John Donvan

This is Open To Debate. I’m John Donvan. Hi everybody. In this episode, we’re again employing our new mock trial format. This time we’re presenting two lawyers who are taking opposite sides in one of this year’s most followed Supreme Court cases with a ruling expected in the next few months actually. The case is called FDA versus Alliance for Hippocratic Medicine. It stems from a lawsuit that a group of conservative doctors brought against the Food and Drug Administration for the Food and Drug administration’s approval and rulemaking around the so-called abortion pill. That’s a drug called Mifepristone.

Available since 2000, it has been accessible since 2021 via telehealth appointment with pills sent through the mail if necessary. Since 2016, it’s been usable later in pregnancy than originally, and it can be dispensed by non-doctor healthcare professionals. Depending on what the Supreme Court rules that accessibility may be cut off. For this debate, I invite you to put yourselves in the positions of the Supreme Court Justices. Much is running on the decision that you would make. So to get our mock trial started, let’s metaphorically all rise and after that, let’s meet our two attorneys. Here to represent the argument of the Alliance for Hippocratic Medicine, Catherine Glenn Foster. Catherine is a senior fellow in legal policy at the Charlotte Lozier Institute. And Catherine, welcome to Open To Debate.

Catherine Foster

Thanks for having me. Uh, in my role at Charlotte Lozier and also serving as president and CEO of First Rights Global, I filed an amicus brief in this case and have been involved in every other case relating to abortion over the last 15 years. So it’s great to be able to present before the justices of your court.

John Donvan

Thanks very much, Catherine. And here arguing the other side, taking on the interest of the Food and Drug Administration and the US government, Julia Kaye. Julia is a senior staff attorney at the ACLU’s Reproductive Freedom Project. Julia, welcome to Open To Debate.

Julia Kaye

Thanks so much for having me, John. I have, uh, spent much of the last eight years parsing every word the FDA has written about Mifepristone and speaking to folks directly impacted by restrictions on medication abortion. So I’m looking forward to bringing that to bear in today’s conversation.

John Donvan

So that’s fantastic. We have two lawyers who are very briefed up on this topic. So let’s get to our opening statements. Catherine, you are up first. You are arguing on behalf in this case of the Alliance for Hippocratic Medicine. The floor is yours.

Catherine Foster

May it please the court. In 2000, the FDA approved a two drug abortion regimen, Mifepristone and Misoprostol. The FDA concluded that the drugs could not be safely used without special measures and limited the approved use to seven weeks gestation. Prescribers needed to be licensed doctors able to diagnose ectopic pregnancies and determine gestational age, and doctors were required to provide ongoing in-person care. The day one in-person administration of the first drug, day three in-person administration of the second drug. And day 14 visit to check for complications. The FDA included a black box warning to alert women that surgical intervention may be necessary and inform them of what to do in the event of an emergency, noting that access to emergency care was critical. In 2016, the FDA eliminated the day three and day 14 visits and increased the maximum gestational age from seven to 10 weeks.

They also eliminated the requirements that prescribers be doctors and report serious non-fatal adverse events to the agency. The piecemeal analysis they engaged in relied on studies that included safety measures like ultrasounds that were emitted under the labeled conditions of use and didn’t rely on any study that addressed the comprehensive changes. Now, by ’21, there was already a push to offer chemical abortion drugs through telemedicine. COVID accelerated that. And in December ’21, the FDA made permanent what had started as a temporary exception, removing that last day one in-person dispensing requirement. The FDA continued to identify emergency medical care, not providers as the backstop for complications. The FDA failed to consider the ramifications and failed to explain why they seem to make a decision counter to the evidence. They justify the removal of all these protections based on the availability of emergency care coverage.

Now, many women believe something has gone wrong when they take chemical abortion drugs. In an average period, a woman loses two to three tablespoons of blood over four to five days. In a chemical abortion, the average is almost nine tablespoons of blood over more than two weeks. And these are averages. Standard deviation is high. So roughly for about a quarter of women, it’s basically an ordinary period. For about half, it’s average for a chemical abortion, six to nine tablespoons. But for the last quarter, it’s a lot more, from 10 to 24 tablespoons. In terms that we can understand, a sugar packet is one teaspoon, three teaspoons and a tablespoon. So for an average period, two to three tablespoons, you rip open maybe six or nine of those packets. Average chemical abortion, 18 to 27 of those. And for that last quarter of women, 30 to 72 sugar packets.

Now, most women who get abortions, almost half of the total in America are in their twenties. So statistically they’ve had at least a hundred periods. By then, you have a pretty good idea of how your cycle works. So let’s take Emma, young woman, 21 senior at a state college, swimmer. Her period’s late. There’s a, a plus on the little stick. So she calls her local women’s clinic where she gets birth control and they schedule a telehealth appointment. She clicks the link on her phone. They ask her some questions, whether she wants surgical or chemical. Chemical. It’s easy, convenient, take a couple pills and get a heavy period like it never happened. The pills come in the mail. She takes the first drug, she waits, takes the second, the cramping starts. NBD, she’s had cramping, but it doesn’t stop, doesn’t let up. It’s bad. She takes the painkillers she takes for period cramps, hoping that that’s okay now, but they’re getting worse and she’s starting to bleed.

Wants to check with the doctor, but he’s hundreds of miles away, ’cause remember it was just a quick video chat and she’s used to that three or four-day period. But this is different. Day 7, 8, 9, cramping and bleeding. And she can’t use a tampon or a cup. So now she can’t swim until it stops. This is not what she thought of when she was told heavy period. This is gigantic. She didn’t expect this. And she’s passing clots, plot, products of conception, maybe sees an embryo, maybe even the size of a cherry and starts to panic. At a hospital or clinic, there are regulations and procedures for disposal of human remains, but Emma doesn’t know whether to flush all this, what to do, and it’s a lot to clean up.

The FDA says, women can deal with this, the physical, mental, and emotional stress at later embryo gestational ages without being given the full information. So it’s not surprising that one in 25 women of the hundreds of thousands who take abortion drugs each year, end up in the emergency room, especially when the FDA itself direct the women to ERs. Chemical as opposed to surgical abortions carry a greater risk of hemorrhage, greater risk of sepsis, and the FDA expanded the gestational age, cut the relationship with the woman’s doctor and fails to educate women. So of course we get more ER visits and the data backed that up. There’s lack of education in there’s fear, and women aren’t the only ones harmed here. Our already taxed healthcare system is being stretched to its breaking point. And the FDA is throwing up procedural roadblocks. This is why respondents sued.

John Donvan

Thank you, Catherine Glenn Foster. And now Julia Kaye, it’s your turn to address the justices. Your opening statement, please.

Julia Kaye

May it please the court. Mifepristone is a safe, effective medication used in most US abortions and as part of the gold standard treatment regimen for miscarriages. Since the FDA first approved it more than two decades ago, nearly 6 million people in the United States have taken this medication and millions more globally. The World Health Organization calls Mifepristone an essential medication. There’s no credible dispute about Mifepristone safety. The nation’s leading medical associations describe the science confirming Mifepristone safety as overwhelming. While all drugs carry risks, these medical experts have explained that Mifepristone is among the safest medications being used in medical practice today. It is safer than Viagra, safer than penicillin. It’s as safe as Advil. According to the FDA, serious complications from Mifepristone are exceedingly rare, experienced in a fraction of 1% of patients. So this isn’t really a case about Mifepristone safety, although it pretends to be. The plaintiffs are organizations and individual doctors who oppose abortion on moral or religious grounds and want to see all abortion banned nationwide.

A few months after the Supreme Court overruled Roe v. Wade, they got together and formed a new shell organization in Amarillo, Texas where the only federal judge is a Trump appointee with a record of hostility to abortion. They then filed this lawsuit in Amarillo and asked that judge to undo every decision the FDA has made relating to Mifepristone going all the way back to the original approval of this medication in the year 2000. They asked the court to order the FDA to take Mifepristone off the shelves everywhere in the country, or at minimum, severely restrict it nationwide. The plaintiff’s evidence rests on the testimony of a few anti-abortion doctors and advocates who travel the country peddling misinformation about abortion safety. When other courts have heard these folks testify, they have discredited them. For instance, one of the plaintiff’s lead experts, Dr. Ingrid Skop, had her testimony on abortion thrown out two years ago by a Florida court for being inaccurate.

Dr. Skop admitted under oath in 2020 that she is not a really good researcher, her words. So it’s no surprise that her research on medication abortion has been published by a fringe advocacy group that claims President Obama hypnotized listeners with his speeches. Several of the studies that the plaintiffs are relying on here have been retracted because they are so profoundly flawed. But let’s set aside for a moment the junk science underlying the plaintiff’s case because their lawsuit suffers an even more fundamental defect. The Constitution says that people cannot challenge a government policy that does not actually affect them just because they dislike what the government did. Instead, these plaintiffs have to show that a specific member of their groups is facing imminent harm caused by the specific government actions they’re challenging.

Now, these plaintiffs don’t prescribe Mifepristone and have no actual connection to the FDA’s regulation of Mifepristone. So the best they could come up with was a long chain of implausible hypotheticals, culminating in an anti-abortion doctor somewhere someday having to complete an abortion procedure in violation of their conscience. The thing is, they couldn’t even find one doctor who could clearly say that this scenario has ever arisen in the past much less show that it’s certainly going to happen to them again in the future. And their witnesses completely ignored that federal laws already exist allowing healthcare providers to opt out of procedures to which they have a moral objection.

Now, even the ultra conservative Fifth Circuit Court of appeals concluded that these plaintiffs are too late to challenge the FDA’s original approval of Mifepristone 24 years ago. But the lower court rolled back the clock on science overriding the FDA’s evidence-based decisions in 2016 and 2021 with respect to its Mifepristone regulations. If allowed to take effect, that order would severely reduce access to this safe essential medication in every single state in the country, including those with legal protections for abortion. Overriding the FDA’s actions here would not only be devastating for folks who need abortion or miscarriage care, it would undermine drug development and impede access to critical medications well beyond reproductive healthcare. This dangerous frivolous lawsuit should be dismissed.

John Donvan

Thank you very much. We’re gonna take a brief recess and when we come back, our two attorneys will have opportunities for rebuttal of one another’s opening arguments. Our question in this mock trial, should the courts restrict access to the abortion pill? We’ll be right back with more from Open To Debate.

Welcome back to Open To Debate. I’m John Donvan. We have with us two attorneys who have laid out arguments for the FDA’s decision to lift restrictions on access to the abortion bill as well as against that decision. Catherine Glenn Foster is arguing in support of the position taken by the Alliance for Hippocratic Medicine and Julia Kaye arguing for the position taken by the FDA. Catherine, you made a very vigorous case that the abortion pill is frankly dangerous and more dangerous than the FDA signaled by giving it approval, uh, for in the first place in the year 2000, and then by lifting restrictions on its use in the years 2016 and 2021. You’re saying that in doing so, they applied a piecemeal analysis that didn’t actually examine evidence that would go directly to the impact of the lifting of restrictions.

Julia Kaye, you’re arguing back saying, first of all, that the, uh, FDA’s approval has been evidence-based. Your point is that the opposing views experts are less than expert, that their science is flawed and that they’re motivated less than they might be indicating about their concern for the safety of women and more for ideological purposes of wanting to see abortion ban nationwide. So there’s a lot to get, dig into there, but I want to point out that a, a lot of what might happen in this case of according to what we’ve heard from the Supreme Court so far goes to the issue that Julia was discussing near the end of her opening. And that’s the question of legal standing. And I think it would be useful to our listeners to understand the role of legal standing and why that matters. I want to ask you to explain them that, what legal standing is, why it matters so much in this particular case and why the side you’re representing, you would say does have legal standing.

Catherine Foster

Legal standing in short, is whether or not there was some harm, whether these are the proper plaintiffs to try to get justice. And I would posit that these are the correct plaintiffs. Article three standing requires no more than defacto causality, and traceability is satisfied when there’s third party action contributing to the plaintiff’s harm when it’s likely attributable, at least in part to the challenged action. And the independent actions of third parties don’t defeat standing where there the predictable effect of government action. You can’t just pin this on women’s decision to take abortion drugs. This is really going back to the FDA legalizing the abortion drugs. Um, and we know this from the case law, this applies here as well.

The FDA’s data shows the predictable results of its actions and the effect of its actions on third parties. We can see that about 500,000 plus in the most recent data per year take abortion drugs in the United States. And that number is only going up. The FDA recognizes that approximately one in 25 women who do use Mifepristone will go to the emergency room and about 7% of women will need, uh, follow on surgery whether to complete the abortion because the, the pregnancy is ongoing or to deal with ongoing bleeding. So tens of thousands of women will end up in an ER each year due to taking Mifepristone and many of them will receive treatment from respondent doctors.

John Donvan

So just to make clear to people who may not be familiar with the case to get, the argument you’re making is that it’s those respondent doctors because they are the ones who may end up having to treat women in various ways who are, uh, seeking or performing an abortion, and that this would violate their conscience. And so that they’re in a sense an injured party in this.

Catherine Foster

That’s exactly it, that it violates their conscience. And the 2021 and 2016 actions make every chemical abortion more likely to result in complications necessitating emergency care.

John Donvan

I just wanna give, uh, Julia a chance to respond.

Julia Kaye

Thanks, John. Well, let me start with those, uh, misleading statistics. The FDA has found over and over again that serious complications associated with Mifepristone occur in fewer than 1% of cases. You heard counsel reference a two to 7% range. What she was referring to there is that in two to 7% of cases, the medication may not be fully effective, but in many of those cases, patients can just take an additional dosage of the medication and that will fully complete the abortion process.

John Donvan

And how would that impact the standing question?

Julia Kaye

The plaintiffs in this case are arguing that hypothetically someday, somewhere some anti-abortion doctor might end up encountering a medication abortion patient in the emergency room and might hypothetically have to complete that abortion in violation of their conscience. This is far, far too speculative to meet the constitutional requirements for standing. This is a medication that is extremely safe and according to leading medical experts, safer than Viagra, safer than penicillin, as safe is Advil. So if these ER doctors are correct that they can challenge this medication, that would open the door to countless medications that Americans rely on being subject to this kind of junk science legal attack.

John Donvan

One more question back to you, Catherine, on the standing question. So what I think I hear Julia saying is that the, the numbers that would be involved and the direct connection and the the probability of a given doctor, an individual doctor having to face this sort of violation of conscience is so small and so unprovable that it’s just not plausible to argue that it would be grounds for standing in this case.

Catherine Foster

Even if some of these complications, even if some of these incomplete abortions may be solvable with follow on medication, where’s that doctor to give them a second, a follow on pill? You have to have a doctor there to give it to the women. And since we have some questions about the data, let’s just go to the FDA’s own label. The current label for Mifepristone, at least as of a couple months ago, it continues to require a black box warning because the drug can cause, and I quote serious and sometimes fatal infections and bleeding.

It also directs women into emergency rooms if one of the many adverse complications like sepsis, massive life-threatening infection or hemorrhage, massive life-threatening bleeding arise. And it estimates that one in 25 women going back to that number, that range will visit the emergency room after taking Mifepristone. And as many as 7% according to the label, will need surgery to stop bleeding or to complete the abortion. The FDA still conceded that the literature, this is again a quote, the literature suggests that there may be more frequent ED, uh, and urgent care visits when dispensed by mail from the clinic that goes down with in-person visits.

Julia Kaye

What counsel is saying there is incorrect. And the bottom line is that serious complications occur in fewer than 1% of cases. I also want to remind folks big picture that all drugs have risks. The FDA frequently for all sorts of everyday medications is directing folks to emergency care in the rare event of an emergency. And I just wanna make one final point here with respect to the conscience injuries. Not a single one of the witnesses in this case even acknowledge that federal laws already exist that allow healthcare providers to opt out of procedures that they have a moral opposition to. And they certainly didn’t explain why the existence of those laws wouldn’t address any injury that they’re claiming.

John Donvan

Okay. I want to, uh, uh, acknowledge that we have disagreement, fundamental disagreement, both about the numbers and how to interpret them, but move on to some other questions. Is there legal precedent for second guessing the FDA in this way? And if in the end the, uh, alliance prevails in this case, what would be the implication, the, and the impact on all agencies more broadly? I’ll take that to you first, Catherine, please.

Catherine Foster

Yeah. We have precedent that agency actions, uh, aren’t absolute that in fact we can ask questions. That’s why we have this arbitrary and capricious standard that we turn to when we’re evaluating decision making. We know from the FDA’s own documents that they ignored relevant studies, that they did not have a comprehensive study that would address all of their 2016 actions and that they didn’t have anything to back up what they did. In fact, the studies they looked at had safeguards in place that simply aren’t there, uh, in their own recommendations. This is why we turn to that arbitrary and capricious standard. And so there absolutely is precedent to examine the actions and determine whether or not they were valid, whether they were justified, and whether they should be upheld.

John Donvan

Julia, can you, can you respond to that? And let’s, let’s put it in light of the 2016 decision to loosen restrictions to the degree that the gestation period was extended, the requirement for multiple visits to the doctor was reduced to one, and also that the abortion pills could be dispensed by non-doctors, by nurses and, uh, midwives, et cetera.

Julia Kaye

Sure. When the FDA updated its Mifepristone regulations in 2016, it did so based on more than 70 high quality clinical studies, as well as real world data from millions of patients both within the United States and around the world. It gave a thoughtful explanation that aligned with the uniform recommendations of the nation’s meeting, leading medical authorities. Now, I wanna just add a crucial piece of context here. Across all areas of medicine, medical research and standards of care evolve much more quickly than the FDA can update its drug labels. So it’s common for healthcare providers to prescribe medications off-label, which means they’re relying on the most up-to-date medical evidence. This is common widespread permissible.

When the FDA updated the Mifepristone label in 2016, it did so to bring the labeling in line with what was already safely happening in clinical practice all across the country and around the world based on the most current evidence. In fact, from 2000 to 2015, the FDA required more comprehensive reporting relating to Mifepristone than for, for any other drug among the 20,000 drugs the FDA regulates. And those data showed that serious complications are exceedingly rare, fewer than 1% of the time.

Catherine Foster

So the, the FDA relied on its adverse event data, but it also concedes that that data cannot be used to estimate the incidents of adverse events or indicate the safety profile of a drug. And so we’re saying that it’s relying upon this data and therefore we’re supposed to show judicial deference to this agency’s decision when in fact the agency’s decision appears to be unreasonable.

Julia Kaye

Counsel is, um, a bit confused about what happened in 2016 and what happened in 2021 and the data that informed both of those decisions. In 2016, the FDA based its decision on extremely comprehensive mandatory reporting requirements that had shown over 15 years that serious complications were exceedingly rare. At that point because the data was so robust and showed so clearly how safe Mifepristone is, the FDA changed the reporting of requirements, even so, the FDA still required more reporting for Mifepristone than for almost any other drug, but it was bringing it closer to the type of reporting that FDA uses across the board for all other medications.

John Donvan

What are you saying Catherine is getting wrong there?

Julia Kaye

She’s just conflating the 2016 and 2021 decisions.

John Donvan

Catherine?

Catherine Foster

Yeah, at that juncture, I was referring to the ’21 changes, and that’s when they relied upon their adverse event reporting system to conclude that there did not appear to be a difference in adverse events when the in-person requirement had not been enforced. And that relates back to that temporary COVID change that I referenced earlier. But the agency’s official position is that that data by itself is not an indicator of the safety profile of the drug and the FDA even cautions that the number of suspected reactions in the system should not be used to determine the likelihood of a side effect occurring.

John Donvan

Catherine, we heard Julia in her opening statement say that the, the people you represent on your side are pretending to care about women’s safety when actually they’re, uh, ideologically opposed abortion across the board. Why would the FDA whose mission is in all cases to protect the safety of people who use drugs, why would the FDA botch this one in particular? What, what would be any kind of motivation they would have not to put the safety of women who use this drug above everything else, which I think Julia’s case is that they did do?

Catherine Foster

It, it could be, you know, the, that in the 20- the case of the 2021 change that it might have been motivated by COVID and the general push and move towards telehealth. In many cases, telehealth is a great thing. Uh, in this case it is not as safe, and the data bears that out. We see the increase in ER visits if nothing else. Uh, so that would be one potential motivation. Perhaps they’ve been lobbied, I don’t know. I can’t speculate. All I know is that in this case, it seems that they may have gotten the answer wrong. They didn’t have the proper data, and I think they moved too far too fast without the data that backs up and supports the changes that they’ve made. Whether or not someone agrees with a woman’s decision to seek an abortion, we do not want that woman encountering harm. We do not want her ending up in the ER, we do not want her facing emergency surgery or extra pills.

John Donvan

You’re clearly not suggesting ideology was involved in the FDA’s decision making. You’re, you’re agnostic on that. You’re just saying the fact is that they, they botched it.

Catherine Foster

Correct. I would not be able to, to render (laughs) an opinion or, or to hazard a guess as to, as to what the reasoning might be. All I know is that, um, is that based on the data, it does not appear to have been a well-reasoned decision. And that’s exactly when we say this appears to be unreasonable, and therefore we’re not going to show judicial deference to that agency’s decision.

Julia Kaye

I just wanna briefly address the changes that the FDA made in 2021. So in 2000 when the FDA first approved Mifepristone, the world looked very different than it does now. And in 2021, the FDA looked at a number of clinical studies both from the United States and globally, as well as real world data that the FDA collected during the pandemic during a period of time when the in-person requirement was not being enforced. And what it showed is that Mifepristone remained safe and effective without a medically unnecessary in-person pill pickup requirement. Patients absolutely still can and do have an in-person visit, either because they prefer that or because they and their healthcare provider determine together that it’s medically appropriate for them to come in for an ultrasound or a physical exam.

But what the plaintiffs in this case are seeking is an across the board mandate that every single medication abortion patient as well as folks using Mifepristone for miscarriage care, travel in person, just to pick up the pill, even when they have already been thoroughly counseled and evaluated through telehealth and even when this trip, which can be hundreds of miles for some patients, is going to be so burdensome that it will effectively prevent patients from accessing this care at all. They had a very, very strong medical basis for making this change that was endorsed by all of the nation’s leading medical associations, including the association that represents 90% of the United States OBGYNs.

John Donvan

I wanna move on, uh, briefly before we come up to another recess. Catherine, I just wanna, uh, I, I just find it interesting, I think, uh, listeners will, that the case has also been intersecting with discussion of the Comstock Act, and that’s, that’s quite an old laws. It’s 151 years old, and it was established in, during the Grant administration to make it illegal to use carriers like the US Postal Service to mail materials, uh, in this case, abortion pills would be relevant, that those with, um, an anti-abortion stance might consider to be obscene. That was essentially an obscenity law. Talk a little bit about the relevance of that law in the conversation that we’re having now.

Catherine Foster

Sure. So the Comstock Act pre- prohibits using the mails to send any drug advertised or described in a manner calculated to lead another, to use or apply it for producing abortion and forbids using a common carrier or interactive computer service to ship any drug designed, adapted, or intended for producing abortion. So the 2021 action by the FDA, it authorizes the widespread mailing and shipping of abortion drugs, but as we saw in the decision below in the lower court’s decision mailing drugs that cause abortion, that’s exactly what the Comstock Act prohibits. The FDA’s main argument was that Comstock only applies to unlawful abortions, but the text has no limitation about unlawful abortions. It’s across the board. Um, and Congress in 1978 actually, um, considered and rejected an amendment that would limit the law to that. There’s been no change in the Act itself that would lead it not to apply in this case.

John Donvan

So still on the books, Julia is what, um, Catherine is saying.

Julia Kaye

Yeah. John, if I can just translate what you just heard. The plaintiffs in this case and anti-abortion extremists across the country are trying to use a law from the 1800s to restrict access to abortion care in 2024. And it is not just that they’re trying to get rid of the option to use telehealth and mail order pharmacy dispensing, they are actually arguing that the Comstock Act from 1873 can be used to ban all abortion nationwide. They are advising Donald Trump that if he’s elected president, he can use this law from the 1800s to ban all abortion without even needing any congressional involvement. So we should all be very, very concerned about this argument. They are getting the law entirely wrong, but it is clear that they want to misuse this 150-year-old law to ban all abortion nationwide.

Catherine Foster

We do have separation of powers for a reason, um, let Congress act. Just because a law is 150 years old doesn’t make it wrong, it also doesn’t make it right. It’s up to Congress to act if it doesn’t like the law, just like as in any other law that we may not like.

John Donvan

We are gonna take a recess here and when we come back, we’re gonna bring in some legal experts to ask questions. And we are, as I wanna point out in the middle of our mock trial on the abortion bill case. I’m John Donvan. This is Open To Debate and we’ll be right back.

Welcome back to Open To Debate. I’m John Donvan. I am joined by Catherine Glenn Foster, and Julia Kaye, who are currently arguing in our mock trial, should the courts restrict access to the abortion pill. And what we’d like to do in these debates is bring in some other voices, people with legal and other expertise to kind of dig into what they’ve heard in the conversation so far, and also to potentially bring in some new thoughts and maybe even some cross-examination of their points. And up first, I’d like to welcome Aziza Ahmed into the courtroom. Aziza is a professor of law at Boston University School of Law, and also director of the Boston University program on Reproductive Justice. Aziza, welcome to Open To Debate. Thanks for joining us. And you have the floor.

Aziza Ahmed

I would love to hear both lawyers respond to sort of the general idea, um, of challenging the FDA who should be able to challenge the FDA. How should the FDA be challenged? What is the legitimate way to bring about change at the FDA if we are unhappy with what the FDA is doing?

Julia Kaye

We agree, and in fact, everyone in this case agrees that no agency is above the law, and that courts have a role to play in ensuring that the FDA, like other agencies make appropriate decisions and stick within the limits that Congress has set out for the agency’s authority. Now, this case is gravely wrong and unfounded, both because these plaintiffs have no actual connection to the FDA’s regulation of Mifepristone. It’s really grounded in their ideological opposition to abortion and also because the FDA’s decisions to update its Mifepristone regulations in 2016 and 2021 were based on extensive scientific evidence, were endorsed by all of the nation’s leading medical authorities like the AMA and were very well, um, reasoned.

A huge number of OBGYNs and family medicine docs and other healthcare providers in this country who prescribe Mifepristone and who can speak to the fact that their very patients need access to this essential medication for abortion and miscarriage care, and in many cases cannot get it because of these outdated, medically unnecessary restrictions. So it’s very, very different from a case where you have these healthcare providers who do not prescribe Mifepristone, who don’t have any direct connection to it, but say, “Oh, well, hypothetically, maybe one day we might encounter an abortion patient.” These are folks who routinely daily care for patients who need this medication, but are facing medically unnecessary barriers.

Catherine Foster

So the reliance upon emergency room physicians and other doctors, not abortion providers to deal with the aftermath of chemical abortions is not a bug in the system, it’s not a flaw. It was exactly the plan that the FDA has come up with as they’ve expressed time and again. And so they keep trying to, to erect procedural roadblocks to standing. But in, in removing those, those safeguards, the, the three in-person visits first two, and then the third, the, the initial in-person visit. And by expanding the gestational age, they expressly counted on OBGYN hospitalists and ER doctors to manage the complications.

And so when faced with emergencies, whether or not these doctors are aware that what they’re facing is in fact the aftermath complications from a chemical abortion, they may be informed or may assume that they’re looking at a miscarriage because they do present extremely similarly. So they may not even be aware, we don’t have full data. And we can go through the list of potential plaintiffs who we might wonder if there is standing, perhaps a woman who was injured who would not have been injured, but for the lack of in-person visits, but for the lack of, of some other procedural safeguard. But someone has to have standing.

John Donvan

It’s clear that both of you think sometimes it does have to be the courts. And to that you agree. I wanna now go on to, uh, Zach Schoenfeld, who’s a courts and legal reporter at the Hill. Zach, thanks for joining us on Open To Debate. Please come on in with your question.

Zach Schoenfeld

I wanna ask you about what the remedy should be. The plaintiffs here, they walked into the Federal District court and they got what effectively had the effect of a universal injunction, not only getting relief for themselves, but relief that applied coast to coast. Is this a, something that we need to be concerned about, about a singular federal district judge coming in and issuing, uh, what is effectively a universal injunction against a government policy?

Catherine Foster

Yeah. We’re not talking about banning the drug entirely. We’re talking about those 2016 and 2021 changes. So what an effective remedy would be would be to undo those and send it back to the agency just like, uh, the Supreme Court may issue a ruling and send a case back down to a lower court for more examination, to take another look at the evidence, to determine how the law applies in light of this further information.

So if here the Supreme Court says, in fact, this does appear to have been arbitrary and capricious, then the answer is that the FDA needs to take another look, get more studies if necessary, look more deeply at the existing studies, and then make a determination that isn’t arbitrary and capricious. That takes a full reasoned evaluation of the studies that we have, explains its decision making, and if necessary gets more studies because I think we can all agree that women’s safety here is paramount, and that’s exactly what plaintiffs are focused on. That’s exactly what the FDA should be focused on. And so let’s just do that. Let’s focus on the women’s safety and ensure that the studies that we’re looking at actually apply to the situation at hand.

John Donvan

I think the implication of what you’re saying, logical conclusion, is that if that were to happen, and if the FDA does do a kind of, um, resurvey or reexamination or new studies, that, that ultimately do prove safety, that you would be okay with a return to the, at least to the 2016 standards and potentially 2021. That there is a world where the FDA can make that case to satisfy your standards, and then you would be accepting of the, of continuing use of the drug and clinics around the country?

Catherine Foster

To be clear, I’m not in favor of abortion across the board. I believe there is always a better solution to a woman who is in a tough situation. It’s a question of getting there, and that’s going to take a lot of legal change, uh, societal change. We have a long way to go. But yes, that would satisfy this immediate concern here because then at least we would know that the FDA had done its job and that women would be more protected from the effects of something that the FDA itself is saying, “Well, you know, if something goes wrong head for the ER.”

Julia Kaye

I want to focus on the profound mismatch between the harm that these anti-abortion doctors are claiming and the remedy they’re seeking. These folks went to court saying, “We are injured because perhaps hypothetically one day we might encounter a medication abortion patient and we might have to complete an abortion in violations, in violation of our conscience.” Uh, as I mentioned earlier, they completely ignored that federal laws already protect healthcare providers who want to opt out of healthcare that they morally oppose. But even setting that aside, the injury, this speculative hypothetical injury that they’re claiming could not possibly justify the remedy that they’re seeking. I put remedy in quotes here, which is to strip away access to a safe effective FDA approved medication, or at minimum, severely restricted in every state in the country, including those with legal protections for abortion.

John Donvan

Thank you for bringing it back to the word remedy, which was the heart of Zach’s question. Zach, thank you so much for bringing your question to us. And I, uh, wanna also now bring in Anna St. John, who’s president of the Hamilton Lincoln Law Institute, which is a public interest law firm that challenges government overreach on a pro bono basis. She’s also a visiting fellow with the Independent Women’s Law Center. Anna, thanks for joining us at Open To Debate and please come in with your question.

Anna St. John

Thank you. I see the legal heart of this case as being whether the FDA acted within its limited authority. Now, when an agency is changing policy as the FDA did here, the law requires that it must provide a more detailed justification then what would suffice for a new policy created on a blank slate, so that courts can determine whether the new rule is arbitrary and capricious. I’d be interested in hearing your views on whether or how the FDA met that standard here where there appears to be no dispute that it did not provide a detailed justification examining whether the removal of multiple safeguards all at the same time could be harmful to women taking these drugs.

Julia Kaye

There is very much a dispute. All of the nations leading medical authorities agree that the FDA had an extremely solid basis for making the updates that it made to its Mifepristone regulations in both 2016 and 2021. Now, I think you may have been referencing what the Fifth Circuit decided, that’s the, the lower court here, with respect to 2016 changes. What the Fifth Circuit found is that it was appropriate for that court to roll back the clock on science and override the FDA’s decisions because supposedly the FDA did not consider any studies that considered all of the safety changes at once.

First of all, that’s wrong. The FDA explained that it looked at multiple studies that encompassed multiple changes at once. But second of all, this is a major reason why folks like the American Cancer Society, the Leukemia and Lymphoma Society, and countless other patient healthcare advocacy groups are sounding the alarm because this idea that the FDA needed a single clinical trial that perfectly encompassed every single one of the conditions of use and reflected all of the changes at once, that’s not required in the law. That’s never been a requirement for any other drug.

John Donvan

And Catherine?

Catherine Foster

So first of all, we may not have a study that perfectly encapsulates the entire range of changes, but we should have a study that doesn’t throw up the safeguards that have been called for, for example, ultrasound to rule out things like ectopic pregnancy, and then claim that in fact it’s safe. And to the extent that there’s any question on statistics, we can look at the labeling itself, we can look at the black box. Just order a, a set it. It’s not hard, it comes through the mail. Um, but really the FDA’s merits defense, it, it, it’s one word, it’s deference. The FDA is so concerned about making the federal courts show deference to its decision making, that it is ignoring its statutory obligations and it’s overlooking its requirements from the APA. And where it does change its longstanding position, as our questionnaire asked, um, it has to adequately explain itself and it has to show that there are good reasons for this new policy. And that has not happened here.

Julia Kaye

The FDA has never required an ultrasound. The FDA has always left it to a provider’s medical judgment to determine medical eligibility, however they deem most appropriate. That was true in 2000, and that remains true today.

Catherine Foster

And that’s accurate. But it also can take place a lot more easily when you’re in clinic for an in-person visit. And when you’re relying on a study that includes ultrasounds, then it creates a problem.

John Donvan

Anna, thank you very much for your question. So we’re gonna come up to closing statements, but before we do that, we’ve got hints of the passion that you both bring to this issue, and I just wanted to, to learn more about that, about what, why you would even want to take part in a debate about this issue, why it matters to you. Katherine, why don’t you go first, please?

Catherine Foster

Absolutely. I talk about human rights issues because I can’t imagine any other topic more important to talk about. We live in a world of injustice, and until there’s equality and justice for all, I am not gonna sit down or shut up. I talk about abortion specifically because as a woman, I’m tired of being told that that’s the default for pregnancy at the wrong time. Uh, that when circumstances aren’t ideal or it’s inconvenient, or a baby doesn’t fit neatly into the nursery I’ve prepared for her, that I should just make her disappear. And as a woman who’s had an abortion, I have experienced that pressure and coercion firsthand. I never want any woman to feel the way that I did, hopeless, like there was no one to support me or offer me another path.

John Donvan

Thank you. And we would like to hear your answer to that question as well, Julia.

Julia Kaye

Thanks John. Every year, it’s become more and more apparent to me how complicated and unique people’s lives are, and that politicians cannot make a decision for you as personal and consequential as whether and when to become a parent. And when I experienced pregnancy and childbirth myself, it was beautiful and spiritual and also dangerous and physically and emotionally all consuming. And it left me even more convinced that no stranger should be able to force someone to undergo those serious medical risks and pains and life altering consequences against their will.

John Donvan

Thank you to both of you for sharing why this matters to you so much. So now we move on to our closing round. And our closing round are basically closing statements from each of you where you get to tell us one more time why you’re taking the side that you do in this and what you think the takeaway should be for our justices as they ponder how they would wanna rule on this situation. Catherine, you have the floor first.

Catherine Foster

Thank you. My friend Dave tells the story of when he was a little boy and liked riding his bike with his friends. One day his tire was going a little flat. He went back in his garage, pulled out the air pump, filled the tire back up and was back in business, out riding again. Hmm, still seems low. Goes back in, fills it back up, back outside. Same thing happens. This time he thought, “I’m gonna fill it up more. I’m gonna make sure this time it won’t go flat again.” So he starts pumping. It doesn’t pull out the air gauge just keeps pumping up that tire, bit more and a bit more. And now it’s bigger, it’s nice and firm, won’t go flat now. And the system, the tube inside that bike tire, it can handle a good amount of air. But Dave was just pumping up that tire over and over more and more instead of dealing with the real issue of why the tire was going flat.

So he goes back out on that big firm, pumped up tire and is racing down the street to catch up with his friends and hits that first bump. Pop. There was so much pressure inside that tube that it burst. And now he’s on the side of the road with a flat tire that’ll never pump up again, that can’t be repaired, watching his friends down the street riding and whooping and having a great time. And he has to wait for his mom to get home, to take him to get a whole new tire. His tire didn’t burst because there was air in it or because he added air to it. It burst because he put in too much air, too fast and ruptured that tube that was inside. And that is exactly what the FDA has done. And the FDA keeps pushing, adding risk, adding pressure to our healthcare system, expanding the, the requirements.

The FDA isn’t making sure that women know what’s going to happen to them when they take these drugs. They’re acting like everything is normal and it’s no big deal. Just keep riding, as they add more drugs into the system. More chemical abortions, now, two thirds of all abortions, more women who weren’t told just what would be happening when they took those drugs, they’re pushing against our healthcare system. That’s irresponsible and eventually it will rupture, it’ll break. Justices of this court, if you care about women, if you want to preserve our healthcare system, you’ll tell the FDA to pump the brakes, pull out that air gauge, get a real measure of where we are, and put back some of those guardrails that they said we needed to protect women.

John Donvan

Thank you very much, Catherine. And Julia, your closing statement, please?

Julia Kaye

When anti-abortion extremists said that overturning Roe v. Wade was about sending this issue back to the states, they were lying. Just a few months after the Supreme Court overturned Roe, they brought this case to try to strip away access to the abortion pill nationwide. Every credible medical authority agrees that Mifepristone is as safe or safer than most of the drugs in your medicine cabinet today. But a few anti-abortion doctors pushing junk science to serve their own ideological agenda are asking the Supreme Court to limit where and how patients can access this safe, essential healthcare everywhere across this country.

Today, 16% of all US abortions are safely obtained through telehealth appointments and pharmacy dispensing just like any other equally safe medication. For many people, losing this telehealth option would mean losing access to this essential medication altogether. And that’s because if you have to make an in-person trip, which can in some cases be hundreds of miles away, you are going to have to take on transportation costs, make childcare arrangements, lose wages for missed work, escape the surveillance of an abuser.

For many people, and especially low income patients, people of color, folks living in rural areas, and women in abusive relationships, these burdens are impossible to overcome. Groups representing patients with deadly illnesses have warned that overriding the FDA’s actions here would cause catastrophic harm well beyond abortion and miscarriage care. If they can come for Mifepristone, they can come for vaccines, for contraception, for HIV AIDS treatment, for lifesaving medications developed with stem cell research and on and on. Do not let that happen. Dismiss this case.

John Donvan

Thank you very much. And with that, we are adjourned. And as we exit the metaphorically hallowed halls of the Supreme Court, I want to thank both of our attorneys for taking part in this mock trial and doing so, so effectively and passionately and in a way in which you taught us so much. So Catherine and Julia, thank you so much for participating with Open To Debate.

Julia Kaye

Thanks very much for having me.

Catherine Foster

Pleasure to be here.

John Donvan

And I wanna also thank our guest, Zach, Aziza and Anna, for contributing your expert questions and your insights. And I wanna thank you, our audience for tuning into this special episode of Open To Debate. I wanna remind you that as a nonprofit, our work to combat extreme polarization through civil and respectful debate is generously funded by listeners like you by the Rosenkranz Foundation and by supporters of Open To Debate. Robert Rosenkranz is our chairman. Our CEO is Clea Connor. And Lia Mathow is our Chief Content Officer. This episode was produced by Alexis Pancrazi and Marlette Sandoval. Editorial and research by Gabriella Mayer and Andrew Foote. Andrew Lipson and Max Fulton provided production support. Mili Shah is Director of Audience Development. And the Open To Debate team also includes Gabrielle Iannucelli, Rachel Kemp, Linda Lee, and Devin Shermer. Damon Whittemore mixed this episode, our theme music is by Alex Clement, and I’m your host, John Donvan. We’ll see you next time on Open To Debate.