The FDA Approved the First Oral Contraceptive for Over the Counter Use

We are thrilled to share with you that the FDA approved the first over the counter (OTC) birth control pill on July 13. The pill, called Opill, was first approved for prescription use 50 years ago and has a 93% effectiveness rate with typical use. It is expected to be the most effective OTC birth control in the market. 

Calls to approve hormonal contraceptives for OTC availability are nothing new. The American College of Gynecology and Obstetrics has long recommended making hormonal birth control available OTC without age restrictions. This includes “oral contraceptive pills, vaginal rings, the contraceptive patch, and depot medroxyprogesterone acetate” (a subcutaneous injection administered every 3 months). Other medical organizations, including the American Medical Association and the American Academy of Family Physicians have made similar recommendations. 

Generally speaking, making oral contraceptives available OTC is safe. When transitioning a drug from prescription to OTC status, the FDA has to consider the toxicity of the drug and whether the medication offers benefits without high safety risks. The birth control pill is thought to be safer than other OTC medications, like ibuprofen. Moreover, research has demonstrated that women are capable of self-screening and deciding whether they have a medical condition that puts them at a higher risk of experiencing a medical problem from taking a hormonal contraceptive. In a panel in May, 17 independent scientific advisors to the FDA ruled unanimously that the benefits of making the pill available OTC outweigh the risks.    

In other words, we know it’s safe to make hormonal contraceptives available OTC. But what makes it reasonable? According to Free the Pill, a coalition that advocates for OTC privileges for oral contraceptives, birth control is a human right, and the pill is “part of the full range of sexual and reproductive care.” Those who need contraceptives may struggle to obtain a prescription for many reasons, including lack of transportation to a traditional healthcare setting, not being able to find childcare or take off work or school while attending a doctor’s appointment, the cost of visiting a provider, being uninsured, and requirements of parental permission for those under 18. Making the pill available OTC circumvents these roadblocks and increases accessibility for many populations. Unsurprisingly, studies have shown that making the pill available OTC has potential to increase uptake and continuation, thus reducing unplanned pregnancy rates.

There is one accessibility problem that making the pill available OTC won’t solve - affordability. Few states mandate insurance coverage of OTC contraceptives, but an executive order from the Biden Administration may change that. Even if insurance coverage was mandated, uninsured people would still have to cover the cost themselves. The company has not shared the cost of the pill yet, so it’s difficult to determine how cost-accessible it will be. 

Opill will be first available OTC in early 2024. It is a progestin-only pill, which means it carries even lower risks than the combined pill, which contains both progestin and estrogen. A separate company, called Caden Hill, has been discussing making the combined pill available OTC as well. Stay tuned for more updates.