FDA Has Made Abortion ‘Wild West’ With Rule Change on Drugs, OB-GYN Says

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The Food and Drug Administration has permanently changed its restrictions on abortion drugs. Following an official rule change in early January, women no longer need to see a doctor in person to be prescribed chemical abortion pills. The move, according to OB-GYN Dr. Ingrid Skop, is opening women up to the “Wild West” of abortion. 

“With all the removal of the restrictions by the FDA, it is the Wild West,” Skop,  a senior fellow and director of medical affairs at the Charlotte Lozier Institute, says. “We know there have already been documented cases of women much further along than 10 weeks who’ve been provided abortion pills by the boyfriend or the father of the baby who did not want her to be pregnant.” 

Abortion pills are only authorized to be used up to 10 weeks of pregnancy, but Skop says there “have been cases of 31-, 33-week infants being delivered because [the abortion pills will in] many cases not kill the baby, but it’ll induce labor because of the misoprostol.”

Skop joins “The Daily Signal Podcast” to explain why the FDA has approved the mail-order abortions for women and is now allowing pharmacies to fill prescriptions for abortion pills. 

Listen to the podcast below or read the lightly edited transcript:

Virginia Allen: Dr. Ingrid Skop is a senior fellow and director of medical affairs at the Charlotte Lozier Institute. Dr. Skop, thank you so much for joining us today.

Dr. Ingrid Skop: Thank you so much for this opportunity.

Allen: You have over 25 years of experience as a practicing OB-GYN, and today we’re talking about an issue that you are very familiar with, and that is the abortion pill. There’s so much debate right now, there’s so much conversation right now about this pill, how it works and what it means for the health of women. Can you begin by just explaining to us what exactly an abortion pill is and what happens in a woman’s body when she takes it?

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Skop: The regimen that’s been approved by the [Food and Drug Administration] consists of two pills. Mifepristone blocks the progesterone receptor, so it cuts off the hormonal support and kills the embryo or fetus. It’s followed generally in 24 to 48 hours by misoprostol, which induces contractions and causes the tissue to be expressed. Unfortunately, it doesn’t always work. Probably about 1 out of 20 times it will not express all the tissue, and the woman will require surgery to complete the abortion.

Allen: In the first week of January, we saw that President [Joe] Biden’s Food and Drug Administration announced that pharmacies are now going to be allowed to apply to carry abortion pills. Explain what exactly this FDA rule change is. Why is the FDA all of a sudden now giving the green light for pharmacies like your local CVS to sell these abortion pills to women?

Skop: The entire history of the abortion pill has been politicized. It was approved under President [Bill] Clinton. Under President [Barack] Obama, the use was extended from seven to 10 weeks gestation. The FDA said it no longer wanted to hear about any complications unless it killed the woman. Then, unfortunately, under President Biden last year, using the COVID pandemic as an excuse, the FDA took away all the in-person requirements. Until now, they’ve had pretty strict requirements about who can prescribe the pill and what the circumstances are.

Taking away that requirement meant the woman did not need to be in the room with the doctor, it could be telemedicine, and actually, women are ordering it online and getting it delivered to their mailboxes without any medical supervision.

This means there’s no physical exam, there’s no ultrasound to make sure that the gestational age is correct, to make sure the pregnancy is not in the fallopian tube where it could rupture. There’s no safeguards to make sure a woman is not being coerced into an abortion. No one’s doing labs to determine if she has an Rh-negative blood type and needs a RhoGAM shot to prevent future pregnancy complications. All of those things are such irresponsible things to do if you say that you care for the health of women.

And then, unfortunately, just a week or so ago, the Biden administration, the FDA approved distribution through the pharmacy. Again, taking it out of the supervision of medical doctors and putting it in the hands of essentially the women. The women are self-managing their own abortions with these medical abortion pills.

Allen: How can the FDA say that this is considered safe from a medical perspective, and how can the medical community say that this is safe, if a woman isn’t having to physically go into her doctor’s office to confirm that she is 10 weeks or less pregnant and it’s still “safe” for her to take the abortion pills?

Skop: Well, it’s clearly not safe. But what happens is they are relying upon studies produced by the abortion industry, and the studies themselves are a bait and switch.

For example, when they were doing studies to say, “Oh, it’s safe to provide these abortion pills to women without the doctor seeing it,” they were still requiring ultrasounds and labs. Actually, the woman’s interaction with the doctor was by telemedicine. But again, in these cases, they’re not getting the ultrasounds or the labs, so they approved it under a different protocol than actually is currently occurring.

And the abortion industry likes to promote this product and say, “Oh, it’s 98%, 99% effective,” well, the reason they can do that is because we have no mandatory complication reporting in this country. They are only counting the complications that they know about that come back to their clinic.

But again, these abortions are happening in women’s homes, and when women have complications, many times they don’t go back to the abortion provider, who in many cases didn’t tell them they could have a complication. They come to the emergency room, they come to doctors like me, their private gynecologist. Again, they say there’s 1% to 2% failures. I say good evidence from records linkage studies and from meta-analyses and from my own clinical experience is that it’s probably about 5% that have complications and need surgery.

Allen: From your time as a practicing OB-GYN for over 25 years, what were some of those common complications that you saw? When women came to you and said, “I took an abortion pill?”, what were both the physical issues that they were often experiencing and then just how are they doing as people?

Skop: Well, I just cared for one of these complications four days ago, so these are very common. I’m in Texas. This was a woman who left Texas because of our laws and went to Los Angeles to a clinic. Apparently, they did not offer her a surgical abortion.

Medical abortions have four times the complications of surgical abortions, and a woman that they know has come to them from out of state, if they truly wanted to care for her, they would offer a surgical abortion rather than a medical abortion, where she’s going to bleed all the way back to Texas.

But nonetheless, they gave her the medical abortion pills. She bled all the way back to Texas, and in fact, continued to bleed for two months. When she came to me, she had been bleeding for two months. She still had pregnancy tissue, and I needed to do a surgical aspiration procedure to help her complete the abortion. This happens frequently, and I’ve seen this both [in the] emergency room and in my office.

But another thing that happens frequently that the women often don’t talk about is the emotional ramifications of taking a pill, going into labor, and delivering your child in the toilet. At about eight to 10 weeks gestation, the fetus is about the size and shape of a gummy bear. He is clearly identifiable as a human being, and women are seeing this in their toilet, and we don’t know the emotional ramifications of that. They’re ashamed and they don’t talk about it.

Allen: How have women traditionally gotten access to these abortion pill drugs? What is the difference of now a pharmacy being able to carry them versus what has been?

Skop: Well, again, it used to be fairly tightly regulated, where a woman would get it from the abortion clinic, the abortionist would look her in the eye and would give her the pills, and in many cases would ask her to take the mifepristone, the first component, in front of them to make sure this is not being used by someone else, this woman desires the abortion.

But of course, with all the removal of the restrictions by the FDA, it is the Wild West. We know there have already been documented cases of women much further along than 10 weeks who’ve been provided abortion pills by the boyfriend or the father of the baby who did not want her to be pregnant. There have been cases of 31-, 33-week infants being delivered because it’ll, in many cases, not kill the baby, but it’ll induce labor because of the misoprostol. So, we know already that there’s inappropriate use of it happening.

I’m very concerned about pharmacists now that big chains like CVS and Walgreens and perhaps Target are saying that they’re going to provide it. What about a pharmacist who does not want to distribute a drug that’s going to end a human life? The coercion and the violation of the conscience of those pharmacists has not been discussed at all, but it’s going to be a problem.

Again, right now, a doctor has to decide they want to be an abortion provider and sign up through the [Risk Evaluation and Mitigation Strategy], which is a program that the FDA uses to distribute these drugs. But very soon, clearly that’s going to be taken away, and every obstetrician is going to be asked to provide these pills, every internal medicine physician, family practice physician, even pediatricians are being pressured to prescribe medical abortion pills. This is going to be a moral injury to health care providers to be not just asked, but to be pressured to provide abortion pills.

Allen: A moment ago, you said the FDA no longer wants to hear about complications with the abortion pill unless it results in the death of a woman. What do you mean by that? Is there no tracking at all of complications from any government entity?

Skop: Federally, there is no tracking. A few of the states have mandated complication reporting, but in Texas, we’ve had a mandate in place since 2018, and it has been my experience that many times emergency room physicians are unaware of this. So, there really is no consistently utilized system for people to report complications.

From the year 2000 when it was approved until 2016 when under Obama they loosened the regulations, it was mandatory to report complications to the manufacturer, but a [Freedom of Information Act] request and an analysis by some researchers that I’m familiar with documented that only about 5% of the expected complications had actually been reported. So even when it was mandated, it was routinely ignored by abortion providers.

Allen: Now, Biden’s Department of Justice, they have said that it’s OK for these pills to be mailed to women even in states where abortion is illegal, like in Texas, where you live. What exactly are your thoughts on mailing abortion pills to women? What is the implication of that moving forward in the modern age?

Skop: Well, unfortunately, it’s a demonstration that we live in a lawless society right now, that both federally and at a state level sometimes the people that we have voted into positions of authority are not willing to fulfill the laws.

Texas is a battleground, I think everybody recognizes that. Texas women are getting these pills. They are going out of state, getting these pills. We are saving lives. There are many women who, when they encounter the barrier, they continue the pregnancy and they grow to love their children, and it’s estimated that we’ve saved probably 5,000 to 10,000 lives with our laws. So, that’s a good thing.

But on the ground, I’m seeing more complications. I work part time still at a hospital and I alerted them the other day, “We’re going to see more. We need to be prepared to take care of these women.”

I’m not too far from the border, about two and a half, three hours. Abortion advocates are recommending that women go across the border and get misoprostol, the second component of the abortion pill. We’re seeing people bringing that across our porous borders, and they’re giving it to women.

And misoprostol fails even more frequently than mifepristone-misoprostol combination. Probably about 1 out of 4, 1 out of 5 women will not have a complete abortion with misoprostol. They’ll present to the emergency room in crisis in emergent conditions, and that is going to be quite a strain on the health care system in Texas.

Allen: When we think about the fight for life as a whole and that obviously, for so long, for almost 50 years, the pro-life movement, we were laser-focused on Roe v. Wade being overturned, now that that’s happened, there’s shifts, there’s changes. This debate over the abortion pill, is this in some ways the new Roe v. Wade for the pro-life movement to fight against? Or is this maybe just one component of a new multifaceted landscape when it comes to the conversation of abortion and the work that the pro-life movement has ahead?

Skop: I’m very proud of the people that have fought so long to have Roe overturned. I’m very proud of the states that are trying to protect the lives of their children. But in my opinion, legislation is not going to end this fight. It’s only going to slow the process down so that we can have a conversation.

Winning the fight for life is going to require changing hearts and minds. It’s going to require all of us who care about the issue to be educated and to be able to tell our friends and peers how abortion hurts women.

So far, the reason I think that a lot of people who really have good intentions, a lot of people support abortion because they have bought into the inaccuracy that it improves women’s lives, and there is no documentation of that anywhere.

Women have made great advances in the past 50 years. It’s not because they’ve had the ability to kill their children, it’s for other reasons. But I have seen so many women hurt emotionally and often physically, and so much socially. Right now, 40% of the babies in our country are being born to unmarried mothers. So, it’s destroyed the family structure.

There’s just so much, of course, to talk about, but we’ve got to be able to win hearts and minds. That’s how we win the battle. The legislation is only part of the battle. But again, we’re seeing that it’s going into so many other areas.

The other thing we’re seeing in Texas that is so frustrating is people are lying about what the laws say if a pregnancy truly poses a risk to a woman’s life. I’m seeing a lot of women who are not being cared for appropriately because the doctors are frightened. They’re frightened that the state is going to charge them with a felony if they do the right thing for a woman, and that is absolutely untrue. Every law allows doctors to use their reasonable medical judgment and intervene. If it means doing a pregnancy termination, they can do that based on what we know to be the standard of care.

So, there’s no reason that women should suffer. There’s no reason that miscarriages or ectopic pregnancies should not be taken care of. But we’re seeing that, because there’s all this media misinformation, the medical societies in so many cases are completely silent because their ideology is pro-choice, and they’d like to see these laws fail. It’s something I talk about constantly, but there’s just a dearth of information out there and doctors don’t really understand the laws.

Allen: It sounds like it’s a real lack of education. Who do you think that falls to? Is it the hospitals that need to be better informing the doctors? What role do you think politicians play in this versus the medical community?

Skop: I’m struggling with it. I’m trying to get the government of Texas to provide some guidelines to doctors, I’m trying to get the medical societies to provide guidelines, I’m trying to get the local hospital system that I work with. To be honest, I don’t know if it’s CYA, I don’t really know what the motivation is, but none of those three sources are really making much of an effort to help doctors understand what the law is, and that’s to the detriment of the health of women. It’s frustrating. I think it will eventually clear itself up, but it’s not happening fast enough, in my opinion.

Allen: Well, and in addition to being an OB-GYN, you’re also a senior fellow and director of medical affairs at the Charlotte Lozier Institute, and that is one of the things that you-all do, is research, is bringing facts and information to the public on the issue of life. If you would just take a minute and share a little bit about the work of the Charlotte Lozier Institute and what you-all do and how individuals can get involved and utilize the resources that you-all offer.

Skop: Well, thank you for bringing that up. I love the Charlotte Lozier Institute. It does a yeoman’s work. There’s not too many full-time employees; we utilize a lot of associate scholars. These are people who are experts in their field that when we need to write a paper or have someone perform testimony, we can tap them and say, “Hey, can you go do this?”

On our website, lozierinstitute.org, we have a lot of papers that explain various aspects of abortion. If your listeners are interested in learning more, which hopefully—none of us know enough, I don’t know enough either. So, it’s definitely worthwhile to go and read and educate.

It is a think tank that’s associated with Susan B. Anthony Pro-Life America, which is a very large pro-life lobbying group. And a third organization that is affiliated with us is called Her PLAN. This is an organization that is trying to connect resources in every state so that when women present with a crisis pregnancy, we can help them find housing, we can help them find food and clothing and emotional support, all of the things that they need.

We’re hoping to create a safety net throughout the entire country to show we care for women. We don’t think abortion is good for them. When they have a crisis pregnancy, we want to be able to offer them so many other options and choices other than ending the life of their child.

Allen: Dr. Skop, thank you for your time today. We really appreciate you coming on to join us, to share about what exactly is going on with the abortion pill and the road ahead. Thank you.

Skop: Thank you so much for this opportunity. I appreciate it.

Have an opinion about this article? To sound off, please email letters@DailySignal.com and we’ll consider publishing your edited remarks in our regular “We Hear You” feature. Remember to include the url or headline of the article plus your name and town and/or state. 

The post FDA Has Made Abortion ‘Wild West’ With Rule Change on Drugs, OB-GYN Says appeared first on The Daily Signal.

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