The Launch and Availability of Opill, the First Over-the-Counter Daily Birth Control Pill

In an interview with Pharmacy Times, Triona Schmelter, Executive Vice President and President Consumer Self-Care America at Perrigo, provided an overview of Opill, the first over-the-counter daily birth control pill. Schmelter discussed Opill's availability in major retailers and online marketplaces by the end of the month, as well as its pricing options. Schmelter also addressed Opill's 98% effectiveness when taken correctly, potential side effects, and safety for all ages. The discussion concluded by examining how Opill could help address barriers to contraceptive access.

I'm Triona Schmelter, I am the President for Consumer Self Care America's Business here at Perrigo.

Wonderful, thank you. So, can you discuss Opill and its impact as the first ever over the counter daily birth control pill?

Key Takeaways

Opill will be available over the counter without a prescription at major retailers and online by the end of the month, making it highly accessible.
Opill is 98% effective when taken correctly and has mild side effects like irregular bleeding for some users.
Making birth control available without a prescription helps address barriers to contraceptive access like lack of insurance or difficulty visiting a doctor.

Sure. It's really a groundbreaking achievement for reproductive health care here in the US. So many women have a need for birth control that have trouble with access. That can be everything from being uninsured, and not being able to take time off work to go to the doctor, or just a busy lifestyle that prevent them from being able to get birth control through a prescription. And so, this really solves that unmet need for consumers. It gives them the accessibility and the availability around the country and most major retailers, so they can pick it up while they're doing grocery shopping or running by a mass merchandiser, or something like that — or even online. It makes it easy; they don't need a prescription. And it's of course safe and 98% effective.

It is 1 pill taken daily and taken daily around the same time. It's 98% effective and becomes effective in 48 hours. So, we definitely recommend a secondary use contraception for those first 48 hours, but very quickly takes a fact.

So, we expect it to be on the shelves and in most major retailers around the country, including Alaska and Hawaii, in the family planning aisle in most of those retailers. Consumers will be able to find it probably by the end of the month. We have already started shipping to the retailers, it just takes a little bit of time to get through the distribution systems. Consumers also can pre order on their local or, I shouldn't say local but retail marketplace. So, from a .com perspective, whether that's the retailer's dot.com or other major online marketplaces, including Opill, as well. It'll be shipped to their home, discreet packaging. So, making it extra convenient.

That's wonderful. I love the discreet packaging. I didn't know you guys were doing that, so that's great.

Primarily that family planning aisle. It will be in retail drugstores, mass merchandisers like Walmart and Target, and a number of grocery stores. And like I said, online marketplaces as well. Any place they're kind of doing their shopping, they should be able to find it.

Absolutely. So, a lot of thought and research went into our pricing. Our manufacturer's suggested retail price is $19.99, for a 1-month pack. We will also have a 3-month pack available for $49.99. And consumers will be able to purchase a 6-month pack online for $89.99. They'll be able to find it on the family planning aisle of most major retailers across the United States.

I do want to note as well, for consumers who are lower income and uninsured, we will be launching a Consumer Assistance Program. There'll be information in the coming weeks on opill.com, on how to access that, but it should be fairly simplistic, just requires a little bit of income verification. Then those consumers will be able to get a code to get Opill for free. So, we really did want to think about this holistically and making sure that consumers who would sometimes have the most need and the least resources would also have access.

That is great. I was going to ask you a question about that later on, so thank you for stating that.

Are there any requirements needed when buying Opill that consumers maybe should know about?

No, no requirements at all. It's really the beauty of this and what was the unmet need in the marketplace. It is the most effective over the counter birth control on the market. You simply, just like any other purchase in a retail outlet, that is all you need to do— pick it up off the shelves or order it online and you can buy it no age restrictions either.

Since individuals can purchase the packs as needed, do you know if there are any adverse effects caused by maybe stopping and continuing the pill?

The main thing to think about is once you stop taking it, you're no longer protected from pregnancy. You would need to have another means of thinking about contraception. And then as I stated before, those first 48 hours when you start taking it, you also want to want to think about having a secondary form of contraception as well, because it takes 48 hours for the pill to become effective. But other than that, no side effects from stopping and starting, I should say.

Since Opill is 98%, effective when taken correctly, like you said, can you expand a bit on the efficiency of the product and what individuals should be sort of aware of when they're taking it? Like you said, there's no big side effects, but is there anything else they should be aware of?

There can be cases of irregular bleeding from a bleeding pattern, which would be similar to what consumers might see from other birth control pills. So longer, shorter periods, no period at all, maybe some intermittent spotting. But in most cases, nothing serious or substantial. Obviously, if any consumer has concerns of something, they should contact their doctor. But for the most part, the side effects are mild.

Great. Like you said earlier, there's no age restriction, so it can benefit a broad age population. So, can you expand on the safety of the product, and if it sort of varies depending on the age of the individual?

Yeah, the FDA has approved this product for all consumers of reproductive age. I would want to mention as well, most major medical organizations, including the American Academy of Obstetricians and Gynecologist, as well as the American Medical Association, agree that this product is safe to use for all persons of reproductive age. There was also a study done to ensure that adolescents understand the directions and can read and comprehend and follow those instructions. That proved that they do as well as adults, and in that capacity. So, that was part of the approval process. So, nothing that adolescents need to be aware of, or think differently about with regard to pill.

You did talk about this before, but what is a little bit more on the reimbursement process for Opill? And how would people know if they did qualify for reimbursement?

Yeah, so the Consumer Assistance Program will be available in the coming weeks. Opill.com can provide more information when it's available in the next week or 2 that will require a phone call where consumers will provide a few pieces of information, including their annual income. Once they get approval, they will be given a code that they can then go back to the website to use to access the product for free.

They'll definitely check that out online. But moving in a different direction, how can the availability of an over-the-counter birth control pill sort of address the barriers to contraceptive access?

We know that 45% about, of pregnancies in the US right now are unintended. Consumers struggle with finding the right type of birth control, or in some cases, birth control at all. There's a varying number of reasons for that, whether that's a lack of insurance or difficulty taking time off work, or potentially getting childcare to visit the doctor and get to the pharmacy. Those are some of the barriers. So, some of it is convenience, some of it is obtaining that prescription, some of it is not understanding the safety. We're really hoping to solve that unmet need, not just with the product and Opill and making it so convenient and accessible, but also with regard to educating consumers so that they can really understand the safety of the product. How to use it, any questions they have on their mind before taking it, they'll be able to use our website, as well as the packaging will come with a consumer leaflet that should answer the vast majority of their questions.

Definitely, yeah. And it also be great to see the impact that it does have in the upcoming months and years.

You did touch on this already, too, but how is Opill changing the reproductive health landscape, and in general?

We see it as a significant advancement for this unmet need for consumers with access to over-the-counter birth control that is highly effective, so 98% effective. And so, in that way, it really is giving consumers more control and access to their reproductive health. We see that as a great leap forward for reproductive health care.

Definitely. That's all the questions that I had. But is there anything else you'd like to add?

I would just add that we're incredibly excited about this launch, as are retailers and some consumers will start to see it shortly on shelves. We know there's a need out there, so we're excited to meet that need. At Perrigo, our mission is really around providing great self-care to everyone. And we really think that Opill provides us a step forward in delivering on that mission because it truly is for everyone. Our Consumer Assistance Program will make sure even those that can't afford it will have access. We're just we're really thrilled to be able to solve this need for consumers.