First over-the-counter birth control pill gets FDA approval

WASHINGTON — (TodayNews) — U.S. officials have approved the first over-the-counter birth control pill that will allow American women and girls to buy birth control in the same store as aspirin and eye drops.

The Food and Drug Administration said Thursday that it has authorized Perrigo’s once-daily sale of Opill without a prescription, making it the first such drug to be removed from the pharmacy counter. The company will not begin shipping the pills 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 US, having been used by tens of millions of women since the 1960s. So far they have all required a prescription.

Medical societies and women’s health groups are pushing for greater access, noting that roughly 45% of the 6 million annual pregnancies in the US are unintended. Teenagers and girls, women of color, and low-income people report great barriers to getting and getting prescriptions.

Some of the problems may include paying for a doctor’s visit, taking time off from work, and finding child care.

“This is really a change in access to contraceptives,” said Kelly Blanchard, president of the nonprofit group Ibis Reproductive Health, which backed the approval. “I hope this will help people overcome the barriers that exist now.”

The Irish company Perrigo did not announce a price. Over-the-counter drugs are usually much cheaper than prescription drugs, but they are not covered by insurance.

In recent decades, many common medicines have moved to OTC status, including medicines for pain, heartburn, and allergies.

Perrigo presented years of research to the FDA to show that women can understand and follow instructions for using the pill. Thursday’s approval came despite some concerns from FDA scientists about the company’s results, including whether women with certain underlying health conditions will realize they shouldn’t take the drug.

FDA action only applies to Opill. This is an older class of contraceptives, sometimes called mini pills, that contain a single synthetic hormone and usually have fewer side effects than the more popular combined hormone pills.

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

However, the FDA’s decision has nothing to do with the ongoing legal battle over mifepristone in the form of an abortion pill. Research into Perrigo’s FDA filing began years before the Supreme Court’s overturning of Roe v. Wade, which upended access to abortion in the US.

With some states restricting women’s reproductive rights, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to ease access to contraceptives. The American Medical Association and the leading professional society for obstetricians and gynecologists have supported Opill’s application for OTC drug status.

The FDA’s external advisory panel voted unanimously to move to a hearing in May, in which dozens of speakers called for Opill’s approval.

Divya Khuitron was among those who spoke, explaining how she could not get a birth control prescription more than three years after becoming sexually active. A 19-year-old University of Alabama student said she was still uncomfortable getting a prescription because the school health system told her parents about checkups and medications.

“My parents wouldn’t let me take pills,” Whitron said in a recent interview. “There was just a lot of cultural stigmatization of sexual activity before marriage.”

Although she uses other forms of contraception, “I’d rather have birth control and use these additional methods to be as safe as possible.”

Huitron spoke on behalf of Advocates for Youth, one of dozens of groups campaigning to make prescription contraceptives more affordable.

The groups helped fund some of the research submitted for Opill and encouraged HRA Pharma, later acquired by Perrigo, to file with the FDA.

Supporters were especially interested in Opill because it caused fewer security issues. The tablet was first approved in the US five decades ago but has not been sold here since 2005.

“That was a long time ago and we have a large amount of data to support that this pill is safe and effective for OTC use,” said Blanchard of Ibsis Reproductive Health.

New birth control pills usually combine two hormones, estrogen and progestin, to help make periods easier and more regular. But their use comes with an increased risk of blood clots and should not be used by women at risk for heart problems, such as women over 35 who smoke.

Opill contains only progestin, which prevents pregnancy by blocking sperm from reaching the cervix. It needs to be taken around the same time each day to be most effective.

In its internal review published in May, the FDA noted that some of the women in Perrigo’s study had trouble understanding the information on the drug’s label. Specifically, the instructions warn that women with a history of breast cancer should not take the pill, as it may encourage tumor growth. And women with unusual vaginal bleeding are advised to talk to a doctor first because it could indicate a medical problem.

Perrigo executives said the company will spend the rest of the year manufacturing the tablets and their packaging so they can be available in stores across the country and online by early next year.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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