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

WASHINGTON – US officials have approved the first over-the-counter birth control pill, allowing American women and girls to buy birth control drugs on the same shelf as aspirin and eye drops.

The Food and Drug Administration announced Thursday that it had granted Perrigo’s approval once a day Opill It can be sold without a prescription, making it the first drug of this type to be pulled out from behind the pharmacy counter. The company won’t start shipping the pill until early next year and there will be no age limit on its sale.

Hormone pills have long been the most common form of birth control in the United States, used by tens of millions of women since the 1960s. Previously, a prescription was required for all.

Medical societies and women’s health groups have done this pushed for broader access, noting that an estimated 45% of the 6 million annual pregnancies in the US are unwanted. Teens and girls, women of color, and those on low incomes report greater barriers to obtaining and collecting prescriptions.

Challenges can include the cost of visiting a doctor, taking time off work and finding childcare.

“This is truly a shift in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit group that supported the approval. “Hopefully this will help people overcome the obstacles that currently exist.”

Ireland-based company Perrigo did not disclose a price. Over-the-counter medications are generally much cheaper than prescription medications, but are usually not covered by insurance.

Forcing insurers to adopt over-the-counter contraceptives would require federal government regulatory change, which women advocates are urging the Biden administration to implement.

Many common medications have gone non-prescription in the past few decades, including pain, heartburn, and allergy medications. Birth control pills are available without a prescription in much of South America, Asia, and Africa.

Perrigo submitted years of research to the FDA to show that women could understand and follow the directions for using the pill. Thursday’s approval came despite some concerns Concerns from FDA scientists about the company’s findings, including whether women with certain underlying medical conditions would understand not to take the drug.

The FDA’s actions only apply to Opill. It belongs to an older class of birth control pills, sometimes called minipills, that contain a single synthetic hormone and generally have fewer side effects than the more popular combined hormone pills.

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

However, the FDA’s decision is unrelated to the ongoing court battles over it Mifepristone abortion pill. Studies on Perrigo’s FDA application began years before the Supreme Court overturned the ruling Roe vs Wadewhich has turned access to abortion across the US upside down

With some states Limitation of women’s reproductive rights, the FDA has been pressured by Democratic politicians, health activists and medical professionals to make contraception easier to access. The American Medical Association and the leading obstetrician-gynecological society supported Opill’s application for an over-the-counter drug approval.

An outside panel of FDA advisers unanimously voted in favor of the switch at a hearing in May that featured dozens of speakers calling for approval of Opill.

Dyvia Huitron was among the presenters and explained that she was unable to get prescription contraception more than three years after her sexual activity. The 19-year-old University of Alabama student said she still doesn’t feel comfortable getting a prescription because the school’s health system relays medical exams and medications to parents.

“My parents didn’t let me go off the pill,” Huitron said in a recent interview. “There was just a lot of cultural stigma about being sexually active before marriage.”

Although she uses other forms of birth control, “I would have much preferred to have birth control and use these additional methods to make sure I’m as safe as possible.”

Huitron spoke on behalf of Advocates for Youth, one of dozens of groups working to make prescription birth control more accessible.

The groups helped fund some of the studies submitted for Opill and encouraged HRA Pharma, later acquired by Perrigo, to submit its application to the FDA.

Proponents were particularly interested in Opill because it raised fewer security concerns. The pill was first approved in the US five decades ago, but has not been marketed here since 2005.

“It’s been around for a long time and we have a large amount of data to show that this pill is safe and effective for over-the-counter use,” said Blanchard of Ibsis Reproductive Health.

Newer birth control pills typically combine two hormones, estrogen and progestin, which can help make periods lighter and more regular. However, their use carries an increased risk of blood clots and they should not be used by women at risk of heart problems, such as smokers and those over 35 years of age.

Opill contains only progestin, which prevents pregnancy by preventing sperm from reaching the cervix. To get the greatest effect, it needs to be taken at about the same time each day.

In its internal review released in May, the FDA found that some women in Perrigo’s study had difficulty understanding the drug’s label information. In particular, the instructions warn that women with a history of breast cancer should not take the pill, as it could stimulate tumor growth. And women who have unusual vaginal bleeding should speak to a doctor first, as it could indicate a medical problem.

According to the FDA, common side effects of the pill include bleeding, headache, dizziness, nausea, and cramps. The label also warns that certain medications can make Opill less effective, including those for seizures, HIV, and high blood pressure.

Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be in stores early next year.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter

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The Associated Press Health and Science Division receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.