reason) but nevertheless right.
In the 67-page Texas ruling, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the anti-abortion groups and repeatedly used the language of abortion opponents, calling medication abortion “chemical abortion” and referring to a fetus as an “unborn human” or “unborn child.”...
This strikes me as being scientifically wrong. As I understand it mifepristone prevents a blastocyst from implantation, so it never becomes a fetus.
The Vault Dweller said...
What is a fetus if not an unborn human?
What is a woman?
Dumb Lefty Mark: "Legislating from the bench, which I recall people objecting to on this blog this week ;)"
Dumb Lefty Mark appears very, very upset that a judge is using perfectly precise and accurate terminology to describe an unborn child and chemical abortions.
This does not surprise me as I recall Dumb Lefty Mark could not define "woman".
Asking Dumb Lefty Mark to comprehend accurate biological and chemical terms is like asking a manatee to demonstrate knowledge of the NYC sewage system.
Long time lurker, rarely comment. I know that anecdotes are not the same as data but here's my story.
In 2013 we were thrilled to discover I was expecting our 3rd child. At the 8 week appointment, we were heartbroken to learn the baby had stopped growing, approx 6 weeks gestational age. There was no heartbeat and there should have been. In case I had my dates wrong, we repeated the ultrasound at 10 weeks, which proved it was not a viable pregnancy. I also experienced intermittent spotting, but nothing more.
We discussed with my Dr and it appeared my body was going to pass things on its own.
2 more weeks passed and there was no progress on a "natural" miscarriage. My Dr was concerned as another ultrasound showed things breaking down internally, and sepsis was a major risk. She prescribed this medication in order to prevent having to surgically remove the not-baby.
After taking the medication, and finally having a miscarriage (during Thanksgiving dinner), Dr recommended I get checked at the local ER to make certain nothing was retained - nothing was, and things went smoothly.
Because I didn't need surgical intervention, I was able to safely become pregnant with our daughter 3 months later. As fate would have it, she's a Thanksgiving baby.
I'm pro-life, and recognize there are situations that chemically-induced abortions may be necessary. It likely saved my own life, or at the very least saved us thousands of dollars in medical bills a D&C would have cost, not to mention recovery time.
Jamie's comment above (12:41 pm) is so apt that from now on I should just refer to it ("Jamie 4/8/23 12:41 pm") rather than offer my own clumsy version. For the record, here it is:
"I am pro-life personally but grudgingly willing to accept Euro-style laws on abortion - I believe that every abortion ends a human life, but I acknowledge that it is going to take place no matter how vociferous my side of the issue is, so I'd rather have the best limits the bulk of Americans will accept than none at all. This pill falls under that rubric for me - if its proponents are being complete and truthful in communicating its risks to the pregnant girls and women to whom they're administering it. We have 20 years of data now; surely we can discover the truth?"
Just found this. Genbiopro makes & sells the drug. Probably not the active ingredient
CALL NOW! PRESCRIBERS ARE STANDING BY!
Could the regulatory change, eliminating the need to see a doctor be involved in this ruling?
I could see an argument that a drug is safe when a doc sees the patient but not by phone with no physical examination.
Is that the argument in this ruling?
https://genbiopro.com/
As of January 3, 2023, the US Food & Drug Administration (FDA) has approved changes to the Risk Evaluation and Mitigation Strategy (REMS) program for generic mifepristone tablets, 200 mg. In addition to maintaining the current system of distribution, the new REMS helps improve access to medical abortion care
John Henry
The FDA made a finding "more than two decades ago" that a pharmaceutical was "safe."
Which of course means that the FDA is always 100% correct and that "Science" never discovers that the earlier "science" was insufficiently informed, incorrect regarding the prediction of future results, or simply ignorant about potential harms.
If the "Science" supports your political belief system, that "science" can never be questioned.
Sure.
The plaintiff's trial bar will tell you otherwise, but what do they know?
The Supreme Court could have put the kibosh on this a long time ago if they had killed the idea that district federal courts could rule for the whole country.
It is amusing to see the progressives get their panties in a wad over jurisdiction shopping when they were so excited it worked when they wanted to stymie Trump.
The abortion pill is readily available and Biden is intent on keeping it that way.
So it is hard to see how any plaintiff that wants the abortion pill in the Washington case even has standing for the court to order its continuation.
"If any form of abortion should be legal, it should be the morning after pill."
Mifepristone is not the morning after pill. The morning after pill is high dose regular birth control and does not cause abortion. Mifepristone is a drug for inducing abortion.
Given the issue, I expect g the FDA was under significant pressure to get the correct results.
Even if the FDA did not follow procedure in approving the drug, it’s been in the market for 23 years. The statute of limitations on that complaint should run out at some point.
UNLESS…the FDA is ignoring evidence of safety problems. That would be damning. And the judge so held.
But what’s with all the left-wing shrieking? This is hardly the only abortion drug, is anybody really inconvenienced? Is anybody’s access to abortion threatened?
I saw that Democrats like AOC are calling on Biden to ignore the ruling, because he’s above the law.
Freeman Hunt, thank you for that clarification!
Jamie: "This pill falls under that rubric for me - if its proponents are being complete and truthful in communicating its risks to the pregnant girls and women to whom they're administering it. We have 20 years of data now; surely we can discover the truth?"'
Covid just irrefutably proved you will never get "the truth" from govt or "independent" third parties/researchers on health related issues that are politicized.
Ever.
This is an object illustration of why Federal judges ability to order injunctions ought to be limited to their jurisdictions, rather than the parties. FDA is now under contradictory orders from courts in two jurisdictions. If an agency chooses to obey globally given the result in jurisdiction A, and there's no conflicting injunction, that's reasonable, but to allow some judge in the middle of nowhere to issue binding orders across the entirety of the US creates terrible incentives to forum shop for the most harebrained judge you can find (c.f. that Hawaiian judge who kept trying to overrule Federal immigration policies).
Where I could see this being a problem is multi-district litigation where the case was filed with courts in all affected jurisdictions but then got consolidated so only one judge in one district is hearing everything. Another possible issue is when agencies (e.g. the SEC) sue in a real court (rather than the administrative court they control) for injunctive relief to prevent a nationwide course of conduct. So stripping district courts of the ability to impose nationwide injunctions isn't a panacea.
But perhaps the process of registering judgments in other jurisdictions to make them enforceable provides sufficient protection. I've only ever done this for money judgments (or challenged it for default judgements) so I don't know how it works for injunctive relief. Perhaps it does limit the reach of a judge's order. But perhaps a judge who got pissed off that his injunction wasn't being enforced two thousand miles away in some other judge's court could start imposing sanctions to bring the losing party to heel.
@Freeman Hunt, thank you for the clarification. My mistake also.
Stunning. Just confirming suspicions, but goes to the cause of the broken pharmaceutical industry. Not political at all. Equal blame.
Take a minute.
https://imprimis.hillsdale.edu/americas-broken-health-care-diagnosis-and-prescription/
Mifepristone is not the morning after pill.
Exactly. Pro-Choice zealots are conflating. Mifepristone is a late-term abortion or homicide pill with diverse adverse effects for the mother. They may as well send women to Planned Parenthood with a diversity (inequity, exclusion or DIE) and profit motive, in lieu of medical care with a life bias. Furthermore, medical care is unaffordable not based on cost but rather progressive prices sustained through Medicare, Medicaid/Obamacares, and similar single/central/monopolistic schemes that ensure that services remain unaffordable and unavailable. In any case, women and girls should not be treated as breeders (e.g. two men and a womb) in socially progressive (e.g. friends with "benefits", immigration reform, top/bottom/back hole... black whore h/t NAACP) cultures, which is an ancient ethical/religious prescription that should be aborted and sequestered, not cannibalized and recycled again, and again, and again.
Freeman,
Good point but not quite complete. This treatment is a two step process
First step is mephiprestone. This kills the fetus. Not sure of the semantics but I don't think this is the "abortion"
The second step, once the fetus is dead, is a dose of misoprostol to expel the dead fetus. I think this is actually the abortion.
Semantics aside, your point is well taken. This is not the morning after pill to prevent a pregnancy.
This is an abortion of an existing pregnancy
John Henry
Post a Comment