Q&A: Opill Ushers in New Era of Access to Birth Control
Stephanie Sober, MD, MSHP, investigator on the pivotal research that supported the prescription-to-OTC switch of Opill, shares insights on how the medicine is reshaping the reproductive landscape.
Oral contraceptives, pioneered in the 1950s, were the first drugs explicitly designed to serve a social purpose—a departure from traditional medicine focused on treating illness.1 This innovation was met with resistance, even from the FDA, which initially hesitated to approve the drug for contraceptive use. Although eventually greenlit by the agency, the discomfort surrounding birth control has persisted.
Birth control blister packs / areeya_ann - stock.adobe.com
For some women, this shame and stigma is enough to deter them from seeking the necessary medication. The bureaucratic process to obtain a prescription adds more challenges, as women must often navigate insurance hurdles, find a reliable health care provider, and deal with logistical issues such as transportation and wait times. This is particularly concerning given the reproductive backdrop of the nation, as more than half of the states in the US have banned abortion in its entirety.2
However, in the 6 decades since approval of the first birth control, contraceptive medicine has progressed rapidly. Last year, a major milestone was achieved with FDA approval of the first over-the-counter (OTC) birth control pill, Opill. The decision was supported by a study demonstrating that women could determine their suitability for contraception without a health care provider. Now, Opill is available on pharmacy shelves nationwide without a prescription.
Developers of Opill hope that its availability in pharmacies will help reduce the stigma surrounding the medicine. According to Stephanie Sober, MD, MSHP, global director of medical affairs for women's health at Perrigo and investigator on the pivotal research that supported the prescription-to-OTC switch of Opill, in an interview with Drug Topics, the science is simple. "The more [contraceptive] options [people] have and the easier access [people] have, the more likely people are to find something that works for them and to be able to continue it," she said.
READ MORE: How Pharmacists Are Expanding Reproductive Care Access
Drug Topics: Can you tell us about the study that supported OTC FDA approval of Opill? Specifically, how did the study demonstrate that women can effectively determine their suitability for Opill without consulting a doctor?
Stephanie Sober, MD, MSHP: One of the key things to understand here is a little bit about the FDA process for prescription-to-OTC switches. It’s a fairly standardized and quite rigorous process especially for a first-in-class switch, which was the case with Opill, since there was no other OTC birth control pill available prior to this. We had to do all the steps, which is not necessarily the case when other products that are similar to OTC products are coming onto the market.
But there are a few key steps in that process. The first is that you need to develop a label. Any OTC medication you're probably familiar with, if you look at the back, it has that standard Drug Facts label template on it. You need to figure out how to get all the key information that consumers need to use the product appropriately into that little template. That piece of the process is actually a big chunk of it and involves numerous studies.
It’s really an iterative process where you test the template with consumers—test a draft—and then go back and see the places where they maybe didn't understand quite as well. Then, you try to make it more easily understandable and go back and test it again. You keep doing that and honing the label until you get to the point where you feel as though it is well understood by the consumers that you're trying to target.
Once the label has been developed, you then take it a step further and do what's called a self-selection study, where now you are going to consumers and no longer asking them hypothetical questions about another person. For example, in a label-comprehension study, you would ask somebody something like, “Sally is pregnant. Is this product appropriate or not appropriate for Sally to use?” But now, with the self-selection study, you're asking about the person themselves, and so they are taking their own medical history into account. So now they're thinking, “Do I want to use this, and is it appropriate for me based on my own medical history?”
Once you do the self-selection part, then you do what's called an actual use trial, where the folks who have decided that the medicine is appropriate for them and they want to try it, then take the product home and use it using only that Drug Facts label. So, no involvement of a health care provider.
Then you monitor it in some way. In the case of our study, we had folks record in a diary whether they took their pill each day, whether they had sex that day, and if they missed a pill, whether they took appropriate actions based on that. What we found, as you might imagine, since the directions for taking Opill are not all that complicated—they’re just to take 1 pill at the same time every day—we found that people really were able to do this and use the product appropriately without the involvement of a health care provider. People did it actually really, really well.
In our self-selection study, 99% of people were able to appropriately choose whether the product was right for them. And then in the actual use trial, on 97% of the days in the trial, folks either appropriately took their pill or took appropriate mitigating action if they missed their pill. So, we found—not all that surprisingly—people can do this on their own. That data was part of the package we submitted to the FDA that led to the ultimate approval of the switch.
Drug Topics: How has Opill changed the dynamic between patients and health care providers? Do you believe it has opened new avenues for patient education and empowerment?
Sober: This is a tremendous achievement, and a game changer. I think it definitely opens up new access and new avenues for empowerment and increased options and increased choice.
In terms of the relationship between patients and health care providers, though, I think we may see lots of different things. For people who do have access to the health care system and have a provider that they want to see, this doesn't change that. They can still see their provider if they want to have a conversation about contraceptive options.
The important thing that this does, though, is for folks who don't have ready access to a health care provider. This opens the door for them to have access to a more highly effective contraceptive option than what was previously available OTC. Because, you know, when you think back to what was previously available, it’s things like condoms and spermicides, and those unfortunately fall into the less effective contraceptive methods. So now we're giving folks who don't have that access to the health care system increased options and freedom to choose a new option.
One important thing to note is that there are many folks in this country who live in what are called contraceptive deserts. The number is around 19 million women who live in these areas. To be deemed a contraceptive desert, there has to be a lack of access to the full range of birth control options. That’s quite a large number of folks who, depending on where they live, wouldn't have access. And so, this really does open opportunities for them to access a more highly effective method of contraception.
Drug Topics: Historically, birth control has faced significant stigma and shame. How do you think the availability of OTC birth control can help destigmatize reproductive health care and encourage open conversations about contraception?
Sober: This is extremely important, and hopefully the availability of Opill, and raising awareness about Opill and providing education about it in a stigma- and shame-free way, can really help to open lines of communication about contraception more generally.
Getting birth control should never be a process that involves shame or stigma. But as it was previously, having to jump through hoops and navigate barriers—certainly some of that has come into play. We hear stories from folks who feel that they haven't had a positive process acquiring contraception. So, hopefully by providing them a new option where they can avoid some of those barriers, but also trying to promote people getting educated about their reproductive health and contraception more generally, we can help to tamp down some of that stigma that does exist.
Drug Topics: What are the potential benefits of OTC birth control in terms of improving access to contraception, particularly for marginalized populations who may face barriers to health care?
Sober: The impetus for this switch was an unmet need in this country for access to contraception. We know that even with all of the contraception methods that were previously available, almost half of the 6 million pregnancies that occur in the US each year are unintended. Some of that is because folks either don't have access to contraception or have barriers to accessing contraception. And we know that even folks who are getting their prescription from their doctor, if there's some interruption in that care that causes them to be in need—all those things were really part of the reason why this was such an important and groundbreaking achievement.
I still work clinically, part time at this point, but those of us who prescribe contraception and do this as part of our clinical work know that the more options you have and the easier access you have, the more likely people are to find something that works for them and to be able to continue it. Even folks who want to have children at some point in their life can spend over 30 years trying to prevent getting pregnant. And what they need and what they want can change, and that's fine, but this certainly can fill in the gaps for those who can't get access in other ways, or who just don't want to have to deal with the health care system and want a highly effective and safe method of birth control.
Drug Topics: Looking ahead, what are the potential implications of OTC birth control for the future of reproductive health care? Do you see any opportunities for further innovations or advancements in this area?
Sober: The short answer is, I hope so. I'm not sure I can fully speculate on what's to come, but I think that certainly the Opill switch is a step in the right direction. I would hope that this switch would pave the way for future reproductive health products or other innovations that would lead folks to have easier access to health care.
READ MORE: Women's Health Resource Center
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