LIZ KUKURA: My name is Liz Kukura. I'm on the faculty at the Drexel University Kline School of Law, and on behalf of the Drexel Health Law Program, I'm really pleased to welcome you here today for an important and very timely webinar about the ongoing litigation regarding medication abortion.

So today we'll get to hear from my Drexel colleague, Professor David Cohen, a constitutional law expert and long-time reproductive rights litigator who, along with his co-authors, Rachel Rebouche and Greer Donley, has been closely tracking legal conflicts that have emerged in the week of the Supreme Court Dobbs decision overruling Roe v. Wade last June. Their latest article, which is called “Abortion Pills” and is soon to be published in the Stanford Law Review, analyzes the regulatory history of medication abortion and helps us unpack why it is that the legal status of the drug mifepristone, in particular, has emerged as a lightning rod in the ongoing conflict over abortion in this country.

So abortion opponents view restricting the availability of medication abortion as central to their overall goals of reducing and eliminating abortion. while abortion rights advocates see medication abortion as central to their goals of preserving and expanding access to abortion, particularly in the face of new, highly restrictive bans.

This issue isn't going away. And so we're grateful to have Professor Cohen with us today to help us understand what's going on in the federal courts regarding medication abortion and how we might expect this litigation to unfold.

So with that, I’ll turn it over to him. He will start with an overview and update on the current status of the litigation, and after that I’ll ask a few questions to help us dig a little bit deeper on some of those points, and then we'll have an opportunity for audience questions. So if you have a question at any point, please use the Q & A function on Zoom to ask it. I'll be monitoring the questions as they come in, and then we'll share them with Professor Cohen for his answer. So, David, thanks so much for being here. The floor is yours.

DAVID S. COHEN: Thank you, Liz. It's really nice to be a part of this and to be talking with everyone in a moment of a little bit of relief and calm, with what was quite an exciting couple of weeks and really hectic couple of weeks around this issue in mid- and late April. So we have a little perspective, and we can step back and think about what happened.

And, like Liz said with her introduction, I really want to stress that a lot of the work that I've done in this area is with my co-authors—Rachel Rebouche, who's the dean at Temple Law School, and Greer Donley, who's a professor at Pitt Law School. The work that we've done on “Abortion Pills,” the article that's going to be published… You know, we wrote this last year… in the beginning of this year, and the stuff that's going on in the federal courts right now is all about this. So I’m drawing on their expertise as well as mine here.

So I want to start with just talking about the basics of medication abortion for those who aren't familiar with it. Medication abortion is a two-drug regimen. The first is mifepristone, and the second is misoprostol, and they are given over the course of about 24 hours, first with mifepristone at the doctor's office, with the medical office, misoprostol at home, and that completes the abortion over the course of a day or two.

Mifepristone is approved in the United States only for abortion. That is the only FDA approval, for the drug. Misoprostol was approved by the FDA for ulcer treatment. But this…is an off-label use of misoprostol in conjunction with the mifepristone.

The two-drug regimen was approved in 2000 by the FDA, and over the past 23 years it has become the most common form of abortion in the country. The most recent data we have is from three years ago, so really pre-pandemic, that 53% of the abortions in this country were medication abortion.

I am sure that number is much higher now because of some of the things that I’ll talk about shortly, and some of the changes over the past few years, but also people over the past few years doing more and more remote, not in-person, medical care for all sorts of medicine, and I think medication abortion expanded even beyond the 53% that we knew about from 2020 over the past few years.

So it is the most common form of abortion. It is incredibly safe. These drugs are safer than Tylenol and Penicillin and Viagra. It's one of the safest FDA drugs out there.

But as Liz mentioned in the beginning, it is right in the crosshairs for the anti-abortion movement, partly because of how … much easier medication abortion has made the procedure for people to obtain medication through the medical system, but also outside the medical system, partly because of the numbers, the anti-abortion movement has thought that if they can attack medication abortion, then they can go a long way towards making abortion more difficult for people to access, and maybe eliminating it for some people.

So once Roe v. Wade was overturned last summer, it was no surprise that medication abortion became a central part of the attack from the anti-abortion movement, and there are a lot of different ways—we can talk about that in the Q & A—beyond the lawsuit that was in the news last month. But I really want to focus on the Texas lawsuit that everyone was talking about in April.

This lawsuit, Alliance for Hippocratic Medicine versus the FDA, was filed in Texas federal court last November. The Alliance for Hippocratic Medicine is an anti-abortion group of a group of doctors who are anti-abortion that was formed specifically to challenge medication abortion in the courts. This is not a long-standing organization that just brought this lawsuit as a sort of offshoot of what they do. This organization was formed just a few months before this case was filed, and it was its home base or its mailing address. Business address is in Amarillo, Texas. Now this is important because Amarillo, Texas, is an anomaly in the federal court system. Now, a lot of people on this call are probably lawyers, and you know that if you file a case in federal court in most places around the country, you don't know exactly which judge you're going to get. There may be a roster of three to 20 or more federal judges who sit in the courthouse where you file your case, and you don't know which one you're going to get.

There are a small number of divisions within districts in Texas where, if you file your case in that particular location, you know exactly which judge you're going to get. And so the Alliance for Hippocratic Medicine filed their case in Amarillo, Texas, where their mailing address is, for a reason, because Amarillo, Texas, has one judge, and that judge is Matthew Kacsmaryk, and Matthew Kacsmaryk is a very conservative anti-abortion judge.

He has a long history of his anti-abortion views, and being a very religious conservative, and when he was nominated to the federal court by President Trump, this was a focal point that people were concerned that he was not going to be able to divorce his personal views about abortion, contraception, same-sex marriage, from being a judge, and he swore he would, as every person who wants to be a federal judge does. But the Alliance for Hippocratic Medicine didn't believe he was going to do that, and they thought they had a friendly judge to file this case before, so they filed in the northern district of Texas in his division, and he was the judge on the case.

What they are claiming—in this case, they have three basic claims. They are challenging the FDA approval of mifepristone. Now, not misoprostol. That's important, misoprostol. The second drug, as I mentioned, is approved for ulcers, and they're not attacking that; they don't really have a basis for attacking that since that in itself is unrelated to abortion, the FDA approval. But the FDA approval of mifepristone in 2000 was for abortion, and they're making three claims: one, that the FDA acted unreasonably when it approved this drug because this drug is not safe, and they have what they think is their own data that contradicts the FDA's data to show that this drug is unsafe. Two, they're claiming that the FDA used a process to approve this drug that should never have been used. This process is under a provision of the FDA laws and regulations that was called Subpart H. At the time in 2000, Subpart H was a regulation that allowed the FDA to approve certain drugs on an accelerated path and to put restrictions on the drugs’ use. There was no way that the FDA could approve a drug but also restrict the drug’s use. So Subpart H was developed in the 1990s as a way to do that, mainly to allow for faster approval of HIV- and AIDS-related medicine, but also to put some restrictions on the use of that medicine.

And so the FDA used Subpart H in its approval of mifepristone, not the accelerated part. There was no acceleration whatsoever—this was a lengthy, drawn-out political process to approve mifepristone in 2000—but rather in order to put restrictions on mifepristone.

And so the challengers in this lawsuit claim that when the FDA used Subpart H, they did so improperly because Subpart H relies on, or requires, the FDA to be targeting an illness, and they say pregnancy is not an illness, so the FDA improperly relied on Subpart H in approving mifepristone.

Their third claim is that the FDA did not follow the Comstock Act. The Comstock Act is a law from 1873. It's a federal law, and it bans mailing certain things that are considered lewd and lascivious. It included contraception at the time, and it also includes anything that can induce an abortion.

This law from Anthony Comstock, the anti-vice crusader that you may have learned about in history class, is, most people thought, relegated to the scrap heap of history because most courts in the 1920s, 1930s very narrowly interpreted this law, and it sort of fell by the wayside, and no one really paid attention to it. It's still in the books, though.

And so the Alliance for Hippocratic Medicine said, If this drug is illegal to mail because of the Comstock Act, then the FDA could not have approved it because you certainly need to use the mail to distribute it, to get it from the manufacturer to the provider, provider to patients, and then also because the FDA relaxed some of its restrictions that it previously required mifepristone to be given in person. But after the pandemic and Biden became president, and the FDA was under his authority, the FDA relaxed that requirement and allowed for mailing of pills so that a provider can give you a prescription, and then you can get those pills from an online pharmacy and have them mail to you at home.

So the Alliance for Hippocratic Medicine said the initial approval violated the Comstock Act. But if that didn't violate the Comstock Act, then certainly the allowance for pills by mail violates the Comstock Act, and so these three central claims form the basis of their attack on the approval of mifepristone, and they asked the court to withdraw the approval of the brand name Mifeprex, which was the approval in 2000, as well as the generic mifepristone, which was approved in 2019, and so they asked for the withdrawal of both of them.

The case was on preliminary injunction. So for those of you who are not lawyers, basically, before you have a full trial on the matter, you can ask a judge to grant you some relief before the full trial, and the Alliance for Hippocratic Medicine asks for a preliminary injunction to stop the approval of this drug while the case is fully litigated.

And on April 7, Good Friday, 6:30, p.m., Judge Kacsmaryk issued a preliminary injunction, pretty much giving them everything they wanted.

It was a long opinion, and what he said in that opinion was that a) He thinks this drug is unsafe. Now, mind you, he is a generalist. He is a lawyer. He is not an expert in medical studies. He is not an expert in food and drug law or food and drug evidence. But he said, On my analysis, my short few months’/ couple-month analysis of the data and of the evidence rather than the FDA, I'm going to say they were wrong, and they were wrong in approving this drug, because I don't think this is safe, and he used a bunch of dubious studies. He ignored the studies the FDA relied on, and just to comment on one of the studies he relied on, he relied on a study of a website that was called AbortionChangesYou.com, literally. That's what it was called.

And he found that this one study showed that 80-some-odd percent of people who wrote posts on that website—and it was a small number of posts; it was about 55 posts—about 85% of those people regretted their abortion, and to him that was proof that this drug was harmful because it led to people regretting their abortion. Now this wasn't a website about medication abortion in particular; it was a website that was clearly aimed at people who weren't happy about getting an abortion, and he used this as evidence to second-guess the FDA and their lengthy process for approval of this drug.

Second, he said that pregnancy is not an illness—it's a natural condition that women go through throughout history—and so the FDA can't use Subpart H.

And then third: For the first time in almost 100 years, a federal judge cited the Comstock Act as evidence, or said that the Comstock Act bans the mailing of pills, and so the FDA could not have allowed that.

So he bought every argument the Alliance for Hippocratic Medicine put forth, and he issued a preliminary injunction, saying he was going to stay the approval of this drug, both the generic and the brand version. So basically, while the case was playing out, for as long as the case takes, this drug, according to Judge Kacsmaryk, is no longer approved.

Now, what he did on April 7: He didn't say that was going to take effect immediately. He said he was going to give the party seven days before this took effect, and this really started a legal whirlwind here. In those seven days, the Department of Justice—that's the Biden Department of Justice—they represent the FDA…Danko, which is the brand manufacturer of mifepristone, and they were also involved in the case. Both of them quickly appealed to the Fifth Circuit Court of Appeals. That's the federal court that covers Texas, the appeals court that covers Texas, and they asked the Fifth Circuit Court of Appeals to basically stop this injunction.

They said it wasn't warranted; that it was not supported by law; that the plaintiffs brought this case too late; that the plaintiffs didn't have standing, meaning they weren't injured by the use of this drug; and we can talk about those issues later.

And they asked the court to basically reverse Judge Kacsmaryk’s order and let this drug continue to be approved. The fifth circuit—now, just something to keep in mind: People may be thinking about what they know about the federal courts and abortion. You know the Supreme Court overturned Roe v. Wade last summer. The Supreme Court is very conservative. It's anti-abortion. The fifth circuit is more so on both of those ways. The fifth circuit is probably the most conservative federal court—appellate court—in the country, more conservative than the U.S. Supreme Court, and certainly more anti-abortion than the U.S. Supreme Court.

And so the request to pause the stay. The Judge Kacsmaryk order went to the fifth circuit, and they issued an opinion within a matter of 24 to 48 hours after the briefing was over, just a few days after Judge Kacsmaryk’s order, and they said, Well, we're going to let most of Judge Kacsmaryk’s order go into effect, but we will allow the drug to continue to be approved.

So what that means is that the initial approval of Mifeprex, the brand name, they said was okay, at least for now. But they're going to basically roll back the clock to 2016, when there were many, many more restrictions on mifepristone. The drug had to be picked up in person. It had to be swallowed in front of a doctor. It could only be prescribed by a doctor, even if the state allowed others to prescribe drugs. It had to be given in a higher dose. It was originally a 600-milligram dose instead of a 200-milligram dose, which is what we have now. And that there have to be three visits: a visit before you get the drug, a visit when you take the drug, and then a visit afterwards to follow up; and that, again, it could not be distributed by mail.

And so these requirements, which the FDA has relaxed all of those three, almost all of those requirements over the past several years, because they say they're not justified by the evidence. The fifth circuit brought all of those requirements back. It also got rid of the approval of the generic brand, the generic drug.

The DOJ and Danko appealed again quickly to the U.S. Supreme Court and the U.S. Supreme Court initially put the ruling on hold while they considered the case. And then two Fridays ago, on April 20, first the Supreme Court voted to stay the entire decision by Judge Kacsmaryk.

So what does that mean? What it means is that the Supreme Court said, While this case plays out, the appeal from Judge Kacsmaryk’s order, and any appeal to the U.S. Supreme Court… While this plays out, nothing changes; we're going to keep the status quo, so both drugs are approved, the generic and the brand name. The same requirements are true now in terms of who can dispense it, and how—those aren't changing; we are keeping the status quo throughout the extent of this litigation.

So there were two dissents from that. Justice Thomas noted his dissent, although he didn't write anything, and Justice Alito wrote a four-page dissent where he said the court should have let the lower court’s stays stay in place. He didn't think it was warranted to change what those lower courts had done.

Now, we don't know exactly how many justices voted for the court's order. You don't have to note whether you're in dissent or not. On an order like this, there do have to be… five justices who vote to stay a lower-court order. So we know at least five, and up to seven, justices agreed with what the court did.

That's important going forward, that there's a minimum of five justices who thought the lower courts were at least wrong, for now, in issuing this stay, and they wanted to put this stay on hold, because eventually this case might get back to the Supreme Court. It probably will get back to the Supreme Court, although what they did a week and a half ago is no certain indication of what they might do when they take the case. Generally it's a push in that direction. It's an indication in that direction that at least five justices were not happy with what the result of the lower courts was.

And so what we're going to see now is mid-May, I think it's May 17, that the fifth circuit of appeals court that covers Texas—they are going to hear the full appeal of this case.

Who knows how long they take to decide the case? It could be a couple of weeks. It could be months; it could be a year.

We're back on to the normal schedule of things. What was happening in mid-April was the rushed version of law. We're back on to the normal version of things, the normal schedule. So the fifth circuit will take whatever, however, long it takes to decide what to do. Presumably there will be an appeal after that, and I would bet that next year or the next term of the Supreme Court, which starts in October this year, the Supreme Court is going to be deciding this abortion case once again, and that we will be back in a position of having this set of justices, barring any change between now and then, back, deciding a major case involving abortion.

During this entire time nothing will change on the ground with respect to mifepristone and its approval and medication abortion, because the Supreme Court has said, While this all plays out, nothing changes.

But when the Supreme Court decides, things could change, right? If the Supreme Court…could say the FDA did everything right, or this case is improper, and then nothing will change. But if the Supreme Court takes any step to change the requirements around mifepristone or agrees with the original decision from Judge Kacsmaryk, and if mifepristone was improperly approved, that would shake up the world of abortion. Provision in this country, which has already gone through a major shake-up over the past year with the overturning of Roe v. Wade… But now the overturning of Roe v. Wade resulted in currently 14 states where abortion is illegal and several others where it’s severely restricted, but in the rest of the country abortion remains legal.

This mifepristone ruling could have an impact everywhere and change abortion provision everywhere, and that was the intent of the case. Now, quickly, I just want to mention one other case that was happening sort of parallel to this case and sort of complicates things, and then we can get into Q & A.

There is a case that was filed in Washington federal court…so the state of Washington, the federal court in Washington state, by 17 state attorney generals, and the attorney general of the District of Columbia, and these are pro-choice attorney generals, and they sued the FDA. They made kind of the opposite claim of the Alliance for Hippocratic Medicine. They claim that the FDA regulates this drug too strictly because the FDA continues to have requirements for the dispensation of mifepristone that go above and beyond almost every other drug.

Now I mentioned Subpart H. But it was approved in 2000; mifepristone was regulated under Subpart H. In 2007, Congress created a more formal program for similar restrictions, called REMS, R-E-M-S. And under the REMS program, the FDA has said, Only certain doctors can prescribe mifepristone. You have to be a certified doctor. The patient has to sign a form that is very different than almost every other drug form, and only certified pharmacies can dispense the drug. And so this limits who can prescribe this drug and where it can be obtained.

And so the pro-choice attorney generals sued the FDA earlier this year, asking for those requirements to be lifted, saying they're not supported by the science. That case has not been resolved yet. But on the same day that Judge Kacsmaryk decided his preliminary order, the attorney generals in those blue states got a preliminary injunction from their judge in Washington, and that preliminary injunction did not grant the relief they wanted in terms of getting rid of the REMS, but they also asked for that judge to require the FDA to keep the status quo with respect to the availability of mifepristone, and the judge granted that order.

So within an hour we have the judge in Texas saying… the mifepristone is unapproved, and we have the judge, also a federal judge, in Washingtons saying that the FDA is required by his order to keep the status quo with respect to mifepristone, and the FDA saw this as, How are we supposed to do both because how are we supposed to say that the drug is unapproved by this Texas order, but we keep the status quo by this Washington order?

And that was part of the request to the Supreme Court to get involved, and to stop the lower court's orders in Texas with saying, It's impossible for us to comply with both.

And so we don't have an issue now, because the Supreme Court has said, Keep the status quo for now, and the Washington case is saying, Keep the status quo. We don't have an issue of a conflict. But that conflict was brewing in these while this lower-court case was going on before the Supreme Court issued that final stay a week and a half ago.

So that's what's going on with those cases around the approval and the REMS with mifepristone. I think I’ll stop here, and happy to talk with Liz and answer questions that folks have.

KUKURA: Great. Thank you so much, David. A couple of questions, maybe, to start with picking up on some of the procedural issues that you mentioned in passing, and then digging in a little bit more on some of the merits here. One question about the timing here. Why isn't it just simply too late for the plaintiffs to bring the challenge that they brought in Texas before Judge Kacsmaryk?

COHEN: So, timing is a big part of this case, and you know, when the Department of Justice opposed what the Alliance for Hippocratic Medicine did, they argued on the merits the three different claims that I talked about. but they also argued that this case was brought too late, that the approval was in 2000. Here we are in 2023. We've had 23 years of safe and effective use of this drug. Yes, it's had people who've suffered complications. Every drug has people who suffer complications. There is no drug on the market that doesn't have side effects for some people and complications, complications that result in hospitalizations for some people. Every single drug has that if a person has been studied before the approval.

It has been used for 23 years, and the complications and safety record is almost unparalleled.

This group didn't bring their case right after the approval in 2000; it waited until 2023, presumably because Roe v. Wade was overturned last summer, so now they saw their opportunity, and they found a judge like Judge Kacsmaryk to bring this case before.

They argued that they shouldn't be thrown out of court because of time because they sent in a citizens’ petition to the FDA in 2002, claiming that the FDA improperly approved this drug, and the FDA took 14 years to respond to the citizens’ petition, till 2016, and so they said that during those 14 years they shouldn't be responsible for the statute of limitations, which is six years on a claim like this, and so they should be able to bring this lawsuit, even though it's so late.

And most experts in FDA law and similar kinds of law have said this argument holds no water, and that if they really wanted to challenge this approval, they should have done so 16 to 17 years ago, rather than wait till 2023. It is very possible that the courts, once they review this like the appellate courts… could rule on statute of limitations grounds. But Judge Kacsmaryk said it wasn't their fault that the FDA took too long and that they did bring it in an appropriate time.

So that's certainly one of the big battles here.

KUKURA: Great. So you told us a little bit about the Alliance for Hippocratic Medicine, and who they are, and their location in Texas. What are they arguing is the harm that they've suffered? What actually gives them a right to bring this lawsuit and challenge the FDA's approval of mifepristone in the first place?

COHEN: Yeah. So basically, every case in federal court, the plaintiff needs to have standing. What that means is, the plaintiff has to show that they've been harmed and that they've been harmed by what the defendant has done. Otherwise, you can't just bring a case in federal court because you think you're unhappy with something in the world. You have to show that you yourself are suffering some injury.

So the Alliance for Hippocratic Medicine is made up of doctors—some who are emergency room doctors, some who are primary care physicians—and they claim that they see the people who take these pills and suffer complications and that by treating those patients when they suffer the complications that they are taking time away from other work they could be doing and that they are forced to be complicit in actions that go against their morals because they are anti-abortion. And so they are caring for people who chose to have an abortion, and that that goes against their morals, and that for some of the patients the treatment is to complete the abortion, and so that they claim—at least one of them has claimed—that they were forced to complete an abortion that goes against their ethics, and that's their harm.

Now this is also another major part of this case, because this kind of injury that we've seen in some patients in the past is usually not enough to get you into court.You have to claim with certainty that you're going to see patients in the future, and that that's going to harm you in some way that's different than your normal work. And if you think of a doctor's normal work caring for people who have complications related to medicine related to medical procedures, that's a normal part of a physician's job. And so to claim that they are being harmed or injured in a way that’s certain to happen in the future, and is different than their normal work, it's a really difficult claim, and I think a lot of people who are both pro-choice and anti-abortion, who are lawyers and experts who have looked at this, are very skeptical of this claim of injury because if this injury were enough to get someone into federal court, then any doctor anywhere could have standing to challenge any drug.

Because, like I said, every drug has side effects. Every drug has complications, every drug has risks, and a doctor—they would just have to say, I might see this patient who is going to see this complication related to Tylenol, for instance, and it's going to happen in the future because we know people are going to have complications related to Tylenol in the future. And so that's enough for me to have standing. If that's true, then you open up the door to the federal courts to challenge any drug, anytime, by any physician, and so the concern is that it would be just opening up a can of worms, turning the federal courts into basically the agency, the legislature itself. Judge Kacsmaryk said that this was enough of an injury that these doctors are injured in a very particular way, and that's enough for him. But I think standing is going to be a major part of the battle going forward with the legal issues on appeal.

KUKURA: Got it. Thank you. So I’m going to sort of combine two questions that we have about safety and the approval process. So you talked about the FDA's original use of Subpart H—that it didn't aid in accelerating the approval process. But it was the mechanism available to the FDA at the time to be able to impose some restrictions on how the drug was actually going to be prescribed and dispensed.

And so you know, I guess, a question about why that was necessary, why that was deemed important at the time to be able to use the Part H to apply these prescription and dispensing restrictions on the drug. And then relatedly, we have a question from the audience to reconcile, sort of. On the one hand… the claims about mifepristone being safer than Tylenol or Viagra, and on the other hand, the fact that there was this black-box warning… is this black box warning on the drug, and then, until very recently, it had to be administered in a physician's office; that there were all of these and continue to be certain restrictions that don't apply to other drugs like Tylenol or other things where the safety profile is claimed to be un-problematic. So can you help us kind of reconcile that and understand why we have these restrictions? Why we've historically had these restrictions, and some of them continue going forward, and how to make sense of that in the context of the court's evaluation of these competing claims about the safety of the drug itself?

COHEN: Yeah, so there's a couple of different things going on here. So, one, it's impossible to divorce the approval …of mifepristone and the restrictions that continue from the politics of abortion. This was not a, you know, an approval of a drug that went under the radar that no one was looking at, that no one was talking about. This was the approval of a drug that took many times longer than any similar drugs with a similar safety profile because of abortion politics, even though it was the Bill Clinton FDA in the ’90s that was looking at this. It took many, many years, and because of the politics around abortion.

The FDA put these restrictions on the drug, so these are widely considered, not by the Alliance for Hippocratic Medicine, but by the experts who have studied this, to be restrictions that were put in place to really sort of thread a needle of approval of this drug, but not look like the FDA is just allowing abortion in a much wider range than it was before. This was also a new form of abortion, so I think the FDA was also playing it cautious that these restrictions were about caution and politics.

But what we've learned over the years as this drug has become more widely used is through scientific study by experts in the field as well as people internationally, because this drug is used all over the world, is that the safety precautions that were put in place as a matter of caution and politics are not supported by the evidence that the drug is, for instance, to use one…

The initial requirement was that only doctors could prescribe mifepristone. There was a massive study out of California looking at nurse practitioners and physicians’ assistants, who have prescription authority under California law. Remember, it's the FDA that regulates the drugs; the states regulate the practice of medicine, so states can determine who has the power to prescribe.

And so California allows nurses and physicians’ assistant to prescribe, and they did a massive study, looking at the prescription of mifepristone by them instead of doctors, and what they found was, there's actually a lower complication rate when nurses and physicians’ assistants prescribe mifepristone than with doctors. Now that could just be statistical noise. There's some who offered that advanced practice clinicians offer better, more counseling along with the use of medicine as a general matter, as opposed to doctors who are busier, and that that may account for the lower complication rate.

But that study was done after the approval of mifepristone, and that, along with other studies like it, convinced the FDA that this initial restriction they put on out of caution and politics is no longer needed.

And so the FDA has been slowly removing these restrictions because they realize they're not needed now. Another one, for instance: Initial dose was 600 milligrams. Now, once a drug is approved, off-label use of a drug is something that is common within medical practice. And so doctors—the initial prescriber—doctors started experimenting with lower doses of this drug, not because it was dangerous. It wasn't causing problems. But because if you don't need to give someone as much of a dose, try a lower dose. And so they realized that 200 milligrams of this drug was just as effective. And so they started using 200 milligrams, and that was studied by researchers, and it was found to be safe and effective. And so the FDA lowered the dosage from 600 milligrams to 200.

So a lot of this is about initial caution, politics, and then using evidence-based research to study the drug and determine what we now know is safe and what we've learned from years—decades—of use that it can be used safely in this manner. And so the FDA has cut back on most of the REMS, but not all of them.

KUKURA: Great. Thank you.

Another question from our attendees: Can you provide some background on why it is the Texas ruling that applies nationwide, while the Washington ruling applies only to the states that are party to the litigation?

COHEN: So this is one of these complicated questions of federal courts and jurisdiction that some district courts, since the district court is the trial court that covers, that hears, cases first in the federal court system…Some district courts say that they have the authority to issue a nationwide injunction, that what they do affects the entire country.

And so Judge Kacsmaryk, the Texas judge, what he did was, he said, my ruling binds the FDA. The FDA covers the entire country. So my ruling, by virtue of binding the FDA, binds the entire country. And he did not entertain any notion that it would be more limited. Now, in theory, he could have said, this drug is only unapproved in Texas or in my district. Even that would have created some logistical problems and complications, but in theory he could have said something like that. But he didn't.

It's controversial when judges do this. But it's a general practice that judges do sometimes do.

The judge in Washington, Judge Rice, was asked to issue a nationwide injunction, but he said, I only have plaintiffs from 17 states and the District of Columbia in front of me, so my order will only apply in those states because they are representing only those states, and so I only want to apply my order in those states.

Now, he could have tried to issue a nationwide injunction as well. He didn't think that was appropriate, and no one has appealed that to ask it. But I think, you know, the propriety of nationwide injunctions is something that is getting a lot of focus and attention. But we don't have sort of a clear ruling from the Supreme Court one way or the other, that generally you can issue nationwide junctions, or generally you can't. So we have lower courts sort of engaging in this practice as they seem useful and warranted by the case before them.

KUKURA: Great. So another question on some federal law, particularly Chevron doctrine. So we have an audience member who would be interested to hear your thoughts on the possible impact of Chevron on the Alliance for Hippocratic Medicine case, whether Chevron is something we might see the Supreme Court invoke in the eventual appeal up to the Supreme Court.

It might be reading tea leaves at this point, but if you maybe could explain just a little bit, what is the Chevron doctrine? And then how does it or does it not relate to this case?

COHEN: So I’m just looking something up here, because this morning the Supreme Court granted cert on a case that directly challenges the Chevron doctrine. It's Loper Bright Enterprises v. Raimondo.

But no, wait. That might not be the case. Yeah. Loper Bright Enterprises v. Raimondo directly raises the question of whether Chevron doctrine should be overturned.

So this is something the court is very much interested in thinking about right now. The Chevron doctrine is a doctrine from the early ’80s that basically says, when a federal agency interprets a statute and that statute is vague and subject to multiple interpretations, the courts will defer to the expertise of the federal agency in that interpretation. So it's really a doctrine related to the expert institutional expertise, that we will look to this agency whose sole job is to think about this statute and think about this area of law, and we will defer to their interpretation over a court’s independent interpretation because the judges, you know, they're not experts in this area. They don't regularly work in this field, and so whatever they do would be second-best to what the agency will do.

And so this doctrine has sort of been the backbone of administrative law for almost four centuries, and it's under major attack from the conservative Supreme Court. The conservative Supreme Court is very much anti the regulatory state. They do not like agencies that regulate private industry, and so they don't want to defer to agency and they've brought about a bunch of new doctrines over the past several years, including one called the major question doctrine, that have really sort of called into question the authority of agencies. But they have not yet revisited Chevron.

The cert grant this morning indicates they are going to revisit Chevron next year. Now how does this play into the mifepristone case? In the mifepristone case, the agency in particular, the safety determination is not subject to Chevron deference, because that is, you know, they are statutory, charged with evaluating the safety and efficacy of a drug. There's no interpretation issue there.

But there is an interpretation issue with the Subpart H, question of what is an illness is pregnancy an illness, and under Chevron deference you would defer to the agency in interpreting that because the agency…It's a little different because it's a regulation, but it's the same idea. The agency knows best what an illness is, and if the agency considers pregnancy to be an illness, then we defer to the agency.

Clearly Judge Kacsmaryk did not defer to the agency there. So it goes to the same idea. Here, are the courts going to trust the agency in making these decisions, or are these non-expert courts going to second-guess the agency?

And this case will absolutely present that issue if it gets to that in America.

KUKURA: Great. So I want to zoom out a little bit and think more broadly about the landscape here of a medication abortion and access to medication and abortion.

One question about some of the other litigation that is currently under way in federal court. There's a case in West Virginia brought by one of the manufacturers, another case in North Carolina. Could you tell us just a little bit about what's going on in those cases, and how they might impact the Alliance for Hippocratic Medicine case?

COHEN: So these two cases that you're talking about are preemption cases. So basically, earlier this year, before the ruling from Judge Kacsmaryk, we had two cases filed on the same day, raising the same general argument, although there's slightly different postures.

The basic argument here is that the FDA approved this drug. When you think about what the FDA does with the approval of drugs, the entire point of having a federal agency approve drugs is so that we have a nationwide drug system and it would make no sense for manufacturers to go through the process of creating a new drug, testing the drug, making sure it's safe, getting it on the market If they can only do that in some states. This is why we have nationwide approval rather than state-by-state approval of drugs.

And so the FDA, in conjunction with the manufacturers, goes through the process of improving this drug, bringing it to market and saying, okay, now you have a drug that can be marketed and distributed all over the country.

But now you have states that ban abortion. In the process of banning abortion, it's all abortion. It's not just procedural abortion. It's also medication abortion, and so these cases raise the question: If the FDA has approved this drug, can a state pass a law that bans this drug? Now it doesn't directly ban the drug. It's the state bans on abortion. Don't say if mifepristone is illegal in West Virginia, but rather it bans abortion, and in banning abortion you're banning mifepristone because it's only approved for one use in this. So this is, you know, Constitutional Law 101. When you have a federal action and a state action, and they contradict, federal wins. The supremacy clause of the Constitution says federal wins, and the technical term is preemption—that the State law is preempted by the federal action or the federal law.

And so GenBioPro, which is the generic manufacturing distributor of mifepristone, they brought a case in West Virginia saying that West Virginia's total abortion ban violates the FDA's approval of mifepristone because that approval should preempt this state ban concurrently. There's a case in North Carolina brought by doctors who say that this…basically, the same claim they make, the claim that North Carolina’s restrictions on abortion go above and beyond what the FDA has said, with restrictions on mifepristone, and so that North Carolina cannot impose separate restrictions beyond what the FDA has already.

And so those two cases are taking their time in the lower courts. They're not on the same expedited calendar that we saw with this Judge Kacsmaryk case. They're taking their time, but they will be impacted by what the approval cases have to do, because if the result of the Texas case is that mifepristone is no longer approved, then that takes away the argument that we have FDA approval on the one hand, and state bans on the other; they conflict. The FDA wins if the FDA approval is said by the courts not to be no longer good law that would really undermine this case or both of those cases. But the point with both of those cases is that it's important to understand it's not just anti-abortion groups who understand the power of abortion pills. The power of abortion pills is totally grasped by pro-choice groups and lawyers and actors, and they want to expand access to these drugs, and so they are using this theory to try and expand access to mifepristone and misoprostol.

KUKURA: So some recent coverage of this litigation has been noting that misoprostol-only abortion is still an option, even if mifepristone gets taken off the market or is severely limited through the course of this case.

Can you talk a little bit about the risks or the downsides to shifting to a misoprostol-only regimen for prescribing and dispensing? And I’ll fold in a related question from the audience: We have somebody asking about the possibility of off-label use of Korlym, which I think is a version of mifepristone that's been approved to treat Cushing syndrome.

COHEN: Yeah. So I’ll start with that one. So Korlym is a branded drug that was approved by the FDA for Cushing syndrome. It is the exact same drug. It is mifepristone.

It has been approved. It is not wrapped into this challenge, but the way the FDA approves drugs is specific to the brand, and so what has been approved is a 300-milligram dose of Korlym, or 300-milligram pill.

Of course, now, that's different than the dosage for abortion. But you know that that's something that can be figured out. The problem with Korlym is that by voluntary agreement from the manufacturer and distributor of Korlym, it is highly difficult, very difficult to obtain. There's only one pharmacy in the country that dispenses Korlym, and you have to buy 30 pills at a time, and the pills are $600-plus per pill. So you have to be able to put out $18,000 for 30 pills at a time.

Now contrast that to the generic brand of mifepristone, which is about $40-plus per pill, so it's a lot more expensive. It's more difficult to obtain because of the pharmacy—one pharmacy—and so that makes it really impractical to use for abortion.

There's been patent litigation over a generic version of Korlym, but that is ongoing and the FDA has said that it will approve a generic version of Korlym in 2034. So we're talking a long time from now. So that's really hard to see as a workaround.

Well, if mifepristone is no longer approved, what might happen if the result of all these court cases is that mifepristone is no longer an approved drug? What happens? Well, there's a couple of different things that can happen. One, the FDA can say that we're going to use our enforcement discretion, and we're not going to go after people who distribute or manufacturer mifepristone. Think of it like a police officer who sees you going 58 miles an hour in a 55 mile per hour speed limit speed zone, and the police officer just doesn't pull you over—not worth their time and effort. They have resources they need to spend on other things. It doesn't mean what you were doing wasn't illegal. It was, but they use their enforcement discretion to go after other things, and the FDA has done this for a long time with unapproved drugs, where they look to unapproved drugs or unapproved supplements and they say, okay, these are unsafe. These are risky. We're going to go after those, but these over here, they're safe. They don't pose much of a problem. We're not going to spend our time going up, and they sometimes issue what's called enforcement discretion notices. And so it's possible that the FDA could react to these cases if mifepristone is no longer approved and keep mifepristone on the market.

But if mifepristone goes away, abortion providers are ready to move to a misoprostol-only regimen. So remember there was the two drugs with mifepristone and misoprostol.

Misoprostol alone is a safe and effective form of abortion around the world. In some countries, this is the standard of care. In fact, the World Health Organization… This is the standard of care for medication abortion: misoprostol alone. Tn the United States and in some countries that use mifepristone. The reason misoprostol is given in conjunction with mifepristone is because it is a faster process, and it is a less difficult process for the person using the drugs.

Misoprostol alone takes a longer period of time and can take up to three or four days for the abortion to be complete, and it also can result in more cramping and more bleeding. Mifepristone with misoprostol reduces the time and reduces the bleeding and cramps. So it is safe. It is effective. And some studies show it nearly as effective as mifepristone with misoprostol. It's just a longer process, and it's not a process that doctors and medical professionals feel like they would choose in this country if mifepristone is available. But if mifepristone isn't, medication abortion won't go away. They'll just change this to a misoprostol-only regimen.

KUKURA: Great. Thank you. We started two minutes late, so I’m going to ask one more, sort of one and a half more questions, folded together. So I want to ask you what it is that we should be paying attention to when the oral arguments take place before the Fifth Circuit Court of Appeals later this month.

And then relatedly, one of our attendees would like to know if Alito's dissent on this case gives us any clues about what we might expect from the Supreme Court when this case likely ends up back before them sometime in the next year.

COHEN: So when the cases argue before the fifth circuit, we should certainly pay attention to who the panel is. The fifth. There were three judges who were involved in looking at the stay two weeks ago.

They are not going to be the same, necessarily. Judges who are hearing the case on the merits in two weeks. So we don't know that; we won't know that till about a week before the oral argument, and so certainly there are some very high-profile, very conservative judges on the fifth circuit, and if any of them are on the panel, I think that would be very notable.

So watching who's on the panel…

And then paying attention to the types of questions that are asked, and whether there's some sense from the judges that the fact that the Supreme Court stayed the lower-court decisions is an indication that they think they should not upset the apple card here, and change the status quo with respect to mifepristone…

Whether they take what the Supreme Court did as any kind of clue about what they should do, or whether they're just going to act as the conservative anti-abortion court they already are.

So I think, paying attention to what kind of signals they get from the Supreme Court is important.

When it gets back to the Supreme Court, and I assume it will get back to the Supreme Court… I don't know if Justice Alito's dissenting opinion matters much at all. He wrote it by himself. No one else signed on to it. It was not an order where Justice Alito wrote a dissent for himself and two or three other justices.

This was just a solo descent that he couldn't even get Justice Thomas to agree with him, at least publicly, on.

So I wouldn't put much stock in what he says, and he also very clearly says: My view on whether we should continue to stay is not related to the merits. Now you know whether it's true or not, we can all have our own view on, but I don't think it's an indication beyond just his editorializing on my own, his cranky thoughts on what was going on with this case right here in the last minute, because he wrote it in a matter of just a couple of days, as opposed to any indication whatsoever of the entire court. If you're going to look for any indication of the entire court's views on this case, it is more that there were at least five justices who voted to keep the status quo, so they understood the seriousness of this case, so much so that they issued this order to keep the status quo pending the appeals.

And so I think that's more an indication of what might happen in the future. It's certainly not a guarantee.

KUKURA: Great.

Well, we are out of time for today. Thank you so much, David, for sharing your insight and expertise and helping us understand this litigation, and thanks to everybody for joining us. This is the first of the Drexel Health Law Program’s new Vital Signs series. And so you should look out for more information about programming coming this fall from Vital Signs.

In the meantime, have a great afternoon. Take care, everybody.

COHEN: Thank you.