Unanimous! An FDA Advisory Panel Votes 17-0 for an Over-the-Counter Birth Control Pill, But It’s Not Available OTC Yet…

Birth control pills are available over the counter in more than 100 countries. 

But when it comes to reproductive rights, the United States seems intent on being the embarrassing exception. 

Individuals face barriers to initiating and refilling birth control options that are only available by prescription, such as difficulty securing a timely appointment or finding childcare —not to mention the 19 million women living in contraceptive deserts amid our biggest abortion access crisis ever. Difficulties obtaining a prescription result in reduced adherence to someone’s method of choice, which can lead to unintended pregnancy. We need easier access to effective contraceptives. One way to improve access is by making more contraception available without a prescription, over the counter. Finally, we’re close to having that happen here in the U.S. On May 10, 2023 a panel of Food and Drug Administration (FDA) advisors voted 17-0 to recommend making Opill, a progestin-only birth control pill, the first over-the-counter (OTC) birth control pill in the U.S.  

This was not a hasty decision.  

It’s a decision that you can trust—and here’s why. 

Taking a peek behind the metaphorical curtain of the FDA’s regulatory process, here’s what happens when a sponsor of a drug product—such as HRA Pharma, the manufacturer of Opill— is seeking to change how that drug is marketed and sold, from being a prescription drug product to nonprescription. To do so, the sponsor submits an application for this switch to the FDA. It must include data from clinical trials and other studies to show that a drug is safe and effective for use in a nonprescription setting. (In this case, they had tons of data, because Opill has been available via prescription since 1973!) 

An advisory committee is then established to help the FDA evaluate this data and make their decision on if a drug can be available OTC. Advisory committees consist of independent experts who bring decades worth of experience in science, public health, and policy. The committee considers the data and the science, and also listens to outside experts and others who want to weigh in. During the 2-day hearing about Opill, the committee listened to in-depth testimony by HRA Pharma, FDA officials, and a panel of speakers, who testified largely in support of Opill being available without a prescription.   

The hearing consisted of intense analysis and discussion on whether the benefits of an OTC pill outweigh the risks, including issues related to correct use of the product and risks of potential inappropriate use by consumers. The committee also heard from a variety of speakers in support of the OTC pill, ranging from board-certified gynecologists who emphasized the ways in which an OTC pill can reduce racial disparities in accessing contraceptive care, to college students detailing the lengths they were required to go to access their birth control and how an OTC pill could improve their lives. One college student shared her experience accessing care in rural Appalachia where young people had access to only one health clinic. Because services at her local clinic were limited, many people had no choice but to drive an hour outside of town to the nearest medical center. For her, and others like her, an OTC pill would fill in the infrastructure gaps to accessing basic reproductive health care.  

The energetic debate between HRA Pharma and the FDA on study design, implementation, and accuracy demonstrated that the panel carefully considered the benefits of the drug’s over-the-counter status, and any potential risks. In the end, the advisory panel voted unanimously to recommend that the contraceptive Opill be available without a prescription, finding that this pill is safe, effective, and appropriate for over-the-counter use for people of all ages. This result also furthers the public health goal of improved access to contraceptive care and bodily autonomy!  

Now that the advisory panel has voted, the FDA will decide whether to follow the committee’s recommendation and approve Opill for OTC sales. The FDA generally defers to committee decisions, and there’s no reason that should not happen here. The agency’s decision is expected by late summer.  

This is a major step to improving contraceptive access, and once the FDA officially approves Opill, I can’t wait to see boxes of it on store shelves in the near future!