Why is the FDA Approving Over-The-Counter Birth Control?

Heritage Explains

Why is the FDA Approving Over-The-Counter Birth Control?

The FDA has made a ruling that a particular kind of birth control will be available over the counter. Heritage Researcher Emma Waters explains why conservatives should oppose this rule, and how it’s related to earlier conversation

John Popp: From The Heritage Foundation, this is Heritage Explains.

Mark Guiney: The first modern pharmacy in America was built by Charles Marshall in Philadelphia, Pennsylvania in 1729. Marshall was an Irish immigrant and proud American Patriot who was an instrumental figure in the Revolution. His store operated for nearly a hundred years and served a critical role in the development of standardized practices of safe and effective medicines.

Today, pharmacies can be found in nearly every town in America. Most of them sell not only pharmaceuticals and over-the-counter medications, but also food, clothing, toys, greeting carts and cosmetics. A recent FDA ruling has determined that a new item may be added to those on offer, and quite a controversial one: oral contraceptives, more commonly known as birth control. The implications of this decision are far-reaching. And here to explain is Heritage Research Associate Emma Waters.

Emma Waters: I am a research associate and the Richard and Helen DeVos Center for Life, Religion and Family. And so, in particular, I work with abortion and reproductive technology here at Heritage.

Guiney: And you are just back into the building?

Waters: Yes.

Guiney: What took you away?

Waters: I had a wonderful four-month hiatus to spend time with my newborn daughter.

Guiney: How’s it going?

Waters: It’s going so well. She is laughing and giggling and we’re convinced that she says Mama now, so she’s a child prodigy in the making. And she just started rolling over too, which is terrifying. So we can’t leave her in any one place and trust that she’ll stay there when we get back, but it’s been so good.

Guiney: So you would recommend it?

Waters: Oh, highly recommend, yes. If you’re married, you should have as many children as you can, soon.

Guiney: Well, that’s great because today on the podcast we were talking about contraception and specifically some of the more recent legislation that’s come out surrounding that particular issue. In particular, the Food and Drug Administration, the FDA, has announced that now a variety of the birth control pill will be available over the counter starting sometime next year. Right? That’s the plan?

Waters: Yeah. Yeah, that’s right. Yeah, starting early 2024, they expect Opill, the first over-the-counter birth control to be available for anyone. Most concerning is that there aren’t any age requirements. And knowing the Biden administration and how terrible they are on sex and gender, they also haven’t made any statements about it being restricted to biological women, which could mean that biological men who think that they’re women or are otherwise confused could also have access to this very powerful hormonal drug.

Guiney: Wow. So just to be clear, the way this works, this means that really anybody could walk into a pharmacy, buy birth control off the shelf. However, a lot of people would say, “Well, you could buy a lot of things that you could potentially harm yourself or someone else with at a pharmacy over the counter. Why is this a particularly bad idea?”

Waters: Yeah, most over-the-counter drugs that you can purchase are things Neosporin or Bengay or other things that are meant to address temporary and generally not severe issues. So not something you need to go to a doctor for, not something that’s really going to change your biological makeup. And so these are also typically drugs that have a long history of positive reviews that have shown that they don’t have adverse effects on other people.

With this new approval for birth control being over the counter, this is the first time that, one, birth control is available over the counter, but specifically that such a powerful drug that affects a woman’s hormones so significantly is just available without any sort of in-person doctor’s visit, which is typically what it takes. And for those of you who aren’t familiar, when you are being put on birth control, typically a doctor will do an array of hormonal tests to see what it is the woman needs, what her body is like.

And oftentimes, it can take trying up to five different kinds of birth control to find one that actually works well for the woman’s body. And even working well for the woman’s body might not be good. I think many of us are familiar with the fact that doctors, starting at age 12, will just try to put girls on birth control it’s candy, even if they’re periods are fine and they’re not having sex and there’s not really a need for it aside from that; it’s just the standard procedure thing.

But the problem is that there are many well-known side effects with birth control that I think most women are probably intimately familiar with: things like weight gain, excessive acne. It really affects your mood, so adding to depression, anxiety, or even somewhat bipolar symptoms where you’re really high one day, you’re really low the next day, or you find yourself very angry and aggravated and not able to regulate yourself emotionally like you would like to. But it can also actually affect even your period and bleeding itself, which can be a very painful thing.

So sometimes birth control can alleviate those symptoms, and sometimes it makes it a lot worse if it’s not a good fit for your body. And then on top of that, for women who have been on birth control for a long time, it can impact your fertility. There are cases of women who have been on birth control for a decade or more, and then they go off of it and are ready to start a family with their partner and then find that it’s a lot harder than they thought because for years... With birth control, it’s typically either progestin or estrogen. The one that was just approved is just progestin, which is important for some of the side side effects. But what happens is birth control actually tells your body that it’s pregnant all the time. And so rather than functioning in a normal state of the potential to become pregnant and then not, it just tells your body that it’s constantly pregnant.

And so then after a decade or more of that, when you’re actually trying to get pregnant, it doesn’t work right for your body because it’s like, “Oh, well we’ve been in this state for a decade. You want us to do something different now?” And now you’re actually trying to conceive a child with it. So the impact that it has on the lives of women and couples is really massive. And so the fact that this has now been just approved as an over-the-counter drug completely downplays all of those things because when you see over the counter, you assume that it’s something that even a 10 year old could use.

A 10 year old gets a cut, they put Neosporin on; that’s a safe thing to do. But a 12-year-old girl buying birth control who doesn’t understand the implications, who maybe doesn’t read the packaging correctly, this could have a very severe impact on her wellbeing that she would have no doctor or even adult necessarily overseeing with her.

Guiney: You also were telling me a little bit before the show about how birth control can have an impact on the decisions that people who are on birth control make. Can you talk a little bit about that?

Waters: Yeah, this is where it gets really fascinating. So there are two different studies that have been done when it comes to who women are attracted to when they’re on birth control. The first study is called the smell test. And so they took two groups of women, one on birth control, one not, the whole control group process. And they started both groups not on birth control, then they gave one control group birth control and then retested them.

So they gave women three different shirts, and they asked them to smell them and say which one was the most attractive to them. Pheromones and the scent can actually tell us a lot subconsciously about the other person when it comes to their immune system and their genetics. And so for the women who were not on birth control, they were most attracted to a scent that was most unlike them, which is very good for gene pool diversity. And it’s also very good for the children that are being created because it means that they’re most likely to have a wide array of immune-fighting bacteria and genetics that will actually help them thrive and make them less likely to get cancer or even just common things like the cold.

But for the women that were on birth control, they were most attracted to the shirt that smelled most like them, in many cases, the shirt of their brother. Because when you’re in this state of taking birth control and when your body is constantly acting like it’s pregnant, you are naturally drawn to things that make you feel safe, and so familiar scents, familiar odors, things that tell you you’re going to be well protected.

But the problem with that is, again, you’re most likely attracted to people that are most similar to you, which means the children that are then created, coming out of unions like that, don’t have the same kind of diversity and even immune system that they would otherwise have.

And so there are some really sad and just difficult moments where women who have been on birth control get married, are really attracted to this guy, they’re ready to start a family, and then they come off birth control, and all of a sudden they realize they’re not actually attracted to their husband anymore because their hormones have just literally changed the way that their brain works for so long.

And obviously they still love one another and that there is a commitment that will ride them through, and you can learn to work with these things. But that’s pretty traumatic to realize that this quote, unquote harmless pill that you’ve been taking has actually radically shifted the way that you’ve even been attracted to your husband.

And the second study is similar, but it asked women to select features or draw faces that they were most attracted to. Women who were not on birth control typically drew very masculine faces: sharp jaw lines, strong muscles, what have you.

And then they put half of the women on birth control and then a couple of months later asked them to select faces that were most attractive. And those who were on birth control, chose far more feminine faces and features that were most similar to them. And that gets into levels of testosterone and what’s attractive or not attractive. And so that’s not necessarily a bad thing, but it does go to show you that birth control has a powerful effect on the way that your body works and then even future fertility concerns that come with that of yeah, if you’re not attracted to your spouse, that’s going to make things a little awkward.

And marriage is wonderful, but anyone who’s married knows that marriage is hard. And the more things that you have to work through just complicate it further and are worth, I think, keeping in mind. And so the fact that most women don’t know about this when they’re put on birth control, I think, is really concerning because you at least should be aware of the full array of difficulties that you could face if you’re continuing on birth control for a long time.

Guiney: There’s also been some recent news about male birth control, which has gone slightly awry.

Waters: Yeah, a couple of years ago, and off an on recently, they were actually testing a male version of birth control, which included, I think they had an injection once every eight weeks that would lower their sperm count so that it was very unlikely that they could get a woman pregnant. And so as they’re testing this drug, they started having men drop out left and right. And the reason is because men were getting severe acne. They were gaining weight, they were finding themselves either very depressed or very agitated and aggressive, and their body was just not handling it. And they weren’t handling it, so they were like, “Forget this. We’re not about it.”

And they had so many men drop out of this study that they actually decided to pull the male birth control so that they discontinued the study so that it’s no longer even an option on the market. And so it was really funny ‘cause I had a lot of friends of mine who are maybe not conservative or not very conservative in their social values, who in that moment realized like, “Oh, this is actually not a very pro-woman industry” because the moment that men even suffered half of the side effects that women have just been expected to bear for decades, they cut the study, and yet they’re still dispensing birth control left and right to women and telling them, “No, it’s fine. You’ll get used to it. Not a big deal.” And it was a pretty big eye-opening moment for people.

But the fact that this is disproportionately put on women rather than if you, say, don’t have birth control and you’re in a marriage, it becomes a decision through natural family planning or other means that you make together rather than disproportionately harming one spouse or the other.

But even in lowering sperm count, there have been studies that show that not only is testosterone decreasing about 1% globally every year, but that sperm counts have been significantly decreasing globally. So this isn’t just limited to one region, but that everyone’s suffering from this.

So when it comes to male birth controls that then further lower sperm count or even female birth control that also potentially harms or limits their fertility, on top of the fact that we have a global fertility crisis, it seems like a very shortsighted solution to a much bigger problem where if we’re already struggling to conceive kids by and large, we probably shouldn’t be putting drugs in our body bodies that will further exacerbate that problem.

Guiney: A related issue would be that of Plan B. Can you talk about what Plan B is and some of the more recent developments we’ve seen, like on college campuses with vending machines for Plan B? What is Plan B? What’s going on?

Waters: Yeah, Plan B or the morning-after pill is marketed as will basically bar a fertilized egg from implanting in a woman’s uterine wall. And so typically a viable pregnancy is defined as a fertilized egg implanting on the uterine wall, in which case it can continue to grow and develop. Plan B will bar that from happening. And if you take it within 72 hours of unprotected sex, in most instances it will be quote, unquote successful.

So Plan B has been something that’s available in pharmacies for a long time now, where you can go in and purchase it with very little oversight. And even recently in Washington DC, there were a handful of universities that actually set up Plan B vending machines on college campuses. So you can go there, throw in your credit card, and then you get the Plan B pill to take.

Now, there’s many problems with this. One, the pill has to be stored at a very particular temperature for it to work. And if the temperature changes or the power goes out, these Plan B pills that students are falsely relying on could not work, which would be pretty jarring. Or the fact that with Plan B, similar to birth control, most women don’t know the side effects that come with it, which can throw your period off, have heavy bleeding, and again, it can harm your ability to get pregnant in the future if it’s used too much.

But this idea that contraception can just be easily purchased, easily accessible, is already in place with Plan B, and now with this new FDA ruling is in place with birth control.

Guiney: Perhaps even more dramatically is the recent Supreme Court case that’s come up surrounding Mifepristone, which is an abortion-inducing drug. Can you talk about what’s going on there?

Waters: Yeah, this is another place where people are really starting to call the FDA’s judgment into question and are suggesting that the FDA is being motivated by political ends, not actually medically-approved ends that are good for other people. With the Supreme Court case with Mifepristone, the plaintiffs are claiming that the FDA did not sufficiently test this at-home abortion drug before approving it on the market. And on top of that, they actually did a speedy approval process in order to get it on the market as soon as possible.

So with this first-step abortion pill, what happens is it cuts off the food supply to the baby effectively. So the baby is effectively starved and then dies. And then there’s a second step that you take that helps you basically expel the baby from your body. Now, with this FDA abortion pill, it’s only approved for women up to 10 weeks as of now. But most women don’t accurately know how far along they are, especially if they weren’t expecting to get pregnant. And so there are terrible instances of women who have taken this abortion pill and are up to 36 weeks pregnant.

And so not only have they killed a child that easily could have existed outside of the womb, but then they’re actually birthing this baby in their toilet at home. And so the emotional, psychological impact of it is huge because even at 10 weeks you see a small human with a little head and with arms and fingers and toes. And women aren’t told this. So Planned Parenthood will tell them to take it or dispense it to themselves and just be like, “Yeah, they’ll just be clumps of cells and fetal matter. And you won’t really see anything, so it’s not a big deal. Just make sure to flush when you’re done.” Incredibly grotesque way of going about this.

But instead, women are seeing small children come out of them and are not prepared for it at all and frankly are being lied to about what’s happening in that process. And so what happens for the FDA to have approved this like it did, they would’ve had to say that the birth control pill was a therapeutic benefit, a necessary therapeutic benefit to a very dangerous illness. And so in this Supreme Court case, what the FDA effectively said when they approved this abortion pill was that pregnancy is a very serious illness and that this birth control pill is a therapeutic alternative to pregnancy, which barely passes a smell test because most pregnancies are actually very healthy. You might not want to be pregnant, but your body actually knows what it’s doing and you’re fine.

And then on top of that, the birth control pill is in no way a therapeutic positive response to pregnancy. Even women who think that it is going in, across the board tend to have higher rates of alcohol or drug abuse, and then easily psychological pushback with depression and anxiety and lots of shame at what’s happened that they didn’t realize.

And this is something that the FDA had been pushing off for years. So different plaintiffs had written letters to the FDA, had asked them to reconsider their approval process, and they had ignored it for about 16 years until this case has successfully made it to the court. And it’s really looking like the plaintiffs will have a good argument in their favor ‘cause again, proving that pregnancy in and of itself is a dangerous illness is going to be a really hard case to prove in the Supreme Court.

One of the main concerns that we at Heritage have and others in the pro-life movement is that when you make birth control and over-the-counter pill, people are going to think about it like a Plan B. And so with birth control, for it to work sufficiently to ensure that you don’t get pregnant, you have to take it consistently every day, usually around the same time, so that your body is constantly on it.

Over a third of women report missing one or multiple days of birth control for any given reason, which means that they could easily get pregnant during that time. And if you’re relying on birth control as this easy solution to barring a pregnancy, in many cases it doesn’t work, especially if you do miss a pill every few days, every couple of months even. And so what we’ve actually seen in studies is that as birth control access increased, abortions increased because instead of people playing an active role, being very thoughtful in who they’re having sex with and their ability to get pregnant, they just think, oh, this one pill will take care of it, not a big deal.

And so with birth control being an over-the-counter pill, it’s actually more likely that you’re going to see more unplanned pregnancies, not fewer. And so in states that are very pro-life and choose to care for the woman and the baby rather than pushing them towards an abortion, they will have access and resources to help them. But in states that are still very pro-abortion, it’s just going to increase the demand in the worst possible way.

And again, women are not going to go into it trying to have an unplanned pregnancy. They’re just going to be using something that they haven’t adequately been, I think, prepared or taught how to use that will put them in even worse situations than before.

Guiney: As conservatives, we believe strongly in the value of life and in human flourishing in a family life, and it can be very discouraging to look at these issues. As you look at these issues, what do you think that people should think about as they do too?

Waters: Yeah, it’s a great question. I think first and foremost, we at Heritage have been celebrating the fact that when Roe v Wade was overturned in the Dobbs decision last summer, that life really did win and that that was a massive step and the right direction for the pro-life movement, but even just for the flourishing of Americans and all of the babies who have been saved that otherwise would’ve been aborted.

And so I think keeping that in mind and knowing that, when it comes to things like birth control or Plan B or even the abortion pill, that policymakers and everyday Americans and advocates in the pro-life movement have been taking very positive steps towards a better America, and that what we’ve seen in the last year is actually a series of wins, not losses. The fact that they pushed to make birth control available over the counter was directly in response to the Dobbs decision because they wanted women to be able to take control of their reproductive rights again or what have you.

So I think this really just comes to, one, parents of children, they have an incredible opportunity to steward the wellbeing of their children, to teach them that children are a gift, that we value life, even when life comes at times where it’s not exactly planned. The statistic that Guttmacher constantly says is that half of pregnancies in the United States are unplanned. But that doesn’t include the fact that there are just a lot of people who are married who get pregnant and have a kid who maybe weren’t quote, unquote planning on it, but were equally thrilled. And so they make the statistic seem really bad and scary when in many cases people are thrilled to get pregnant even if it wasn’t intended.

And so it’s cultivating that appreciation for life and knowing that policy, thankfully, is working in our direction in a lot of ways. And even though the FDA has ruled that birth control is an over-the-counter drug, it doesn’t go into effect until 2024, which means that there’s a long time for potential lawsuits or rebuttals to be put in place to try to slow this down, or at least have much stronger precautions put in place for who can access it and when.

Guiney: Thanks to Emma Waters for sharing her expertise on this show. And thank you to all of you for listening to Heritage Explains. Check out our show notes for more work by Emma Waters. You can also find her on Twitter at EML Waters. If you have any thoughts or feedback for us, send it our way at [email protected].

We’ve got a great show lined up for you next week. Maybe you’ve been hearing about the recent talking points from the left, calling for so-called ethics reform at the Supreme Court. Are we in an ethics crisis at the highest court in the land? Join us next week with Heritage legal expert Tom Jipping to find out. You’re not going to want to miss it. We’ll see you then.

Heritage Explains is brought to you by more than half a million members of The Heritage Foundation. It’s written and produced by Mark GuineyLauren Evans, and John Popp.

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