FDA Approves First Over-the-Counter Birth Control

Image: NBC News

In a move that’s been long-awaited by some users and health advocates, the Federal Drug Administration (FDA) officially approved the U.S.’s first over-the-counter oral birth control pill, Opill, on July 13, 2023. Opill will be available to purchase without a prescription. 

Opill, according to the FDA, is an estrogen-free birth control tablet taken by mouth that contains the hormone norgestrel and belongs to the class of medications known as progestins. The FDA added that with “perfect use,” Opill can be 98% effective at preventing pregnancy. 

Opill is manufactured by Periggo, Inc. and is expected to be available sometime in early 2024. 

Image: Twitter

How Does Opill Work?

Opill works through norgestrel, which is a type of synthetic progesterone. Because it’s progesterone only, it’s commonly referred to as a “mini pill.” 

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The American College of Obstetricians and Gynecologists (ACOG) explains that progestin-only pills work in three main ways:

• Thickening cervical mucus, which stops sperm from fertilizing an egg

• Stopping ovulation, although not consistently

• Thinning the uterine lining, which prevents implantation

According to the FDA, norgestrel was approved for prescription use in the U.S. as birth control in 1973, but the company stopped selling it as a business decision—not a safety one. It has now undergone a rebranding as Opill. 

Opill was also approved after a group of 17 FDA advisors concluded in May 2023 that the benefits of allowing a non-prescription over-the-counter birth control tablet in the U.S. significantly outweigh the risks. 

As previously stated, the FDA noted that Opill has seen as high as 98% effectiveness in preliminary clinical trials with “perfect use.” To achieve perfect use, the FDA explained, means people who take Opill have to:

• Take one tablet at the same time every day

• Never take any breaks in their monthly packs

• Use a backup birth control, such as a condom, if they miss taking their daily Opill tablet by more than three hours

With perfect use, an effectiveness rate of 98% means that out of every 100 people who use it, two will become pregnant every year. 

However, the FDA conceded that real-life use is typically not perfect use, which will most likely impact Opill’s efficacy. The effectiveness of all hormonal contraceptives in general may also be impacted by people using them who have higher weights. 

However, the FDA also stated that “norgestrel contraception is very likely to be more effective than other currently available nonprescription contraceptive methods.”

Who Can Use Opill?

The FDA says that Opill is safe for most people who can become pregnant. When it is available, they urge potential users to talk to their doctors before using it, especially if they are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, or pulmonary hypertension or a supplement containing St John’s Wort because the pill may be less effective. 

The following people should not take Opill, according to the FDA:

• People who have breast cancer

• People who have had breast cancer in the past

• People who are pregnant

• People who suspect pregnancy

• People who are using another birth control pill, vaginal ring, patch, implant, injection, or an IUD (intrauterine device)

• People who are male

Opill is also not effective as an emergency contraceptive (morning-after pill). 

When Will Opill Be Available?

Full details have yet to be released about Opill—including its price and how exactly shoppers can acquire it. One pharmacist, for instance, told NBC they plan to keep it behind the counter, despite the fact that no prescription is needed to purchase it. 

However, The New York Times reported that Opill will be available to purchase in-store and from online retailers as well.  

Image: Twitter

The FDA also noted that Opill may “reduce barriers” to contraceptive access and reduce the more than 3 million unintended pregnancies each year in the U.S.

“Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental, and child health outcomes,” the FDA stated. “Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.”

There have been no formal endorsements from any leading nursing organizations yet about the FDA’s approval of Opill. In 2022, Nurse Practitioner published an article supporting the approval of an over-the-counter oral contraceptive in the U.S.