FDA Advisors Recommend Over-the-Counter Birth Control Pill for the First Time

A birth control pill is one step closer to being made available for sale without a prescription in the United States.

A panel of advisors to the Food and Drug Administration (FDA) voted unanimously today to recommend allowing Opill (norgestrel), a progestin-only oral contraceptive, to be sold over the counter. If approved, this would be the first hormonal birth control to be available without requiring a visit to the doctor.

The vote is non-binding and the FDA is expected to make a final decision this summer.

“This represents a landmark in our history of women’s health. Unwanted pregnancy can really derail a person’s life and especially an adolescent’s life, so I’m very pleased that the FDA is really considering this and I look forward to it being on the market,” said Margery Gass, MD, a panelist and a professor emerita of clinical obstetrics and gynecology at the University of Cincinnati College of Medicine.

During a two-day meeting, the panelists discussed whether consumers would be able to use Opill properly without the guidance of a healthcare provider. If people do not correctly follow the medication’s instructions, the pill may not be as effective and could lead to unintended pregnancy.

Opill has been on the market for 50 years with no age restrictions. The drugmaker HRA Pharma and many reproductive health experts said that decades of research show it’s safe and effective. Offering OTC oral contraceptives, they said, is much needed for reducing unintended pregnancies among teenagers, people with unreliable health care, and others who face barriers to accessing birth control.

Irene Laurora, PharmD, senior director of scientific affairs at HRA Pharma, said that making a contraceptive pill available without a prescription could increase patients’ likelihood of taking it consistently. Of people who reported having missed a dose of the prescription birth control pill, 58% said it was because they ran out of medication.

There were between two and four unintended pregnancies per 100 Opill users per year, according to estimates presented at the meeting. That’s lower than most OTC methods, including condoms and spermicides, which cause between 13 and 27 pregnancies per 100 women per year.

FDA scientists questioned whether people who are at high risk of complications, namely people with active breast cancer or unexplained vaginal bleeding, will know to avoid taking Opill. They also raised concerns about how well consumers would follow the package instruction, especially if they are adolescents or have limited literacy.

Opill Is Safe for OTC Use

Opill is not available over the counter in other countries, but other brands of hormonal birth control pills are sold in more than 100 countries. But in many of those countries, the pills are available in places where a pharmacist can help answer a patient’s questions, according to Karen Murray, MD, deputy director of FDA’s Office of Nonprescription Drugs.

In the U.S., the Opill would be available at big box stores and gas stations, where no healthcare professional is available.

In one of several studies conducted by HRA, researchers mimicked an OTC environment to see how well participants would follow instructions and take the pill correctly.

People who are on a prescription birth control pill typically take about 85% of their pills on time. People taking the Opill did about the same, and sometimes better, at taking the pill every day compared to that threshold.

But the FDA raised concerns about the reliability of that data: 261 out of the 883 study participants reported taking more pills than necessary. It’s not clear whether these people took the pill incorrectly, or just reported doing so incorrectly.

The drugmaker said that some bad numbers from participants who over-reported shouldn’t disqualify the data from the rest of the group. Excluding those numbers, the company saw that 97% of women took Opill daily or correctly followed the instructions for missing a pill. In nearly 70% of those cases, participants only missed a single day.

The findings are evidence that “the guidance of a healthcare provider is not necessary to achieve good adherence,” Laurora of HRA said.

Some studies indicate that progestin-only pills must be taken within the same three-hour window, and ideally at the same time each day. However, data showed that a single missed or later pill didn’t seem to affect the efficacy.

FDA scientists and panelists also raised concern that young people or those with low literacy may not understand the importance of taking a pill every day and abstaining from sex or using another form of birth control if they miss a dose.

But providers often prescribe birth control pills once a year and sometimes less frequently. Various panelists emphasized that even when patients see a provider for a birth control prescription, they don’t always get much counseling.

“All of us that have had experience taking care of adolescents and adult females realize that it is very difficult for people to take birth control pills the same time every day even when they see a provider,” said Abbey Berenson, MD, PhD, a panelist and a professor of OB-GYN and pediatrics at the University of Texas Medical Branch in Galveston.

There was no data to show that accessing contraception through a provider is much safer than through self-use.

Who Will Benefit From OTC Birth Control?

Nearly a third of people have a hard time accessing prescription contraception, and that number is even higher among Black, Indigenous, Latinx, Asian American, and other people of color. Patients may lack health insurance, a routine provider, or the time and means to travel to an appointment, said Kelly Blanchard, MSc, president of the nonprofit Ibis Reproductive Health.

Out-of-pocket costs for popular prescription birth control pills can be up to $50 per month. HRA hasn’t yet set a cost for an OTC version of Opill.

“For people who don’t have insurance or for people who may not want to use their insurance, it’s important that the individual price point is affordable too,” Blanchard, who was not on the panel, told Verywell.

Many of the FDA panelists emphasized that improving access would be especially useful for adolescents, who may have to overcome stigma and have a hard time getting prescription medication without an adult’s OK. One survey found that 58% of young people who faced barriers to contraceptive access had a pregnancy scare.

Who Shouldn’t Take OPill?

Opill is a progestin-only pill, which is considered safer than oral contraceptives that contain both estrogen and progestin. The only high-risk contraindication for progestin-only contraceptives is breast cancer.

Breast cancer patients will have to be able to identify that they’re not good candidates for the medication and choose not to take it, according to FDA’s Pamela Horn, MD.

Deborah Armstrong, MD, a professor of oncology at the Johns Hopkins Kimmel Cancer Center, said that most breast cancer patients are often under the care of an oncologist and that most women with active, or a history of breast cancer would be aware of the potential harms of taking a hormonal drug.

Taking Opill within five days of the emergency contraceptive Ella (ulipristal acetate) can reduce the efficacy of both. However, that would be an efficacy issue and not a drug safety one.

Progestin-only contraceptives are just one of many effective birth control options that are now only available via prescription. Blanchard said she hopes this approval will open the door for patients to access a broader array of birth control options without prescription.

“I really hope that this is just the beginning. And that we will see many additional birth control pills and other hormonal methods move over the counter,” Blanchard said.