The FDA on Thursday gave approval to a birth control pill to be sold over-the-counter, making it the first such pill to be sold without a prescription in the U.S.
The approval comes after a panel of 17 independent scientific advisers to the FDA voted unanimously in May that the benefits of making the Opill available over-the-counter far outweighed any risks.
The Opill is a “mini pill,” which contains just progestin, while another type of birth control pills known as “combination” pills contain both progestin and estrogen. Cadence Health, which makes a combination pill, has also been in talks with the FDA about applying for its drug to be sold on an over-the-counter basis.
The panel’s recommendation in May was largely based on the history of safety and efficacy of the pill, which was first approved for use 50 years ago and is 93 percent effective at preventing pregnancy with typical use.
Concerns about the drug’s over-the-counter approval centered on whether women who have certain medical conditions that prevent them from taking birth control pills, including breast cancer and undiagnosed vaginal bleeding, would yield the product’s warnings not to take it. FDA analysts also raised concerns about whether younger adolescents and people with limited literacy could follow the pill’s directions.
However, advisory committee members largely dismissed these concerns, suggesting that women with breast cancer, which is the main medical condition that would prevent a woman from taking hormonal contraception, would have doctors to tell them to avoid the pill. They also suggested it is important for adolescents to have access to an over-the-counter method of birth control that is more effective than condoms and other methods of contraception that are currently available over-the-counter.
“The evidence demonstrates that the benefits clearly exceed the risks,” said Kathyrn Curtis, a health scientist at the CDC’s division of reproductive health and a member of the advisory committee.
The drug, the Opill, will likely become available in the U.S. in early 2024, its Dublin-based manufacturer, Perrigo Company, said. It was not immediately clear how much the pill would cost, but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.”
While the Affordable Care Act requires health insurance plans to pay for prescription contraception, that mandate does not currently extend to over-the-counter methods. President Biden issued an executive order last month directing officials at the Treasury Department, Labor Department, and Health and Human Services to “consider new actions to improve access to affordable over-the-counter contraception.”