First US over-the-counter birth control pill gets FDA approval for availability next year

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WASHINGTON (AP) — U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

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Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they aren’t covered by insurance.

Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies.

Perrigo submitted years of research to FDA to show that women could understand and follow instructions for using the pill. Thursday’s approval came despite some concerns by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand they shouldn’t take the drug.

FDA’s action only applies to Opill. It’s in an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally carry fewer side effects than more popular combination hormone pills.

But women’s health advocates hope the decision will pave the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.

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