FDA OKs first over-the-counter birth control pill

By MATTHEW PERRONE

AP Health Writer

Published: 07-13-2023 8:02 PM

WASHINGTON — 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.

Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

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

Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.

Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa.

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.

That said, FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone. The studies in Perrigo’s FDA application began years before the Supreme Court’s reversal of Roe v. Wade, which has upended abortion access across the U.S.

With some states curtailing women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to birth control. The American Medical Association and the leading professional society for obstetricians and gynecologists backed Opill’s application for over-the-counter status.

An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May where dozens of public speakers called for Opill’s approval.

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