FDA Panel Unanimously Recommends Approval of an Over-the-Counter Birth Control Pill

On Wednesday, an advisory committee for the Food and Drug Administration voted unanimously to recommend an over-the-counter birth control pill without an age restriction. All 17 panelists agreed that the benefits of approving the drug for use without a prescription outweighed the risks. If the FDA approves the application, the medication, Opill, would be the first OTC daily birth control pill approved in the U.S. The FDA doesn’t have to follow the recommendations of these panels, but it usually does.

Opill is a progestin-only contraceptive, so it differs from combined estrogen-progestin formulations. Some people call progestin-only birth control the “mini pill” since it uses only one hormone. The active ingredient in Opill is 0.075 mg norgestrel, which the FDA approved for prescription use back in 1973. The combination pill has a small risk of blood clots and stroke, but that risk is lower for progestin-only pills, which is likely why a manufacturer is pushing this option for the first OTC pill.

During two days of meetings, FDA advisers reviewed scientific data about safety and efficacy. Some advisers highlighted the importance of expanding birth control access for people who live far from healthcare providers, don’t have a regular provider, and for teens who can’t involve their parents. It’s also important for people to have more options to prevent pregnancy given that at least a dozen states have active abortion bans. Importantly, insurance isn’t required to cover over-the-counter drugs like it is prescription medications, so while a full approval could improve access for some, it could still be unaffordable for others.

But this isn’t truly over until the FDA itself weighs in, and agency staff raised concerns in a briefing document about some of the data submitted by manufacturer, HRA Pharma: Specifically they were worried about whether the pill remains effective for people at higher weights (which is an issue with OTC emergency contraceptives, including Plan B) and whether people could follow the label’s directions properly. (Taking the pill properly to ensure maximum effectiveness can be a problem even for those who get the pill via prescription.)

This is the same agency that had to be sued over age limits on Plan B and is still over-regulating the abortion pill, so it’s still possible that they’ll require more research before approval. We’ll see what happens.