New Over-The-Counter Birth Control Pill: Here’s Everything You Need to Know

The first over-the-counter (OTC) birth control pill will be available in the United States as early as next year, thanks to a move by the Food and Drug Administration (FDA) Thursday.

The decision is being lauded by doctors and other medical organizations alike, who have long advocated for increased accessibility to birth control. 

Christopher M. Zahn, M.D., interim chief executive officer of the American College of Obstetricians and Gynecologists (ACOG) called the decision “critically important to the advancement in the accessibility of reproductive health care.”

“ACOG has long supported OTC access to hormonal contraception, and we are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Zahn said in a statement released by the organization. 

Similarly, Planned Parenthood praised the decision in a statement, calling the announcement “a historic moment for health equity, sexual health, and reproductive rights.” 

Earlier this year, the American Medical Association also released a statement endorsing OTC access to oral contraceptives and applauding the FDA’s committee recommendation at that time.

“This strategy uplifts the agency of women and all people who can become pregnant to practice bodily and reproductive autonomy and reduces barriers to contraception,” Monica V. Dragoman, M.D., M.P.H., system director of the Complex Family Planning Division in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology and Reproductive Science at Mount Sinai, told The Messenger via email. “The U.S. is joining over 100 countries around the world who provide contraceptive pills without a prescription.”

The approved pill, called Opill, is a progestin-only oral contraceptive, and is sometimes referred to as a “minipill,” since it does not use a combination of estrogen and progestin. Like other oral contraceptives, this pill must be taken at the same time each day in order to be most effective. 

“I think it’s quite safe,” Mary Jane Minkin, M.D., an ob/gyn and clinical professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, tells The Messenger. “My concern with the progestin-only pills is they are not as effective as the estrogen-containing pills.”

With perfect use — meaning the person takes their medication at the same time each day and never misses a dose — progestin-only birth control pills are over 99% effective, according to ACOG. 

“But we're human. We forget to take pills,” Minkin says. If you can’t get to the pharmacy to pick up a new pack, say, and don’t take the pill for a day or two, that efficacy drops. In typical use, studies show that 9 in 100 women will get pregnant during the first year of taking the pill. 

Aside from efficacy, there’s been no announcement yet about the cost of this pill. “A low cost option is really needed to deliver on the public health potential of over-the-counter access,” Dragoman says. 

The convenience is a key aspect to this decision, since restricting access to essential medicines leads to worse health outcomes, notes Dragoman. “Unnecessarily holding people’s contraception hostage to a doctor’s visit or using it as a carrot to drive other preventive health care is a losing strategy,” she adds. 

Still, when possible, Minkin advised it’s best to see a health care provider to find a birth control option that’s right for you. While that could be an oral contraceptive — and birth control pills are among the most popular forms of contraceptives in America — it could also be a long-active reversible contraceptive, like an intrauterine device (IUD). 

According to the National Institutes of Health, IUDs are the most effective form of contraceptive currently available. The devices can last three to 10 years depending on the type, and are reversible, meaning that a woman can get pregnant after an IUD is removed. 

However, both experts we spoke with emphasized that this announcement is a step in the right direction — especially since current recommendations from the Centers for Disease Control and Prevention do not require any routine examinations or tests prior to the initiation of the progestin-only pill, Dragoman explains. In other words, barring a few medical contraindications (including, for example, currently having breast cancer), Opill should be safe for many.

“The health risks of an unintended pregnancy are way higher than the health risks of taking birth control,” Minkin adds.