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Brian Lehrer: Brian Lehrer on WNYC. The big news from the Food and Drug Administration yesterday, for the first time, it has approved an over-the-counter birth control pill. In other words, a birth control pill women can get without a prescription. It's called Opill. Maybe if women controlled science for all those years instead of men, it would be men who have to mess with their hormones to keep their partners from getting pregnant, but we are where we are.

Let's talk about the science and the social implications of this news. We're very happy to have with us Dr. Colleen Denny, MD, associate professor in the Department of Obstetrics and Gynecology at the NYU School of Medicine and director of Family Planning at NYU Brooklyn. Dr. Denny, thanks so much for coming on and making the time. Welcome to WNYC.

Dr. Colleen Denny: Thanks so much for having me. This is a really exciting time.

Brian Lehrer: Listeners, we can take your questions right out of the gate about the over-the-counter birth control pill now approved by the FDA, or about contraception generally. 212-433-WNYC, 433-9692 for Dr. Colleen Denny. Again, 212-433-WNYC. You can call or you can text. What is this Opill that the FDA has approved?

Dr. Colleen Denny: The Opill is a form of a progesterone-only pill. Progesterone is a female hormone. It's a daily pill. People take it one by mouth every day, and generally, it prevents pregnancy. This is not an abortion pill. We're not in that conversation. This is just like other birth control pills that are meant to help people, prevent them getting pregnant in the first place.

Brian Lehrer: Now there are birth control pills that require a prescription and this one that won't once it actually comes on the market. Why is the FDA making that distinction?

Dr. Colleen Denny: Yes, that's right. Every birth control pill that's ever been on the market in the United States, and we've had both progesterone-only pills like Opill is, and also combined oral contraceptive pills for, I don't know, since the 1960s or so, but the Opill, the manufacturers that specifically went to the FDA and said, "This pill is so safe that we actually think it's appropriate for over-the-counter use."

There hasn't been, in recent memory, any oral contraceptive pill that's gone to the FDA with that request. It's not to say they wouldn't also qualify, but nobody's asked before. The FDA looked at the data. They have a very strict process for deciding whether something is safe for being over-the-counter, and much to their credit, they agreed, so we will now have our first progesterone-only birth control pill available just for purchasing right off the shelves just like you would Tylenol or allergy medicine or anything like that.

Brian Lehrer: How will you as a doctor, as an OB-GYN, advise women who want to be taking a birth control pill on how to decide between the prescription and non-prescription choices?

Dr. Colleen Denny: That's a good question. I think that there's a lot of things that go into people's decisions about contraception. As doctors, we often think that people want something that's highly effective. There are people who think about when they actually would like to have a child or a pregnancy in the future. People might come to the table with other medical conditions that influence what's safe, what's not safe, and some people just don't like pills.

Some people are terrible at taking pills, and this isn't a good option for them at all, so I think that all goes-- That goes into our conversations now about deciding whether or not somebody wants this form of contraception versus another form of contraception. In terms of deciding whether or not they want the over-the-counter pill versus something they get a prescription for.

I think that'll come down to their medical history and as well as, honestly, things like insurance cost, whether they prefer to have a regular period, or whether they don't mind having irregular spotting occasionally. Those are all the conversations I have with people now. I prescribe progesterone-only pills just like are very similar to Opill all the time. It's not like this type of pill is new. It's just this particular brand is going to be over-the-counter, and that's the big news.

Brian Lehrer: Well, how do you decide already whether to prescribe progesterone-only pills or progesterone-estrogen pills?

Dr. Colleen Denny: Generally, there are a few groups of people who shouldn't have estrogen-progesterone pills, and it's mostly the estrogen. These people are uncommon. Most people taking birth control pills tend to be young and healthy, but for someone, say, with a history of high blood pressure, someone with a history of problems with a stroke or clots, there are a number of other medical comorbidities that are listed out and the CDC has a great list for them, but those people shouldn't take estrogen.

In that case, if someone says they have that medical problem in their own history, but they would like to take a pill, they prefer that form of contraception, that's when I start talking them about, oh, well, there's also progesterone-only pills. Progesterone-only pills are safe for virtually all populations. All those groups I just mentioned, history of clots, hypertension, people who have recently had a baby, all those people can take progesterone-only pills safely. That's why it's so exciting that this type of pill and, honestly, so likely that this was the first one to cross the border over into over-the-counter availability. Progesterone-only pills are incredibly safe.

Brian Lehrer: In your opinion, should all progesterone-only pills become over-the-counter non-prescription?

Dr. Colleen Denny: I think that would be entirely appropriate. It really depends on the manufacturer of the pill to bring that back to the FDA and say, "We want you to look at this, again. We'll pay for the studies to prove safety and all those things." Now getting over-the-counter approval is a long process and really relies on the drug manufacturer themselves to initiate it, but I think if manufacturers are willing to go through that process, yes, I would be entirely in favor of progesterone-only pills being over-the-counter, and all the different formulations of progesterone that are out there.

Brian Lehrer: But not the ones with estrogen?

Dr. Colleen Denny: Well, that's a good question, Brian. The American College of Obstetricians and Gynecologists has actually gone on the record and said, actually, estrogen-progesterone pills should also be over-the-counter. We agree that there are some people, small percentage, of people who have medical reasons why they shouldn't take those pills, but people are able to know their own history and screen whether this form of birth control is acceptable for them.

The benefits of being able to access contraception and to avoid unintended pregnancy are so important that it outweighs that small risk of people having access to medicine that they would have to know is not appropriate for them. That hangs with other over-the-counter medicines. Something like, say, Tylenol. People with really severe liver disease, they shouldn't use Tylenol, but we still make it over-the-counter.

We say that the benefits of having Tylenol available to everybody outweigh this small percentage of a risk to people who may inadvertently take Tylenol, so that's the balance we strike with over-the-counter medicines. Going back to your question, I actually think that estrogen-progesterone pills should also be over-the-counter, but I think this is the low-hanging fruit of oral contraception. Progesterone-only pills are for sure safe for widespread use among almost all patient populations.

Brian Lehrer: Emma in Brooklyn, you're on WNYC with Dr. Denny. Hi, Emma. Thanks for calling in.

Emma: Hi, Brian. I'm a young woman, and I just want to preface this by saying I'm extremely pro-choice, extremely pro-access to contraception. I think that this development is wonderful. That said, I struggled for years with trying different forms of hormonal birth control pills and dealing with the mental health side effects of them. My doctor wasn't as helpful as I would have hoped in helping me foresee these side effects and handle them on my own.

I don't know. I don't even know how we begin to talk about this because it's so important that women everywhere have access to contraception and the contraception of their choice, but how do we talk about the potential mental health side effects of hormonal birth control pills especially now that this is becoming available over-the-counter?

Brian Lehrer: Dr. Denny?

Dr. Colleen Denny: Yes, and that's an important question. I'm sorry you had that experience. That sounds deeply frustrating. Usually, when I talk to patients just generally about birth control pills and they ask me about mental health side effects from hormonal contraception I say that, on average, we don't expect people to have changes in their mental health. There's not an average increase in depression or anxiety or things that we worry about, but I also say, that being said, that's just an average.

People can have responses to hormonal birth control that might make them feel like a mental health condition is worsening or emerging that they didn't have before. There are also people who feel much better in terms of their mental health when they're on hormonal birth control, and so that's what makes the average neutral. I always say to patients that is a personal reaction. No one should tell you that's not real. People can have all different responses to using all different types of medicines.

I think, as we go to look at this progesterone-only pill, the FDA reviews, certainly, mental health side effects in terms of safety, and again, on average, this Opill does not cause changes in mental health. We don't expect an increase in anxiety or depression, we don't necessarily expect all people to feel better, but some people will be in both groups so it ended up being a wash. I think it's part of a general conversation that we should really be having about, even as we're working to decrease barriers to access by making these birth control pills over the counter, we should certainly be working on all other fronts to make reproductive health care services better.

This isn't the end. Not everybody is going to want to take progesterone-only pills. We still have to make sure that people have access to their primary care doctors, but also reproductive health specialists who can talk to them about the other options that are out there in terms of contraception, how to manage side effects, whether or not something might be more appropriate for them. There are some forms of contraception that require a physician to place or remove.

We can't pretend that this is a band-aid that'll solve all of our reproductive health access issues or healthcare issues, right? This is all embedded in a system that needs a lot more fixes. Whether or not this is a net good for people being able to access reproductive health care without having to hack their way through the system to make a clinic appointment and to make sure their insurance covers seeing your doctor and find the pharmacy that'll take your drug benefits, that has to be a huge weight on the scale in terms of benefit.

I agree with you 100% That we have to make sure we're also working on all the other things that support people as they're making decisions about their sexual and reproductive health for sure.

Brian Lehrer: Emma, anything else you wanted to add?

Emma: No. Thank you so much for your answer. Yes, I agree. There's all sorts of factors to consider, but in general, more access is always better.

Brian Lehrer: Thank you. Thank you for your call, and keep calling us. 212-433-WNYC. Call or text. I'm going to read you a text message question that came in next, Dr. Denny. If you're just joining us, listeners, we're talking about the FDA approval yesterday of the first over-the-counter birth control pill for women. 212-433-9692.

Listener text, "Renewing my birth control prescription was the only thing that motivated me to make my dreaded annual GYN exam. Are there any concerns that fewer women will seek routine health care as an unintended consequence of this change?" Interesting question, right? Like Emma who just called in, it's another concern that somebody has about taking doctors out of the routine equation.

Colleen Denny: Yes, and certainly, I've had conversations with my colleagues that OB-GYNs about saying, even before the Opill came on the market, if I just automatically renew this person's birth control, will she ever come for a Pap smear or a mammogram or things that we know are important for health care generally and health care maintenance? I think that that's an unfair way to think about it.

I remember a colleague told me that, we shouldn't hold someone's birth control hostage until they're able to come in for their Pap smear just because we're worried that she won't get her Pap smear. That's not fair. What if we subjected her to an unintended pregnancy because she's a month late in getting her Pap smear? That's entirely inappropriate, and so I think decoupling birth control access and healthcare maintenance appointments, is appropriate.

We've had all these aspects of healthcare packed together for such a long time, but I think healthcare, generally, is going through a reckoning where we're saying like, we've had this system in place just because it was convenient for us as doctors, but it wasn't super convenient or appropriate for patients. They had to take time off of work, they had to make sure their insurance worked with us. They had to figure out childcare. They had to get to the clinic for our convenience, so we could do everything at the same time.

I have come around very strongly to the idea that access to safe, effective reproductive health care trumps all of those concerns. Like we were saying for the last caller, there certainly is bigger gaps in the healthcare system where we should make people be able to access healthcare, including preventative health care, more easily, but the idea that we should deny them other care, other safe care that they can manage on their own until they meet our criteria for that, I think that idea of thinking has to just be really examined for what it is. It's not fair to patients, and it's not an appropriate way for us to pack healthcare together unnecessarily.

Brian Lehrer: Miranda in Queens, you're on WNYC. Hi, Miranda.

Miranda: Hi, can you hear me?

Brian Lehrer: Uh-huh. Yes, you're on.

Miranda: I was just wondering how this is going to come into the political discourse about women's reproductive rights. I know that in a few states there's been legislation introduced about birth control provided in clinics, about Plan B pills, and other emergency contraceptives, so I'm wondering if you've seen any issues with that so far, or if you anticipate this becoming an issue at all.

Colleen Denny: Well, never say never in our current political climate, but I do think there's fairly good precedents for how we deal with over-the-counter birth control that already worked very smoothly. This is not the first over-the-counter birth control option available out there. We've had condoms. You can just walk into CVS and buy condoms. You can buy spermicide, and you can buy Plan B, which is the over-the-counter emergency contraception. All those precedents have been set.

Plan B is a little bit contentious sometimes, I think mostly because folks don't necessarily understand how it works, but all these are forms of contraception. They don't interfere with an ongoing pregnancy, they're not abortion pills. Opill, a progesterone-only pill like that, will certainly be on the side of preventing pregnancy, not interrupting an ongoing pregnancy. That is the science. The science is very clear.

Will there be people who try to block access to reproductive health care generally? There always are, and I think it's incumbent upon the states and the people actually rolling out the policies for this new medicine to be very concrete in terms of there's no age limit specified on this, you do not have to ask a pharmacist for this medicine, that these are the ways it's supposed to be marketed, this is the ways it's been approved by the FDA, and I think we have to stand by this.

In terms of whether it'll run afoul of existing regulations, it's well clear that. It's very obviously a contraception and not abortifacients. We will see how well we do in terms of promoting the science of what this is and making sure that people have a clear message. My hope is that, honestly, this is a way of people to take more control of their reproductive-- This is a way to prevent unintended pregnancies. This is a way to have fewer people who need abortion care. I think that we should promote ways that help people control their health in a way that's safe. I really would like to see more support on both sides of the aisles for this, but we'll see how that plays out.

Brian Lehrer: Yes, we will, because the right to privacy established around birth control by the Supreme Court in the 1960s, which was the legal basis on which Roe was decided, has now been rolled back, so in theory, they could go beyond Dobs and even overturn that Griswold decision as it was known from the 1960s. Maybe there isn't the political will to overturn a right to contraception like there is to abortion. To what you were just saying, do you expect this over-the-counter pill coming on the market to reduce the total number of unintended pregnancies in the US and therefore reduce the demand for abortion, or is it just way too early to speculate on that?

Colleen Denny: I think it's very early to speculate. The number of people who take a prescription for progestin-only pills is pretty low. Mostly because most people are taking the combined pill instead just because they don't have any medical reasons not to, and it tends to have a slightly more favorable bleeding pattern. Will more people use progestin-only pills once they're just available over the counter? I think that depends on so many factors that it's even hard to say. A large one of which is price.

If you can get a prescription birth control that's free versus paying $40, $50, or whatever, they end up pricing it out of pocket, people will make different decisions on whether or not they-- What kind of effort they want to put into actually seeing their doctor and getting that prescription and getting insurance coverage. Which is all to say it's hard to know how many people will actually end up using it, but I think the people we're trying to reach are people who cannot easily access a person who can write prescriptions.

We're trying to access to reach the people who don't have a healthcare provider, or don't have a good insurance, or don't have someone who can help them navigate the healthcare system easily. I don't think it has to be a net zero equation. It's not necessarily that people are going to switch to the over-the-counter birth control pill. It's where we're hoping is people will, who didn't have any access to contraception at all, will be able to access it, or people who are only using something that's less effective like condoms will be able to also use these birth control pills.

I think the hope is to bring more people into the group of patients who are using some form of highly effective contraception. That's the real goal.Not necessarily to pull people out of other categories.

Brian Lehrer: Few more minutes with Dr. Colleen Denny in the OB-GYN department at the NYU School of Medicine and Director of Family Planning at NYU Brooklyn as we talk about the FDA decision yesterday to approve an over-the-counter birth control pill for the first time. Angie-- Angela, I'm sorry, in Hastings-on-Hudson, you're on WNYC. Hi, Angela.

Angela: Hi, Brian. Hi, Dr. Denny. Earlier, you guys were talking about how people might prefer progesterone-only pills, but I didn't hear why some women still need or want the estrogen component.

Brian Lehrer: Good question. Doctor?

Dr. Colleen Denny: Yes, good question. Really it just, we learned in very early studies of birth control pill formulations, estrogen tends to make people's bleeding a little bit more regular. Like they have a more regular period. The main side effect that people notice with progesterone-only pills is they tend to have more irregular bleeding, like more unscheduled spotting. It's rarely very heavy but it can be just kind of bothersome or annoying for people.

It tends to be the most prominent right at the first couple of months and then it tends to even out a little bit with time. That's not dangerous, spotting, because you are taking these progesterone-only pills or having irregular cycles is not something that is problematic in terms of your medical health. It doesn't affect your long-term fertility, nothing like that, but just some people prefer to have a more regular predictable period. That tends to be what estrogen does.

When estrogen was added to the birth control pills, patients reported higher satisfaction with that aspect of it so many pills started having that formulation instead. Estrogen does have these risks for these certain medical conditions, so we have to be a little bit careful with that when we are prescribing it or whether people are thinking about whether they want to use that kind of pill, but it's just a historical fact about a patient preference rather than a medical comorbidity if that makes sense.

Brian Lehrer: Yes. I read that scientists are working on hormone-free birth control pills. Do you know how close they are to being developed or how that would work?

Dr. Colleen Denny: I don't know much about hormone-free pills. I think there's a lot of things that are always in the pipeline in terms of how we could provide good contraception. There are a number of hormone-free options. Probably the most well-known and the most effective is the copper IUD which is just a intrauterine device that provides long-term contraception but it's not permanent. It can be removed and people go right back to their regular fertility.

Then most of the other non-hormone options are things that are used at the time of sex, so condoms. There is a gel that is a contraceptive gel called Phexxi that came on the market a couple of years ago, but most of the other options we have do use female hormones. That's just the most effective and safe way we know to prevent pregnancy by stopping that cycle of growth and development.

Brian Lehrer: Do you see the biological possibility of a pill or other medical application for men? I guess somehow it would have to make the sperm non-active but to somehow take 100% of the burden other than condoms off women?

Dr. Colleen Denny: Yes, there's certainly a lot of interest in that among my patients and among my colleagues. There are some things that I've read about that are in trials, so not FDA approved for men, that both would basically decrease the sperm count to the level that would be very unlikely to make your partner pregnant but also don't give the men intolerable side effects. They're in the works, but we've heard that before, so we'll see if they actually make it to the point of FDA clearance

Then, of course, whether or not people actually use them. Having something on the market doesn't necessarily mean that people will use it or they'll feel comfortable asking their partners to use it. There's always the two-part aspect of contraception, Whether or not it's safe and effective, which the FDA is on top of, and then whether or not anybody uses it. There's a million things that go into that second question including patient preferences, insurance cost, availability, supply chains, and all those things are really hard to predict.

Brian Lehrer: Power equality or inequality in the relationship.

Dr. Colleen Denny: Yes, exactly.

Brian Lehrer: Last thing, last question from a listener. You kind of touched on this before, but I think it's worth dealing with it explicitly. Listener texts, "I worry that having all birth control pills become over-the-counter could make it harder for many women to get it because insurance won't pay for over-the-counter. Only prescription."

Dr. Colleen Denny: Yes. I think that's an interesting question. This is a very exciting announcement, of course, but I know a lot of groups are expressing their excitement and also discussing the idea that we need to put, really, a lot of attention on whether or not this is going to be priced at a range that people can afford. The Opill will be brand name. There will not be a generic available. We know the generic availability is a big factor in driving prices down.

I would love to see what happens if people start putting generic birth control pills over the counter. There's something along like generic Tylenol. That's quite inexpensive for most people, not all people, over the counter. That's affordable over-the-counter medicines. When the Plan B became generic a couple years ago that also pushed down prices over an over-the-counter medicine.

I think that it'll be interesting to see first what happens whether other currently available by prescription birth control pills decide to go back to the FDA and try to be over-the-counter. Especially what happens if one of them has been on the market for a sufficient amount of time, for 20 years, and is available as a generic form because I think that'll make a big difference in pricing.

That will give people more options which in turn will increase the market competition for the ones that might be trying to price at a higher level, but I certainly agree with the caller that we certainly don't want to push to a world where people are paying out of pocket for medicines that they used to be able to get at a much cheaper rate with prescription. The goal will always be to both decrease the access to care in terms of actually needing a prescription, but again, that second question, making sure that it's truly available to patients in a real way and price has to be a big part of it.

Brian Lehrer: Dr. Colleen Denny, MD, Associate Professor in the Department of Obstetrics and Gynecology at the NYU School of Medicine and Director of Family Planning at NYU Brooklyn. Thank you so much for coming on with us and talking about this news and answering listener questions. We really appreciate it.

Dr. Colleen Denny: Thank you, Brian.

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