WASHINGTON — Federal regulators on Thursday approved the nation’s first over-the-counter birth control pill in a landmark decision that will soon allow American women and girls to obtain contraceptive medication as easily as they buy aspirin and eyedrops.
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, women of color and those with low incomes 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 supported the approval. “Hopefully this will help people overcome those barriers that exist now.”
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. They are a fifth of women who are child-bearing age.
But how many women will actually gain access depends on the medication’s price, which Perrigo plans to announce later this year.
“The reason why so many of us worked tirelessly for years to get over-the-counter birth control pills is to improve access … cost shouldn’t be one of those barriers,” said Dr. Pratima Gupta of the American College of Obstetricians and Gynecologists.
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.
The FDA approval gives U.S. women another birth control option amid the legal and political battles over reproductive health, including last year’s reversal of Roe v. Wade, which has upended abortion access across the U.S.
That said, Opill’s approval is unrelated to the ongoing court 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, that has done little to ease fears that contraception could someday 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 put the high court’s same-sex marriage, gay sex and contraception cases on the table.