What’s Next In the Fight Over the Abortion Pill?

with one part of the Texas ruling. It left in place that lower court's order that blocked changes the FDA has made in recent years to make miffipristone more easily available, like allowing delivery of the drug by mail. Those restrictions on the pill from the Texas ruling may now go into effect while the case goes through the courts, so it may not become more difficult to get the The Biden administration said that it will continue to challenge the

court's decisions. And we get into all of this in this episode from Bloomberg News and iHeartRadio. It's the Big Take. I'm Westkasova Today. What's next in the rights push to outlaw abortion? The ruling by a federal judge in Texas that would invalidate the FDA's decades old approval of the abortion pill MITHA pristone is the latest example of how conservative activists are now seeking to block abortion, not just

in individual states but nationwide. Today, my Bloomberg colleagues Kelsey Butler, Cynthia Coons, and Madeline Meckelberg, who are covering this story, tell us where the case goes from here, and later in the show, Bloomberg's Greg Store explains why the Supreme Court's conservative majority, which will almost certainly weigh in, might actually side against blocking the abortion pill. Madeline, let's start

with the ruling in Texas. There is this seven day hold that the judge put on it, saying that it wouldn't be enforced while the appeals process can get started. Where are we right now with that? So the judge said that this ruling will go into effect on Friday,

almost immediately afterwards, the first available business day. The Department of Justice appealed that decision to the Fifth Circuit Court of Appeals in New Orleans, and they asked the judges there to issue an order blocking implementation of that ruling. Come Friday, and what happens next, Well, what happens next is all eyes are on the Fifth Circuit Court of Appeals in New Orleans, which is the next stop on

this legal process us for this lawsuit. We're waiting to see what they're going to do, whether they're going to issue this stay. If they don't, then on Friday, the FDA approval of mythopristone is going to be blocked across the country, Cynthia. Immediately after this ruling, we saw quite a big response. What are those arguing against this ruling

doing now? So, basically, for the companies that distribute the pill, the pills distributed through online only pharmacies, the FDA has had long standing restrictions on the drug in place, so you can't get it at like a typical pharmacy on the street corner necessarily. But the online pharmacies that distribute the drug, basically, their response to this has been continue to sell the drug while they wait to figure out

what's happening next. There really isn't any reason for them to do anything differently, because until the FDA decides to take action, the FDA themselves have to decide whether or not they're going to comply with the judge's order. So until the FDA takes action, there's nothing that the companies really need to do or change about their businesses while they wait for the next steps here. And so, if you are a person seeking to buy nfipristone, you're able

to get it right now, yep. You can either buy it go through the typical channel where you might go to an abortion clinic and get it through a provider that way, or you can use their services that distribute it online. Or you might be able to buy it in advance of needing it sometime in the future. So there has been a surge in demand from people who are interested in making sure that they have it if they need it, but nothing has actually changed as a

result of the ruling. It's really actually been, if anything, a jolt to sort of pick up business in anticipation of something changing. We've seen in recent months since the Supreme Court overturn Rov. Wade, patients going to tell ahealth more and more in order to get abortion care. In April, before the Supreme Court decision, virtual care accounted for about four percent of all abortions in the US. By December,

it was eleven percent. So it's really showing that trend upward in the wake of more restrictions and the overturning of Roe v. Wade. And also just some context around that too. I mean, you couldn't get the pill through telemedicine. For much of the pill's life on the market, it wasn't so it's almost probably been on the market for

twenty years before you could get it through telehealth. Legally, the FDA themselves have always been very conservative about the administration of this drug, even though there's a lot of safety data showing that it's quite a safe drug and it can be used by someone self ministering an abortion at home. And so what happened during the pandemic was there actually were other lawsuits that led to the government deciding to loosen it up and allow the pill to

be sent through the mail. It used to be that a woman had to actually go to a provider's office, and just when you think about that, it's it's so unique in the practice of medicine. If you think about any medicine you've ever taken, when do you go to the doctor's office to pick it up, And particularly for a drug that is widely within the medical community known to be safe outside of just people in reproductive healthcare, the American Medical Association has also come out and talked

about the safety of this drug. And so this sort of pickup is building on some momentum that's been going on because of other lawsuits forcing the FDA to say, hey, this drug should be more accessible. So that's the sort of cross current in the background, and probably what also led to the suit and what we're what we're seeing today is this sort of liberalization of the pill led to this kind of crescendo and this lawsuit. Kelsey States

had been anticipating this ruling. What did they do while they were waiting to see what the court would decide? In Texas, what we've seen is states stockpiling mythopristone ahead of the ruling or in response to the ruling. Earlier this month, Washington's governor said that he had directed for the purchase of a three year supply mephapristone. Massachusetts also announced that it would be stockpiling fifteen thousand doses of the drug. California now among multiple states trying to stockpile

as much of that abortion medication as it can. The goal, according to Governor Gavin Newsom is to purchase as many as two million pills. It's really unclear how these stockpiles are going to be handled. I've been reaching out to advocacy groups to find out if there's any type of precedent for what exactly could happen if mefapristone is no longer available. It's still kind of up in the air.

So many things are right now, but there is one situation that recently happened that could provide some type of roadmap or some type of game plan. Earlier this month, the FDA pulled approval of another drug called McKenna, which is a preterm birth treatment, and when it did so, it did acknowledge that a limited supply of these drugs had already been distributed to doctors, offices, pharmacies, and acknowledge that some doctors might continue to prescribe or administer that

remaining supply to patients. So I don't know that that will exactly happen, but it provides a possibility, Cynthia. As you say, the FDA has been pretty conservative in dispensing miffa pristone. It's the judge in Texas, Judge Kasmeric ruled the FDA head bowed to political pressure and ignored medical evidence that called into question the drug safety, and that led to a backlash from doctors and medical researchers who say this drug has been proven over many years to

be safe. What does the science say about Miffa pristone. So, Miffi pristone has been on the market for twenty three years now. It's widely considered to be safe and effective. When used properly in combination with another drug, it works ninety seven percent of the time. I believe it is to induce an abortion. Like any drug, it has side effects,

but all drugs do. A large research study looking at women who'd taken this drug and tried to ascertain the incident's rate of them ending up in the AR showed that it was less likely to put a person into the AR as a common everyday drug like tylan. All. So, it's widely considered to be safe, it's an effective drug, and it's really just come down to politics at this point. Cynthia, you talked about the other drug that Nifa pristone is often paired with, which is mysapro stall. Why have abortion

opponents not also gone after that drug. So mysapro Stall is actually a drug used for other things. It's used to prevent stomach ulcers, and it's been on the market a lot longer, and its history is actually quite interesting. It was an abortion treatment itself. As the story goes, women in Brazil had seen on the packet that no pregnancy signed and started using it and it actually did work for abortions, and so that has been around for a while. But it's actually just on the market for

other things. It can be used for abortions, but it's more effective in combination with Miffy pristone, and Miffy pristone's the only drug that's approved solely for termination of a pregnancy, so that's the one that's in target, and my suppost All is going to, you know, stay on the market for the other things it's approved for, but women will be able to turn to my suppostall and use that as an abortion option if Miffy pristone's taken off the market.

It's just not as effective as a treatment. And so if it is taken off the market, do you think that we'll continue to see my sapprostall used by itself. Yeah, that's already happened. And happening in some parts of the country. One of the first online pharmacy providers of Miffy pristone

started offering the drug. Went through the steps to become a provider of Miffy pristone because she had noticed a pickup in my suppostall prescriptions in Texas after the ban on abortions after six weeks went into effect, and so basically what was happening there was she was seeing women were already doing this. Doctors were already offering this regiment.

So there are places where this may already be happening their states with much stricter rules around use of the pill already that make it much harder to get even than what the FDA terms of the drug are at this point. And so my supposed to all will be an option for women, it's just not as effective as an option. After the ruling, several executives at pharmaceutical companies wrote an open letter opposing it. What exactly did they say?

Executives from a lot of drug companies signed onto a letter calling out the decision and how dangerous it is for politics and lawsuits like this to question the way that the FDA operates. What the drug companies want is standardized system where things operate and work in a certain way,

and with the FDA, that's always been the case. They have their own negotiations with the FDA, but the way that they conduct clinical trials, if it's getting called into question on a lawsuit by lawsuit basis, it makes it impossible for them to do the work that they do because the clinical trials they do cost billions of dollars. So I think what they were stepping up and saying here out a lot more than just this drug and

about abortion access. It's really about the idea that they don't want to be at the whim of what a judge's perspective is on a given treatment instead of the practice of science and the way they've been doing things for decades. Jumping off that, we know that so much about healthcare has become politicized right now, and I know that you all have talked on the show in the past about healthcare for trans youth has also been part

of the political and policy conversation going forward. What these drug companies are really saying is, let's not open this door here to having judges make decisions that the FDA should and Obviously there's a real self interest there, but it's certainly an interesting take, just given how much about healthcare right now has become politicized, especially when we talk about underrepresented groups, Madeline, This question about whether federal judges

can step in and essentially say no, the FDA is wrong and invalidate their rulings is something new, isn't it. Absolutely this case is completely unprecedented. If that wasn't clear already from our conversation, there's a ton of questions about what the heck this means, what it means in practice, and what the implications are for this decision. This is the first time we've seen a federal judge come in and overturn FDA approval of a drug that they went

through their own safety procedures to approve. And this Texas ruling was further complicated by a ruling that came almost at exactly the same time from Washington State that said the opposite of what the judge in Texas said. How does that play into what happens next? That's exactly right. It's incredibly confusing. I'll be the first one to tell you that I think there's a lot of questions here.

The case in Washington stems off that idea that the FDA has been historically conservative when it comes to regulating this drug. That case was brought by a group of Democratic Attorneys general who said that the FDA has two many regulations on this drug, and the judge in Washington agreed and said that the federal government should not take any steps at this point to limit access to mifipristone

while he considers the larger arguments behind their case. That decision is the prevailing decision right now because the Texas ruling does not go into effect until April fourteenth, So

as of right now, there are not conflicting rulings. But should the Fifth Circuit not stay this decision from Texas on Friday, both of these rulings will be in effect at the same time, and they conflict, and people aren't really exactly sure what that's going to look like if the Supreme Court does not step in and provide some clarity when we come back. Why did the Texas judge say it's against the law to send abortion pills through

the mail? Kelsey, For a long time anti abortion advocates said that what they wanted was to allow each state to decide whether abortion should be legal. But what we're seeing now with this Texas ruling is something different, which is a push to make abortion legal at a federal level nationwide. I think there's definitely questions right now and some conflicts on strategy when it comes to the anti

abortion side. I've been doing quite a bit of reporting on states that are somewhere kind of in the middle. We obviously have states in the camp that said we're going to become haven states patients can come to us, like in New York and California, saying that they will

make sure that they're shoring up abortion access in their states. Obviously, we know that there's states like Texas where there's been near total bands, But then there's a lot of states in the middle where the political landscape is a little bit different. What we're seeing is conservative politicians try to find that spot that they feel they can satisfy their base while at the same time not generating a lot

of backlash. We've seen this several times over since the Supreme Court overturned Row that voters don't want total abortion bands. So now there's this kind of calculus being done about how far politicians can go with bands before they get that backlash. And it's fifty different states, so there's kind of fifty different answers. I think that idea is what

makes this case so interesting and significant. This ruling will have more of an effect nationwide on restricting abortion than the Dab's decision will, which was this decision made by the Supreme Court that overturned Rovweight and ended federal constitutional protections for abortion. It will limit access to a pill that's used in every state, even states where abortion is legal.

This will have the ability and the practical effect of restricting abortions in states where it's legal by their laws.

On the other side of that, when you're talking about the legal arguments here, there's a lot of eyes on the Supreme Court for if this decision comes to them, because in the Dab's decision, they said this is an issue that should be decided by the elected representatives, and yet here they are again being confronted with a case that would create national precedent based off of litigation through

the courts, not through decisions made by local officials. In addition to the question about whether the FDA improperly approved MIFA priss Stone, there is another argument in the Texas judges ruling that has to do with this old and somewhat obscure law called the Comstock Act. Exactly what does that say? The Comstock Act is a pretty broad federal statute from one hundred and fifty years ago that prohibits the mailing of obscene materials through the mail that includes pornography,

and it also includes articles to furnish an abortion. This statute has not been enforced in decades. The Department of Justice has said we don't believe that this applies to mailing abortion pills, but abortion opponents have turned to this Act ever since the federal government said that the pill could be distributed through the mail, arguing that it's still on the books and it prohibits the drug to be mailed,

and Judge Casmerican, Texas he agreed. In his order. He said that this act does prevent the federal government from allowing the drug to be sent through the mail at this point. Since his ruling blocks federal approval of mefopristone, it's kind of a moot point whether or not it can be sent through the mail, but it could have larger implications for other groups that are attempting to challenge

the mail band. This broad ruling, which he includes criticism of the way the drug was approved and also invoking this law, has brought up criticism that this ruling was looking for a reason to outlaw methopristone. That's exactly right, and I don't think that the conservative group behind the

lawsuit is shying away from that fact. This lawsuit not only challenged the two thousand approval of mythopristone, but it challenged several subsequent decisions made by the Food and Drug Administration to expand access to the pill, and it also challenged their decision to allow it to be sent through the mail. They were trying any avenue they could to limit access to this drug because they believed that the FDA improperly approved it. This is part of a concerted, organized,

and long standing anti abortion effort. So we know that over the past five decades, US states have passed more than a thousand laws that either restricted abortion or made it more difficult for clinics to operate. So it is part of a larger, organized, concerted effort to get to a total ban. And Kelsey because anti abortion activists have been pressing in so many different directions what is the next thing that you think is going to become part

of this effort. We can't minimize the seismic impact that methopristone going away will have on patients in the US. More than half of abortions are done via pill in the country at this point, so it's certainly a really, really big one. Anytime we have any precedent to chip away at healthcare for women and pregnant people, we're talking about what comes next. A lot of times the abortion pill is used in the same conversation as emergency contraception,

which is different. So we want to look for if there are going to be further attacks on birth control, which anti abortion activists have hinted at and potentially started to lay the groundwork for. I just wanted to add the abortion pill is the next frontier in this fight over reproductive access, and this decision thrusts us into that frontier.

And I think it's important for us to be really clear that this decision that we're talking about from Judge Casmic, it's the first significant decision in this lawsuit, but it is not the final ruling in this case. This is a preliminary injunction that he has issued, and that is ventially is the guiding rules that will govern the United States while he hears the case on the merits and makes an actual decision. So this is just the first

legal step in this case. It will go back to Judge Kasmaric before this issue is settled, and it's going to probably go back up through the Fifth Circuit and to the Supreme Court once again at that point. Cynthia Kelsey Madeleine, thanks so much for coming on the show. Thanks for having us. After the break, Why the US

Supreme Court might be skeptical of the Texas ruling? As we've heard one way or another, the US Supreme Court appears likely to get involved in this case over the abortion pill, but it's not at all certain that anti abortion activists who brought the case will be pleased with what the court's conservative majority will have to say. Greg Storr Bloomberg Creame Court correspondent and friend of the Big

Tag podcast is covering the case. Greg. The Fifth Circuit Court of Appeals in New Orleans is the next stop for this case, and it's known to be a very conservative court. Is it a foregone conclusion that the Court will back up the Texas Judge Kasmeric's ruling. I wouldn't go quite that far, but certainly the challengers to method press Stone start with that very big advantage that the

Fifth Circuit has. So many of the recent Supreme Court cases have come from the Fifth Circuit because conservative groups are filing and states are filing cases, they are knowing they have a really really good chance of winning there. And you know, the fact that they filed in Judge Kasmeric's court, the fact that they know what's going to be appealed to the Fifth Circuit, you know, suggests they

kind of have a home field advantage there. If the Fifth Circuit does allow the Texas order to stand, then presumably the US Justice Department will ask the Supreme Court to weigh in. What do you think they would say?

One would expect there's a pretty good chance the Supreme Court will at least issue an administrative stay, which means they're buying themselves a few more days to decide whether to grant a longer term stay, and that longer term stay potentially would last all the way through the appeals court process, meaning that this drug would not be effected until there's a final decision on the merits and so the Court doesn't want to actually decide the case itself

before it's gone through the lower courts completely. I wouldn't think so. It certainly doesn't need you that. The normal course is that the Supreme Court wants to see both a federal district judge and a federal appeals court decide the matter before it even considers curing it. That's the normal practice. We've seen the Court deviate from that in a few recent cases. That's usually when there's a really compelling circumstance where something is happening, like an election for example,

that requires them to sort of push things along more quickly. Here, there's no reason why the Court has to do that, all the more so because there's this other case out in Washington State is percolating as well. Let that process play out. That may clarify exactly what the Supreme Court might need to decide. And so if it does end up with the Supreme Court, what do you think happens? How do they then weigh and measure both the Texas

case and the Washington State case which concluded exactly the opposite. Yeah, Well, first, keep in mind, this is very, very different from a legal standpoint from the Dobbs versus Jackson case that overturned the constitutional right to a portion. This is a case about federal statutes, a case about federal administrative procedure, and about some really technical doctrines like standing and whether you exhaust your administrative remedies before you go to court. So

there's a lot of stuff going on there. The other thing I would say keep in mind is, you know, when the Supreme Court overruled the constitutional right to abortion, the Court as a whole, and particularly just As Kavanaugh, who's really a key vote here, emphasized that what they were trying to do was put this decision about abortion

back in the hands of the people's representatives. Well, so here's a ruling where a judge, an unelected judge, as the Supreme Court justices would like to say, is overturning something that an agency that answers to the president has done and making something illegal even in states where the people there say we want legal abortion. So that cross current, I think is going to create a very different dynamic

for the Supreme Court here. And then you add on the fact that we're talking about second guessing an expert agency on something that a judge, you know, doesn't have an any expertise, and that's the kind of thing that even the conservative justices have suggested they're not willing to do. So it is by no means a sure thing that this conservative court is going to back up this conservative judge. Now, you also asked about the Washington case. That is an

additional complication in there no question about that. But the answer may still be for the Supreme Court that we disagree both with the judge in Texas and with the judge in Washington. This is something where judges don't really have a role, and so in that case, what would they then say if it comes as a stay application. You could see them focusing on any of a number

of issues. I mentioned this whole issue of standing. These are anti abortion groups that sued to challenge Mipopress Stone, and one key question is how are they hurt by this? What right do they have to go to court to file suit against this? So you could see the case being decided just on that ground that they don't have

a right to be in court. And then, as I said, there's some other very technical administrative law doctrines about whether you have to first go to the agency and try to get what you want directly through the agency before you go to court. There are a lot of different

ways the court could ultimately reverse this ruling. One of the questions that's come up in a lot of the discussions since this decision in Texas is the idea that if a judge is able to overturn the FDA's decision about a drug in this case, that judges all over the country could be looking to overturn agency decisions just

because someone complained to them about it. Yeah, that is certainly a concern that will be on the minds of I think the conservative justices as well as the more liberal ones that how do you draw a line here? This is really an area where we all rely on expert at the FDA and at the drug companies for that matter, and you know, not something where judges have a whole lot of ability to say, no, I can make a better decision on this stuff. And it's hard

to know how to stop that. And even some of the conservative justices and slightly different contacts have expressed a lot of reticence about having judges get involved in this sort of thing. There's yet another complicating factor is that the Texas decision didn't just say that the FDA had concluded wrongly about Mytho Preston, but had actually run afoul of another law called the Comstock Act. Can you talk

about how that works. It's a law that says you can't mail certain things, and it lists things that describes like obscene things and indecent things, and it does mention things that can cause an abortion. But the understanding of that law for really a century has been that it outlaws things that can cause an illegal abortion. If a drug is not being used illegally, it's not covered by

the Comstock Act. And so you have this dynamic where the judge I just looked at the language of the law, and there's a, you know, a non laughable argument that the language of the law suggested bans the mailing of pills that can induce an abortion. But that runs up against this long held understanding of the law. And so that's the hill that opponents are going to have to

get over if they're going to win this case. And with the Supreme Court have to decide on each of these components in figuring out how to come down in this case. Now they really only need to decide on one of these components. So to go back to that concept of standing, anti abortion groups sued to challenge this law here, it's not clear how these anti abortion groups are injured by the fact that this drug is legal.

That one of the things they say is, oh, it's not safe, and therefore women who take this drug may overwhelm the health system and affect us because we you know, some of our members are doctors, and it will affect us. It's not clear that there's evidence that that has happened

so far. So that is certainly an area where if the court, especially if they don't want to get into the substance of whether the FDA has made a good decision here, they could take one of those procedural avenues to say this case never belonged in court in the first place. As someone who covered the court for a long time, how do you think this ultimately turns out?

As I sit here, it's hard for me to imagine there are five votes on this court to say it's okay for a federal judge to go in and second guests and agency's long held opinion that a drug is safe. That seems like a really high hurdle, even for this conservative court to get over. Do you think this is overturned at the abortion pill remains legal. I think that is the most likely scenario as we sit here. Whether the Supreme Court ends up being the one that has

to do that, not sure about that. Greg. Oh, it's great talking to you. Thanks for being here, my pleasure. Thanks for listening to us here at The Big Take. It's a daily podcast from Bloomberg and iHeartRadio. For more shows from my Heart Radio, visit the iHeartRadio app, Apple Podcast, or wherever you listen, and we'd love to hear from you. Email us questions or comments to Big Take at Bloomberg dot net. The supervising producer of The Big Take is

Vicki Virgolina. Our senior producer is Katherine Fink. Our producers are Moe Barrow and Michael Filero. Phil de Garcia is our engineer. Our original music was composed by Leo Sidrin. I'm West Kasova. We'll be back tomorrow with another Big Take.