FDA approves first over-the-counter birth control pill in 'groundbreaking' move

Federal regulators on Thursday approved the nation’s first over-the-counter birth control pill in a landmark move that will soon allow American women and girls to obtain contraceptive medication as easily as they buy aspirin.

The Food and Drug Administration cleared 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 manufacturer, Ireland-based Perrigo, 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 for decades, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, poor women and others report greater hurdles in getting prescriptions and picking them up: 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 nonprofit group that welcomed the approval. “Hopefully this will help people overcome those barriers that exist now.”

About 14% of women aged 15-49 currently use oral contraception pills, based on CDC data from 2017 to 2019, released in 2020, and 65.3% of women age 15 to 49 use contraception in general.

Perrigo says Opill could be an important new option for the estimated 15 million U.S. women who currently use no birth control or less effective methods, such as condoms. 

But how many women will actually gain access depends on the medication’s price, which Perrigo plans to announce later this year. Most older birth control pills cost $15 to $30 for a month’s supply without insurance coverage. 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.

Dr. Brian McKenna, an obstetrician/gynecologist and managing director for women's health care for the Eastern Suffolk County region for Northwell Health, praised the decision.

“Anything that we can do to reduce the incidence of unexpected or unintended pregnancy will help women,” he said. “It’s a very emotional and difficult decision to begin with, but it's complicated by what is happening everywhere socially … in my mind, I think this is going to be a bit of a game changer.”

McKenna said while it is important for women to consult with their doctors about their medical history and health screenings as part of a wellness program, not all of them have the ability to immediately see a clinician.

“This is going to provide a way for women to start a contraceptive program right away when they need one to avoid having an unintended pregnancy,” McKenna said. “Women have been asking for this for a long time.”

He also pointed out that some women may work for companies that do not allow their health insurance to pay for contraception.

Dr. Leah Kaufman, associate professor, Division of Obstetrics and Gynecology at Stony Brook Medicine, also praised the announcement.

“It’s a groundbreaking move forward for us to have an over the counter birth control pill,” said. “This is something that physicians have been pushing for years because of what it means for access for reproductive health and reproductive choice for women.”

She said having the pill available over the counter will help a broad spectrum of patients ranging from busy working women to adolescents and those who may not have access to transportation on Long Island.

The copay on prescription birth control is also a barrier. Kaufman said she hopes there will be subsidies to help lower the cost of the over-the-counter version so it is readily available to women who need it.

Birth control pills are available without a prescription across 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 by FDA scientists about the company’s results, including whether women with certain underlying medical conditions would understand that they shouldn’t take the drug.

The 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 combinations.

With Matthew Chayes and Lisa L. Colangelo