US approves its first over-the-counter birth control pill in landmark decision hailed by advocates

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 been the most common form of birth control in the US 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 US are unintended. Teens and girls, women of colour 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 US 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 between €13 to €26 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. 

Women’s health advocates hope the decision paves the way for more over-the-counter birth control options and, eventually, for abortion pills to do the same.