Abortion Access Could Be Limited Further By Mifepristone Case : The NPR Politics Podcast Was the FDA wrong to approve a drug that's used in nearly all medication abortions in the U.S. — and should the drug, mifepristone, be taken off the market? Those questions were argued in court Wednesday, in a case heard by federal Judge Matthew Kacsmaryk, a Trump appointee, in Amarillo, Texas.

This episode: White House correspondent Tamara Keith, national correspondent Sarah McCammon, and political correspondent Susan Davis.

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Abortion Access Could Be Limited Further By Mifepristone Case

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SCOTT: Hello, NPR POLITICS PODCAST listeners. This is Scott.

KATIE: And this is Katie.

SCOTT: And we're on our way to referee a soccer tournament this weekend, where we will do 12 games together as a father-daughter referee team.


SCOTT: This podcast was recorded at...


1:07 p.m. on Thursday, the 16 of March.

KATIE: Things may have changed by the time you hear this...

SCOTT: But one of us will still be taking ibuprofen and trying to stretch out our sore muscles. OK...

SCOTT AND KATIE: Here's the show.


DAVIS: That's a lot of running.

KEITH: Yeah, that is just a lot of soccer - youth soccer. I wonder if there could be, like, a parent brawl on the sidelines.

DAVIS: (Laughter).

KEITH: That'd be fun.

Hey there. It's the NPR POLITICS PODCAST. I'm Tamara Keith. I cover the White House.

DAVIS: I'm Susan Davis. I cover politics.

KEITH: This week, a federal judge in Amarillo, Texas, heard arguments in a lawsuit against the FDA over their decision more than 20 years ago to approve the widely used abortion pill mifepristone. Friend of the podcast, Sarah McCammon, is here with us from Amarillo. Hey, Sarah.


KEITH: You cover abortion politics here at NPR. You are also one of the very few reporters there in the courtroom. But before we get to the case itself, can we talk a bit about mifepristone? What is it? How widely is this medication used?

MCCAMMON: Well, as of a couple of years ago, more than half of abortions that take place in the U.S. are done with abortion pills, not a surgical procedure. And of those, according to the Guttmacher Institute, 98% involve mifepristone. So this is a drug that was approved by the Food and Drug Administration in 2000 for use in combination with a second pill to terminate first-trimester pregnancies. It's been used by about 5 million people since then. And major medical groups, including the American Medical Association and others, say it has a very strong safety record. But it has been the subject of a lot of political debate because it's an abortion pill, and it continues to be.

KEITH: So tell us about this lawsuit. Who is suing? What are they asking the judge to do? Like, what is the goal of this lawsuit?

MCCAMMON: Well, the goal is to take mifepristone off the market. So the group that brought this suit - it's called the Alliance for Hippocratic Medicine, and it's a coalition of anti-abortion groups and doctors. These are medical groups and doctors that oppose abortion rights. And, you know, more specifically, they are challenging the FDA's approval back in 2000 of this drug, asking the judge to force it off the market. And, you know, that would have a lot of ripple effects - right? - for both patients and doctors who've been relying on this for what is probably most abortions now in the United States.

DAVIS: Sarah, can you talk about the judge in this case? 'Cause one thing I think is fascinating here is that, when the Supreme Court made their ruling overturning Roe v. Wade, one of the arguments the conservatives made for the court is abortion policies should be decided by the legislatures, not by the courts. And now we're in another situation where a singular, unelected judge could have a potential huge national impact on abortion access.

MCCAMMON: His name is Judge Matthew Kacsmaryk, and he has a long, consistent track record of alliances with conservative groups, conservative religious groups. He worked for a Christian legal firm here in Texas at one time. He was appointed by former President Donald Trump. And, you know, as a judge, he has tended to rule in favor of conservative causes. Just last year here in Texas, he sided with a Christian father who filed a lawsuit trying to prevent Title X family planning clinics in the state from dispensing birth control without parental consent for minors. He said that the possibility that his teenage daughters could get birth control without his knowledge or permission violated his Christian beliefs. So he's clearly a conservative-leaning judge.

And to your point, Sue, about, you know, the legislatures versus the courts, I thought it was really interesting in the hearing yesterday - this kind of came up, and conservatives are almost sort of inverting that argument. One of the lawyers for the plaintiffs, Erin Hawley, made the argument that, because these abortion pills are so widely available, people can sometimes get access to them in places where abortion is illegal - that they are undermining the ability of states to enforce their abortion restrictions. Now, the lawyer for the Department of Justice, who's arguing on behalf of the FDA, responded to that, saying, essentially, you know, that's irrelevant. She said that's beside the point. This case is not about these state laws. This is about whether or not the FDA's approval of this drug is legitimate, and, you know, she pointed to many years of studies that suggest a strong safety record.

KEITH: Well, so can you take us into the courtroom? What was it like? And in terms of the arguments, then, what is the legal argument that a decision that was made 20 years ago is now flawed?

MCCAMMON: It was a four-hour hearing. There were a lot of issues, and we can't get into all of them here. There was a lot of discussion of the particulars of the FDA approval process because that's obviously the issue here. Then, there was a lot of discussion about what's called standing, which probably a lot of people are familiar with - essentially, does this group even have a right to bring this case? And the argument for the plaintiffs from the anti-abortion groups goes kind of like this. The lawyer, Erin Hawley, said the doctors that we represent, who have deeply held opposition to abortion, are being harmed - which is a legal term - being harmed by the widespread availability of these drugs because, sometimes, women come into their offices or their hospitals where they're working, whatever the case may be, you know, needing follow up care after a medication abortion - maybe having bleeding, maybe cramping, and they may need to be seen. They may need a surgical procedure to complete the abortion. That does happen in a small percentage of cases. And their argument is that this is both, you know, at odds with their deeply held beliefs of these doctors and also that it's taking time and resources away from their normal practice.

A lawyer for Danco, which is the drugmaker of mifepristone, which has also joined with the FDA in this suit as part of the defense - their lawyer responded that, you know, all drugs have side effects. This drug has a strong safety record, and it's part of a doctor's job to treat people who are experiencing normal side effects of drugs.

DAVIS: Sarah, if this judge in this case rules in favor of the plaintiffs - of the anti-abortion doctor group - what are the implications of a ruling like that for access to this drug?

MCCAMMON: Well, I feel like I answer every question about potential court rulings in this way, but it's very true - it all comes down to exactly what the judge says. And there was a lot of discussion about that in the courtroom on Wednesday, too. I mean, he asked both sides' lawyers, really, a lot of questions about what's known in legal speak as remedies. So if he were to side with the plaintiffs, at least to some extent, and say that, yes, there are problems with this approval, with this drug, what would a remedy look like? You know, he talked about could I, should I just order it directly taken off the market? Should I order the FDA to begin some kind of a process? Because there is a withdrawal process for drugs to be taken off the market. And that, as I understand it, involves, you know, public comment, and there are processes in place. And that can take longer - right? - than just immediately saying take it away. There are all sorts of half measures he could take. In the last couple of years, the Biden administration has relaxed some of the restrictions on mifepristone, made it a little easier, for example, to mail the drugs and to get them in other ways. You know, the judge could just say, I'm putting all of those rules back in place.

So I've talked to a lot of lawyers about this, and, you know, who knows what he will do? Everyone will be reading the opinion very closely. Even if he does in one way or another order the drug to be removed, how that would play out; there are lots of questions about that. Would it just apply to the FDA? Would that apply to doctors as well? And then the other thing I should mention is that lawyers for the defense, for the government, have already indicated that if the judge overturns the approval or tries to take the drug off the market, they'll immediately appeal that. So we're most likely looking at an appeal either way to the 5th Circuit, which I think we know is a very conservative circuit. So it's unclear what they would do. And this could end up at the Supreme Court.

KEITH: All right. We're going to take a quick break, and we'll have more on that in a moment.

And we're back. And, Sarah, we were talking about how this could well end up at the Supreme Court. And another way it could end up at the Supreme Court, I think, is that several attorneys general from blue states have filed almost a countersuit. It's a separate suit saying that the FDA has too many restrictions on this abortion drug that make it too hard to get. So where does that case stand? And how does that case interact with the case that you've been following there in Texas?

MCCAMMON: Yeah, Tam, you sum that up really well. So this lawsuit that was filed by 12 Democratic attorney generals led by Washington AG Bob Ferguson and Oregon's AG, Ellen Rosenblum, it really seeks to push - clearly is written to push back against this lawsuit in Texas. And for years, groups like the American Medical Association and the American College of Obstetricians and Gynecologists have been pushing the FDA to relax some of the rules around this drug now that it's been out there for so long. And, you know, as I mentioned, it's always been very political. But this group is basically kind of taking that argument into a federal lawsuit, was filed in Washington in federal court. And that is at an earlier stage, of course, than the Texas lawsuit. But what you could end up with is dueling federal rulings, essentially pointing in opposite directions. And what does that sound like? A Supreme Court challenge, right?

KEITH: Yeah, that sounds like something that the Supreme Court would take up to de-conflict.

DAVIS: Sarah, I know you've been covering sort of the policy and the lawsuits here, but you've also covered the politics of abortion rights for a long time, too. And one of the things that I have been fascinated with watching the politics after the Supreme Court decided to overturn Roe is how little these really impactful decisions and debates that are still ongoing are being amplified by conservative political activists. When the Conservative Political Action Conference met, they didn't even have a single panel devoted to abortion, which used to be a dominating conversation among conservative activists. And there seems to be something happening here politically where conservatives are very excited by the victories they have had or could continue to see in these court challenges.

But they don't like to trumpet them as much anymore, in part, I think, because electorally they're not as popular with the country as they are with the conservative political base. And there's a real conflict here. I mean, I don't know about you guys, but I don't get any fundraising notices bringing up these fights that are happening in the courts. Lawmakers I talk to don't - no longer really like to talk about that Supreme Court decision because they felt like it hurt them in the midterm elections. It's just a fascinating collision between the policy interests of conservative activism and the political reality of the country, which, frankly, isn't really in step with the conservative right on a lot of abortion access questions.

MCCAMMON: I think you're really right, Sue. I mean, poll after poll that we've seen since the Dobbs decision last June overturned Roe v. Wade has indicated that it is out of step with public opinion. You know, while many Americans support some restrictions on abortion, most Americans supported Roe and didn't want to see it go away. I think we saw some of the after-effects of that, of course, with the November election, with several ballot measures where voters essentially voted in support of abortion rights. And, you know, I think we all did some reporting around that time, too, that Republicans were kind of staying away - a lot of them away from abortion in their ads. And I think we're still seeing that now. You know, one thing I'm noticing is the anti-abortion movement is still very active, still engaged in a lot of litigation and legislative efforts. But they also seem to be trying to retool their message a little bit. There's been - you know, there have been some murmurs about tweaking state laws to clarify exceptions for things like rape, incest and medical emergencies, although most of those haven't gone very far.

And, you know, another thing I've noticed is that there are some segments of the movement that are talking more about helping women, helping families, supporting policies that - you know, like, Medicaid expansion during the postpartum period - again, not getting a ton of traction in terms of policy, but I'm hearing chatter about it. I talked to a few Republican strategists recently about this, and they told me that they - you know, there's an awareness, at least among some Republicans, that they need to kind of walk a careful line here in how they talk about this issue. Because banning abortion, taking all abortion pills off the market, that is just not in line with what most voters want.

KEITH: Well, and particularly fascinating is that this is an abortion drug for the first trimester. Support for abortion wanes as you get further into the term. But this is early in the term.

MCCAMMON: Correct. I mean, these pills are approved for use up to 10 weeks, so, you know, within the first trimester. You know, some doctors, I think, will prescribe them off label a little bit later. But we're talking about a period of time that, yes, most Americans would say that abortion should be, you know, a woman's decision, a pregnant person's decision.

KEITH: Well, we are going to be watching this closely. And we appreciate all of your reporting, Sarah. Thank you so much.

MCCAMMON: Yeah, thanks for having me.

KEITH: I'm Tamara Keith. I cover the White House.

DAVIS: I'm Susan Davis. I cover politics.

KEITH: And thank you for listening to the NPR POLITICS PODCAST.


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