FDA Approves First OTC Birth Control Pill

OAN Abril Elfi

10:00 AM – Thursday, July 13, 2023

The first non-prescription birth control pill in the United States, Opill, was given the green light on Thursday by the U.S. Food and Drug Administration to be sold over-the-counter.

About two months after a third-party advisory council unanimously recommended making Opill available without a prescription, the FDA took action by making this available with no age restrictions.

This approval is a significant victory for medical organizations that have long advocated for an over-the-counter (OTC) birth control pill, such as the American Medical Association and the American College of Obstetricians and Gynecologists.

Perrigo, the product’s manufacturer released a statement after the announcement.

“Today’s approval is a groundbreaking expansion for women’s health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access,” Perrigo said.

Frederique Welgryn, Perrigo’s global vice president for women’s health, stated during a news conference on Thursday that Perrigo is “committed to ensuring that Opill is affordable and accessible to people who need it.”

Additionally, the FDA released a statement on Opill and its potential effect on unintended pregnancies.

“Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider,” the FDA mentioned. “Almost half of the 6.1 million pregnancies in the U.S. each year are unintended.”

One hormone, progestin, can be found in Opill, which is also referred to as the “mini-pill.” The FDA granted its initial prescription approval in 1973.

In the statement it’s reported that for the pill to be effective it needs to be taken at the same time everyday. It also may cause side effects like dizziness, nausea, abdominal pain, irregular bleeding, cramps or bloating.

By the end of March 2024, retailers should have over-the-counter versions of Opill available at drug, grocery, and convenience stores as well as online. In the upcoming months, the suggested retail price will be disclosed.

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