FDA Approves First Nonprescription Birth Control

Woman taking birth control: © jamie grill photography/Stocksy - stock.adobe.com (Adobe stock 280653001)

On July 13, 2023, FDA approved the very first over-the-counter (OTC)/nonprescription birth control in the US. More specifically, FDA approved the Opill (norgestrel) tablet, a progestin-only contraception, to prevent pregnancy. It’s the first daily oral contraceptive approved without a prescription in the US. Frederique Welgryn, global vice president for women's health, Perrigo, shares insight into this approval in an exclusive Q&A with Pharmaceutical Executive.

Pharm Exec: Could you tell me about the steps leading up to this approval? What led the company to pursue the OTC label?

Welgryn: Opill (norgestrel) was first approved by FDA in 1973. HRA Pharma, a Perrigo Company, acquired norgestrel in 2014 with the clear intent to conduct an Rx-to-OTC switch because we knew there was a massive need for more access to effective contraception in the US. It has been a long journey to get here and to prove that women could select and use Opill without the supervision of an HCP. For more than nine years we have been working to conduct the research (label comprehension studies, actual use trials, and other clinical research) necessary to apply to FDA to bring Opill over-the-counter in the US. It has been a journey fueled by the passion of our team, researchers, health providers, advocates, and women themselves, driven by the unwavering belief that the women and people of this country should have greater access and fewer barriers when it comes to their reproductive health. This approval is truly historic!

Pharm Exec: How has the political climate in the US factored into the decision to pursue having Opill available without a prescription?

Welgryn: At a time when so many freedoms are being taken away from women and people, this feels like a win and step forward. Making Opill available OTC is a groundbreaking expansion for women’s health and a significant milestone toward addressing a key unmet need for contraceptive access.

Another win in this process is for science: this approval is based on a thorough research program from Perrigo. We have more than 50 years of evidence demonstrating that POPs are safe and effective. Independent experts from FDA’s Advisory Committees voted unanimously to approve Opill OTC, confirming that the benefits of having oral contraception available OTC outweighed the risks. In addition, major medical organizations including the American College of Obstetricians and Gynecologists, the American Medical Association, The Society for Adolescent Health and Medicine, and the American Academy of Family Physicians support birth control OTC. Finally, 77% of women are in favor of birth control OTC, and there is bi-partisan support of OTC birth control.

Pharm Exec: Opill is expected to be available OTC in stores in early 2024. What still needs to be done before then? Anything at the state or federal level?

Welgryn: We have already launched the manufacturing process. We will work with our retail partners to build launch and distribution plans nationwide, and we will be working hard to help ensure that everyone in this country in need of contraception hears and gets educated about Opill and about how it can make women’s contraceptive journeys easier.

Pharm Exec: What’s next for Opill? Will you pursue approvals in other countries for it to be available without a prescription?

Welgryn: This is certainly a milestone that should be achieved globally,and we are continuing to evaluate other opportunities to bring birth control pills OTC to other countries in the world.

Pharm Exec: Will Perrigo be working to get any other prescription therapies available OTC, specifically in the contraceptive space?

Welgryn: Perrigo is committed to expanding women’s health and recently created a dedicated global women's health organization with a specific focus on the sexual health needs of women. Our goal is to create a world where people have the freedom to shape their reproductive and sexual lives on their own terms. These projects take time, and our efforts are worth it. It can really be transformational for women and for society as a whole.