Over-the-Counter Birth Control Pills May Soon Be a Reality

Known as the 'mini-pill,' Opill is one step closer to being sold without a prescription. Why this is a major step forward for reproductive health access.

Photo of Opill Daily Oral Contraceptive
Opill Birth Control Pills. Photo:

Courtesy of Perrigo

An over-the-counter birth control option is one step closer to becoming a reality. It's a critical step that could open up access to birth control for millions of Americans.

An advisory panel to the Food and Drug Administration (FDA) unanimously endorsed sales without a prescription. In a 17-0 vote, the advisors agreed the birth control pill Opill, generically known as norgestrel, should be available over the counter. The FDA will be making a final decision over the summer.

What is Opill?

Opill is hormonal birth control, commonly called the “mini-pill.” It works by thickening the cervical mucus to prevent sperm from reaching an egg. Unlike combination birth control pills that use progesterone and estrogen, Opill is made up of a synthetic form of progesterone. 

“It is very safe,” explains Libby Wetterer, M.D., chief resident with Montefiore Family and Social Medicine. “Birth control is over the counter in more than 100 countries.”

Though Opill has been approved for use since 1973 in the United States, it’s currently only available for purchase with a prescription from a health care provider.

Barriers to Birth Control Access

With all of the birth control options on the market, oral contraceptives like Opill remain the most popular. According to one poll, 77% of reproductive-aged females support the idea to make them available over the counter.

Despite their popularity, birth control pills can sometimes be hard to access because of a prescription barrier. The lack of adequate health care to even see a doctor and be evaluated for a prescription is just one of the ways oral contraceptives can be a hassle to obtain, explains Varuna Srinivasan, a spokesperson for Planned Parenthood.

“A person may not have easy access to a provider, either because they do not already have an established provider, can’t take time away from work, don’t have transportation or childcare, or their doctor's office has long wait times for appointments,” Srinivasan says. “These long wait times have worsened as reproductive health clinics face unprecedented demand after the Dobbs v. Jackson Women's Health Organization ruling overturning the constitutional right to abortion.”

Other hurdles Srinivasan highlighted were privacy concerns as well as the individual power healthcare providers have to deny patients birth control for religious or moral objections. “In at least 26 states across the country, people have been refused contraception at the pharmacy counter,” she added.

Safety Concerns About Over-the-Counter Birth Control

While the advisory panel gave a favorable recommendation, it was not without some safety concerns about having birth control pills more readily available. 

As part of the panel’s review, the agency laid out the need for over-the-counter options citing statistics showing 72% of adolescent pregnancies are unintended. They said this underscores a great need for more attainable birth control options. 

Needs and wants aside, the advisors still had several worries related to the sale of Opill without the guidance of a medical professional. That includes the possibility that some users with certain conditions may not properly assess the safety of the product for their use. 

“The FDA has noted concerns about obesity and the failure rate of Opill,” Dr. Wetterer says. “All forms of hormonal contraception are approved for people with obesity.  Regardless of being over the counter or prescription only, people with obesity can use Opill.”

The mini-pill, unlike its combination pill cousin, adheres to a stricter regime where the user must take it at the same time each day for the best results. The less forgiving nature of the mini-pill was another worry the FDA brought up. 

“Many people use the mini-pill currently and are happy with the method,” Dr. Wetterer says. “Some don’t like the need to be so precise with timing, which is why I hope other methods are soon approved to be over the counter as well. It doesn't change my calculation of whether or not Opill should be over the counter. When clinicians act as gatekeepers, we aren’t doing our jobs.  We should be empowering patients and communities to make decisions for themselves and their bodies!”

What Parents Should Know About Over-the-Counter Birth Control

Talking about birth control with your teen can be challenging for parents, which is one of the reasons why adolescents often face several barriers to obtaining birth control options. Rest assured, Srinivasan emphasizes the mini-pill is a safe option for all ages. Having easier access to contraceptives like the mini-pill helps teens stay safe and healthy. 

“Parents and caregivers may worry about navigating these conversations, or [may] not be sure how or when to begin,” Srinivasan explains. “Know that you are not alone. Many of us didn’t have these conversations with our parents, so it can feel hard to know where to start. A great place to begin is creating a safer space to have conversations about sexual health and birth control at home.”

It’s not yet known whether there will be an age restriction should the pill become available over the counter. The FDA panel didn't include age restriction guidance in its recommendation. However, when the emergency contraceptive pill Plan B was approved for non-prescription use, an initial age limitation was in place. That age limit was later lifted. 

The Future of Birth Control Distribution

Opill’s possible move to pharmacy shelves is a major step for reproductive health access and Dr. Wetterer only sees more potential in the near future. 

“Coming up next: over-the-counter Ella (a more effective form of emergency contraception), other types of birth control (combined oral contraceptives, patches, rings, and depo-provera), and ideally, pills to manage miscarriage and abortion,” she says. “All of these things should be free or low cost and available to people of all ages and identities.”

Accessibility would be just one of the victories for reproductive health advocates should the FDA formally approve the Opill application. As Srinivasan explains, birth control, and the wider availability of it, is basic health care that is much needed and appreciated for various reasons. 

“There’s a lot to celebrate around birth control,” Srinivasan says. “The ability to plan, prevent, and space pregnancies is directly linked to benefits for all people—not just those who can become pregnant—including more educational and economic opportunities, healthier babies, and more stable families.”

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  1. Kaiser Family Foundation. Interest in Using Over-the-Counter Oral Contraceptive Pills: Findings from the 2022 KFF Women's Health Survey.

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