Causes.com
| 6.13.24
SCOTUS Upholds Access to Abortion Pill Mifepristone
Should the Supreme Court block the abortion pill nationwide?
Updated June 13, 2024
- The Supreme Court has decided to uphold access to the abortion pill, a drug that the FDA has approved for over two decades. The justices unanimously rejected the argument from a group of anti-abortion advocates, known as the Alliance for Hippocratic Medicine, that questioned the FDA's decision. The verdict came down to the plaintiffs' standing to question the FDA's expertise.
- The case was centered around changes made by the FDA in 2016 and 2021 to widen the pill's accessibility by mail and telemedicine.
- The ruling reaffirms the FDA's role as a regulator for medications of all kinds.
What they're saying
- President and chief executive Jodi Hicks of Planned Parenthood Affiliates of California said:
"The court issued the only reasonable decision in this case — for now. But we can't let our guard down."
- SBA Pro-Life America, one of the nation's most active anti-abortion groups, said the decision is "deeply disappointing." President Kristan Hawkins of Students for Life of America, a pro-life advocacy organization, said:
"We'll be back."
- President Nancy Northup of the Center for Reproductive Rights said in a statement:
"The anti-abortion movement sees how critical abortion pills are in this post-Roe world, and they are hell bent on cutting off access. In the end, this ruling is not a 'win' for abortion — it just maintains the status quo, which is a dire public health crisis in which 14 states have criminalized abortion."
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
The high priest Inquisitors and supreme wizards of our Supreme (?) Count are moving the country toward the Christian Nationalist theological, oligarchical autocracy that their supremely wealthy benefactors crave for our immediate future.
Leonard Leo has to be very proud of his chosen pet lapdogs obedience to ‘the cause’. There has never been so much neglect of the basic precepts of our democracy nor the constitution as this bizarro excuse for a Supreme Court have continued to take unto themselves an unconstitutional authority to vastly rewrite the laws of this nation, ignore any and all precedents that the court has previously enacted and repeatedly re-asserted, and their poorly justified conclusions which are basically forcing any established governmental decision process to be regulated by the Supreme Court.
Getting rid of the country’s abilities to let agency experts interpret congressional regulatory mandates via a new and ill-defined concept of ‘big-decisions’ ultimately will let the Supreme Court be the arbiter for all government regulations instead of the experts. Gorsuch’s recorded writing of this decision used smog regulations for an example - and repeatedly referenced the chemical composition of laughing gas (eg. Nitrous DiOxide) for the regulated Smog pollutant of Nitrous Oxide. I am glad that we can no longer spew laughing gas but a still concerned about the hazards of smog emissions. Otherwise I find the court's decisions quite inept and laughable (stop releasing laughing gas dammit).
Democrats need a big win in the next election. The Supreme Court needs a lot of fixing and they won’t be able to re-establish democratic norms and restore the freedoms taken from women, the looming ban of contraceptives and LBGTQ rights, State gerrymandering and the right of every citizen to a free and fair election process - without overwhelming presidential wins and majorities in both houses of congress.
We have to get organized big money out of buying political influence and need to get rid of the Citizen’s United decision and make it illegal for the Federalist Society to use vast donor funds to shape the federal judiciary. Something has to be done to prevent carefully designed disinformation and outright propaganda authored and distributed through a cooperative and coordinated effort with Russia, China and Iran complete with a central coordination and worldwide supposed news sites to spew this crap from many sites concurrently to make it look credible. The Russia Propaganda Fox Entertainment news outlet needs to be throttled or liability sued out of existence and Republican Cartel maga-nuts need to be accountable for knowingly spreading this crap because it is politically expedient.
There is a lot to do and no one can help get this done except the people who care about a future for this country.
To get started we need to support Biden’s reelection.
CNN has got to stop beating the drum and pushing Biden’s incompetence because he is not good at providing 30 second gotcha soundbites. When did that ever become a criteria for the abilities of a President to address the short and long term issues of import? CNN cannot accept any responsibility for their role in, for example, not allowing debaters to have notes available - and cannot drop the issue because they need someone to blame. CNN’s all hands effort to discredit Biden is a threat to our democracy. F.U. CNN!
I will vote for Biden and I will even if he is in a coma when I cast my vote. A vote for the trump would likely become our last chance to ever cast a vote again,
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.
Life, liberty, and the pursuit of happiness is illegally taken from the unborn. Life begins at the time of conception. Sadly, many Americans are having their religious rights taken from them because their tax dollars are being used against their will to kill these precious children. Evil to murder these little ones and evil for our government to force unwilling taxpayers to fund their deaths. There will be a day of reckoning.
So zero recourse for women who are raped.
This is a war on women.
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/
Again another misleading headline...... the case wasn't about banning the pills, its about mail access. If a woman's health is that important, they should at least be required to do a telehealth call with a physician in case they run into trouble.
The abortion pill should be blocked. Abortion is murder of a child. Furthermore, the drug is not safe for women. Complications do arise requiring a trip to the emergency room and surgery. This can be dangerous for some medical personnel who honor their oath "to do no harm," legally jeopardizing their medical careers.
On this, Fourth of July, I fear for our country more than any other. With a crazy man and criminal Donald Trump running for president a man with no moral code whatsoever and a supreme court that is totally unhinged this country is in more danger than it has ever been. May God help us.
After today's decision, I feel the need to once again beg (yes, I'm begging) Congress to put some check in place & reform the courts. This is a repost:
REFORM THE COURTS!!!
1. ALL justices require a highly qualified rating by the American Bar Association
2. No more than one justice difference between left- & right-leaning justices
3. No appointments to our highest within 6 months of a presidental election
4. Justices should not receive gifts/advantages/monies from any individual or entity which would compromise the court. Discovery of such, disqualifies the person from serving...ever again.
in this country today we have a Supreme Court that is totally off the rails take clearance Thomas decision on bump stocks as an example, he sided in his decision an a Amicus brief that was written by a right wing anti-government organization! It was never fact checked where the brief came from or if it was at all accurate and he used drawings and sketches in his brief from that organization that were faulty. Thomas also went on to say that anybody with a lightning fast trigger finger could do the same thing! I want to see Clarence Thomas pull a trigger 800 times in one minute in fact I want to see any human being do that. This is just a small example of members of the Supreme Court that are on the take taking hundreds of thousands of dollars worth of free the trips from billionaire donors, it's disgusting. It's where the Republican party has led this country.
I don't know what the endgame is for the Republican party, but it looks like it's the destruction of our freedoms, our safety and our American way of life. Wake up America this is what's happening now.
Women's healthcare should not be controlled by any governing body - Full stop
A white male moron idiot of heritage foundation president Kevin Robert! Three days after birth is not an abortion! The heritage foundation is one of the worst organizations of America, democracy and the republic! Speaking of misleading, misguided and misinformation?
Instead why not block Alito and Thomas from the supreme court?
They need to reluse or rersign.
Not just NO but HELL NO! Block access why? Finally SCOTUS makes the correct decision!
FIRST, all anti-abortionists need to have a 20-year ongoing plan to support educate, and medically care for the children they will be responsible for.
No person has the right to tell anyone else what to do with their body. Women and doctors make these decisions Not politicians and not religious people.
So the American Taliban is anti-abortion and will murder you over this made-up issue, but this time it pits them against the big pharmaceutical companies who own ALL republican politicians and judges. The fact the pills are still legal is one of the good things to come out of this conflict of interest.
There are several members of the Supreme Court, most notabily Justice Alito, who have made it abundantly clear that they are opposed to abortion rights for women. The mifepristone decision is NOT the end of this.... it is simply that the justices could not demonstrate that harm was done to the plaintiffs. We have not seen the end of this.
Simple solution if you don't beleive in abortion then don't get one. Quit trying to force your believes on others.
Republican so-called lawmakers have demonstrated that they are spectacularly uninformed about women's health. The latest crop of right wing extremist judges on the supreme court are similarly uninformed and intellectually lazy. They have not the first clue as to the biology of pregnancy, menstruation, menopause, etc., and therefore need to BUTT OUT of legislating or ruling about such issues. HELL NO, mifepristone should NOT be banned anywhere and should be available to use for anyone when necessary.
Should have free access!
I keep saying this!! The government does not belong in an individual's health care decisions!! The governments sole function is to ensure affordable health care is available for all and all medications are safe!!
I wonder if anyone remembers the 1950s when to get an abortion you had to either go to a backstreet doctor or use a wire hanger? Women also used to drink spoiled milk so that they could abort an unplanned pregnancy. Please let's not go back to the 1950s!
No stop trying to take pour rights away & stop putting women's lives in danger. The abortion pills are safe & effective. Stay out of issues that should be strickly between a woman & her doctor. Abortion pills are approved by the FDA, are safe & have been fro a really long time. Congress & the supreme court are not doctors & are not qualified to make health decisions. Abortion pills are safer than tylenol.
I have already made comments on the issue of abortion before but I will say it again. Abortion is a personal choice and not a political subject. Breath of Life or being "Born" occurs outside the womb.
More children alive are killed due to violence than unborn fetuses are removed from the womb for any reason. This is a womens decision and men are trying to make decisions for us.
If we leave the decision to the women you might be surprised to know how many women will carry to term for a couple wanting what they may not be able to have. So many unwanted babies are abused or neglected in our society and we can't keep up with them as it is.
Child protection should be more important than whether or not a women decides to bring more children in the world that she is not prepared to protect, care for and teach the morals of right and wrong. A good many of those are in a foster system that is about 25% effective if that, and may be filling up our jails by dishonoring a decent sense of respect for the life of others.
Moralities are taught by example. As a society what are we teaching our people? Let's use the energies being eaten up by the subject of abortion to creating a country that puts the needs of others first. Just maybe there will be one less child born into poverty, self destruction, or abuse.