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Health Affairs This Week places listeners at the center of health policy’s proverbial water cooler. Join host Jeff Byers, editors from Health Affairs Publishing, and guests as they discuss health policy’s most pressing news and trends.
Hello and welcome to Health Affairs This Week. I'm your host Jeff Beyers. We are recording on 05/14/2026. Next month, we have an insider event on antitrust and health care and beyond. Speakers include Lemore Daphne, Catherine Gudixson, and Nathan Hostert.
Jeff Byers:So check out the show notes to learn more about that event. Today on the pod, we have Chris Fleming and Katie Keith to talk about a mifepristone court case. Katie and Chris, welcome back.
Chris Fleming:Thanks, Jeff. Really appreciate it, and thank you, Katie, for joining us.
Katie Keith:Yeah. Thanks for having me as always.
Chris Fleming:Well, in the last couple of weeks, access to abortion, specifically medication abortion, has been in the news. Of course, this has been an ongoing topic of debate, for decades, but, it's been even more so lately, and this is, you know, the particularly the issue of medication abortion is a pretty big deal since listeners may or may not know about two thirds, I think, of all abortions are performed through medication rather than surgically. So can you tell us what happened to bring this back into the fore and the front pages even more than usual?
Katie Keith:Yeah. Absolutely. And as always, I will start by emphasizing that mifepristone, the primary drug used in medication abortion, has been approved as safe and effective by the Food and Drug Administration for more than twenty five years at this point. It was approved first in the year 2000, and women have been able to access this medication through telehealth and by mail really since 2020 at the height of the pandemic. So I think that's important context as we talk about what's going on in this court case.
Katie Keith:If it feels a little bit like you've seen this movie before, it's because you have, and we'll get into that, I know. But we saw sort of similar headlines back in 2023 and I'm grateful to be here to unpack all the latest. So, there is a historic fight here. What is happening at this moment in time is really a focus on changes that the FDA made to the regulation of mifepristone in January 2023. So, FDA finalized and made permanent the fact that women could access mifepristone through telehealth and by mail.
Katie Keith:That was the first big change. The second big thing that they finalized was to enable pharmacy access, so pharmacies for the first time could be certified to prescribe and dispense the medication that would allow women to go to the pharmacy counter and pick up mifeprazone just like you would pick up any other prescription medication. And I would emphasize what the FDA did in January 2023 really just finalized what had been happening since 2021, which was long before the Supreme Court's decision in Dobbs to overturn Roe versus Wade, and and really, you know, created those access points because of the pandemic. And I would also add in full disclosure, you know, I was in the Biden administration when this was finalized in January 2023, but we took the FDA's independence very seriously, so I was not involved in any of those decisions. And if readers are interested or listeners are interested, there's a great analysis out in JAMA showing that, you know, looking back at thousands of internal documents for FDA, all about their decisions on medication abortion that showed that the vast majority of the decisions made by the agency about this drug have been largely unpoliticized and driven by scientists at the agency at the career level and the evidence base itself.
Katie Keith:But this, back to the court case that we're seeing now, this fight is really about the fact that women can access this medication through telehealth right now. So that is, if you want to call it a controversy, is what this is about. Telehealth makes it easier for women to access the medication they need, and that's really frustrated anti abortion advocates who are you know, we're talking about the court cases today, but have, you know, attacked access to this medication in multiple fronts. So in states, in congress, and in the courts, all with a quite strong emphasis on trying to eliminate telehealth access itself.
Chris Fleming:So thanks, Kay. So as you alluded to, what we're talking about in the immediate term, as I understand it, is that there was a challenge to these the ability of women to access mifepristone through telemedicine or to go to the pharmacy like any other drug and pick it up. A challenge that the trial court said, no, we're gonna let the FDA look at this. The Fifth Circuit didn't rule on the merits, but said, well, this is ongoing. We're gonna basically say women cannot access mifepristone in these ways.
Chris Fleming:We're gonna essentially put a hold on this, go back to the old regime where they had to go in person to their physician. Is that right? And can you talk a little more about what happened?
Katie Keith:No. That's exactly right. So, you know, and there's a there's a longer history here, of course. I think the case that we're talking about here is exactly what you said. The Republican attorney general of Louisiana, joined by a Louisiana woman, went to court, district court in Louisiana to sue over the 2023 changes.
Katie Keith:The Trump administration and and they sued. They filed their lawsuit. I think this is important to emphasize, in October 2025. So more than two years after the January 2023 changes were made, waited a long time to to sue over this. You know, we can get into, you know, why Louisiana thinks that it's being harmed by telehealth access if that is of interest.
Katie Keith:But, you know, when they filed their lawsuit after the Trump administration had already publicly committed to doing a review of the safety record of mifepristone. And so you have this situation where the FDA is saying, we're looking at all the evidence. We're, you know, going back to the drawing board in some ways, and there's a separate court order telling them they they have to, you know, redo their work on methopristone because even the restrictions that are currently in place are too restrictive. And so they're they've got these sort of dueling court decisions. The FDA had said, why don't you let us do our work?
Katie Keith:You don't need to have a court decide this question right now. Louisiana didn't like that, but that's what the district court said. The district court said, you know, I think the state is harmed. I think the FDA probably didn't do the right thing when it adopted these changes in 2023, but the FDA is doing its work. Courts shouldn't second guess that and get in the way of that kind of evidence based review, and so he would have put a hold on this court case.
Katie Keith:That is where Louisiana went up to the Fifth Circuit Court of Appeals and asked for emergency relief. You know, they argue that they're being so harmed and this is so egregious that this nationwide change, and again, I think this is really important, a change to whatever FDA has in place affects, access in every state, but especially the states where abortion is still legal. There's telehealth access within states like Minnesota and New York and California and states where abortion remains lawful after Dobbs. And, you know, one state sort of asked to set aside this nationwide regime on an emergency basis, and that is what the Fifth Circuit allowed, very quickly. So in a pretty short 19 page opinion, the fifth circuit said, yeah, we're gonna, you know, set aside vacate stay the twenty twenty three changes.
Katie Keith:And so over the week, this happened on a Friday evening over the weekend before the supreme court stepped in briefly on Monday, you saw sort of widespread chaos and disruption that I that I know we'll get to. And so, you know, where we are today is and we're recording on the morning of May 14 as we wait for, you know, some kind of information from the supreme court later today about what's gonna happen as this appeal continues. So there's a long road here. This is still very early. It's on all these emergency postures as you alluded to, Chris.
Katie Keith:But the question right now is what happens to access while the litigation plays out? And the fifth circuit seemed just fine with allowing that kind of disruption while the litigation played out, and we'll see if the supreme court is also okay with that and and making it, you know, extremely difficult for women to access this long standing medication.
Chris Fleming:Katie, you you mentioned that we've that there's a long road ahead. There's also a little bit of a long road behind. In fact, some of our listeners might have been experiencing a little bit of deja vu watching all this. This you know, we saw this movie before, right, a couple years ago?
Katie Keith:No. That's right. I keep saying, I would like to get off this roller coaster now. That's exactly right. But, you know, so the history here, folks might remember a supreme court decision in 2024.
Katie Keith:So if you're scratching your head going, where have I heard this all before? It's because there was a prior lawsuit first filed in 2022 by a group of anti abortion physicians who challenged, you know, the FDA approval and regulation of this drug. There were similar sort of starts and stops like what we're seeing in this case where there was never full disruption, but there were multiple times where there could have been had the supreme court not ultimately stepped in in the way that it did in 2023 before, fast forward, in 2024, sort of throwing out the case, because the doctors didn't have what we call standing to sue. And the conclusion that the Supreme Court reached then was that, you know, doctors who do not prescribe a medication aren't sufficiently harmed by, and there's other parts of that too, but can't go to court to sue the FDA because that's too attenuated of an argument for why they're harmed. And so they did not have standing to sue their the but the litigation didn't go away.
Katie Keith:In the meantime, while it had been pending, you saw Republican attorneys general from Missouri, Kansas, and Idaho asked to intervene in the litigation. And so as of last year, that lawsuit had been in Texas, and now it's moved to Missouri. And then over time, we've also seen two more lawsuits from Republican attorneys general, the Louisiana case that we're talking about now, and a separate case from Florida and Texas that's been filed in Texas. And so when we say there's both a long history and a long road ahead, you know, again, this is about what happens to access through telehealth and the mail and pharmacies right now as a lot of these court cases continue to play out. And and so I think even regardless of what news we get from the supreme court here today, it's just really worth emphasizing that this drug continues to be under attack.
Katie Keith:And frankly, as the Trump administration is doing whatever review, you know, it says it's doing, that could be another way that we start to see nationwide changes to access to medication abortion as well. But I think, you know, here again the idea that one state that has some of the most extreme abortion bans in the country can use the courts to make sudden sweeping nationwide changes to how this drug that's been on the market for more than twenty five years is, regulated and available to women, should give everyone pause. And in fact, you've seen amicus briefs from former FDA commissioners and pharma talking about how destabilizing you know, if the court allows these kinds of lawsuits, how destabilizing that will be to the biopharmaceutical industry. I think one one quote was, you know, we'll have to be developing drugs while looking over our shoulder out of fear that, you know, there could be states that sue because they don't like, you know, what our drug does or how it's being used. So I I think the implications could be much broader for certainly, they're huge for abortion access itself, but much broader for people who care about access to who care about research and development and innovation and, you know, access to prescription medication.
Chris Fleming:As if the implications for abortion access and and reproductive health weren't enough. As you say, you've got this this much broader possible impact on drug development overall. So, you know, coming back to to where we are now, you mentioned that we're waiting to hear later today probably from the court. Can you talk a little bit about sort of what the stance is? What, you know, what we're waiting to hear from the court?
Chris Fleming:And then maybe talk a little bit, we've alluded to this FDA review, you know, what's happening there? What should we expect from that process? And I would note that, you know, there there's a background to that. Obviously, there's a background to everything here. You've got, you know, a lot of folks in the who are in the anti abortion movement, as Katie mentioned, who you know, have been impatient with the administration for not doing more to restrict abortion.
Chris Fleming:On the other hand, you've got people in the administration, I think, who are wary of doing anything because abortion restrictions tend to be unpopular with voters who wanna sort of push this, make this go away till after the election. And, you know, one consequence already from all of this, when you look at the litigation we've been talking about, you know, it's Louisiana versus FDA, and after FDA comes a series of of officials of the FDA who are also named in their official capacity. The first one on that list was Marty Makary, who was, but is no longer commissioner of FDA, and this case, this poll debate may have had a lot to do with that. So that's a broad question, but I'm hoping you could talk a little bit about where we are now and what we might expect both on the litigation front and from the FDA.
Katie Keith:Yeah. Thanks, Chris. So some of that is above my pay grade in terms of what's going on at the agency or or with the Trump administration, but it certainly has been a big week for the FDA. I think at least in terms of what is going on at the Supreme Court and and what to expect, You know, I haven't mentioned this yet, but two of the three drug manufacturers that make mifepristone have intervened in these lawsuits to to defend access to the medication. And so they quickly, after we got the Fifth Circuit ruling on a Friday afternoon, they quickly asked the Supreme Court for what we call an administrative stay.
Katie Keith:And so that's what Justice Alito, who is in charge of requests that come from the Fifth Circuit, entered on Monday. So you sort of had this disruption over the weekend when the Fifth Circuit's decision was fully in effect, but that was halted on Monday. When justice Alito halted it, he gave a deadline, though. So he first put this, what we call an administrative stay, until this past Monday, May 11. And then on May 11, as we were all waiting on pins and needles, he extended it to today, May 14 at 5PM eastern.
Katie Keith:And so all eyes today are very much on the supreme court, asking, you know, will they or won't they? So will they extend the administrative stay? Will they grant the drug manufacturer's request to put this fifth circuit ruling on hold while the litigation plays out. We've also seen some agreement amongst the parties that maybe the Supreme Court should take this issue up quickly. Louisiana, for instance, sort of suggested there is no point in going back to the Fifth Circuit on this because of how many times they've ruled on similar questions.
Katie Keith:I would argue not the same question, but similar questions in the past, saying, like, we'd be fine having a rule argument soon if you wanna just go ahead and take this up supreme court. But you do see the parties looking for a certainly this stay while things play out, but potentially a quick resolution on this issue. I think, one party you did not hear me mention that speaks to, you know, some of the politics that you were touching on, Chris, is that the Trump administration did not sort of make the same request as the drug companies here. And so for the lower courts, for its part, you know, the Trump administration was emphasizing that they were doing this review and there was no need to rule on this question right now. They had also challenged and argued that Louisiana didn't have standing to sue here, but they didn't really do kind of a full throated defense of what FDA did in 2023, which was you know, kind of used against them by the district court and the fifth circuit.
Katie Keith:But they did maintain that position up to the fifth circuit, and so it's been silent and pretty quiet from the Trump administration. So they, I think, one way to read that is they are perfectly fine with the chaos and confusion, that, you know, allowing the Fifth Circuit's decision to take effect would have, even though it would essentially be a nationwide ban on telehealth access, especially when you have a president Trump who has sort of said, we'll leave this issue to the states and not, would not support a nationwide abortion ban. So I think all of that's going to play out. I don't know enough about how to think through the personnel changes at the FDA, but I do know this is gonna continue to be a huge issue. I think the Trump administration have been trying to avoid weighing in on this issue during a midterm election year, and turns out it is not a fight that they can avoid.
Chris Fleming:Well, thanks, Katie. I should mention to listeners that Katie has a very good piece that discusses all this at much greater length than we could today on Health Affairs Forefront. So I would encourage you all to go check that out. And with that, Katie, thank you for joining us. As always, it's been a pleasure and I appreciate your ability to shed light on all these very complex issues.
Katie Keith:Thanks for being on the roller coaster with me altogether.
Chris Fleming:And, with that, I'll turn it back over to Jeff.
Jeff Byers:Yeah. Thanks, Katie. Thanks, Chris, for joining us today on Health Affairs This Week. If you, the listener, enjoyed this episode, please send it to the court watcher in your life. Thanks, and we will see you shortly.
Jeff Byers:Bye.