BONUS. What’s Next for Abortion Pills?
Breaking down the confusing legal battle over mifepristone and what it means for the future. Plus: What you need to know about the Comstock Act, the 150-year-old law that could lead to a national abortion ban.
Past episodes referenced:
Episode 15: How Anti-Abortion Doctors and Hospitals Put Pregnant People in Danger
Episode 3: The At-Home Abortion Revolution
Resources:
Logo by Kate Ryan, theme music by Lily Sloane. Photo by Robin Marty.
[00:00:00] Garnet: Welcome to ACCESS, a podcast about abortion. I'm your host, Garnet Henderson. Abortion pills have been in the news nonstop lately, and as usual, I've got a lot of thoughts about what has been left out of a lot of the media coverage around this legal battle. So right up top here, I wanna clarify that when we talk about these lawsuits around medication abortion access, we're talking about the FDA approval of mifepristone, which is one of the two drugs used in most medication abortions nowadays. And the most important, top line update here is that last Friday, April 21st, the Supreme Court issued a stay, meaning it essentially pressed pause, stopping a lower court ruling from going into effect, which could have limited access to mifepristone.
What does that mean? It means that the status quo will remain in place for now in states where abortion is legal.
I also saw a lot of headlines along the lines of, "The Supreme Court secures broad access to abortion pill," or "The Supreme Court protects abortion pill." And I just wanna clarify that access to mifepristone, legal access to mifepristone is not broad. As of this recording, 14 states currently ban all abortions and a 15th, Georgia, has a near-total ban, a six week ban, with Florida potentially to follow in the next few months, and several states where abortion bans are blocked by court order and could also go back into effect. So, access to medication abortion is not broad. Access to any type of abortion is no longer broad in the United States, if you could ever say that it was, especially in the last 10 to 15 years.
So let's recap just a little bit. This lawsuit was brought by an anti-abortion group known as the Alliance for Hippocratic Medicine. What this is, is actually a coalition of several groups of anti-abortion doctors, and they are suing the F D A, the Food and Drug Administration, which regulates drugs in our country. And they're arguing that the FDA approval of Mifepristone should be reversed entirely. So they're asking the federal court system to just reverse a process that the FDA is really supposed to handle independently. And there's actually a doctor involved in this whole thing who you've heard about before on the show. Back in episode 15, we heard a story from a guest named Kristyn, who told us about being denied an abortion in West Virginia despite the fact that she was experiencing really dangerous complications in her pregnancy, and that happened before Roe versus Wade was overturned, by the way.
And the doctor who denied Kristyn an abortion is named Byron Calhoun, and there's a paper that he wrote that is actually cited in the original legal filing in this case. It was published in a Catholic medical journal, and he argues that medication abortion is dangerous despite an overwhelming scientific consensus and just overwhelming evidence to the contrary.
And that in fact is the central argument in this case, this anti-abortion group is saying that Mifepristone is dangerous. So I just wanna be really clear here. Mifepristone was first approved by the FDA in the year 2000. That means it's been on the market for 23 years and it has a phenomenal safety record.
It's far safer than several of the things you probably have sitting in your medicine cabinet right now, like Advil, aspirin. It's much safer than Tylenol, and again, far safer than a lot of other prescription medications that are really common, like penicillin and Viagra. Serious complications of medication abortion occur less than one half of 1% of the time. I'm gonna say that one more time. Less than one half of 1% of the time.
In fact, this lawsuit actually argues that mifepristone is dangerous, while citing several studies that prove it is safe. The suit also claims that mifepristone's approval process was rushed. That is also false. The process took four years, and that was after mifepristone had already been in use since the 1980s in France, which is where it was developed. And finally, they've got a bunch of anti-abortion doctors who are claiming that they are injured. By the fact that mifepristone exists and is on the market because they're saying that they may in the future have to treat patients who are dealing with complications following abortions. They're saying that that harms them, and that's part of their argument for why the FDA approval of a drug that's been on the market in the US for 23 years should be revoked.
So all of the arguments they're making are simply ridiculous on their face. But they filed this case in federal court in Amarillo, Texas, and they did that for a very specific reason. There's only one federal judge in Amarillo who hears almost every case that's filed there. His name is Matthew Kacsmaryk. He was appointed to that seat by Donald Trump, and he is well known for being extremely conservative and has a long history of anti-abortion views and involvement with anti-abortion groups.
There's nothing covert about this. He is very clearly an anti-abortion operative. And he was installed in that seat for a reason, because he's extremely conservative and known for essentially deciding that the law says what he wants it to say. And so conservatives can file cases there and they know that Kacsmaryk will hear them, and then any appeals go to the. Fifth Circuit Court of Appeals, which is also notoriously conservative, for example, that is the circuit court, the appellate court that allowed SB 8, the near total six week abortion ban in Texas, which had that bounty hunter provision, to go into effect when Roe versus Wade was still the law. So they notoriously let a law that clearly violated Roe versus Wade go into effect and, and then of course the Supreme Court did that as well, because now we have an anti-abortion majority on the Supreme Court. So anti-abortion groups and frankly, lots of other types of conservative groups have actually created a few districts like this in the country where they can file cases and they know that they will get favorable rulings there, both from the original district court judge, that's the first judge that hears a case, and from the appellate court, and then now, of course, from the Supreme Court.
So this is an extreme case and they took it to a place where they knew they could get an extreme ruling. I also wanna note that one of the lawyers leading this charge is named Erin Hawley. She's an attorney with the Alliance Defending Freedom, which is a firm that represents a lot of conservative groups that are attacking civil rights via the court. Just as one example, they were also involved in Dobbs versus Jackson Women's Health Organization, that's the case that overturned Roe. And if that last name Hawley sounds familiar, it's because she is married to Missouri Senator Josh Hawley, and this judge Matt Kacsmaryk, actually donated to Josh Hawley's campaign back in 2018.
So, these people all know each other and they all agree with each other. It's a really stacked deck. Now, all that has happened so far is that there was a hearing in district court in Kacsmaryk's courtroom, to decide on a preliminary injunction. So what that means is that the Alliance for Hippocratic Medicine, this anti-abortion group, was asking Kacsmaryk to block the FDA's approval of mifepristone right now temporarily so that it can remain blocked while the trial goes forward. This is a very common thing. Advocates also ask for temporary injunctions to stop abortion bans, for example.
So they had a hearing and Judge Kacsmaryk issued a ruling that would've done pretty much exactly what they wanted to do. He said, I am blocking the FDA's approval of mifepristone while this case moves forward. So the Department of Justice, representing the FDA, and Danco Laboratories, which is the maker of Mifeprex, the original brand name version of mifepristone here in the United States, both immediately appealed that decision from Kacsmaryk to the Fifth Circuit.
And the Fifth Circuit did kind of a halfway thing where they said, Okay, Kacsmaryk can't completely block the FDA approval of mifepristone because it's too far past the statute of limitations. Technically, you only have six years after a drug is approved to file this kind of challenge. It's been 23 years.
It's way too late. But they did say that he could block the changes that the F D A has made from 2016 on. So if we roll back the clock on Mifepristone to pre 2016, what that means is it's FDA approved for use up until seven weeks of pregnancy instead of 10, which is what it's approved for today. And more significantly, we would go back to an older version of the Risk Evaluation and Mitigation Strategies, or REMS.
So REMS are special regulations that the FDA places on drugs that are known to be dangerous. Now, mifepristone is not dangerous, and experts have long said that the FDA should remove these restrictions on mifepristone entirely.
And so far the FDA has not done that, but over the years they have rolled them back. You've probably heard, and certainly we've talked on this show about the fact that, for example, mifepristone can now be sent in the mail, and just a couple of years ago that wasn't the case. You had to go pick it up in person from your provider.
But the pre 2016 REMS are much more strict. So first of all, they say that only a doctor, only an MD can prescribe mifepristone. So no nurse practitioners, physician assistants, nurse midwives can prescribe anymore even though they can prescribe other drugs. And most significantly, the pre 2016 REMS require three in-person visits to get a medication abortion.
One to get your mifepristone, and you have to take it there in the office with your provider, the second to get your misoprostol, that's the second drug in the regimen, and a third an in-person follow-up two or more weeks later. So that makes getting a medication abortion incredibly difficult and it's the reason why medication abortion was not that popular in the United States prior to 2016.
I'd also like to point out that a few of the states where abortion is still legal have a waiting period where you have to go into a clinic or a provider's office in person, at least 24 or more hours in advance of that first appointment where you're gonna get the mifepristone. So in those states, it would be a total of four visits for a medication abortion, and those REMS are incredibly difficult to work around.
And I'm about to get just a little bit into the weeds here, but stick with me. The REMS are one thing and the drug label is another. So all FDA-approved drugs have a label. That's basically the information you can look up online about any medication that says, this is how this medication is used, this is what it's for, this is how it's dosed, et cetera.
And it's totally legal and normal for medical providers to prescribe drugs off label. As long as it's FDA approved, if it has other uses, generally speaking, doctors can prescribe it for those other uses, even if they weren't part of that FDA approved label. So the seven week versus 10 week thing, that's a labeling issue. So if this Fifth Circuit ruling had gone into effect, providers probably would've been able to continue prescribing mifepristone up until 10 weeks of pregnancy. In fact, many of them currently prescribe it up until 11 or 12 weeks. That is a permissible off-label use. That doesn't mean that all providers would feel comfortable doing it, even though it's legal though. But the REMS are a completely different animal. So all that stuff about only MDs being able to prescribe mifepristone and the three in-person visits, that stuff, unless the FDA does something about it, which I'll talk about a little bit later, you can't work around. So we were looking at turning the clock back to a time when medication abortion was far less accessible and therefore just not a lot of people got medication abortions in the US prior to 2016. However, that Fifth Circuit ruling never went into effect because the Department of Justice and Danco Labs both immediately appealed that Fifth Circuit decision to the Supreme Court. And really to everybody's surprise, the Supreme Court issued that stay preserving the status quo.
So I know that's a lot. But the bottom line is that for the moment, nothing has changed with mifepristone. You can access it just the same way you could before this whole case got started. However, the Supreme Court hasn't weighed in at all on the content of the case, yet the arguments being made here. They just pressed pause on any changes while the trial continues to proceed. So what happens next? The Fifth Circuit has oral arguments scheduled on May 17th. That's just in a couple of weeks here. And remember, we are only talking about a temporary injunction. So the normal order of operations here would be that the Fifth Circuit would make a decision on the temporary injunction, whatever their decision is, and then they would kick the case back down to the district court to have a full trial.
And then whatever the outcome is there, it will probably get appealed back up to the Fifth Circuit and then back up to the Supreme Court. So it is possible that if, for example, the Fifth Circuit essentially reaffirms its previous decision and decides that there can be new restrictions on mifepristone, we could see changes sometime after they hear oral arguments on May 17th.
But there's really just no way to know exactly what the outcome is gonna be here, because legal processes can be kind of variable, but also, again, because we are dealing with extremist judges who definitely have an agenda here.
I also wanna point out that there are actually two other cases involved in this whole confusing soup. So there was a case filed in federal court in Washington State where 17 states plus Washington DC are basically asking the opposite. They're asking a federal judge to order the FDA not to make any changes, and they had won their temporary injunction. So that judge did say, yeah, FDA, no changes right now. So we could have ended up in a situation where those 17 states and DC were under that order preserving the status quo, and the rest of the country because of the Fifth Circuit decision, saw a rollback in access to mifepristone. But remember, that Fifth Circuit decision never actually went into effect.
And now there's actually a third case that was filed in federal court in Maryland. Again, trying to get a federal judge to order the FDA to maintain the status quo. So, again, I know that all of this is super confusing, but basically the bottom line is that we've got multiple warring lawsuits here, two on one side and one on the other that are asking for different outcomes, and this is exactly the kind of situation that the Supreme Court is designed to address. When there's conflict between different circuit courts, different regions of the country, the Supreme Court steps in and is the final judicial decision maker. That is why we know that this issue is almost certain to make its way back to the Supreme Court some way, somehow, potentially as early as their next term, which would mean they could hear oral arguments in the fall, and we would get a decision next spring. That is, 2024 in the spring. But, if they allow, for example, a temporary injunction to stand during that time, we could see changes in access to mifepristone, even before we get a final decision from the Supreme Court, the same way that SB 8, for example, was allowed to go into effect in Texas before we got a decision from the Supreme Court that actually overruled Roe.
Now I'm about to add another layer of confusing stuff on, because the thing is that federal courts don't actually regulate drugs in this country. The FDA does. Congress has given the FDA that power. And the FDA and all federal agencies actually have discretion over how they enforce the law. What does that mean? That means it is within their power to make decisions about how exactly they enforce the laws that Congress has directed them to be in charge of.
So all that convoluted stuff I just said about the label and the REMS and the various changes that could happen with mifepristone and the ones that would be easier and harder to work around? The F D A could make all of that go away. Because it would be perfectly legal for the FDA, no matter what happens in this case, to say, you know what? Thanks for your opinion, but we're not gonna enforce this ruling. We're gonna be consistent with science and evidence, and we're gonna stay with the status quo we had in 2023.
In fact, even Justice Samuel Alito, the Supreme Court Justice who wrote the opinion overturning Roe, acknowledged in his dissent when the Supreme Court decided to issue this stay, that the FDA can do that. So everyone agrees the FDA can do that. And that's something that I think has also been really missing from a lot of the media coverage of this case. It's the FDA that has the power and the final say here, and that's one of the most important things for us to be keeping an eye on. Because especially now that our federal judiciary is off the rails, it's important not to give those courts too much power. Because yeah, the Supreme Court has a lot of power, but they actually aren't supposed to have absolute power in our system. And when it comes to medications, it's the FDA that's got the power.
So, Let's hold 'em accountable to that.
Another question I've gotten a lot is why this lawsuit is attacking mifepristone and not misoprostol, the second drug that's involved in medication abortion. So if you're feeling a little bit lost, now might be a good time to go back to episode one, the very first episode of ACCESS, where we covered in depth what actually happens during an abortion and how medication abortion works. But just a quick recap. When you use the two drug protocol for medication abortion, you take one mifepristone pill, and 24 to 48 hours later, you follow that with a dose of misoprostol. And if you're nine or more weeks pregnant, typically you need additional doses of misoprostol after that.
However, misoprostol can work on its own to cause an abortion. And in fact, this was the first abortion pill that was discovered. Misoprostol was invented in the 1980s, and women in Brazil where abortion was illegal are the ones who discovered that they could use it to have abortions just because of the warning on the label that people who are pregnant shouldn't take it.
And the ironic thing is that. Misoprostol doesn't have REMS. It doesn't have these special FDA regulations, and that's in part because it was actually invented and developed and originally marketed as a drug to treat stomach ulcers. We now know that it can be used for abortion, and it also has all these other really important uses in obstetrics. For example, it's used to help induce labor and perhaps most importantly, to stop postpartum hemorrhage. So it's a drug that's actually on the World Health Organization's list of essential medications. But, all of that came just from a little ulcer drug, so it can't be attacked in quite the same way because it's not just approved for abortion. Whereas mifepristone, when you look at that FDA label, all it says is abortion.
Now there is a slightly different version of mifepristone, a different dose that is approved to treat a disease called Cushings, and that will stay on the market even if changes are made to the abortion pill version of mifepristone. And it's possible that it could be used for abortions, but it really only comes from one specialty pharmacy. So it's not a super viable option. However, as I said, misoprostol alone does work and you can use that alone for a medication abortion. And lots of providers have said they are ready to go with a misoprostol only backup in case something changes with mifepristone. And misoprostol only abortions are still very safe and effective, but they are slightly less effective than the two drug mife and miso regimen.
And that's why the two drug regimen is the one that's preferred. Misoprostol only abortions can also involve more side effects like nausea and vomiting and cramping. And so it's just a less comfortable experience, and I think that's part of the point. I think anti-abortion groups wanna make it not only more difficult to get abortions, but more painful.
And it's important to note that because it is slightly less effective, if miso only abortions become the standard, we will see a larger number of people who need follow-up care after their abortion. Which doesn't mean anything really bad has happened. It just means they might need to see a doctor to either get more doses of medication or to have a procedure to follow up if their abortion isn't complete. And that not only means spending more time and more money on your abortion. For a lot of people, it could expose them to risk of criminalization.
Unfortunately, even before Roe versus Wade was overturned, a lot of people in the United States had been criminalized for their pregnancy outcomes, whether they had miscarriages or did self-manage an abortion. And most of those people were turned into the police by healthcare providers. So that's a real concern.
And if you wanna learn more about self-managed abortion and the potential legal risks involved, you can listen back to episode three, where we covered that in detail. And we also talked a lot about medication abortion and the FDA regulations around it in episodes two and three. And those episodes, I will say, are slightly out of date now because the FDA did make some updates to its policies this year, in 2023, but I think they're still useful for getting a little bit of background here.
Another thing I wanna note is that even if regulations around mifepristone change in the United States, you will still be able to order abortion pills online from sources like Aid Access that ship abortion pills in from overseas, and they would be able to get you that two drug mifepristone and misoprostol regimen.
However, the last thing I want to talk about today is the Comstock Act, because both Matthew Kacsmaryk, the Texas judge, and the Fifth Circuit Court of Appeals cited this law in their opinions. And the Comstock Act is a law that has the potential to outlaw not only medication abortion, but all abortion and contraception as well as healthcare for LGBTQ people and all sorts of other forms of freedom of expression in the United States.
So what am I talking about? The Comstock Act was passed in 1873, so just try to situate yourself in history. We are talking about the reconstruction era immediately after the Civil War. Okay? That's how far back we're talking, and it's named for a man named anthony Comstock, who was an anti vice crusader, who really got his start as a narc, turning brothels into the police. And he actually wrote the Comstock Act and then got Congress to pass it. And what it did was outlaw the mailing of any materials that were considered obscene. So that might sound like porn, and it did mean porn, but the law also specifically forbids any items related to contraception or abortion. And Anthony Comstock was so zealous about this, that he actually got Congress to make him a mail inspector, so he became a mail cop in order to personally enforce this law. Margaret Sanger, the founder of Planned Parenthood, famously violated the Comstock Act and was charged for it because of the content of her feminist magazine. She actually fled the country, but only after distributing a hundred thousand pamphlets about contraception. Emma Goldman, the famous feminist and anarchist, was also arrested and jailed for violating the Comstock Act because of her lectures and information that she used to distribute about contraception.
And what happened is this law, first of all, became unpopular because of public trials of people like Margaret Sanger and Emma Goldman. And it was also chipped away at over the years by the courts, including in Griswold versus Connecticut, which is a case that legalized contraception for married people and formed a lot of the basis for the Supreme Court decision in Roe versus Wade.
However, Congress never took that law off the books, so it's essentially a zombie law. It hasn't been enforced in many decades, almost a hundred years because it was largely invalidated, but it's still there waiting to be resurrected, especially if the Supreme Court continues to roll back its precedents.
So the fact that the Comstock Act has even come up should really concern us all, because think about it for a second: I know when you hear me say mail, it sounds like medication abortion by mail. But everything that you see in a doctor's office pretty much traveled through the mail, was shipped at some point. And that's what we're talking about here is a law that is so far reaching that it completely limits all medical care related to abortion, and contraception, and really anything else that conservatives don't like and consider obscene.
So I am sorry to end on that slightly bleak note, but I will just remind you again that mifepristone remains available today, and there will be no changes for at least the next several weeks. Even if there are changes, you will be able to order abortion pills online or have a misoprostol only abortion if that is what you want. And remember, the final decision maker we are waiting on here is the FDA, not the federal courts.
That's all for today folks. Please let me know if you have any more questions about this very confusing legal battle. I hope I cleared some things up today. I also wanna put a call out to say, that I am planning an episode reflecting on the one year anniversary of Dobbs versus Jackson Women's Health Organization, the decision in the case that overturned Roe. So if you have had an abortion this year, or if you work in abortion care, or volunteer in abortion care in some capacity, I would love to hear from you. If you would like to contribute to that episode, you can record a voice memo on your phone and send it to me at accesspodcast@protonmail.com. That's in the show notes as well. And remember, if you make a free Protonmail account, your message will be fully encrypted end to end.
ACCESS is produced by me, Garnet Henderson. Our logo is by Kate Ryan, and our theme music is by Lily Sloane. Additional music in this episode by Blue Dot Sessions. ACCESS is an independent production, so if you like the show, please support us. One of the best ways you can do that is just by sharing the show with a friend. You can also buy merch at Bonfire or TeePublic, or make a monthly, yearly, or one-time contribution. All of those links are in the show notes. Please subscribe to ACCESS wherever you get your podcasts, and leave us a rating or, review and follow us on Twitter and Instagram @accesspod. See you next time.
