— “After a year during which there has been very little good news about people’s reproductive health, this is the first solid win in a long time,” says BU gynecologist

By Molly Callahan

The FDA’s approval of the first over-the-counter birth control pill in the United States could be a revolutionary change in birth control and reproductive health, says Katharine O’Connell White, an associate professor of obstetrics and gynecology at the Boston University Chobanian & Avedisian School of Medicine.

White, who is also vice chair of academics and associate director of the complex family planning fellowship at Boston Medical Center, says she felt “jubilation and glee” at hearing news of the Food and Drug Administration’s approval of Opill, a hormonal birth control pill, on Thursday.

“After a year during which there has been very little good news about people’s reproductive health, this is the first solid win in a long time,” she says. “And it finally puts the United States on par with most other countries in the world, where people have always had access to pills without a prescription.”

The news was received with support from almost every major reproductive health organization in the country, including the American Medical Association, the American College of Obstetricians and Gynecologists, the North American Society of Pediatric and Adolescent Gynecology, and the American Academy of Family Physicians.

The FDA’s approval comes amid myriad legal battles over reproductive rights—and almost exactly a year after the Supreme Court overturned Roe v. Wade, rescinding the right to abortion nationally.

Perrigo Company, which manufactures the pill, says it will likely be available in stores and from online retailers in the United States in early 2024.

BU Today spoke with White about the safety and effectiveness of Opill, as well as questions that still remain about its rollout and accessibility.

Q&A

with Katharine O’Connell White

BU Today: Based on what you’ve seen or read about Opill, how effective is it compared to other, prescription or nonprescription, birth control options?

White: The pill that got approved for over-the-counter use is a progestin-only pill. There are two types of birth control pills: the vast majority of pills—the ones you think about when you hear “The pill”—have estrogen and progesterone in them. But a few varieties are progestin only, for people who can’t or don’t want to take estrogen. So, this pill looks to be like other progestin pills. And all pills have roughly the same effectiveness rate—that they’re about 97 percent effective when taken perfectly, and about 93 percent effective when taken like a typical human being.

So, it’s a very effective method of contraception. And it’s now the most effective birth control that you can buy at the drugstore without a prescription. When you compare it to condoms and spermicides, or Plan B and other emergency contraception, all of those are effective, but they’re not as effective as a daily birth control pill.

BU Today: It sounds like in terms of effectiveness, it’s not necessarily better to get a prescription birth control pill vs this over-the-counter version. Is that correct?

White: So much of it is about access, which sounds like an advocacy talking point. But access has a real impact on people’s lives.

From the medical perspective, there’s no difference between a pill you take by prescription or a pill that you would then get over the counter. But the best birth control method for any given person is the one they’re most likely to take. And to take consistently. And now, we have a method that is not behind the walls of a doctor’s office. You don’t have to go in for a visit or a pap smear or even just get through on a telephone line in order to access this birth control. You can just walk into a place and get it and take it. That, for a lot of people, is going to be the key to feeling in control of their birth control.

BU Today: Do you see this as a step toward equalizing access to birth control or reproductive healthcare?

White: Hopefully—although I’m hesitant.

What’s really great about this is that it’s finally a highly effective method—a hormonal method—of birth control for which you don’t need medical insurance and you don’t need access to a doctor. This is great news for people who work weekdays and can’t get to a doctor’s office because they can’t take the time off of work. It’s great news for people who don’t have health insurance, or who are underinsured, meaning their insurance doesn’t cover a lot, or any, contraceptive methods. If you are new to this country and don’t have health insurance or if you are in a new job and in a new state and don’t yet have access to your insurance, this is going to help.

I’ll also add that this is birth control that you do not need to persuade [a healthcare provider] that you should take or want to take. It is a completely independent decision that you get to make, and that’s important.

The reason I’m hopeful that this will equalize access, but not certain, is because we don’t know how much it’s going to cost. And so it’s only an equity issue if everyone can actually access it. The company says that it’s committed to widespread access for the pill and that it’s going to have some kind of voucher or savings program for people who don’t have insurance coverage. Along with advocacy groups, it is going to push for coverage by insurance companies so that even though it’s over-the-counter, you can still use your insurance card, like you can in many places for emergency contraception, or until recently, COVID tests. But we need to see what the sticker price is.

BU Today: Besides the price, are there other things that you, or your colleagues in the medical community, are waiting to learn?

White: The implementation of something is always important. For example, when emergency contraception first went over-the-counter, it was actually, in a lot of cases, behind-the-counter. You had to ask a pharmacist for it, which meant that not only did you have to have a conversation, and possibly justify why you wanted something, there was a chance they would say no.

I want to see this product on the shelf, next to Plan B, next to KY jelly. I want it to be as easy as just taking it off the shelf, putting it in your cart, and checking out.

I also wonder: is it going to be behind in a clamshell? Are you going to have to get an employee to unlock it for you? Are you still going to have to deal with people’s judgment? Will mom-and-pop pharmacies refuse to stock it? Will Amazon stock it? Will national pharmacy chains make it available online? Because in that case, I can get it with my ibuprofen when I do an Amazon run. All of this remains to be seen. But I’m hopeful.

BU Today: Are there certain populations who might find an over-the-counter hormonal birth control option especially helpful?

White: Adolescents—you might not want to ask your pediatrician, who’s been seeing you since you were a baby, about the fact that maybe you need birth control. Adolescents are also people who maybe haven’t yet figured out how to get to the doctor on their own. Maybe they don’t have a car or don’t have access or even know how to navigate the system to try to get their own gynecologist. Now, they can just take matters into their own hands and get it.

I also think anyone who is on someone else’s insurance, where an explanation of benefits goes home whenever you have a visit with a provider or get a prescription filled. An over-the-counter option leaves less of a record. So if you are in a situation where you are not wanting your parents to know or not wanting your partner to know, this provides another layer of protection.

For people who have medical problems, whose doctors just tell them not to have sex so you don’t get pregnant—which is actually a thing—and don’t know who to turn to for advice, they can now do their own reading, decide this might be right for them, and then access it on their own. People who just changed jobs and whose new insurance hasn’t kicked in, or who have not yet found a new doctor. People who’ve just moved to a new state.

There are also all these situations during which there can be gaps in birth-control use. Let’s say you are a prescription-pill user or a patch or a ring user, but you find yourself in this position where you’re between insurance providers, between doctors, between homes, you then can just go get a pack [of birth control pills] to bridge that gap.

Or people who travel and forget their pack. You’re crazily packing for the airport, and you realize you’ve forgotten your pills. No worries, you can just go get a pack and take those pills for a week and then resume your birth control back at home.

This means that birth control doesn’t have to be this precious, Hope Diamond–like resource. Now, your birth control pills can be available to you whenever you need them, wherever you are. That is revolutionary. No one should have to fight for birth control. And now you have an option where you can just go get it.

BU Today: What about from a safety viewpoint? Is it safe to take these over-the-counter pills?

White: I think there’s a natural hesitancy to embrace something as safe, especially when, for so long, people have been telling you that it’s not. There’s this idea that, ‘Well, we’ve had birth control pills for 50 years, why hasn’t it been available over the counter until now? Is it actually safe?’

It’s so important for people to know that we have reams of good evidence about how safe the pill is. There are very few people who cannot use this pill, and it is very well labeled for who shouldn’t use it.

There’s a very small group of people who can’t, and everybody else can use it safely. People who have breast cancer or certain kinds of liver disease or certain kinds of benign liver tumors, and some people with lupus, should not use this. But people who have the kinds of conditions on this list are people who are already plugged into a healthcare system where they can get access. The vast majority of healthy people who don’t need to see doctors can all take this.

BU Today: What should people who might use this as their first hormonal birth control know?

White: One of the common side effects of a progesterone-only pill is irregular bleeding. This might be occasional spotting, it might be bleeding more days than not, though not usually as heavy as a period. If people are not prepared for that, it can be very surprising. I’ve had more than one patient who stopped their birth control pills when they were spotting, because they thought that meant either it was making their body sick or that it wasn’t working. My message is that you may have weird bleeding for three months, possibly even a little longer. And that is normal. Weird is normal when it comes to bleeding on this pill. So don’t be alarmed.

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