US authorities have approved the first over-the-counter birth control pill, which will allow American women and girls to purchase contraceptives on the same shelf as aspirin and eye drops.
The powerful U.S. Food and Drug Administration announced on Thursday that it is allowing Perrigo’s once-daily Opill pill to be sold without a prescription, making it the first drug of its kind to be offered before the pharmacy counter.
The company won’t start shipping the pill until early next year, and there won’t be any age restrictions on sales.
Hormone pills have long been the most common form of birth control in the United States, and have been used by tens of millions of women since the 1960s. Until now, all of these pills required a arrangement.
Medical societies and women’s health advocacy groups have pushed for broader access, noting that about 45% of the six million annual pregnancies in the United States are unintended. Teenage girls and young girls, women of color and low-income people report that it is more difficult to get a prescription and pick it up.
Some of the challenges include paying for a doctor’s visit, being able to miss work, and finding daycare.
This decision also comes at a time when access to abortion is under attack from all sides in the United States.
Irish company Perrigo has not announced a price. Over-the-counter medications are usually much cheaper than prescriptions, but they are not covered by insurance.
Perrigo submitted years of research to the FDA to show that women could understand and follow the pill’s instructions for use. Thursday’s approval came despite concerns expressed by FDA scientists about the company’s results, including whether women with certain underlying conditions would understand that they should not take the drug.
The FDA action only applies to Opill. This drug is part of an older class of contraceptives, sometimes called minipills, which contain a single synthetic hormone and generally have fewer side effects than the more popular combined hormonal pills.
Women’s health advocates hope the move will pave the way for more over-the-counter contraceptive options and, eventually, abortion pills.
That said, the FDA’s decision has nothing to do with ongoing court battles over the abortion pill mifepristone. The studies presented in Perrigo’s FDA application began years before the Supreme Court overturned Roe v. Wade, who revolutionized access to abortion across the United States.
With some states limiting women’s reproductive rights, the FDA has come under pressure from Democratic politicians, health advocates, and medical professionals to make birth control easier to access. The American Medical Association and the leading professional society of obstetricians and gynecologists supported the Opill’s over-the-counter application.
An outside group of FDA advisers voted unanimously in favor of the change at a hearing in May, where dozens of stakeholders sought Opill’s approval.
Human rights advocates were particularly interested in the Opill because it raised fewer security concerns. The pill was first approved in the United States five decades ago, but has not been marketed there since 2005.
New 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 smokers and women over 35.
Opill contains only progestin, which prevents pregnancy by preventing sperm from reaching the cervix. The hormone should be taken around the same time every day to be most effective.
In its internal review published in May, the FDA noted that some women who participated in Perrigo’s study had difficulty understanding the information on the drug’s label. The instructions specifically warn that women with a history of breast cancer should not take the pill as it may stimulate tumor growth. Women who experience unusual vaginal bleeding are advised to seek medical attention first, as this could be a sign of a medical problem.
Perrigo executives said the company will spend the rest of the year manufacturing the pill and its packaging so it can be available in stores nationwide and online early next year.