Appeals court partially blocks ruling that imperils access to key abortion pill
Category: News & Politics
Via: perrie-halpern • last year • 41 commentsBy: Lawrence Hurley and Laura Jarrett (NBC News)
S E E D E D C O N T E N T
A federal appeals court late on Wednesday blocked part of a ruling issued last week by a Trump-appointed judge that endangers access to the abortion pill mifepristone.
The 5th U.S. Circuit Court of Appeals granted the Justice Department's emergency request to put on hold the part of the decision issued by U.S. District Judge Matthew Kacsmaryk that suspended the Food and Drug Administration's original approval of mifepristone, which dates back to 2000.
But the three-judge panel said that a separate part of Kacsmaryk's decision, which suspends changes the FDA made to the drug's approved use in 2016, could go into effect. The panel also determined that the agency's finding in 2021 that mifepristone can be distributed by mail would be paused as well, as Kacsmaryk ordered.
The court's decision imperils widespread availability of the drug, as it would require patients to make in-person visits to obtain it.
The 2016 changes among other things reduced the number of in-person visits that patients are required to make from three to one.
The appeals court said it would expedite its full consideration of the case.
The Justice Department can still ask the Supreme Court to intervene in an attempt to completely block Kacsmaryk's ruling. The administration would need to win the votes of at least five of the nine justices on the court, which has a 6-3 conservative majority.
The panel was divided 2-1, with Judge Kurt Engelhardt and Judge Andrew Oldham, both appointees of former President Donald Trump, in the majority. Judge Catharina Haynes, an appointee of President George W. Bush, said she would have temporarily blocked the ruling in full.
The Biden Administration and Danco Laboratories, the maker of Mifeprex, the brand version of mifepristone, both filed requests seeking to put Kacsmaryk's ruling on hold.
Kacsmaryk's decision "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," Justice Department lawyers wrote in court papers.
The anti-abortion coalition challenging the FDA's approval of the drug in 2000, called the Alliance of Hippocratic Medicine, waited too long to bring its lawsuit and does not have legal standing to do so, the lawyers wrote.
Danco's lawyers said that Kacsmaryk's ruling adopted a "one-sided narrative" that "omits crucial facts," including the benefits of the drug to millions of women.
Those challenging the drug's approval said in court papers that a decision in favor of the federal government would "perpetuate FDA's unlawful mail order abortion regime and result in further harms from a dangerous drug the district court found should never have been approved."
If the ruling issued on Friday goes into effect in full, it would suspend the Food and Drug Administration's longtime approval of mifepristone — the first of the two-drug regimen used to carry out medicated abortions. That would jeopardize access to mifepristone nationwide. However, Kacsmaryk gave the federal government a week to appeal his decision before it takes effect.
"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," the Justice Department lawyers wrote in the most recent filing. "This harm would be felt throughout the country, given that mifepristone has lawful uses in every State. The order would undermine healthcare systems and the reliance interests of businesses and medical providers."
Complicating the situation further, a federal judge in Washington state issued a preliminary injunction in a different case on Friday barring the FDA from "altering the status quo and rights as it relates to the availability of mifepristone."
That ruling applies only to the 17 liberal-leaning states and the District of Columbia that filed a lawsuit in February challenging the FDA's regulations over the drug. The Justice Department has filed a motion in the federal district court in Washington state, asking for clarification on Friday's ruling.
The dueling decisions in Texas and Washington could mean that the Supreme Court, which last summer overturned the landmark Roe v. Wade ruling, may soon take up the matter on an accelerated basis.
Kacsmaryk's ruling, if allowed to stand, would not mean that access to mifepristone would immediately be cut off nationwide. Instead, anyone involved in manufacturing, distributing or prescribing it would face legal risk, said Greer Donley, a professor at the University of Pittsburgh School of Law who specializes in reproductive rights.
The FDA could help alleviate that risk by announcing that it would not take enforcement action against anyone involved in distributing the drug, she added. The agency has broad power to do so, with the Supreme Court in a 1985 ruling saying that such decisions generally cannot be challenged in court.
While misoprostol can be used alone for abortions, experts have said that it's not as effective in terminating pregnancies as it is in tandem with mifepristone.
A majority of abortions in the U.S. are carried out with the use of pills, according to a survey conducted by the Guttmacher Institute, a research group that supports abortion rights.
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I told you so. Gee, it sucks being right all the time!
Here is more on the ruling from the 5th US Circuit Court of Appeals:
"The 42-page order issued by the New Orleans-based Fifth U.S. Circuit Court of Appeals late Wednesday in effect returns restrictions on the drug to what they were before 2016, when the pill could only be used up to about seven weeks of pregnancy, required three in-person doctor’s visits and couldn’t be sent to patients through the mail.
The three-judge panel seemed skeptical of the plaintiffs’ challenge to the drug’s initial 2000 approval , but were more persuaded by arguments that the U.S. Food and Drug Administration had failed to properly scrutinize more recent changes that loosened access to the drug.
The plaintiffs—antiabortion medical associations and individual doctors—had argued that even though their challenge to the drug’s 2000 approval appeared to be time-barred by the statute of limitations, the FDA had essentially reset the clock by making subsequent changes."
Hopefully there is enough in place now for a so-called woman to terminate her pregnancy, especially if the drug is used in a timely manner.
In 70 odd years I have never met one, are they a new species?
We have the outer parts but we don't have uteri or ovaries
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No, I can't say that without creating an uproar that will get me a suspension.
It would also cause a lot of crying
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So a woman is only a woman if she wants to be pregnant? If she can't carry or doesn't want a baby at that time in her life, or if there is something wrong with the pregnancy, she isn't a woman. That is freaking insulting Vic. When a man can get pregnant, then he can have an opinion on this.
He is probably referring, in a weak way, to the "inability" of the "woke" to define "woman".
It's beyond insulting. It's the kind of shit that comes from someone who either hates women or is jealous of them
I don't like to generalize about any demographic group, but I believe that woman are amazing and so much better and more interesting than men:
If women have high heels and a short skirt , and an apron on, some old timers have a more favorable view of them.
Yeah because they turn them into sex objects. He's already said in the past that he doesn't think women should wear pants
Now, Drinker, I know you are a man who loves women. Btw... Can you tell that I agree with your assessment?
I wouldn't expect you to disagree with the truth.
Really can't argue with any of your points. In human history how many wars were started by women?
Actually when you look at it, men are basically responsible for almost all the awful shit that happens and has happened in the world.
Women are without a doubt far better looking, and from a biological perspective are infinitely more valuable than men.
Completely agree. As the Godfather of Soul sang:
You toot your own horn quite often, and wrongly so.
And what is a "woman" in your mind?
Gotta love the party of "small" government continues to insinuate itself into a woman's health care.
I expect to see an appeal to the SCOTUS today with a request a complete hold until it works it's way through the system. In the meantime Dems are trying to push a new medical records privacy bill through to make it harder for states to pursue abortion charges where patients get out of state care. We are certain to see HIPPA violations and rulings before too long anyway.
They will consider that BIG government over reach. After all all men need to know the health issues and treatment of ALL women everywhere - even if they don't know them.
Until someone wants to collect data on the use of erectile drug use. Using the logic of the Texas judge's ruling where he talks about how a woman may regret her termination decision, could very well apply to the use of sildenafil. Unwanted pregnancies are way more harmful to women than using mifepristone both medically and mentally.
This argument drives me CRAZY. What about women that decide to give birth & then regret their decision? No one talks about that.
While this is off topic, I do hope (yeah, I know. It's Congress. Long on pontification but short on thought) they think this all the way thru because we do need to get mental health issues reported to NICS.
As for abortion, I hate the patchwork laws we have now. This is nothing but a return to the 60's without the flower power. I would like to see a bipartisan approach to a compromise bill on abortion worked in Congress.
I don't see how that would work given the whole idea was to "leave it to the states" to decide. Then again as soon as it was ruled that way we had the idiotic Republicans in Congress vowing to push a national ban too.
What I think we will see is a period of chaotic laws and lawsuits wind their way through the system. Most of these laws are unworkable and intrusive. The system will take care of the unworkable one while the voters will eventually take care of the intrusive. Then we'll be in a better place for a national compromise bill. I would expect it to be somewhere between the 16 weeks Republicans originally wanted and the old 20 week standard.
Actually I don't believe it was ever a leave it to the states to decide thought. Congress was too split on the idea and it was punted to SCOTUS thru numerous law suits coming due to state laws. The SCOTUS ruling created a right for abortion, even RBG felt it was wrong for SCOTUS to take it up. So when it was recently overturned, all SCOTUS did was say this is not a constitutional right and we should not be making this decision. By default it was returned to the states to decide as Congress would not.
But I think you are correct in that there will be a period of lawsuits and elections that will play a big part in this. But that takes a lot of time, many years I'm afraid before a national compromise can be found. One thing I'm sure of is that any political party who ignores abortion will pay at the ballot box. We saw in 2022 how the younger generation will come out in numbers to vote for issues they feel are important and abortion is more on the minds of the young than the Social Security crowd.
State rights on abortion was the right wing populist talking point...until they got what they wanted and now they want more.
RGB said the Roe was decided from the physician side and didn't go far enough to advance women's rights. The Roe decision was supposed to be a stepping stone for women's advancement.
The SCOTUS said there wasn't an unenumerated right to privacy overturning decades of precedents and undermining laws like HIPPA and Parental Rights that were built on it.
Yes. I agree with all this, though I think the whole part of this where states are trying to end around from being sued by letting anyone sue anyone else will be shut down sooner rather than later. It makes a mockery of the system and is already being tested in court.
This has nothing to do with states' rights. Nothing.
sn't an unenumerated right to privacy overturning decades of precedents and undermining laws like HIPPA and Parental Rights that were built on it.
No, it didn't.
Does this mean I won't have to certify on HIPAA every year?
I wonder if any of these justices would like their private health issues paraded out in public. You know if any of them have ever had crabs - tested positive for HIV. Just wondering.
LOL!
I just had the image of the Town Crier ringing his bell and yelling:
"Hear ye! Hear Ye! Judge Podunk has the crabs! Even the local working girls won't touch him!"
Now that made me laugh.... thanks.
you're welcome
I'm hoping I can drop the company HIPPA compliance requirements at work and we can transmit all our customer data in unencrypted emails. /s
Yea - I just got an email about my unencrypted external hard drive...
snort
And here it is-
Yeah, the federal government has no say in what drugs are prescribed.
Down with the FDA!
The interesting thing about the kerfuffle over this case about the FDA's processes is that it pulled back the mask, once again, on the Democrats' purported fealty to the rule of law. Democracy and the rule of law became the most sacred thing to them on Jan 7, 2021 (pay no attention to 2020). So pious, so exalting of the Constitution and quick to hysterically denounce all who opposed them as fascists, insurrectionists intent to overthrow the government, constitution etc..
Then a district judge issues a ruling that touches upon one of their favored policies and, bam, Democratic Congressmen and legal scholars want to throw the Constitution out of the window and wage war upon the judicial branch of government. Not really a surprise to anyone paying attention. Any protest, any assault on our Constitution is justified because of their wants. No different than a five year old. Laws, rules, democratic institutions only matter when they do what they are supposed to.
Just read an article that now Big Pharma is wading into the abortion fight and against the anti-choice crowd. Looks like they fucked up big time.