Causes.com
| 3.27.24
SCOTUS Hears Arguments of Abortion Pill Mifepristone Case
Should the Supreme Court block the abortion pill nationwide?
Updated March 27, 2024, 12:30 p.m. EST
- On Tuesday, March 26, the Supreme Court heard arguments about the mifepristone case, challenging the Food and Drug Administration's approval of the medication that is used in nearly two-thirds of abortions in the U.S.
- The justices appeared skeptical of the arguments to limit access to the pill, which the FDA has approved for over two decades. At the case's core is whether the agency had the authority to expand access to the drug in 2016 and 2021 by allowing doctors to prescribe it through telemedicine and send the pill by mail.
- Several justices questioned whether the plaintiffs have standing, bringing skepticism to their entitlement to sue the FDA. The justices also challenged the plaintiffs' request to apply nationwide restrictions to the drug, which would be the first time a court had second-guessed the FDA's expert judgment about drug safety. Justice Neil Gorsuch said:
"This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an F.D.A. rule or any other federal government action."
What's the story?
- The U.S. Supreme Court has agreed to hear a case that could make mifepristone, the popular abortion pill, less accessible.
- In April, Texas-based U.S. District Judge Matthew Kacsmaryk imposed a nationwide ban on mifepristone. The Supreme Court put a hold on the decision until the justices could hear the case this term, keeping the abortion pill widely available for the time being.
- This case could not only affect access to mifepristone, but also the FDA's authority to regulate medications.
The big picture
- The Alliance for Hippocratic Medicine, an association of anti-abortion doctors and organizations, filed a federal lawsuit last year arguing that the FDA had overstepped its power in approving mifepristone.
- Kacsmaryk revoked the FDA's clearance of mifepristone, declaring that the administration had improperly approved the drug 23 years ago. He claimed the approval process was inadequately expedited, leading to an unsafe drug regimen entering the market.
- The Biden administration and the manufacturer of mifepristone had requested the high court to intervene and halt Kacsmaryk's ruling.
- Since Roe v. Wade was overturned, over a dozen U.S. states have either banned or heavily restricted abortion. Other states have passed laws and approved ballot measures to safeguard abortion rights. Anti-abortion activists are now focusing on medication abortion, which can be received through the mail and taken at home.
- Mifepristone is the first of two pills that make up the most popular method for terminating pregnancies. It's responsible for more than half of all abortions in the U.S.
- While the Supreme Court hears the case, the medication will remain available. A decision will likely be released by the summer of 2024.
What they're saying
- The Alliance for Hippocratic Medicine argues that the "FDA always envisioned that emergency room doctors…would be a crucial component of the mifepristone regimen." The group says doctors would suffer if they had to treat patients who have taken the medication. The Biden administration said the alliance failed to show "any evidence of injury from the availability" of the drug.
- The government asserts that the drug has been "safe and effective" since 2000. The administration said the FDA has "maintained that scientific judgment across five presidential administrations, while updating the drug's approved conditions of use based on additional evidence and experience…"
- Danco, the maker of mifepristone, said anti-abortion doctors have no authority to bring this case to the court, as they "do not prescribe or use the drug," and their only "real disagreement with the FDA is that they oppose all forms of abortion."
Should the Supreme Court block the abortion pill nationwide?
-Jamie Epstein
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Bad precedent to have judges and lawyers with no medical background even contemplating overturning FDA drug approvals based on comprehensive medical evidence reviewed by medical thought leaders.
Mifepristone was approved in 17 countries before the US approved, using the US studies as well as studies from other countries, as well as, 10 years of safety surveillance data from 17 countries which is far more data than most drug approvals. Studies available at approval
7 US studies - 16,794 subjects
15 non-US studies - 18,425 subjects - 17 countries
11 studies self administered at home - 30,763 patients
Mifepristone is safer than aspirin, penicillin or Viagra. Viagra has 10X as many deaths but is anyone pulling viagra approval?
Now there is 30 years of data available for ongoing safety monitoring which CDC and FDA would intervene if safety signals emerge.
100+ studies
5 systematic reviews (of all studies)
147 published research articles
124,000 1st trimester abortions
19,000 study patients
26 countries
30 years of data
5.4M safety data on abortions
https://www.causes.com/comments/71569
https://www.causes.com/comments/76932
https://www.drugwatch.com/viagra/#side-effects-of-viagra
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1857095
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020MedR.pdf
So zero recourse for women who are raped.
This is a war on women.
Whether they do or not, it won't work. What really needs to happen is outside the legal system. People need to be convinced that abortion is wrong so they don't even consider it. Better yet, they need to be convinced to not get into that situation in the first place. Same thing goes for gun control, homosexuality, transgenderism, etc. Making things illegal is usually ineffective at changing behavior. Our churches and other social organizations need to do a better job getting the message out. We're often too "touchy feely" instead of being practical and scientific about these things. Everyone can have (and is entitled to) an opinion about religion, morality, and the like, but it's harder to argue with facts.
Just like Presicne Trump I don't support abortion unless it will harm the mother, rape, or incest. Every life matters no matter what, that unborn could be the person who solves a lot of the worlds problems. Also the Bible says not to take a life. Lastly our birth rate and population is going lower instead of up. Our adversaries China and other countries have larger birth rates. They are low because of the gay communities and having access to Overton since the 70's. My where could the us be now if we never had Roe v wade. Probably have strong cities and a strong military to protect us in this ww3 time that the Biden administration has put us in with a weak military! And that's why I don't support this pill.
The Alliance for Hippocratic Medicine that filed suit to have mifepristone approval removed so it can’t be marketed in the U.S. does not represent a single woman who had a serious adverse event from this drug, nor does it have one doctor forced to treat a woman against their beliefs after taking mifepristone. So how can a case like this be accepted by any court if there is no harm to be addressed known legally as standing?
Mifepristone is safer than Tylenol, penicillin or viagra after being on the market in the U.S. for 23 years and 17 countries before the US for 30 years. If mifepristone was unsafe based on serious adverse events the FDA would have initiated this.
Instead the Alliance for Hippocratic Medicine which made campaign contributions to Sen Hawley, had his wife, a Yale lawyer as well, and both Hawleys clerked for Supreme Court Chief Justice Roberts, strategically file suit by selecting Judge Kacsmaryk, a Trump appointed judge with known anti-abortion connections, working in a district where he is the only judge.
Judge Kacsmaryk should have refused to hear this case since it didn’t have either a patient or doctor who had suffered harm but instead this district court imposed a federal ban on a federally approved drug without any ancedotal reports, surveillance reports, or well controlled studies. Both junk science studies used in the initial case have been retracted due to conflicts of interest and unreliable findings.
So, why did the Supreme Court even hear this case when it had no standing instead of just sending it back to district court?
And why are Alito and Thomas suggesting the Comstock Act be used by red states to stop mifepristone being used in their states? Are Supreme Court Justices coaching Hawley’s wife in court?
“Hawley, an Alliance Defending Freedom lawyer in her 40s, has kept largely out of the political spotlight even as her husband, Sen. Josh Hawley (R., Mo.), has become a polarizing national figure. After the 2020 election, he was the first senator to say he would object to certifying Joe Biden’s electoral-college victory, and on the day of the vote, Jan. 6, 2021, he pumped his fist at Donald Trump’s supporters gathered outside the Capitol before the riot.
“Josh Hawley was a year behind her at Yale, but the two fell in love while clerking for Chief Justice John Roberts. “He likes to take credit for our marriage,” the senator joked on stage last year at a summit of the Family Research Council, a Christian advocacy group. “We like to say to him that we’re the most conservative thing he has ever done.”
“Erin Hawley joined the Alliance Defending Freedom, a conservative legal group, several years ago and has worked on some of its most prominent cases.
“On November 18, 2022, AHM [Alliance for Hippocratic Medicine] filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to overturn the FDA’s approval of mifepristone. AHM relied on junk science and bogus claims about the medication’s safety record, in direct conflict with a wealth of studies and data demonstrating that mifepristone is safe, effective, and critical to filling the gaps in abortion access for communities with limited access to healthcare and other resources.”
“In bringing this lawsuit, AHM cherry-picked a notoriously anti-abortion judge, who in April 2023 delivered the extreme and unprecedented result they wanted: invalidating the FDA’s original approval of mifepristone, effectively instituting a nationwide ban on its use. An appeals court reversed that extreme result, but instead put back in place harmful restrictions on mifepristone that are not medically necessary and impede access to the medication.”
“The Fifth Circuit Court of Appeals is also notoriously hostile to reproductive rights. On April 12, 2023, a panel of three judges recognized that Judge Kacsmaryk went too far in overturning the FDA’s approval of mifepristone. A majority of two Trump-appointed judges then took the extraordinary and unprecedented step of reinstating the outdated pre-2016 REMS restrictions that had been lifted by the FDA”
“Two of the key studies cited by plaintiffs and judges as evidence that medication abortion should be pulled from the market or heavily restricted have been retracted because of undeclared conflicts of interest and unreliable findings, academic publisher Sage announced Monday.”
“Tuesday’s hearing was the first time she had argued in front of the Supreme Court. Josh Hawley sat in the gallery and watched the arguments.”
“The Alliance Defending Freedom “is swinging for the fences at the moment, and that means testing how much the Court will buy cases like this one with glaring issues.”
“Justices Samuel A. Alito Jr. and Clarence Thomas repeatedly invoked the Comstock Act during Tuesday’s oral arguments over the abortion drug mifepristone, pressing all three lawyers about whether the 1873 federal law should apply to abortion drugs sent through the mail in 2024.”
“Kacsmaryk’s ruling in the mifepristone case, known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, has a lot in common with the Dobbs opinion penned by Justice Samuel Alito: It ignores science, wholly reimagines facts, and cites less-than-credible sources to arrive at a preordained destination.”
https://www.causes.com/comments/71569
https://www.causes.com/comments/76932
https://www.causes.com/comments/115567
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020MedR.pdf
https://www.washingtonpost.com/politics/2024/03/26/abortion-pill-supreme-court-arguments-mifepristone/
https://washingtonstatestandard.com/2024/02/06/study-cited-by-texas-judge-in-abortion-pill-case-retracted/
https://theintercept.com/2023/04/11/mifepristone-abortion-fda-matthew-kacsmaryk/
https://www.wsj.com/us-news/law/erin-hawley-abortion-pill-supreme-court-03c14274
https://nwlc.org/resource/fda-v-alliance-for-hippocratic-medicine-the-supreme-court-could-devastate-nationwide-access-to-a-safe-and-effective-medication-used-in-over-60-of-all-abortions/
Lawyers aren't doctors. They are completely outside having any medical experience or knowledge.
It's like putting a professor in charge of replumbing your house.
The abortion pill should not be dispensed by mail. A wom should see a medical professional for a prescription
I'm pro-life.
Once again I side with the mindset that abortion is a personal choice and not a political subject.
Breath of life is outside the womb.
AZ now putting into effect a law from... wait for it....1864!
You can't make this 💩 up!!!
Under his eye.
Trump used the alleged killing of 25-year-old Ruby Garcia by an undocumented immigrant to illustrate his strong stances on immigration and crime. "She lit up that room, and I've heard that from so many people," Mr Trump said. "I spoke to some of her family." The only problem with that statement is that it’s an absolute lie. The family of this girl has come out and said no one from Trump’s campaign, nor Trump has ever spoken to any of their family members. Trump is one sick lying idiot.
it's way past time to limit the terms of the Supreme Court to six years.
on another note: House Republicans have introduced a bill to rename Washington Dulles International Airport after a convicted sex offender, a convicted business fraud, proven liar and over 36 courts across this country, etc. etc. etc. how much more down the toilet can the Republican party possibly go?
Why is he not in jail, that's right he was pardoned by Trump. Also why would Any educated college women want to be with Steve Bannon or any women for that matter?
Just another day in religion in the name of God! So what's the teaching that Jesus taught?
And they said there is no judge shopping?
Trump touch is the kiss of death, obviously the MAGA cult has not figured it out!
How about naming it Benedict Arnold, Hitler or Putin?
What about Trump and all his followers?
Do we have to wait tell November to vote out the republicans?
Matt Staver is a freaking moron, what do you think would happen? It's healthcare moron, women healthcare not yours. If you have any girls or grandkids that are girls they can thank you and the Republican Party for putting it in the back-alley were it was before!
Hands off doctor/patient relationships.
The Supreme Court of the United States is one of three branches of government, yet it is populated by unelected individuals with lifetime appointments and treated as the highest, most unchallengeable of the three. The justices have also operated with impunity despite clearly showing long term corruption. This has to change, and this decision is one of many reasons why. Also, with respect to this case particularly, the Comstock Act must be repealed and relegated to the darkest abyss of American history, for study about why it was a bad idea and should never be repeated.
I'm so tired of this! Stay the hell away from making decisions about what women can and cannot do with their own bodies! This has to stop!!!!
Bad SCOTUS! Just a matter of time... 🤨
Generally speaking, it should not be any court's place to make medical decisions. Especially when the law in question isn't even a federal one.
It's not the Supreme Court's job to decide of drug approvals and denials.
The Supreme Court is completely ignorant about the biology of fertilization, implantation, gestation, embryology, pharmacology, etc.
They are not scientists.
They are not physicians.
They are not even dulas.
Most are men who don't have one clue about menstration, contraception, pregnancy and its complications.
WHY ARE THESE IDIOTS DECIDING ON ABORTIFACIENTS?
No, absolutely not their place to ban women's health care choices.