On Friday, two federal judges in Washington and Texas handed down opposing rulings regarding abortion pills. How this plays out could have a huge impact on public health. I partnered with Dr. Heidi Moseson, a reproductive epidemiologist, and Professors Rachel Rebouche and David Cohen, reproductive health scholars, to translate what’s going on, the public health science in one case (and lack thereof in the other), and what it means for people today.
...It doesn't matter if you live on the coasts, or if your governor is Democratic, or if Biden won your congressional district in 2020 by more than 20 points. It doesn’t matter if you live in a city that has more gay bars than churches or where every church flies a pride flag; it doesn’t matter if every mom you know planned all of her pregnancies, and it doesn’t matter if you’ve been managing your own reproduction rights with flexibility and privacy for your whole adult life.
It doesn’t matter if you think you’re safe or that abortion will always be legal where you live. Because the anti-abortion movement wants to impose a national ban on abortion and to take away your right to one. And they already have enough of their partisans in high enough positions – in elected office, yes, but mostly on the federal courts – to do so right now.
That’s the theory behind an injunction that was issued late last Friday by Matthew Kacsmaryk, a Trump-appointed district court judge in Amarillo, Texas, who issued a nationwide injunction invalidating the FDA’s 23-year-old approval of mifepristone, the first of two drugs used in a standard medication abortion. It is the most significant ruling affecting abortion access nationwide since Dobbs.
Mifepristone has been through the most rigorous medical testing possible, has a lower rate of serious complications than Tylenol and has been used to safely and effectively terminate pregnancies by hundreds of thousands of women both in the US and around the world for decades. It will remain available for now, as Kacsmaryk stayed his order for seven days so as to allow the Biden administration time to appeal, which they have done.
Complicating matters further, another district court in Washington state issued a conflicting injunction in another lawsuit – ordering the FDA to keep mifepristone on the market – just an hour after Kacsmaryk’s ban order was issued. The result is a complicated legal struggle, now almost certainly headed to the US supreme court, in which the lives, health and self-determination of millions of American women – and the dignity and full citizenship of all of them – hang in the balance.
Medication abortions using mifepristone now account for more than half of abortions in America. If you’ve ever had an abortion that you only had to take pills for, one of the pills you took was mifepristone. If the ruling goes into effect, abortion providers will be forced to perform only surgical abortions – which are more invasive and demand more resources – or medication abortions using only the second drug, misoprostol – which, while also very effective, are more painful and time-consuming.
There is already a thriving market of mail-order mifepristone in America, much of which is sent into the country from overseas, and which might have in theory evaded Kacsmaryk’s ban; but his ruling also revives the 1873 Comstock Act, a long-dormant and partially invalidated federal statute that prohibits sending abortion drugs or instruments through the mail, while also banning large swaths of material labeled “obscenity”.
Beyond its revival of a Victorian morality law, Kacsmaryk’s injunction is a dramatic escalation in anti-abortion jurisprudence, embracing fringe and extremist positions on abortion, pregnancy and women’s rights, adopting theories of judicial authority and legal standing that range form the tenuous to the bizarre, relying on discredited studies and anti-abortion junk science as statements of fact, and using exclusively the inflammatory, inaccurate and sensationalizing rhetoric of the anti-abortion movement. Throughout, the opinion refers to all pregnant women as “mothers”. Fetuses and embryos are described as “unborn humans”, or “unborn children”.
Kacsmaryk has never been shy about his personal views. For years, he sat on the board of an anti-abortion center, where his sister gave birth at 17; before his appointment to the bench by Trump, he worked at a rightwing legal shop that brought anti-abortion legislation. His injunction order embraces theories long held by only the most extreme fringes of the anti-abortion movement.
He makes empirically untrue claims about the supposed harms of mifepristone specifically, and abortion in general, to women, and he equates reproductive rights to eugenics. He gestures at dark conspiracy theories in his account of the original approval of mifepristone in 2000. And he signals and embrace of fetal personhood, a concept which, if enshrined in law, would ban all abortion nationwide, outlaw many kinds of birth control, curtail women’s access to medical treatments for everything from pre-eclampsia to depression to cancer, and vastly increase the government’s ability to monitor, surveil and punish a long list of activities in the daily lives of pregnant and reproductive-age women.
The order, in short, has none of the traditional judicial pretexts of impartiality or indifference to the policy outcome; it is not a document concerned with the law, but with enforcing an ideology. It reads like the rantings of an extremist activist, because it is.
But because Kacsmaryk is a judge, now those rantings have the force of law. If allowed to stand, Kacsmaryk’s order would deeply curtail access to abortion nationwide. Women in blue states and red states alike would find themselves degraded and humiliated by the law, taken out of control of their own lives, treated by the state as something less worthy than citizens and less competent than adults. But this was always how it was going to go: ever since the supreme court overturned Roe.
The current system, that tenuous balance in which abortion is nominally legal in some states, banned and sadistically punished in others, was never going to hold. The anti-abortion movement was never going to allow women in legal states to remain free; the pro-choice movement, at least the worthy parts of it, was never going to leave women in ban states behind.
The supreme court, controlled now by a group of ravenous rightwing partisans hardly more subtle than Kacsmaryk, is going to try to ban abortion nationwide – if not in this case, then in another one, sooner than you think. And the nation’s pro-choice majority, a newly enraged and motivated group of women voters and their allies, will stand up to them – with more fury than they anticipate.
How is it that all of a sudden, circuit courts are able to issue nationwide "rulings"? Also, how is it that the TX "ruling" applies nationally, but the WA one does not? This doesn't past the smell test.
I have some pretty strong anti Christian views and this issue is a large part of why. If they don't want an abortion, the answer is simple., don't have one. I reject the premise of their religious mythology being used as a basis to dictate people's rights.
The bigger issue in the Texas decision is whether a single judge can impair a Congressionally mandated agency with a well established legal and transparent regulatory process and prevent it from taking an action or revoke a decision after it completed a due process public review. In the short term this will throw all of health care into chaos as the established foundation of safety and efficacy for prescription medicines will be brought into question and subject to legal attack. In the long run, such precedent has the potential to impair all federal regulatory activities.
Thank you for this great summary. My soul hurts over this assault on women’s health and rights. Reproduction justice includes both the choice to not continue a pregnancy, to prevent a pregnancy (that will be next) and also the right to become pregnant (sterilization without informed consent as seen historically in Puerto Rico, the “Mississippi appy”).
You missed the boat. This is not about attacking an individual's beliefs. It's about the Judge forcing his beliefs on everyone else under the pretense of concerns about health and safety. The arrogance of his decision is glaring. The data supporting the safety of Mifepristone including its use for years is overwhelming-read about it.
This Judge’s decision had nothing to do with health and safety concerns. It was a decision motivated by a zealot who misused his power. His convoluted reasoning was designed to make it more difficult for women who seek an abortion to get one.
In our day-to-day understanding of the word “illness”, pregnancy does not seem like an illness. However, law and regulations that govern the FDA define “illness” as a “condition that can cause significant bodily harm or death”. Maternal mortality due to pregnancy as of 2019 causes death in 17.6 of 100,000 women. This mortality rate has been trending upward from 7.2 in 1987 (per CDC studies). This varies greatly by race and ethnicity, from 62 in Hawaiian & Pacific Islander women, to 39.9 in Black women to 14.6 in non-Hispanic white women.
The Republican war on science keeps getting uglier.
Science is the best means we have of discovering truth. A basic understanding that its practice and translation is best performed by scientists was a bipartisan acknowledgement for decades ... especially since our elected leaders were mostly lawyers and businessmen, and mostly ignorant about the scientific method. But they knew their lane.
The destruction of norms, institutions, and basic respect for truth/science represents a slow motion civil war. I hate to admit that. Especially since it’s coupled with unfettered access to AK 47s, the other very related problem we’re talking about here this week.
This country is reeling.
I liked this quote from NYT article today:
“This is a frontal assault on the legitimacy of the F.D.A. and their discretion to make science-based decisions and gold standard approval processes,” said Lawrence O. Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “It ultimately takes us on an extraordinarily dangerous path for F.D.A. as an agency, and for science-based public health decision-making more broadly.”
While all of you rage against "anti abortion" people and their views, and some against Christians, and while some of you continue ad hominem attacks on the Texas judge, you fail to address the issue of the FDA approving the drug under Subpart H, which is for treating "serious or life threatening illnesses". Regardless of how the FDA wants to spin the issue, nobody can defend the idea that a pregnancy is a serious or life threatening illness.
So, please, quit attacking groups of people and respond to the issue at hand in the judge's ruling.
It is amazing to me that the same people that complain about Christians or other groups being "intolerant" are some of the most intolerant people themselves as evidenced by many of the comments in the post.
Please, don't attack someone's beliefs, but rather argue the point at hand, which is the improper FDA approval.
So, just to clarify...this WILL eventually go to the Supreme Court because of the different rulings, correct? Do we have any idea of timeline on when the Supreme Court will hear this case?
Thank you. I was given both as the "morning after pill" for free, without caveats at a university student health clinic 50 years ago. Times have certainly changed, but I doubt it was because of new scientific knowledge about anything.
Noway2, could you please address the issue of the FDA approving this drug under subpart H, which is specifically related to illness, which pregnancy is not.
.
Moira Donegan
The Guardian
11 Apr 2023
...It doesn't matter if you live on the coasts, or if your governor is Democratic, or if Biden won your congressional district in 2020 by more than 20 points. It doesn’t matter if you live in a city that has more gay bars than churches or where every church flies a pride flag; it doesn’t matter if every mom you know planned all of her pregnancies, and it doesn’t matter if you’ve been managing your own reproduction rights with flexibility and privacy for your whole adult life.
It doesn’t matter if you think you’re safe or that abortion will always be legal where you live. Because the anti-abortion movement wants to impose a national ban on abortion and to take away your right to one. And they already have enough of their partisans in high enough positions – in elected office, yes, but mostly on the federal courts – to do so right now.
That’s the theory behind an injunction that was issued late last Friday by Matthew Kacsmaryk, a Trump-appointed district court judge in Amarillo, Texas, who issued a nationwide injunction invalidating the FDA’s 23-year-old approval of mifepristone, the first of two drugs used in a standard medication abortion. It is the most significant ruling affecting abortion access nationwide since Dobbs.
Mifepristone has been through the most rigorous medical testing possible, has a lower rate of serious complications than Tylenol and has been used to safely and effectively terminate pregnancies by hundreds of thousands of women both in the US and around the world for decades. It will remain available for now, as Kacsmaryk stayed his order for seven days so as to allow the Biden administration time to appeal, which they have done.
Complicating matters further, another district court in Washington state issued a conflicting injunction in another lawsuit – ordering the FDA to keep mifepristone on the market – just an hour after Kacsmaryk’s ban order was issued. The result is a complicated legal struggle, now almost certainly headed to the US supreme court, in which the lives, health and self-determination of millions of American women – and the dignity and full citizenship of all of them – hang in the balance.
Medication abortions using mifepristone now account for more than half of abortions in America. If you’ve ever had an abortion that you only had to take pills for, one of the pills you took was mifepristone. If the ruling goes into effect, abortion providers will be forced to perform only surgical abortions – which are more invasive and demand more resources – or medication abortions using only the second drug, misoprostol – which, while also very effective, are more painful and time-consuming.
There is already a thriving market of mail-order mifepristone in America, much of which is sent into the country from overseas, and which might have in theory evaded Kacsmaryk’s ban; but his ruling also revives the 1873 Comstock Act, a long-dormant and partially invalidated federal statute that prohibits sending abortion drugs or instruments through the mail, while also banning large swaths of material labeled “obscenity”.
Beyond its revival of a Victorian morality law, Kacsmaryk’s injunction is a dramatic escalation in anti-abortion jurisprudence, embracing fringe and extremist positions on abortion, pregnancy and women’s rights, adopting theories of judicial authority and legal standing that range form the tenuous to the bizarre, relying on discredited studies and anti-abortion junk science as statements of fact, and using exclusively the inflammatory, inaccurate and sensationalizing rhetoric of the anti-abortion movement. Throughout, the opinion refers to all pregnant women as “mothers”. Fetuses and embryos are described as “unborn humans”, or “unborn children”.
Kacsmaryk has never been shy about his personal views. For years, he sat on the board of an anti-abortion center, where his sister gave birth at 17; before his appointment to the bench by Trump, he worked at a rightwing legal shop that brought anti-abortion legislation. His injunction order embraces theories long held by only the most extreme fringes of the anti-abortion movement.
He makes empirically untrue claims about the supposed harms of mifepristone specifically, and abortion in general, to women, and he equates reproductive rights to eugenics. He gestures at dark conspiracy theories in his account of the original approval of mifepristone in 2000. And he signals and embrace of fetal personhood, a concept which, if enshrined in law, would ban all abortion nationwide, outlaw many kinds of birth control, curtail women’s access to medical treatments for everything from pre-eclampsia to depression to cancer, and vastly increase the government’s ability to monitor, surveil and punish a long list of activities in the daily lives of pregnant and reproductive-age women.
The order, in short, has none of the traditional judicial pretexts of impartiality or indifference to the policy outcome; it is not a document concerned with the law, but with enforcing an ideology. It reads like the rantings of an extremist activist, because it is.
But because Kacsmaryk is a judge, now those rantings have the force of law. If allowed to stand, Kacsmaryk’s order would deeply curtail access to abortion nationwide. Women in blue states and red states alike would find themselves degraded and humiliated by the law, taken out of control of their own lives, treated by the state as something less worthy than citizens and less competent than adults. But this was always how it was going to go: ever since the supreme court overturned Roe.
The current system, that tenuous balance in which abortion is nominally legal in some states, banned and sadistically punished in others, was never going to hold. The anti-abortion movement was never going to allow women in legal states to remain free; the pro-choice movement, at least the worthy parts of it, was never going to leave women in ban states behind.
The supreme court, controlled now by a group of ravenous rightwing partisans hardly more subtle than Kacsmaryk, is going to try to ban abortion nationwide – if not in this case, then in another one, sooner than you think. And the nation’s pro-choice majority, a newly enraged and motivated group of women voters and their allies, will stand up to them – with more fury than they anticipate.
Moira Donegan is a Guardian US columnist
How is it that all of a sudden, circuit courts are able to issue nationwide "rulings"? Also, how is it that the TX "ruling" applies nationally, but the WA one does not? This doesn't past the smell test.
I have some pretty strong anti Christian views and this issue is a large part of why. If they don't want an abortion, the answer is simple., don't have one. I reject the premise of their religious mythology being used as a basis to dictate people's rights.
The bigger issue in the Texas decision is whether a single judge can impair a Congressionally mandated agency with a well established legal and transparent regulatory process and prevent it from taking an action or revoke a decision after it completed a due process public review. In the short term this will throw all of health care into chaos as the established foundation of safety and efficacy for prescription medicines will be brought into question and subject to legal attack. In the long run, such precedent has the potential to impair all federal regulatory activities.
Thank you for this great summary. My soul hurts over this assault on women’s health and rights. Reproduction justice includes both the choice to not continue a pregnancy, to prevent a pregnancy (that will be next) and also the right to become pregnant (sterilization without informed consent as seen historically in Puerto Rico, the “Mississippi appy”).
You missed the boat. This is not about attacking an individual's beliefs. It's about the Judge forcing his beliefs on everyone else under the pretense of concerns about health and safety. The arrogance of his decision is glaring. The data supporting the safety of Mifepristone including its use for years is overwhelming-read about it.
This Judge’s decision had nothing to do with health and safety concerns. It was a decision motivated by a zealot who misused his power. His convoluted reasoning was designed to make it more difficult for women who seek an abortion to get one.
Pregnancy is not an illness, but it IS a comorbidity and it IS a preexisting condition? SURE, AMERICA
In our day-to-day understanding of the word “illness”, pregnancy does not seem like an illness. However, law and regulations that govern the FDA define “illness” as a “condition that can cause significant bodily harm or death”. Maternal mortality due to pregnancy as of 2019 causes death in 17.6 of 100,000 women. This mortality rate has been trending upward from 7.2 in 1987 (per CDC studies). This varies greatly by race and ethnicity, from 62 in Hawaiian & Pacific Islander women, to 39.9 in Black women to 14.6 in non-Hispanic white women.
The Republican war on science keeps getting uglier.
Science is the best means we have of discovering truth. A basic understanding that its practice and translation is best performed by scientists was a bipartisan acknowledgement for decades ... especially since our elected leaders were mostly lawyers and businessmen, and mostly ignorant about the scientific method. But they knew their lane.
The destruction of norms, institutions, and basic respect for truth/science represents a slow motion civil war. I hate to admit that. Especially since it’s coupled with unfettered access to AK 47s, the other very related problem we’re talking about here this week.
This country is reeling.
I liked this quote from NYT article today:
“This is a frontal assault on the legitimacy of the F.D.A. and their discretion to make science-based decisions and gold standard approval processes,” said Lawrence O. Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “It ultimately takes us on an extraordinarily dangerous path for F.D.A. as an agency, and for science-based public health decision-making more broadly.”
While all of you rage against "anti abortion" people and their views, and some against Christians, and while some of you continue ad hominem attacks on the Texas judge, you fail to address the issue of the FDA approving the drug under Subpart H, which is for treating "serious or life threatening illnesses". Regardless of how the FDA wants to spin the issue, nobody can defend the idea that a pregnancy is a serious or life threatening illness.
So, please, quit attacking groups of people and respond to the issue at hand in the judge's ruling.
It is amazing to me that the same people that complain about Christians or other groups being "intolerant" are some of the most intolerant people themselves as evidenced by many of the comments in the post.
Please, don't attack someone's beliefs, but rather argue the point at hand, which is the improper FDA approval.
I looked at the links provided for the question "is pregnancy an illness" but saw only a discussion of
its safety and this did not answer the question. Is there another reference you can give for the answer
to the question or am I missing something.
Thank You
You nailed it!
So, just to clarify...this WILL eventually go to the Supreme Court because of the different rulings, correct? Do we have any idea of timeline on when the Supreme Court will hear this case?
thanks for clear summary.
Thank you. I was given both as the "morning after pill" for free, without caveats at a university student health clinic 50 years ago. Times have certainly changed, but I doubt it was because of new scientific knowledge about anything.
Noway2, could you please address the issue of the FDA approving this drug under subpart H, which is specifically related to illness, which pregnancy is not.