FDA approves first over-the-counter hormonal birth control pill in the USA

July 14, 2023

On Thursday, July 13,the Food and Drug Administration on Thursday approved the oral contraceptive Opill for over-the-counter sales, making it the first hormonal contraceptive pill available in the United States without a prescription, reports NBC News.

The approval is a major win for medical groups, including the American Medical Association and the American College of Obstetricians and Gynecologists, which have been pushing for years for an over-the-counter (OTC) birth control pill. It also comes amid legal battles over women’s reproductive rights.

“This is a monumental decision,” said Dr. Melissa Simon, a professor of clinical gynecology at Northwestern University. “OTC birth control is available in over 100 countries, so we’ve been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy.”

Opill, also known as the “mini-pill,” contains one hormone, progestin, and is taken daily. It was first approved by the FDA as a prescription in 1973.

The FDA said it is approving the over-the-counter version for all users of reproductive age, including teenagers, a move that is expected to remove barriers to access and reduce the risk of unintended pregnancies.

Almost half of the 6.1 million pregnancies in America. each year are unintended, according to the FDA.

“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release.

Opill was found to be 93% effective in preventing pregnancy with typical use, similar to prescription oral contraceptives. Opill must be taken at the same time every day. If it isn’t taken within a three-hour window, experts advise a backup method, like a condom, for the next two days.

The medication is expected to be available at drug stores, convenience stores, grocery stores and online, according to the FDA. People who want to grab the medication off store shelves will have to wait a little longer, however. The maker of the Opill, Perrigo’s HRA Pharma, said it doesn’t expect it will be available until “early 2024.”

Another concern was side effects, such as vaginal bleeding, and whether users, particularly teenagers, would know to seek the help of a health care provider.

Still, ultimately, the FDA committee agreed most women could determine on their own whether the medication was appropriate for them to use.

Over-the-counter birth control pills are already available in more than 100 other countries, according to Free the Pill, an advocacy group dedicated to educating about birth control.

2022 survey from KFF, formerly known as the Kaiser Family Foundation, found more than three-quarters of women of reproductive age were in favor of making birth control pills available without a prescription. The leading reason for supporting the switch from prescription to over-counter was convenience, according to the survey.

Research contact: NBCNews