The Daily Signal - INTERVIEW | Dr. Donna Harrison Explains Lawsuit Against FDA, Says Agency Illegally Approved Chemical Abortion Drugs

Episode Date: December 9, 2022

A group of medical doctors and organizations argues that the U.S. Food and Drug Administration illegally approved chemical abortion drugs, and has filed a lawsuit to remove such pills form the market.  “We believe that women should be empowered with accurate information, and what we’ve seen in this chemical abortion push is deception from square one, and this is wrong,” says Dr. Donna Harrison, a board-certified OB-GYN who is chief executive officer of the American Association of Pro-Life Obstetricians and Gynecologists. The Christian legal organization Alliance Defending Freedom recently filed suit in federal court on behalf of four physicians and four groups, including Harrison’s organization. Harrison and attorney Erik Baptist, a senior counsel at Alliance Defending Freedom, join this episode of “The Daily Signal Podcast” to explain how chemical abortion drugs first entered the market and why suing the FDA was necessary. Harrison also details what chemical abortion drugs do to a woman’s body.  Enjoy the show! Hosted on Acast. See acast.com/privacy for more information. Learn more about your ad choices. Visit megaphone.fm/adchoices

This is the DailySingle podcast for Friday, December 9th. I'm Virginia Allen. A group of medical doctors and medical organizations are saying the FDA illegally approved chemical abortion drugs, and they are suing to get the pills off the market. Today, I am sitting down with one of those doctors, Dr. Donna Harrison, a physician, board-certified OBGYN and the CEO of American Association of Pro-Life OBGYNs. I'm also talking with Alliance Defending Freedom Senior Council, Eric Baptist. They explain why they filed the suit and Dr. Harrison details what chemical abortion drugs due to a woman's body. Stay tuned for our conversation after this. As conservatives, sometimes it feels like we're constantly on defense against bad ideas. Bad philosophy, revisionist history, junk science, and divisive politics. But here's something I've come to understand.

When faced with bad ideas, it's not enough to just defend. If we want to save this country, then it's time to go on offense. Conservative principles are ideas that work, individual responsibility, strong local communities, and belief in the American dream. As a former college professor and current president of the Heritage Foundation, my life's mission is to learn, educate, and take action. My podcast, The Kevin Roberts Show, is my opportunity to share that journey with you. I'll be diving into the critical issues that plague our nation, having deep conversations with high-profile guests, some of whom may surprise you. And I want to ensure freedom for the next generation. Find the Kevin Roberts Show, wherever you get your podcast. A group of medical doctors and organizations have filed a lawsuit against the U.S. Food and Drug Administration over its approval of chemical abortion drugs.

One of the doctors suing the FDA, Dr. Donna Harrison, is a physician. board-certified OBGYN and CEO of the American Association of Pro-Life OBGYNs. She joins us now along with Alliance Defending Freedom Senior Counsel Eric Baptist. Dr. Harrison, Mr. Baptist, thank you both so much for being here today. Thank you for inviting me. Thank you very much. Well, Dr. Harrison, I want to start with you. You are part of this lawsuit that is ultimately seeking to ask the court to order the FDA

to withdraw chemical abortion drugs from sale in the United States. Could you just explain some of the history of how this lawsuit came about? Sure. Let me start with explaining the American Association of Pro-Life OBGYNs so that you will understand that our major mission is not only to protect the pre-born human being in the womb, but also the women who are their mothers, who carry this child. They are our patients. And what we've seen from the very beginning of the attempt to approve RU-486, Miphyprix, the abortion pill,

is that the pill poses dangers to women, significant dangers, and the further in pregnancy, the higher the risk. So the normal safeguards that should have been in place prior to this approval, they were never put in place. place. The way the approval was done was completely unscientific in that the approval was not based on two randomized, blinded, placebo-controlled trials, as was supposed to have been done, but rather on an industry-sponsored study that didn't have any control. It wasn't blinded, it wasn't randomized, it wasn't placebo-controlled. And because of that, the basic safety questions of how does this really affect women were never answered. And so it was approved without real safety and even without real good efficacy data. And that affects women. That hurts women. It causes women

to be exposed to a drug that's basically a little better than experimental. And that never should have happened. Mr. Baptist, I want to pull you in here. You are an attorney with Alliance Defending Freedom and you represent the pro-life doctors and the organizations that have filed this lawsuit. Could you just explain who these doctors are, who these organizations are, and why this legal action is being taken now? Yes, we have four medical associations and four individual doctors, including Applog, who Donna Harrison represents, and also the Alliance for Hippocratic Medicine, the American College of Pediatricians, and the Christian Medical and Dental Associations, as well as the these four individual doctors, one of which who resides in Amarillo, Texas, where our case is being conducted right now. And why we're bringing this case is because all these doctors, the individuals,

these associations, they represent doctors and patients who have been harmed by chemical abortion drugs. These drugs are pretty much pushed onto women and girls in the Planned Parenthoods of this country. And then these women and girls are kind of essentially pushed out the door and to administer their own abortions in their home. in their dorm room, in their bathroom, all by themselves without any medical supervision. And because this is a dangerous regimen that essentially induces labor and delivery, women are presenting themselves to emergency rooms. Frontline doctors, such as our clients, are the ones treating them for life-threatening bleeding,

life-threatening infections, and other complications. And so we're bringing this case to protect these women and girls, because as Dr. Harrison has noted, the FDA has never had the science or the studies to support the safety and efficacy of these drugs for use in the United States. States. And why now? The FDA, we have been challenging the FDA. Our clients have been challenging the FDA for over two decades on the approval and then subsequent elimination of necessary safeguards and protections for women and girls. But the FDA has stonewalled our clients and evaded responsibility for decades as well. The FDA, for those who don't realize, the FDA requires

folks to challenge them before you can go to a court to challenge any new drug approval. That's exactly what our clients did. They filed a challenge with FDA saying, you should never have approved this. You didn't have the legal authority. You didn't have the science to back you up. And the FDA stonewalled our clients for 14 years. They sat on that petition and did not rule on it. And the day they ruled on it in 2016, they changed the entire regimen. So we again filed another challenge. And just at the end of last year, they responded and denied our challenge. So this is the first time, even though it's been legal in the United States for 22 years, it's the first. time we can take chemical abortion drugs to court and put the FDA in trial for its neglect of America's

women and girls by approving these dangerous drugs and not including necessary protections for those who do take these drugs. And Dr. Harrison, you all make the argument that not only are these drugs dangerous for the women and the girls who take them, but you actually say that the FDA illegally approved chemical abortion drugs in America. Explain what you mean by that. How was the approval process of this drug illegal? Well, the FDA is required for the basis of an approval to have two blinded placebo-controlled trials.

Well, what does that mean? That means two trials that minimize the ability of the researchers to have bias. Because the bias was not controlled for and because the approval was done by the industry, by the very people who are going to profit from the approval, that was not a sufficient scientific basis for the approval. And furthermore, the study was done under a very different condition than what the drug was approved for. So the study was done where the patients had to be able to have access to an emergency room,

where there were doctors that had admitting privileges, where the gestational age, that is, how far along she was in pregnancy, was documented by ultrasound. All of that was done. But when it was actually released on the market, these were not adhered to. So we have no idea of what the actual real-world consequences are of this drug because no one, no one is tracking the complications. And further, the FDA approved under something called the subpart which was an emergency approval process for drugs that would treat dangerous or life-threatening conditions,

pregnancy is not a disease. It never has been a disease. Pregnancy is a normal physiological process. And this is a drug designed to interrupt a normal physiological process and cause the death of the human being inside the womb. This is not a therapeutic drug. This is a drug done with the intent of feticide of killing the human being in the womb. So not only was where the conditions did, different. And not only did the FDA not fulfill its scientific requirements, but they also approved it under the false premise that pregnancy is a disease, and it's not. So when a woman takes chemical abortion drugs, what happens in her body? So the first drug is a drug called Miphyprix, which is what the approval was based on, Miphyprisone,

Miphyprix. That drug is a progesterone receptor blocker. What does that mean? That means, That means that it blocks the natural hormone progesterone in a woman's body. The bad news is when you block that hormone in the woman's body, it blocks the ability of the woman's body to continue the pregnancy because the placenta, the organ that feeds the baby that's attached to the mom's womb, the placenta is nourished or is allowed to be sustained because of progesterone. But there's not only progesterone, receptors in the placenta, there's progesterone receptors in the woman's ovary, her breast, her brain.

The effects of that haven't been studied. So once the blockage of progesterone happens, then the baby can't get nourishment and it dies. But the baby would not be expelled most of the time, like basically only 4 or 5% of the time would the mom expel the baby within the first 48 to 72 hours after taking the Miphyprix. So, the abortionist gives the mom a second drug called mesoprostol or cytotech. Cytotech is a drug that's normally used to treat ulcers, but it also has the side effect of causing the uterus to contract, the womb to contract and expel the baby who's died.

So to add irregularity upon irregularity, the manufacturers of cytotech never ask for an approval for this indication. And yet the FDA unilaterally said, well, even though the manufacturers didn't ask for the approval, we can't approve Mipaprax without approving it with the use of mesoprostol. So we're going to approve both as a regimen. And that's never been done before. The FDA has never approved a drug for an indication that the manufacturers have not requested. So it's just the irregularities mount one after another. And do we have any way of knowing if there are medical complications that have taken place with women who've taken these drugs?

Yes, we do. We know a couple of things. We know that there have been adverse event reports submitted to the FDA. So when the FDA initially approved the drug in 2000, one of the post-marketing requirements was that the abortionist report complications to Dancoe, who's the manufacturer of Mephyprix, and Dancoe would then report those complications to the FDA. So I personally, with the whole team of other doctors, reviewed the over 5,000 adverse event reports as of 2019, and we classified them. There were thousands of life-threatening situations.

There were deaths. The life-threatening situations would have been deaths, except the woman had access to emergency room services quickly enough to save her life. There were serious complications. talking transfusions. There was one case of a woman who had to have 10 units of blood transfused. Now, we normally have about five units of blood in our body. So that gives you an idea of how serious the hemorrhage is with these kinds of drugs. And so we know that that represents

about 1% of the actual adverse event reports. How do we know that? Because in other countries where a country owns the medical record, we know that up to seven weeks, about 5% of women are going to have complications that require emergency intervention. And up to maybe one out of five, depending on their gestational age, depending on how far along in the pregnancy that she is

when she takes the drug, she may need surgery to complete that, to complete the abortion. We also know that after 10 weeks of pregnancy, when you get up to 13 weeks and 14 weeks of pregnancy, we know that one out of three women are going to have to have surgery most of the time for excessive hemorrhaging. So we have data, and we know how many, approximately,

how many of these pills have been used because the manufacturer is required to keep that data. So we know that the adverse event reports reported to the FDA represent less than 2% of the actual adverse event reports that have been going on. And I participated in a secondary study which looked at a publication by a woman named Cleland, who published Planned Parenthood data for just 2009, 2010, for a couple years. And we looked at the adverse events published in that document and compared them with the adverse events reported to the FDA. And we found that the FDA only had a fraction of the

actual adverse event reports reported by the Planned Parenthood document. So we know from multiple different sources that the adverse event reports only represent a small fraction of the actual damage and harm that's being caused to women in this country by these drugs. Dr. Harrison, I want to ask, you know, I know that there are individuals who will argue, who are arguing and raising concerns that if the, um, if the, um, if the, um, If the chemical abortion drug is no longer available, you know, for sale kind of legally, and if it's pulled off the shelves and the FDA, you know, loses its approval of the drug, then it's just going to create a black market for abortion drugs.

What's your response to this? There's already a black market for abortion drugs, and it's being promoted by the abortion industry itself. The whole idea that there are currently now 70 different websites where a woman can go and order drugs, abortion drugs, without any idea of how far along she is, without any idea of whether or not she has an ectopic pregnancy. And unfortunately, the abortion industry is promoting this. This is the black market, and it's promoted by the very people who profit from abortion. And what's even worse is that the abortion industry will moan and sigh about illegal abortion or unsafe abortion, and yet they're the very ones promoting unsafe abortion

right now as we stand, even while Mifaprex is still legal. Mr. Baptist, has there ever been an instance in the past where a court has ruled to pull a drug off of the shelves that the FDA had already approved? Yes and no. Most of the time when we see this instance, it's usually when a brand manufacturer sues over the approval, the generic approval. But rarely do you see the FDA gets sued, or almost never, over an approval of a new drug. And part of that's because FDA has kind of rigged the system and by itself, it's regulations of requiring us to go to the FDA first to challenge its approval and then only going to court to challenge it. So this is unprecedented in many ways.

And where does this case stand right now? We filed our lawsuit back in November. And at the same time, we filed a lawsuit, we filed a motion for preliminary injunction, and essentially that's asking the court for expedited review of a lot of our claims early on. So we're hoping to get an answer from the court within months as opposed to a year or two. So we're hoping to get this all filed and briefed up with the court by February, and then the court can rule shortly thereafter. Okay. And what does the process look like going forward? I mean, is this a case that we could see rise to higher and higher courts and even maybe the Supreme Court would rule on something like this? We're playing at one court at a time.

I don't really want to predict where it would go, but you can assume if the government gets an adverse decision, they would likely appeal it because it's very important to the Biden administration to have chemical abortion drugs available and widely available as it is. So what we're hoping for is a quick ruling and hopefully a positive ruling. But the next thing to see is actually the government's response to our complaint and to our motion for an injunction because it will be very interesting to see how the government defends its actions because a lot of it, in my opinion, and our arguments, it's indefensible.

The failure to actually study the regimen in its labeled use, the failure to study the impact of these drugs on pediatric populations as required by law, they're supposed to study the impact of these hormone-blocking drugs on teenage girls who are allowed to take chemical abortion drugs, but they fail to do so. And so to me, the law is pretty clear, and what the FDA did is in flagrant violation of it. Dr. Harrison, I want to give you the last word here, you know, for yourself as a medical professional and for the other medical professionals who are involved in this lawsuit with you, why do you feel like this is a fight worth fighting? I'm sure there's lots of other

things you could be doing with your time, investing that time in your medical practice. Why take on this fight? I personally am a firm believer in informed consent for patients. And I, as an OB-GIN and as the head of APLG, and Applog itself, we believe that women should be empowered with accurate information. And what we've seen in this chemical abortion push is deception from square one. And this is wrong. This is wrong for our patients. And even abortionists have said, and have been quoted to say, medical abortion is a lousy way to do an abortion. So women, it's our patients that are being hurt. It's our patients that are being lied to. And it's our patients who are being abused in this way. And we think that's worth

fighting for our patients. Dr. Donna Harrison and Alliance Defending Freedom Senior Counsel, Eric Baptist, thank you both so much for our time. We really appreciate you joining today. Thank you for having us. Thank you. Well, thanks so much for joining the conversation. We always appreciate you all taking time out of your day to join us right here on the Daily Signal podcast. If you have not had the chance already, be sure to take just a moment to leave us a five-star rating and review on Apple Podcasts or wherever you like to listen. It's so helpful for us when we get to hear your feedback and know what you all like about the show, areas that you want to see improved, things that we should

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