CV NEWS FEED // Erik Baptist, senior counsel at the Alliance Defending Freedom, told CatholicVote’s Erika Ahern that the FDA’s approval of chemical abortion drugs mifepristone and misoprostol is “dangerous, reckless, and frankly illegal” on last week’s episode of the Loopcast.
Baptist, a practicing Catholic, is the lead counsel in ADF’s lawsuit on behalf of the Alliance of Hippocratic Medicine against the FDA in the district court for the Northern District of Texas. This case comes as President Biden’s FDA continues to deregulate distribution and use of chemical abortion drugs.
Erika: My guest today is Erik Baptist. Erik serves as senior counsel at the Alliance Defending Freedom, focusing on administrative litigation and regulatory advocacy. ADF is known for its defense of religious freedom in cases such as the Masterpiece Cakeshop, which we’ve covered here on Loopcast. Erik is an active member of the DC Bar and is admitted to practice between the Supreme Court and various federal courts of appeals. And contrary to what his name might suggest, Erik is a fellow Catholic. Erik, welcome to the Loopcast.
Erik: I’m very happy to be here. Thank you for having me.
Erika: Before we jump in to the case that we’re going to focus on today, can you give our viewers a brief overview of the legal status and actual, on-the-ground use right now of the abortion drug mifepristone, which is the first in a two step chemical abortion, is that correct?
Erik: Yes,that’s correct. Chemical abortion drugs are mifepristone and misoprostol. The FDA approval on them and the current regimen has evolved over time, but today where it stands is that a pregnant woman can obtain mifepristone without ever visiting a doctor in person. So, she can get telehealth, sometimes online. Over 50 percent of all abortions are performed by chemical means these days, so it’s a very loosely regulated drug that the FDA has approved— and the FDA no longer requires a doctor to actually prescribe this drug. It can be prescribed by a physician’s assistant or a nurse practitioner or another healthcare provider. So, the woman never has to go visit a doctor, doesn’t have to see a doctor, doesn’t have to be screened for any complications such as an ectopic pregnancy. We can talk about that more, but very loosely, as of January, now your local CVS or Walgreens can start dispensing this drug. It used to be that it had to come directly from the abortionist by mail or in person, but now the Biden administration’s FDA has permitted pharmacies to start selling these drugs to young women and girls.
Erika: So, this drug has been legal now for over 20—or approved by the FDA—for over 20 years. Do we have any long-term studies or indications on how this drug actually affects the mother who is taking it?
Erik: We have to look outside the United States to determine whether this drug is safe or how unsafe it is, because frankly we just don’t have the data here that is robust and reliable in the United States. One area where we look is Finland, because Finland has a national abortion registry. They know every woman who has ever taken mifepristone for chemical abortion purposes and they also have socialized, nationalized healthcare so they can track the same woman in the healthcare system and identify if she has presented herself to the emergency room within 30 days with complications associated with a chemical abortion drug.
There have been some seminal studies coming out of Finland that show that upwards of 1-in-5 women will have severe complications that result in subsequent medical intervention due to chemical abortion drugs. It’s also four times less safe than surgical abortions—which is not safe in its own right—but chemical abortions are four times more dangerous. We look to that information to provide a kind of a guidepost to tell us how unsafe this regime is here in the United States.
Erika: Those are shocking numbers. Are there any current legal safeguards for the mother at this point? Is there any limit to how this drug can be used?
Erik: There are very few limits. There’s no age restriction or minimum. So any girl of any age—a 13-year-old girl or a 15-year-old girl—can obtain these drugs without parental consent and without seeing a doctor or medical professional. They can get these without any medical supervision. This drug essentially induces labor and delivery and women are being advised by the abortion industry to do this in their own bathroom, in a hotel room,in a dorm room without any medical supervision and sometimes without any support. Inducing labor and delivery of a baby upwards of 10-weeks, sometimes even longer, is highly dangerous and in many ways very traumatic for the woman to go through. There are very few limitations or restrictions left, but it’s basically paperwork for the prescriber to go through with the drug manufacturer, or for the pharmacy to ensure that whoever is calling them is certified to dispense and prescribe these drugs. And finally for the woman, to sign a patient agreement form and give informed consent that she understands the dangers of these drugs. And unfortunately, the FDA has minimized the dangers of these drugs and the potential complications such that this patient agreement is sometimes not as robust as it should be to where the woman frankly can’t give informed consent because there’s no information that would inform that consent.
Some pro-abortion states are seeking to remove those few basic restrictions remaining, but as of now those are the few restrictions remaining, which are very minimal in our eyes.
Erika: Let’s dig into the case. Just some background for the listeners: Last November, November 2022, ADF filed a federal lawsuit in the U.S. District Court for the northern district of Texas, based out of Amarillo, against the FDA on behalf of the Alliance on Hippocratic Medicine and Catholic Medical Association, among others. What exactly did your suit challenge, how were you able to bring it, and why Amarillo, Texas?
Erik: We are putting everything the FDA has done to approve and deregulate abortion drugs before the court. I’ll give you a little history of what the FDA did over the years that is subject to our litigation. People may have heard about mifepristone in another form. I kind of came of age in the 1980s and 1990s and we heard this drug that came from France called RU-486. That’s mifepristone but that was the name it is was given in France. There was talk about bringing it to the United States in the early 1990s and finally when President Bill Clinton assumed office, on his second full day as president that’s exactly what they did. He directed his cabinet to find ways to bring RU-486 – mifepristone – to the United States. And that’s exactly what they did. First they had to strong-arm the French manufacturer, which wanted no part of the U.S. market, to donate for free the U.S. rights for the drug to an entity known as the Population Council. The Population Council, as you might guess, is actually interested in population control, so they got rights to this drug and then submitted a new drug application with the FDA. The FDA then worked hand-in-hand with the Population Council to get this drug approved. Because, even then, the FDA recognized the inherent danger associated with these drugs. The FDA wanted to put some post-approval restrictions on the distribution of this drug, and appropriately so, but to do so they had to use its fast track approval authority. And that authority was very limited. Initially it was intended for AIDs patients and cancer patients so they could receive life-saving and life-affirming drugs. Here, what the FDA had to do was call pregnancy an illness and then argue that chemical abortion drugs provide a meaningful therapeutic benefit for women and girls who take them. Those are simply false statements and we’re presenting that to the court.
In the year 2000, the last year of the Clinton administration and maybe as a legacy item, Clinton’s FDA approved abortion drugs for use in the United States. And then nothing really happened from the FDA’s perspective until 2016, in the last year of the Obama administration— again, if it were an election year, who knows, but politics is always a theme in this case—the Obama administration did a wholesale change to the regimen. Now, they expanded the gestational age of the baby for which a woman could have a chemical abortion from 7 weeks to 10 weeks. During that time period a baby more than doubles in size. It has fingers and limbs, it can move its face—obviously it’s a human being. But it’s even more traumatic for a woman when she had to self-administer her own abortion in her bathroom by herself. We have reports of women saying, “I gave birth to my baby and I had no idea to expect this.” Because the other side, the abortion side, tell them it’s just a clump of cells and you won’t even recognize it. But then a baby coming out, sometimes with a beating heart, is so traumatic to a woman. But the FDA did that and said you can give labor and deliver your own baby at 10 weeks, and sometimes even longer, because they get the gestational age wrong, and you can do that in your own home and without any medical supervision. They also no longer require a doctor—I mentioned this earlier—but they no longer require a doctor to see a woman. And finally, they took away adverse event reporting by the abortionist. They said that no longer do they have to report non-fatal adverse events to the FDA; they only have to report deaths to the FDA. You don’t even need to report it directly to the FDA, you just need to give it to the chemical abortion manufacturers and assume they’ll give it to the FDA.
So, that happened in 2016. And then in 2021 the Biden administration went full-force into chemical abortion and said we’re no longer even going to require a doctor at all. Actually, I should go back to the Obama administration and the Clinton administration. The Clinton administration required three doctor visits to get the drug—on day 1 to get the first drug, on day 3 to get the second drug—and on day 14 days to make sure there were no fetal parts remaining inside the woman or no other complications as a result of the chemical abortion. The Obama administration said you don’t need to have three in-person office visits anymore, you only need one. Then the Biden administration came in and said you don’t even need to see a doctor and through telehealth or other means you can get these drugs without ever having to be screened in-person and by a doctor. That to us is dangerous, reckless, and frankly illegal.
If a woman isn’t meeting with a medical professional to confirm she’s pregnant, to determine her gestational age, within the legal limits the FDA has prescribed, you need to have an ultrasound and an in-person examination. Finally, you need to screen if the woman has an ectopic pregnancy, which is a life-threatening condition that occurs in 1 in 50 pregnancies. If that’s not screened for properly then a woman could face death in a life-threatening situation. We’ve seen woman die in ectopic pregnancies taking mifepristone—RU-486—having life-threatening bleeding and die. The symptoms of taking of taking mifepristone are the same as an ectopic pregnancy, so if you’re not screened for an ectopic pregnancy and show signs of severe pain and bleeding, an abortionist will tell you that’s perfectly fine, we expect you to be in pain and have severe bleeding. But it could have been an ectopic pregnancy and a lot of times that has occurred and women have presented themselves to emergency rooms and sometimes died because of that. And the Biden administration says you no longer have to see a doctor and you can do this on your own. Everything I just described is subject to our lawsuit. We think the approval was illegal for many reasons and stripping away of basic protections for women and girls in the last six years have been really traumatic and escalated the amount of women presenting themselves to emergency rooms across the country.
Erika: So, NPR, has described the case as “challenging the FDA’s approval after more than 20 years of the abortion drug.” And it’s sort of implying that the safety of the drug is settled science— that we settled this twenty years ago. So the question is why bring the lawsuit now, so many years after the FDA told us the drug is safe. Why did you wait 20 years?
Erik: I think it’s a fair question to ask why did you have to wait two decades to file a lawsuit. But hopefully they give our answer fairly: Because the FDA has a requirement that the courts have followed a lot of the time that says, before you go to court to file a challenge against the FDA over new drug approval, which would have been in this case, you need to file a challenge with the FDA first. You need to file what they call a “Citizen Petition” challenging the approval. That is exactly what our clients did in 2002—they filed a robust, 90+ page citizen petition arguing that the FDA’s approval was illegal and unscientific and therefore the drug should be taken off the marketplace. By its own regulations the FDA is supposed to reply within six months. But in this case, the FDA stonewalled our clients and evaded responsibility for 14 years. So our clients patiently waited for the FDA to respond until March of 2016. And then the FDA denied our client’s petition and strategically timed that denial to the 2016 major changes in the abortion regimen. They did that on the same day so our clients went back and said we’re going to file a new petition challenging these wholesale changes to the drug regimen. That’s exactly what they did but the FDA sat on it and our clients were stonewalled by the FDA and that denial lasted until December 2021, when we filed our lawsuit shortly thereafter. This is the first time our clients have been able to bring their case to a court and present to the court the entirety of what the FDA did over the course of the last two decades to harm women and girls by approving this dangerous drug regimen and then taking away the basic protections for the women and girls who do take these drugs.We’re happy to be in court now but it has been the FDA’s own stonewalling and delay tactics that have resulted in us not being able to bring this case until now.
Erika: Tell me a little about the Amarillo, Texas, connection. We’ve had people reach out and ask why this is happening in Texas and not in Washington, D.C.m where everyone associates the FDA.
Erik: Well, Congress has empowered the American public to sue federal agencies where the public resides, works, and where they’re injured. That’s exactly what we did here. We don’t have to go inside the beltway to sue a federal bureaucracy because Congress recognizes the American public should be empowered to sue the government where the government has enacted its harms. And that’s what we did here because we have two plaintiffs based in Texas. One, a doctor who has recently treated a woman with severe complications from a chemical abortion drugs. She was in the Amarillo area, went to New Mexico to get the drugs, and came back to Amaraillo and proceeded to have severe bleeding and hemorrhaging almost died but for the intervention of our Amaraillo-based doctor, who saved her life. That’s truly important here because our doctor did not need to come to Maryland or Washington D.C. to sue the FDA over these harms. He is entitled to bring this case where he resides. We also have a medical association that represents a lot of other medical organizations and religious organizations that is based in the Amarillo area, and they have been harmed as well because they represent these organizations that have filing these citizens petitions and doing their own studies that the FDA fails to do to find out these drugs are not safe. We have many reasons to be in Texas but that’s why we’re in Texas—because Congress has empowered our clients to file in Texas where they were harmed. I will note ADF files lawsuits across the country. We’re filed lawsuits from California to New York—we go wherever our clients take us.
Erika: I won’t ask you to speculate about what the outcome will be in the case but, I was trolling the mainstream media and I did see several quotes from other counsels at other firms—such as the Center for Reproductive Rights—and they were explaining how this case is a threat to women’s health and so-called “reproductive freedoms” because the outcome of this case, should the judge rule in favor of ADF and its clients, that this would be a nationwide ban on medication of abortion. And they said it would have a greater impact than Dobbs. Is that true and what could be the ramifications of this case?
Erik: I won’t go so far to make those statements about the ratification of this case, but we are asking the court to set aside the FDA’s approvals of these dangerous drugs for chemical abortion purposes. I should have started out saying both drugs are used for benign purposes. Misoprostol is used on-label to treat gastric ulcers but off-label a lot of doctors will use it to induce labor and delivery. People and patients who rely on that drug for those purposes will not be impeded because our lawsuit does not seek to take away that approval. The same with mifepristone. It’s used to treat Cushing’s Disease and our lawsuit does not go after the approval for use in that. So folks who rely on these drugs for those uses will continue to have their drug available to them because they’re made by different manufacturers and approved under different actions by the FDA. So I put that out there.
We are asking the court to set aside the approval of mifepristone and misoprostol to the degree the FDA has approved both drugs for chemical abortion purposes. So it’s an ambitious lawsuit in that we’re asking the court to do this, but it’s a reasonable one because the FDA, from the beginning to the end, has failed to follow the plain requirements of the law. We’re not second-guessing the medical judgment or the scientific judgment of a federal bureaucracy; we’re saying Congress gives the FDA the power to protect the American public from dangerous drugs, and the FDA failed to live up to its obligations when Congress gave it the power to evaluate these drugs. In this context the FDA was directed and required by Congress to review and analyze a new drug under the conditions of use per the proposed label. The FDA has never had, in the over 20 years of use of this drug, required or relied on a study that actually evaluated the approved chemical drug regime. Those studies the FDA relied on, from the initial clinical study to other studies that were frankly provided by the abortion industry, all have protections that are not embedded in the labeled use. And the biggest ones are ultrasounds. The clinical investigations in the 1990s—every woman had not just one but two ultrasounds. An ultrasound to determine gestational age and determine ectopic pregnancy at the beginning of a chemical abortion, and then an ultrasound at the end to ensure she had no fetal parts inside her that would lead to life-threatening conditions. The FDA’s approved regimen does not require an ultrasound. We’re just asking the court to hold the FDA accountable and to comply with the law that it was given when it was empowered to serve as gatekeeper of drugs in the United States.
Erika: Just to back up and return for a second about the question of the FDA, I think you said it was in 2016 that they were suppressing or saying we no longer need to report adverse effects, and it seems like that request alone was suppressing information that, if we’re really thinking about the welfare of women and scientific accuracy and medical responsibility, then why would we suppress any information about the outcome of a drug.
Erik: With that decision the FDA essentially said we want to be willfully ignorant about the consequences of its changes in 2016.
Erika: It’s stunning to me – hashtag “science”.
Erik: What’s even more stunning is that they got rid of those adverse and bad reports, but it was inherently flawed from the beginning since it only required the manufacturer and the abortionists to report adverse events. But what my clients will tell you is that, because the FDA has absolved the abortionist from treating women from complications, most of the women who have severe complications requiring subsequent medical intervention, go to emergency rooms and go to doctors. So that’s what our doctors end up treating, but our doctors are not legally required by the FDA to report any of these adverse events. Some of them do it voluntarily, but at the end of a 12-hour shift some of them have to spend up to 2 hours to submit an adverse event report, and that’s even if they understand the system and if it accepts it. So it’s a frustrating process because sometimes the reporting doctors don’t know about the adverse event requirements or the possibility of doing it, some of them don’t have the time to do it, and even when they have the time to do it it takes them a long time to do it and they still get rejected by the system. It’s an inherently flawed system but what I find even more stunning is that in 2021, when the Biden FDA decided to remove the in-person dispensing of mifepristone, essentially permitting and authorizing mail order and do-it-yourself abortions, the FDA explicitly relied on the adverse events reports and said, well, we don’t have any adverse event reports so we think this drug is fine and we don’t need to have you see a doctor. But at the end of the day they got rid of the requirements so how can you actually rely on it? It was just audacious for them to do and frankly illegal. That’s what we have presented to the court as well.
Erika: So the clock has all struck 13 o’clock and is very 1984. Are you aware of any other drug regimen or procedure for which the FDA has suppressed or just stopped collecting adverse effect reports.
Erik: I am not aware of that but I can’t say that it hasn’t been done. Everything I’ve seen about the history of this drug approval and the removal of basic protections for women and girls who do take these drugs indicates this is not business as usual at the FDA; everything seems to be politicized and prioritizing politics over science. So this is just something atypical. Everything just reeks of impropriety and illegality and that’s why we’re in court today.
Erika: Well it’s a disgusting disregard for women and certainly for infants. I was looking it up and I think it’s a 75% to 80% effectiveness rate in actually killing the child, so not to forget the baby, who certainly their safety is of no one’s concern. But thank you so much Erik for your insight, your articulate discussion of what the case means, and we are all eagerly awaiting the ruling and what it will mean for our country,
Erik: Thank you very much for having me. I appreciate being here.
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