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

WASHINGTON — Federal regulators approved the nation’s first over-the-counter birth control pill on Thursday, a landmark move that will soon allow American women and girls to get birth control drugs as easily as they buy aspirin and eye drops. for eyes.

The Food and Drug Administration has cleared Opill for sale once a day without a prescription, making it the first drug of its kind to be removed from the pharmacy counter. The manufacturer, Ireland-based Perrigo, won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

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. Until now, all required a prescription.

Medical societies and women’s health advocacy groups have been advocating for broader access for decades, noting that about 45 percent of the six million annual pregnancies in the United States are unintended. Teenage girls and girls, women of color, and low-income people report greater barriers to obtaining and collecting prescriptions.

Challenges can include paying for a doctor’s visit, getting time off from work, and finding childcare.

“It’s truly a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a nonprofit group that backed the approval. “I hope this helps people overcome the barriers that currently exist.”

Perrigo says Opill could be an important new option for the estimated 15 million American women who currently use no birth control or less effective methods, such as condoms. They represent a fifth of women of childbearing age.

But how many women will actually have access to it depends on the drug’s price, which Perrigo plans to announce later this year.

“The reason so many of us have worked tirelessly for years to get over-the-counter birth control pills is to improve access…cost should not be one of those barriers,” she said. said Dr. Pratima Gupta of the American College of Obstetricians and Gynecologists.

Most older birth control pills cost between US$15 and US$30 for a month’s supply without insurance coverage.

Over-the-counter drugs are usually much cheaper than prescription drugs, but they are usually not covered by insurance.

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

The FDA approval gives American women another birth control option amid legal and political battles over reproductive health, including last year’s overturning of Roe v. Wade, who revolutionized access to abortion across the United States.

That said, Opill’s approval has nothing to do with ongoing legal battles over the abortion pill mifepristone. And anti-abortion groups have generally emphasized that they do not oppose contraceptives, which are used to prevent pregnancies, not end them.

However, this has done little to allay fears that contraception could one day become a target. When the Supreme Court overturned Roe, Justice Clarence Thomas wrote a separate opinion in which he explicitly called on his colleagues to bring the high court’s same-sex marriage, same-sex, and contraception cases to the table.

Over the past year, the FDA has faced pressure from Democratic politicians, health advocates and medical professionals to improve access to birth control. The American Medical Association and other leading medical groups have supported Opill’s request for over-the-counter status.

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 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 medical conditions would understand that they should not take the drug.

The FDA action only applies to Opill. These are an older class of contraceptives, sometimes called minipills, that contain a single synthetic hormone and generally have fewer side effects than the more popular combined hormone pills.

Women’s health advocates hope the ruling will pave the way for more over-the-counter contraceptive options and, eventually, for abortion pills to do the same.

An external panel of FDA advisers voted unanimously in favor of the change during a May hearing in which dozens of public speakers sought Opill’s approval.

Dyvia Huitron was among those who came forward, explaining how she was unable to obtain prescription contraception more than three years after becoming sexually active. The 19-year-old University of Alabama student said she still isn’t comfortable getting a prescription because the school’s health system reports medical tests and medications to parents .

“My parents wouldn’t let me take the pill,” Huitron said in a recent interview. “There was a lot of cultural stigma around being sexually active before you were married.”

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 was as safe as possible.”

Defenders were particularly interested in Opill because it raised fewer security concerns. The pill was first approved in the United States fifty years ago.

“This has been around for a long time and we have a large amount of data supporting that this pill is safe and effective for over-the-counter use,” Blanchard said.

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

Opill contains only progestin, which prevents pregnancy by preventing sperm from reaching the cervix. It should be taken at around the same time daily to be most effective.

In its internal review released in May, the FDA noted that some women in Perrigo’s study had difficulty understanding information on the drug’s label. The instructions warn in particular that women with a history of breast cancer should not take the pill because it could encourage the growth of the tumor.

Common side effects include irregular vaginal bleeding, headache, dizziness and cramping, according to the FDA. The label also warns that certain medications may interfere with Opill’s effectiveness, including medications for seizures, HIV, and hypertension.

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