Litigation Update: AHM v. FDA: Challenging the FDA on “Chemical Abortion Drugs"

[Music and Narration]

 

Introduction:  Welcome to the Regulatory Transparency Project’s Fourth Branch podcast series. All expressions of opinion are those of the speaker.

 

Chayila Kleist:  Hello, and welcome to this Regulatory Transparency Project webinar call.  My name is Chayila Kleist, and I'm an Assistant Director of the Regulatory Transparency Project here at The Federalist Society.  Today, February 16, 2023, we are excited to host this litigation update on the "Alliance for Hippocratic Medicine v. The United State Food and Drug Administration: A Challenge to the FDA's approval of certain chemical abortion drugs." 

 

As always, please note that all expressions of opinion are those of the experts on today's call, as The Federalist Society takes no position on particular legal or public policy issues. Today, we are pleased to have with us Erik Baptist, who is the Senior Counsel at Alliance Defending Freedom, which is representing the plaintiffs in this case, and who is a litigating attorney on this case. At ADF, Mr. Baptist focuses on administrative litigation and regulatory advocacy.

 

Prior to joining ADF, Mr. Baptist was a partner at Wiley Rein LLP, where he employed his expertise in administrative and environmental law to represent clients on litigation, regulatory, and enforcement matters. Prior to his time at Wiley, Mr. Baptist also served as a senior executive service appointee at the U.S. Environmental Protection Agency, where he served as both the senior deputy general counsel and a deputy assistant administrator. Finally, Mr. Baptist began his career in the trial department at the international law firm McDermott, Will & Emery LLP. 

 

Also joining us today as our moderator is Dr. Roger Klein, who is a faculty fellow at the Center for Law, Science, & Innovation at Sandra Day O'Connor College of Law at Arizona State University. Dr. Klein is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A.  He was formerly a Chief Medical Officer at OmniSeq, an oncology-focused genomic profiling company that was recently acquired by LabCorp.  

 

Previously, Dr. Klein was the Medical Director at the Molecular Oncology Division at the Cleveland Clinic.  He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. And, prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology of the BloodCenter of Wisconsin.

 

Dr. Klein has been an advisor to the Department of Health and Human Services and the Food and Drug Administration and the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention. He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute. Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. And he's licensed to practice law in the District of Columbia and Ohio.  

 

Now, in the interest of time, I kept my introductions fairly brief.  But if you would like to know more about either of our panelists, please feel free to visit regproject.org and check out their impressive full bios. One last note: throughout the panel, if you have any questions and are joining us live on the Zoom webinar, please submit them via the question-and-answer feature so that our speakers will have access to them when we get to that portion of today's webinar. With that, thank you all for being with us today.  Dr. Klein, the floor is yours.

 

Roger Klein:  Thank you, Chayila. And thank you, everybody, for joining for what I think is going to be a very interesting presentation and vibrant discussion. We're going to have Erik Baptist, who is Senior Counsel, as mentioned, on the case. He's going to present the case to you. And then we're going to have a question-and-answer session. He and I have got some questions that I'm going to bring together, and then we'll bring the audience into the discussion. So, looking forward to really a terrific presentation, which I think you'll all find both fascinating and valuable. So, Erik, why don't you go ahead and start. 

 

Erik Baptist:  Thank you very much, Dr. Klein. And I just joined ADF last year. And many of you may be in the same boat as me when I joined ADF, and learning about chemical abortion. What is it? When did it get to the United States? And how did we get here today? So, I'm going to give some background before we get into some question-and-answering, because I think it's going to be helpful to understand why we brought the suit and how we were able to bring it.

 

So, let's rewind back to the early 1990s, on day two of the Clinton administration. On day two, the second full day of President Bill Clinton's first term, he directed his cabinet to do whatever is necessary to get chemical abortion drugs approved in the United States. Now, I came of age in the 1990s, and so I remember hearing about RU486. It was this drug in France. And there was discussion of whether it was going to come to the United States. Well, it did. 

 

So, you might have heard the term, "RU486," "chemical abortion," "medication abortion," "medical abortion," "mifepristone. It's all the same thing we're talking about here. For the sake of brevity, we're going to talk about "chemical abortion." And that actually involves two drugs, not just RU486 or mifepristone. It also involves misoprostol as well. So, there's mifepristone and misoprostol. And I can tell you about how they work and then we can talk about what the agency did.  

 

So, mifepristone pretty much blocks progesterone, which is a necessary hormone for a developing baby inside the womb. So, when you have taken mifepristone, it actually prevents the baby from receiving nutrition and ultimately starves the baby to death. But, just because a woman takes mifepristone, it doesn't necessarily mean that she's going to have a complete abortion. And, therefore, the second drug comes in, and induces labor and delivery of the baby inside of her.  So, sometimes it works without the second drug, but, many times, or often times, it needs that second drug to complete the abortion, if it works as described. 

 

And so we'll talk about the complications that are associated with this two-drug regimen. But I want to have a working knowledge of what we’re talking about here. So, in January of 1993, President Clinton directs his cabinet to get RU486 and mifepristone approved. And so, the FDA gets to work. But one problem that hits right off the bat is the French manufacturer of this drug doesn't actually want to enter the United States market. So the Clinton administration works for over a year to compel the French manufacturer to donate for free its U.S. rights to this drug to an entity known as the Population Counsel, which was founded by John Rockefeller III.  

 

I won't go into all the details about that entity. But it's not your traditional pharmaceutical company. So just keep that in mind as this process goes forward. So, the Population Counsel, a few years after that, submitted a new drug application for this. And, fast-forwarding to September of 2000, the FDA approved chemical abortion drugs for use. And it approved the two-drug regimen. Not just the first drug, but both drugs were on the labeled use for a chemical abortion drug.

 

Now, what were the terms and conditions for this drug? Well, the FDA at least recognized that this drug has a lot of severe potential adverse outcomes or complications. So it did a fast-track approval, which was under Subpart H of the FDA regulations. It's for accelerated approval authorities. But, to use that authority, which was first implemented in 1992, that was originally formed for treating patients who have AIDS, HIV. That was the genesis behind this. So it was explicitly written for drugs that treat life-threatening or serious illnesses. 

 

But the FDA used this fast-track authority to approve mifepristone or chemical abortion drugs, because this authority allowed the FDA to have post-marketing, or post-approval restrictions on the distribution of this drug. So they used that vehicle to anchor down and create some type of protections associated with those who use these drugs and sell these drugs. There's only one problem with that, and I think all of us can agree. And even the FDA agrees. Even the drug manufacturer agrees. Pregnancy is not an illness.  

 

So the FDA kind of had to redefine what an illness was and turn it into a term called "conditions," even though the regulation is explicitly saying, "illnesses," and then also say that it provides a meaningful therapeutic benefit. Those issues aside — which will come up in the litigation later — it approved it with certain restrictions. So, the FDA said a woman can only take it if she's up to 49 days gestation, so seven weeks into her pregnancy. 

 

They also said you had to come to a doctor's office three times. One to get the first drug on day one; day three, to get the second drug and take it in front of the doctor. And then, day 14, to come back to the doctor to ensure that there are no fetal parts remaining or any other pregnancy tissues inside of her, or if she's experiencing any other adverse complications, such as severe hemorrhaging or a life-threatening infection. And, again, the FDA required a doctor to give these drugs and administer them, not just any medical profession.  

 

We're going to fast-forward to 2016 now. So, in 16 years after that approval, in September of 2000 — again, in the waning days of the Clinton administration — we're going to fast-forward to the waning days of the Obama administration. So, in March of 2016, the Obama administration does a wholesale change to the drug regimen. It expands the timeframe for a woman to use it, from 49 days gestation to 70 days gestation. 

 

So now we're up to ten weeks. And in the time between seven weeks and ten weeks, a baby doubles in size. I think it's about two and a half inches long at that point. They completely changed the dosage for both drugs, as well, and the route of administration for misoprostol. And then, the FDA also said you no longer have to have three doctor's visits, you only have to have one. The first one to get the first drug. And then the rest you can do at home. And you don't have to come back in person to see the doctor after the completion of a chemical abortion.

 

Finally, the FDA said you don't even have to be a doctor anymore. You can just be a healthcare provider — an undefined term, but you can think about it as other — your nurse practitioners, your physicians' assistants, nurses. They can now prescribe this as well. There were other changes too. But I'm just kind of noting that this is a wholesale change, expanding the timeframe and how this drug is administered, and, importantly, how many times you have to go see a doctor. 

 

And then, fast-forward again. Nothing happens during the Trump administration, except for when President Joe Biden takes office. A few months after he comes into office, during the COVID pandemic, he says, "We're going to get rid of the requirement for you to see a doctor at all. You can get these drugs by mail." So, now, mail-order abortion became legalized through a non-enforcement policy change by the Biden administration in April of 2021, but later finalized by the Biden administration in December of 2021, when they removed that formally, notwithstanding the COVID pandemic, but permanently taking away the in-person dispensing requirement. And, again, I'll get into the dangers and problems associated with that. 

 

But I wanted to give a general lay of the land of what the FDA did over these periods, from 2000, 2016, and 2021. There's a lot to unpack here. And I'm going to do something very quickly just so you can see. I believe it's page 73 of our complaint. We have a 113-page complaint that we filed with the court in November. So, you may want to look at it. It's light reading. It's entertaining, I hope. But, if not, I'm going to give you a cheat sheet right here and share my screen. And, God willing, this will work, because I'm not that bad with technology. But we shall see in a second.

 

So, this shows you what exactly happened. And the red marks the changes that the FDA did over the course of time. And, again, we think there was a heavy hand of the politicals, to the detriment of science, and, obviously, to the detriment of women and girls who take these drugs. And that's kind of what we're looking at here. I'm going to stop the share, because it's probably too much for you to take in and appreciate. But the red showed, at least, the amount of changes that occurred when the FDA made these actions, over the course of two decades. 

 

That is, essentially, what the FDA did. I think some of you are questioning why file in November of 2022? This drug has been legalized for over 22 years. Why are you bringing this lawsuit now? And I'm glad you asked that question because that's an important one. The FDA has a regulation — and the courts have recognized it to be true — that you have to actually exhaust your administrative remedies with the FDA before going to court, because the drug approval process is closed. 

 

You have the FDA on one side, and the drug manufacturer on the other, or the sponsor of the drug. But you don't actually, necessarily have any outside parties having any influence or providing additional or deferring data with the agency. So the citizen petition process is the opportunity for citizens, and the American public in general, to file challenges to FDA drug approvals, or any modifications to those drug approvals. Our clients -- we represent eight different plaintiffs in this lawsuit. 

 

So, a subset of our clients filed a citizen petition back in 2002, challenging the FDA's approval of this drug, again, trying to exhaust their administrative remedies before ever potentially proceeding to court. And what the FDA did was sit on it and stonewall our clients for over 14 years. So, in March of 2016 — so, 14 years later, after they submitted that — the FDA denied their petition. On the same day the FDA denied that petition, the FDA also completely did that wholesale change to the regimen. 

 

So, what our clients did, again, was file a new citizen petition. And that was rejected in December of 2021. So, 11 months later, our clients finally said, "Enough is enough. We’re just going to go to court. We're going to put what the FDA has done on trial, for the last two decades, because we have exhausted our administrative remedies. And we have every right to be here and put both actions on trial with the court. 

 

So that is why we're here today. And I'll briefly talk about our clients really quickly. And then, maybe, Dr. Klein, you can take over and ask a lot of questions, because I don't want to talk too much about this case by myself. I love the interaction. The first thing is, our clients are four medical associations — and they represent a variety of interests among those associations — and then, four individual doctors who are from across the country.

 

The interesting thing about these individual doctors and the declarations of the members in support of these medical organizations is that they have been the front-line doctors in all of this. They have been the ones to treat women in the emergency rooms and care for them. Because the other thing that the FDA has never done — and I should have mentioned this before — is they've never required the abortionist to actually treat women who have been harmed and have experienced complications. Instead, they said, "You just need to ensure that she has access to an emergency room," and be on the way.

 

So, essentially, what the FDA has authorized is for the abortionist to push these drugs onto women and then to, figuratively, push them out the door of these clinics and into the emergency rooms of our clients. And so this is why we're bringing the case, because our doctors have treated and cared for these women. They are being impacted. They are concerned for the welfare and safety of their patients. And that's why they are bringing this lawsuit today. 

 

The one thing the FDA never required — and I want to bring this up just really quickly and then I'll turn it over to you, Dr. Klein — is a basic common-sense protection for women and girls. And that is an ultrasound. An ultrasound is important for three different reasons. One, it confirms a pregnancy. Two, it also confirms gestational age. And three, it identifies an ectopic pregnancy. And an ectopic pregnancy occurs in one in fifty pregnancies. And, it also leads to life-threatening conditions, if not treated in time. 

 

And one of the problems associated with this is an ectopic pregnancy and its symptoms are the exact same symptoms that you experience when you go through a chemical abortion. And so sometimes ectopic pregnancies are missed. And women have actually died because of this. It's been reported to the FDA. The FDA acknowledged that these deaths have occurred because the women never had an ultrasound to determine whether she had an ectopic pregnancy. 

 

And so, this is kind of the harms that we have been seeing and that could be prevented if the FDA did not enact a dangerous regimen in the first place, and then took away the few safeguards and expanded the regimen to more women, in terms of longer gestational age, increasing the likelihood for complications. And, in terms of complications, when you look at the robust data, I believe it's one in five women have severe complications associated with it. And so that will include life-threatening infections, severe hemorrhaging requiring blood transfusions. And so, this is exactly what our doctors have seen. 

 

And I'll give you one anecdote, really quickly.  Sorry Dr. Klein. I know I told you I was going to turn it back over to you, and I didn't. But one example is in Indiana. One of our doctors who filed a declaration in this case had to treat a woman, because what had happened was that Planned Parenthood gave this woman these drugs. She took the drugs in the clinic. But then she left and took an Uber on the way home. And what happened was the woman had experienced severe bleeding, and the Uber driver had the wherewithal to take her to the emergency room, as opposed to her home.  

 

He said, "You need to get medical attention as soon as possible." And, but for the intervention of our clients, and the doctors at the hospital, she would have died. So this is the real-world example that we're seeing, based on the data that we have also researched. So, with that, I'll stop talking and, Dr. Klein, you can go ahead. 

 

Roger Klein:  Thank you, Erik.  That was a terrific summary of really a complex case, both from legal and medical perspectives. So, you mentioned the plaintiffs. And I've been an organizational plaintiff in a lawsuit, a challenge. And we had some individual plaintiffs and we had organizational plaintiffs. You've named your plaintiff. You've described the plaintiff. Standing was an issue in our case. Is standing an issue in this case? Why do they have standing? Can any doctor come in and challenge an FDA approval? Can any organization do it? Who can go in and challenge? And what are the considerations here?

 

Erik Baptist:  Well, we argue that we have standing six ways from Sunday. And I should also note, when we filed our complaint, we filed a motion for a preliminary injunction because of the irreparable harm that's occurring every day to many girls who take these drugs. And so, we filed that motion for preliminary injunction. FDA filed their opposition brief. And, also, Danco Laboratories, which I didn't mention — they're the drug manufacturer of the brand name Mifeprex — they moved to intervene and were granted intervention, and then filed an opposition brief as well. 

 

So, yes, standing is an issue in this lawsuit, because they have both raised it, in terms of likelihood of success. And they're arguing that plaintiffs do not have standing. We, obviously, believe strongly that we have standing, for multiple reasons. We have organizational standing, associational standing. Our individual doctors have standing. And the associations have standing to bring the lawsuit on behalf of their member doctors and medical professionals. 

 

And, finally, we have standing to bring the lawsuit on behalf of our doctors' patients. So, we've spelled all of that out. But, in terms of organizational standing, our clients have been challenging the FDA since day one of the approval. They've conducted their own studies, done their own communications and outreach to people to educate them about the dangers of these drugs. They have filed two citizen petitions and taken other actions. 

 

And the Fifth Circuit has recognized organizational harm in such cases, because the amount of effort that went into all this effort has detracted and taken away from the other actions by these organizations. And then, these doctors are frontline doctors. And they have treated multiple women who have been harmed by these drugs. And they're going to see more of these women coming into their emergency rooms and offices, so they have standing on their own, as well.  

 

Roger Klein:  Thank you. So, as you mentioned, the mifepristone was approved in 2000. And it sounded like the reason that the lawsuit is being filed now, over 20 years after approval, is because of the need to exhaust administrative remedies for the plaintiffs. Could you please maybe just explain that a little bit? What's the requirement to mount the challenge in court, from the administrative law perspective?

 

Erik Baptist:  Right. And this will be mentioned in our brief as well, because there is a question of whether this is actually a true legal requirement, whether required by the Supreme Court or the Administrative Procedure Act. But that may be a question for a different day and for a different court. What we're saying, and what certain courts have done, is recognize that the FDA has a requirement, a regulation on the books under its citizen petition provisions, where, if you don't file a citizen petition first, making your argument, submitting the data that you want to do, the FDA will ask the court to dismiss you from the case because you failed to exhaust your administrative remedies. 

 

Now, the Supreme Court and the APA say, "Well, if there's a regulation on the books that holds inoperative the action that they're challenging from the FDA, or from any agency, then you must exhaust your administrative remedies." The problem here is the FDA actually doesn't hold anything inoperative when you file a citizen petition. The drugs are on the marketplace. They're not going to pull it back or hit the pause button.

 

So, there's a question whether it's truly required. But the FDA has required it -- moved, in certain cases, to do so -- to dismiss the plaintiffs, I should say. And the courts have blessed and granted those motions to dismiss. So we know that there is precedent for this action.

 

Roger Klein:  Thank you. So, I'm trying to understand. I know that there were changes. This was such a complex progression. And I'm trying to understand. So, initially, it sounded as if certain physicians who met specific requirements were exclusively allowed, or permitted, to prescribe these drugs. And that's been loosened. So, right now, who can prescribe these drugs, and who can dispense the drugs? And what are the conditions, basically, under which a woman, a girl, can basically self-administer an abortion? Tell me, where does it stand, in terms of restrictions and safeguards? 

 

Erik Baptist:  Sure. It started with, back in 2000, only medical doctors can provide these drugs. That has changed over time. And maybe some of you have seen, since January, there have been even further changes: now, just a healthcare provider can prescribe and give these drugs to women, and where a woman can get it. She can get them through telemedicine without ever having to leave her own home or to see a doctor in person, so he can screen her for other potential complicating factors, such as a blood type that may not be good, or if she's on other medication.  That is not necessarily going to be picked up. 

 

Again, as I mentioned, a physical examination or ultrasound is very important as well. So now there's a mail-order abortion opportunity, where you can get mail-order pharmacies. And then, just last January, this past month, the FDA made further changes. Now your local CVS and Walgreens are planning to be able to distribute these drugs as well, by mail and in-person. So, that's an additional avenue that the FDA has recently authorized. 

 

Roger Klein:  So, anybody who would be, under state law, under a license to prescribe medicine can register and give these drugs: a nurse practitioner, physician assistant? What do you have to do to be able to prescribe these drugs?

 

Erik Baptist:  There are two now, drug manufacturers. There's Danco Laboratories, the brand name. And then, the generic got approved a few years ago, called GenBioPro. And you have to work with either or both of those manufacturers and sign a certification form attesting to certain things and capabilities.  And, essentially, if you sign that form, you are now a certified prescriber for these drugs, and you can start prescribing women to have these drugs. 

 

Roger Klein:  You mentioned telemedicine, which, because of the COVID epidemic, has really blossomed. And, of course, I think those of us who have been following the issue in the news — it's been a lot in the late press — there have been a number of cases of problems or abuse, whatever you want to call it, of telemedicine, where, for example, certain stimulant drugs were obtained through this route. I'm wondering, just trying to understand what the current dynamic is. 

 

For example, I have a 15-year-old daughter. Could my daughter go on the internet, have a telemedicine visit, get a prescription for these drugs without really being supervised and take them without me knowing about it? Is it possible, under today's restrictions, for that to happen? Would it be prohibited in restriction, but maybe literally, but maybe not so much in practice? I'm trying to understand what the real state on the ground is here. 

 

Erik Baptist:  Well, speaking of standing ground, it may depend on which state in which your daughter were to reside. Well, let's assume, just looking at the federal regimen and what the federal government has approved and authorized, the answer is yes.  She can obtain these drugs without ever visiting a doctor, just through the comfort of her own home, through the laptop, and getting them by mail. But this problem is two-fold. One, that's highly dangerous, because, again, telemedicine is great for certain things: a consultation, talking to a doctor. 

 

But if you need to go in person, whether you want to get confirmation you have pneumonia, you broke something, you might need stitches, you can't beat going to the doctor. There's no substitute for that. The same when it comes to chemical abortion, because to confirm pregnancy, to confirm gestational age is so important. In one case we've recently read about, a girl was told that she was six months pregnant, just based on her cycle, or at least that's what she thought. And the abortionist didn't perform an ultrasound, and just said, "That sounds right to me." Turns out it was not six weeks. It was over 30 weeks. And so these mistakes can occur without an ultrasound, without a physical in-person examination. 

 

So, that is highly dangerous. And that reminds me of one thing that the FDA failed to do, that it was required to do by law, each time it approves a new drug or makes significant changes to the regimen. It is required to study the impact of all new drugs or any new drug, on pediatric populations. There's a rule out there. There's a law that Congress codified that says you need to know the impact, whether it's the safety or the effectiveness of that drug on teenage girls, in this instance. We don't know, because the FDA, in 2000, waived that requirement improperly, which they later recognized was an improper waiver.  

 

And, again, they've never conducted, or required the conducting of a study that specifically looked at how these drugs interact with a developing girl's body in the short-term, long-term. But the FDA just has said, "Well, we assume a 15-year-old girl would be reacting the same way as a 35-year-old woman." We simply disagree. And there's not science to prove that the FDA's assumption is correct. If anything, it's shown that it's highly dangerous for these young girls. 

 

Roger Klein:  Thank you. So, I guess, central to your lawsuit, it's really a factual issue, in some senses. Your clients are alleging that the approval and subsequent modifications weren't supported by sufficient evidence and that the restrictions themselves on use are insufficient. And these have been relaxed over time, one of which is gestational age. So, initially, I guess it was seven weeks, and it's been moved to ten weeks, in terms of the approval.  

 

But doctors can do things off-label. And then you've got all sorts of other providers. It sounds as if it could, potentially, in some states, be legally allowed to offer these drugs. Is there any indication or data on whether or not they’re being used in accordance with the label, as to gestational age? Are people administering these drugs for women who are further along in their pregnancy? And, if so, do you have any sense for how often that's happening?

 

Erik Baptist:  We really don't have the data. We can talk about a lot of the deficiencies, and how the FDA has structured this and approved it over time, which I will want to talk about in just a second, because you reminded me of something that I really want everybody to listen to and understand what the FDA did or did not do.

 

But, to answer your question, we understand — just basically looking at what's out there in the public domain, statements made by the abortion industry — they're definitely prescribing this off-label, or past the ten-week gestation mark. That is confirmed. They say they do that. They're conducting tests to see if they can do it in the second trimester as well. So we know that's a fact in what they're trying to do. 

 

And there are a few points I want to raise. One, there's a difference, in terms of legal liability, in my mind, when the FDA gives a stamp of approval for safety and effectiveness of a drug, versus an off-label use. And so, when someone does something off-label and prescribes it, that, to me, heightens their potential for malpractice and other civil tort liability. So that's just something to keep in mind as they continue to push off-label uses. That may increase malpractice claims, class action claims. I don't know. That's well beyond the scope of what I do here.

 

But, going back to the studies and the evidence that the FDA had or did not have, I think this is important. Because, in the big changes in 2000 and 2016, the FDA never required nor relied on a single study that evaluated the conditions of use in the real world. And this is required by the statute. The Federal Food, Drug, and Cosmetic Act requires the FDA to have substantial evidence, adequate testing, and sufficient information to show that a drug is safe for use under the conditions of the suggested label.

 

What they did in 2000, they had two ultrasounds, not just one. They had an ultrasound for every woman in the clinical investigation to determine gestational age, which would also capture, presumably, ectopic pregnancies. And at the end of the chemical abortion, they performed ultrasound to determine whether she had any fetal parts remaining, or any other pregnancy tissue there as well  

 

They also required the woman to stay in the clinic. They also required a doctor perform it, and to have admitting rights in order to be able to treat her, as opposed to dumping her off at the emergency room. So, what did the FDA do? They had none of those safeguards when they approved this regimen. So they have no basis to determine that this was ever safe in 2000. I can say the same thing in 2016. They had a little more studies that the drug manufacturer didn't directly submit. They submitted, but they didn't actually sponsor themselves, directly. And maybe some of the money went to these studies.

 

But the same problem, every time: you almost look at every single study that they primarily relied upon had ultrasounds, routine antibiotics that were given. That's something that's never a part of the equation in the label as well. And it could have other adverse societal impacts with that. But these are things that we see. And these protections that are just not appropriate, because the FDA's label has nothing to do with what these studies have conducted. And we need to know for sure, whether these are actually safe.

 

And I'll leave you with this: why I always say, "We need to know." The FDA never required a national abortion registry. Other countries in Scandinavia -- let's say Finland, for example, has a national abortion registry. They also have socialized medicine. But, because of those two factors, you can track the outcome of a woman much more robustly and reliably than you can do in the United States. We just simply lack the data to know how many of these abortions are being performed, and then how many complications are associated with them, especially because, in 2016, the FDA also eliminated the non-fatal adverse reporting requirements by doctors.

 

So, at the end of the day, if a woman goes to the hospital in the emergency room, almost dies, codes, they save her, give her a full three units of blood, and she would have died because of a life-threatening infection, severe hemorrhaging, the FDA will never know about that, because they've never been required to do that, since 2016. So, simply, the FDA doesn't want to know about the impacts of its reckless behavior, especially since 2016, but I would argue since the beginning of this regimen, in 2000.

 

Roger Klein:  So that last point was one of our audience questions, so I'm glad you answered that, as to whether or not FDA had eliminated or minimized adverse reporting. And it sounds as if only deaths would be reported. Correct? 

 

Erik Baptist:  The fatal outcomes are required to be reported. But how they're supposed to be reported, too, is kind of complex, convoluted, and likely a game of telephone, where if the abortionist — the person who prescribes the chemical abortion drugs — finds out that a woman had to go the emergency room and died, or if she just died in her own home or in her dorm room or in a hotel room, if they somehow find out that the woman died, then they call the drug manufacturer. And then the drug manufacturer has to report it to the FDA. There's no direct reporting system. 

 

So, a lot of times, what's happening is that the woman goes to the emergency room. The emergency room doctors have no idea about this FDA requirement, or just even the reporting ability. Sometimes it takes upwards of two hours to submit an adverse event report. Again, busy emergency room doctors may not have two hours of free time to do that. And, even if you look online at the FDA's training manual, this is kind of a complex thing. It's a 48-page training manual of how to submit an adverse event report. There are so many barriers to getting this information that we simply don't know the dangers of these drugs, because the FDA has failed to make that reporting required.

 

Roger Klein:  Thank you. And I can tell you, from a medical world perspective, people are very busy now. And spending hours having to figure out how to file a notice to notify a government agency about some problem, when you've got a bunch of patients sitting there, it's going to be a lower priority. So, it makes sense, what you're saying.

 

I'm glad you mentioned product liability and malpractice. I was going to ask you if you had any evidence. I went to Google, and I put in "mifepristone" and "product liability." And there was one attorney who came up, and he's got a whole bunch of stuff talking about, "Were you injured by this drug?" etc. But it sounds like you don't have any direct knowledge of whether or not there's been litigation toward either malpractice or products liability over these chemical abortions. Any sense, or --?

 

Erik Baptist:  That's correct. That's outside the scope of this lawsuit. That's outside the scope of my experience. I'm an administrative lawyer, fighting the regulatory state most of the time in my career. So I just haven't actually had the opportunity to look into this more. And it's not something that I would ever look into professionally, just because it's not within the scope of what I have been doing. So, the answer is no. But that's not saying it doesn't exist. It's just not within the scope of what I do.

 

Roger Klein:  Okay. So, getting back, then, to administrative [inaudible 00:35:46], you're a renowned administrative lawyer. So I think it's an interesting issue here of to what extent can courts sort of overrule an FDA determination that a drug is safe and effective? Have they ever done it? And do they have the authority to come in and overrule a decision of safety and effectiveness by FDA and remove a drug from the market, independent of FDA, as part of an oversight function?

 

Erik Baptist:  Yeah, let's take a step back. We're speaking to The Federalist Society here, and so I think it's always important to remember, why does the FDA exist, and how do they get their power? Congress delegated its authority to the FDA with specific instructions of how to approve or reject a new drug, because they can't just delegate and say, "Well, this bureaucratic agency can do whatever it wants and never be challenged." It has to give specific instructions, directions of how to determine whether a drug is safe. And, there, of course, there is some level of deference, depending on what the agency action is. But, at the same time, our case brings up multiple forms of claims. 

 

First is the FDA hasn't given specific instructions. It's failed to do that. The Congress told the FDA to review these new drug applications and determine safety and effectiveness under the label conditions use. Everybody agrees in this case that they never did that. The FDA's response is, "So what? We don't have to do that." And that's just not, obviously, going to be the answer. So, that is not right. So the court can just look at it, "Well, what was your evidence to support this label?" And the answer is, "We don't have any. And you can't tell us what to do." That's not a very compelling argument to me. But that's the primary argument by the FDA.

 

The other is they have to have a reason or explanation for why they deviated from the statutory requirements, or why they even came to the safety determination which they did. They've never had, for many of these changes, a reasoned explanation. They never had the evidence to back it up. And their explanations for the failure of evidence also just lacks as well. So courts can go back and tell the agency to provide a better explanation. They have removed other drug approvals. There are multiple forms of new drug approvals. 

 

You sometimes have a generic getting approved, and the brand manufacturer comes in and asks the court to take that off the marketplace. And we've seen that before. Other times, we've seen even then-Judge Merrick Garland tell an agency its approval was inappropriate because it didn't have a reasoned explanation for its scientific determinations and sent it back to the agency as well. So, it's well within the courts' jurisdiction to compel the agency to live up to its statutory obligations. 

 

Roger Klein:  Thank you. So, some have expressed concern about this lawsuit. For example, should you prevail, it would create uncertainty in the drug approval process and potentially lessen investment, because, all of a sudden, drug manufacturers wouldn't have confidence in the durability of FDA approvals and the fear that maybe somebody could come into court and invalidate approval of a drug on which they've spent billions of dollars to bring to market. How would you respond to that? Is it a legitimate concern? Is it something you feel needs to be addressed? 

 

Erik Baptist:  I won't characterize it as legitimate or illegitimate, but I'll put it like this; We're challenging the FDA's characterization of pregnancy as illness, or taken the term, "illness" to mean "condition" for its expedited use. Well, I can't think of another example where a life-saving cancer drug or a life-saving AIDS drug would not be approved, because those are illnesses. And so, I'm not sure anybody would be adversely impacted if the court were to say, "No, FDA, this accelerated approval authority is only for illnesses. It's not for your undefined conditions, which allows you to go and call pregnancies illnesses."

 

So, I think that's the first response. The second is I really hope that these pharmaceutical companies are submitting new drug applications that are consistent with the statute, that they actually have studies to support their approval, under the label conditions of use. So, I'm presuming that's going to be fine too, and they are not going to have any concerns. 

 

The third and final point I would note is part of the problem here is the FDA has changed the regimen over time and they have reopened this drug approval and called it into question repeatedly. If these drug manufacturers get an approval, 20 years down the road they don't touch it, it's likely not going to be challenged at that point. So I think there's going to be some certainty in the marketplace, regardless of how this court decides.

 

Roger Klein:  Thanks. And so it sounds as if you don't see this as something having broad implications. It's more narrowly directed toward this particular scenario. 

 

Erik Baptist:  I will follow up with this one other observation. Last week, Friday, was the deadline for amicus briefs to be submitted. Not one pharmaceutical company submitted a brief saying, "We're worried," or their trade associations filed a brief saying, "Watch out. This is going to be dangerous for our industry." So that may be a telling sign.

 

Roger Klein:  So, in looking through your brief, one of the things that caught my attention was — I'm sorry, your complaint — you mentioned laws against utilizing the mail or other carriers to distribute abortifacient drugs. There wasn't a lot of discussion, just some mention. It sounds as if the FDA didn't really acknowledge these laws. I was wondering if you could tell the audience, say a few words about these laws. What are they? And what would be their potential impact on this case?

 

Erik Baptist:  Yeah, these are laws that have been on the books for over a hundred years that pretty much have broad application in the sense it doesn't just apply to chemical abortion drugs. But there is a provision that says that it is a crime to distribute these drugs by postal mail, common carrier, or third-party express company, to sell and market these in the United States. So, the FDA, since its 2000 approval, has approved a distribution plan that directly violates these long-standing criminal laws. 

 

And then, fast-forward to 2021, they expressly approved mail order of chemical abortions and the transfer and distribution of these drugs by mail, which, again, is directly contradictory to these long-standing laws. I will note, as you probably have seen as well, in December, the Department of Justice Office of Legal Counsel decided to file a memorandum and publicly put it out there, saying that "Yes, the plain text of these laws say that you can't mail abortion drugs. Well, don't believe the plain text. There's some subtext that you just don't see." And they went on to, I think, 21 or 23 pages, to redefine the plain text of these statutes. 

 

And the FDA is now relying on that to tell drug manufacturers, to tell the Postal Service, to tell anybody else who touches these drugs in distribution that you now have a pseudo get-out-of-jail-free card, because the Department of justice has taken the opinion that it's not actually illegal, at the end of the day. And that's a very dangerous get-out-of-jail-free card, one I would not really take very far, because administrations do change. And there are other forms of enforcement against violations of these laws. So I would very much tell those companies that are thinking about it to think twice, because these long-standing laws can be enforced and they may be soon enough.

 

Roger Klein:  So, there are long-standing laws that have been on the books for a hundred years or more and probably haven't been enforced for many, many, years, are sort of lying there dormant, but, in effect, you would argue, make distribution of these drugs, themselves -- because if you use any form of carrier, mail or similar carrier, it would be illegal under these laws. That would be your argument?

 

Erik Baptist:  Right.  The problem here is the FDA has expressly approved a regimen that violates these laws. It's one thing to say, whether the Department of Justice enforces it or not is a different question. But the FDA can't take actions that are not in accordance with the law. And that's any law, not just the laws that directly govern the agency, but any law across the federal court. And so, they can't be willfully ignorant to these laws. And, if they are, thinking it doesn't apply, they need to at least explain themselves, and say, "Well, we know these laws are on the books. We don't think they apply." And, historically, the FDA has never done that. Except until this last month, they've never acknowledged these laws.

 

Roger Klein:  That's helpful. I was really wondering about that. So, another statute you cite in your complaint, the Pediatric Research Equity Act of 2003 -- could you please explain what that is, and what the impact is on your suit? What are the violations of this law that you're alleging?

 

Erik Baptist:  Yeah. This act was put into place in 2003. But that was in response to a district court striking down the FDA's own regulation having the same requirement. So those requirements were there in 2000, when the drug was approved. And then it got codified into law in 2003. And that was essentially saying that any new drug that gets approved or any change to a drug regimen needs to require the sponsor of these drugs to conduct studies and submit them before the agency on the impacts — whether the safety or the effectiveness of these drugs — on the pediatric populations.  

 

And, here, these would be teenage girls who can get pregnant, and how would they be impacted in the short-term, long-term. We just don't know, because, again, the FDA failed to follow this law. And they have done some inappropriate extrapolation along the way, thinking that a 15-year-old girl would have the same result as a 35-year-old woman and have no safety issues in the short term or long term.

 

Roger Klein:  Thank you. So, I'm looking here. I see some questions in the chat. Well, I'll start with this one, because it's quick and easy: "What percentage of abortions in the United States are carried out pharmacologically, as opposed to surgically?"

 

Erik Baptist:  Again, I say, I'll always caveat that we don't really know exactly, because there's no reporting requirement. And we're just relying on the voluntary reporting and statistics by the abortion industry. But my understanding, it's about 50/50, if not a little more now in the majority for chemical abortions.

 

Roger Klein:  So, these drugs have a broad impact nationally. If half of abortions are performed chemically, this is an important lawsuit. 

 

Erik Baptist:  This is an important lawsuit, because the way the FDA has approved these drugs recklessly has endangered and threatened and harmed women and girls over the last 23 years. So, it is an important one, because it is, I believe, four times more dangerous than surgical abortion. So that's something to keep in mind as well. Surgical abortion has its own risk, but it's even riskier when it comes to chemical abortion drugs.

 

Roger Klein:  So, getting back, there was an original question about standing, which I also had. But there was kind of a follow-on. Does it extend to an actor who seeks to protect the health of others, as opposed to his own? So the doctors who are suing on behalf of potential harms or previous harms to patients, does that confer standing on a physician?

 

Erik Baptist:  The Supreme Court has said it does. Now, people can disagree whether that should be the case. But current Supreme Court precedent says a doctor can bring a lawsuit via third-party standing on behalf of a patient only, not necessarily the doctor's harms. But, here, it's a little different, because we have organizational harm. We have associational harm, who are the member doctors and other medical professionals. 

 

The doctors, themselves, have asserted and alleged harm as well, through declarations. And, if you notice, in the complaint, there's other elaborations under those harms as well, and on behalf of their patients. So, we have it, like I said, six ways from Sunday, because there are many ways to prove standing in this case.

 

Roger Klein:  Thanks. Okay, so now somebody's asking about the statement that these drugs increase the risk of serious infection. And the person's asking, "How do they do so, since they're oral drugs?" And I kind of had my own thoughts. But, maybe, why don't you go ahead and explain how these drugs would increase the risk of a serious infection? I mean, if you're comfortable with that.

 

Erik Baptist:  Well, yeah. And I don't see the question. So, why are these drugs dangerous, essentially, is what I'm hearing. And how does it create these dangerous situations? And the reason is because what these drugs essentially do is induce labor and delivery in your own home without any medical supervision. No doula, no doctor, no OB, nothing, most of the time, so you're on your own. And so women end up having severe hemorrhaging, because the two-drug regimen creates such an environment, and because it's a mode of action that reduces your body's immunity to infection, that you're more likely to have an infection that way. 

 

And I'm always happy to bring one of our doctor/plaintiffs here, because they're much more eloquent. I'm a lawyer for a reason. But they can explain it a little better. But there is a reason why it is more dangerous. And when we look at the robust data that has compared the two modes of abortion, it is comparatively and significantly more dangerous because of that, because you're doing things to your body that are not normal, and because you don't have the medical supervision to ensure that you're not going to have these life-threatening complications down the road. 

 

I will also note that surgical abortion, in theory, can only last a few hours. Chemical abortion can last anywhere between a few hours to many weeks. So that's something to think about as well, how quick and easy it is. Easy is a very loose term. I shouldn't probably say that. But how quick it is in surgical abortion, and you're in a medical facility most of the time, versus chemical abortion where you're outside the medical facility, maybe conducting this and administering your own abortion by yourself, without parental knowledge, without any friends nearby, and definitely without any medical professional.

 

And I see one question that I'm going to just answer while you're looking, "Where does the research come from to support -- [crosstalk 00:51:09]

 

Roger Klein:  -- for the questioner. If you were to have an incomplete abortion, that could potentially lead to infection if there is retained products within the uterus. And maybe you want to say something about how often does this work, and how often does it fail? Because anytime it fails, then you would need to potentially go in and surgically remove any retained conception products, otherwise there could be a risk of infection. So how often does it work? And how often does it not work?

 

Erik Baptist:  Yeah, that's a good question. And the answer, I hate to say, is we don't know exactly, because the studies that are out there are not very reliable and not very robust. Sometimes incomplete abortions are omitted from the adverse complications when they're reporting them, just because they say, "Well, it was incomplete, but we were able to treat it. So that's not a complication." So my answer to you is, depending on the study, some break it down and explain it. But we really don't know. But it's higher than what the FDA purported it to be. That's for sure, infinitely more than that. 

 

Roger Klein:  Thanks. So, somebody's asking whether or not anyone has looked at the prevalence of side effects and complications, and whether it's related to the experience of the prescriber. And, I suspect, based on this discussion, you don't have those kinds of data. But I think there seems to be an argument attached to it that it should continue to be prescribed by physicians with expertise in the area, rather than having, for example, nurses and PAs, and maybe doctors who don't really have a whole lot of knowledge or experience. What are your thoughts about that?

 

Erik Baptist:  Yeah. I think, for some medical issues, you can see a nurse and she can draw your blood and she can give you your shots and immunities. But when it comes to something as dangerous as a chemical abortion, it makes sense to require a doctor to do it, at least, especially when you have a high likelihood of severe complications associated with this regimen.

 

Roger Klein:  So, here's another question that -- we have about five minutes left. "Isn't this drug claimed to be the appropriate treatment to remove ectopic pregnancies, rather than being problematic, specifically for women who may have an ectopic pregnancy?" And I think you can answer that.

 

Erik Baptist:  This drug has not claimed to treat ectopic pregnancies. It's explicit on the label that if you have an ectopic pregnancy, you should not take these drugs, because it will not treat your ectopic pregnancy. If anything, if you don't know you have an ectopic pregnancy, and you take these drugs — I mentioned this before — you're going to have the same symptoms. And women who take the drugs are saying, "Wow, I'm bleeding out. This is painful." And the abortionist will say, "Well, that's just the normal symptoms for a chemical abortion," as opposed to, "Maybe you have an ectopic pregnancy. Come in. Let's check it out." 

 

Because the FDA has never required that the abortionist, the doctor, the healthcare provider, to ever look to see if there's an ectopic pregnancy by ultrasound, this has happened, because of it. But they have warned, at least, if you know you have an ectopic pregnancy, do not take these drugs. 

 

Roger Klein:  So there's another question from the audience. And the person is specifically asking, "Where does the research come from to support the claim that chemical abortion is four times more dangerous than surgical, if I heard that correctly?"

 

Erik Baptist:  So I go back and say where is the most robust data that we do have? And that, I'm pointing to Finland here, because Finland has a robust data set because of their national abortion registry. So you can really track the outcome on a woman, both in the short term and long term. Some of the problems with the United States studies is they only look at a woman after six weeks, but sometimes these complications can appear even after six weeks. Or sometimes they only look at seven days after the chemical abortion. So, when you look at the Finland data — and the FDA also relies on this data for different purposes — it shows, definitively, that it is four times more dangerous than surgical abortion in that county, and, presumably, similarly, here.

 

Roger Klein:  So, the data would be from Finland.

 

Erik Baptist:  Correct.

 

Roger Klein:  So if you want to look that up, you can Google "Finland" and "RU486" or "chemical abortion" and probably be able to find it.

 

Erik Baptist:  You can also find some domestic studies that share the same research or similar outcomes, but with different numbers. But it's still relatively four times more dangerous. But I would question whether those numbers are reliable or not. 

 

Roger Klein:  Okay. So we have a couple minutes left. We are The Federalist Society. Oh, wait, there's an audience question. Let's let them ask. "Are most abortion prescriptions paid for by Medicaid or private insurance? How does insurance coverage interplay in this issue, if at all?"

 

Erik Baptist:  I don't have the answer to that, in terms of it doesn't play, in our case. It really doesn’t matter how these abortions were funded for the purpose of this litigation. But I don't know the tips of the scales. Again, we just don't know, because the FDA has refused to require this reporting information. We don't record it. So you can look in various states, but you only get one side of the ledger. You don't necessarily get the private side. So you just don't know.

 

Roger Klein:  Okay. I'm going to ask one more question. We have two minutes. We're The Federalist Society. State regulation, you mentioned -- so let's say a state wants to restrict use of these drugs in a manner that is more stringent than the FDA approval. Are there preemption issues?

 

Erik Baptist:  The U.S. Department of Justice these days would like to lead you to believe that there are. But no, states are free. It's their primary jurisdiction to protect the health and welfare of their citizens within the states. And they have the primacy of that. So it is their job to protect. And so the FDA sets the floor, in theory, in terms of safety for drugs. But states can do more to protect their citizens. And that's going to be litigated soon enough, because there are two lawsuits pending that raise this very issue.

 

Roger Klein:  We don't seem to have any more questions from the audience. I think that we're just about at the top of the hour, so I think that concludes this session. Thank you, Erik. This has been so interesting and informative for me, learning about this. And I know and hope that it's been the same for the audience. And you've done such a great job in explaining this case. So thank you very much.

 

Erik Baptist:  Thank you very much. I really appreciate those kind words. I will note, I just saw a question, "Can you share the lawsuits, please?" I'll note that if you want to find any of the documents or the filings in our case, you can go to adf.legal.org and find our case, Alliance for Hippocratic Medicine v. EPA, and you can pull all our filings and the amicus briefs in support of our case there. And these two other lawsuits -- one is pending in West Virginia, that's GenBioPro, the generic manufacturer, is suing the state over that. And then there's a lawsuit brought by an abortionist in North Carolina. I don't have the name for that one, unfortunately. 

 

Roger Klein:  And your website URL was?

 

Erik Baptist:  adflegal.org.

 

Roger Klein:  Okay. Thank you. 

 

Chayila Kleist:  Absolutely. Thank you both. On behalf of both myself and the Regulatory Transparency Project, I want to thank our experts for sharing their time and expertise with us today. And I want to thank our audience for tuning in and participating. We welcome listener feedback at [email protected]. If you're interested in more from us at RTP, you can either follow us at regproject.org, or find us on all major social media platforms. Again, thank you all for joining us today. And, until next time, we are adjourned.

 

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Conclusion:  On behalf of The Federalist Society's Regulatory Transparency Project, thanks for tuning in to the Fourth Branch podcast. To catch every new episode when it's released, you can subscribe on Apple Podcasts, Google Play, and Spreaker. For the latest from RTP, please visit our website at www.regproject.org.

 

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This has been a FedSoc audio production.