Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.
Two FDA advisory panels agreed that people would use the Opill safely and effectively and said groups – including adolescents and those with limited literacy – would be able to take the pill at the same time every day without help from a health care worker.
The advisers were asked to vote on whether people were likely to use the tablet properly, so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.
If approved, this would be the first birth-control pill available over the counter in the United States.
“This would dramatically increase the ability of kids not having unintended pregnancies,” adviser Dr. Leslie Walker-Harding from the University of Washington said, adding that “it’s also equally urgent for those with limited literacy to be able to have the opportunity to take this medication.”
Walker-Harding noted that Opill is just as safe as many other medications available on store shelves.
“The safety profile is so good that you know, we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths, and people can get any amount of that without any oversight, and this is extremely safe, much safer than all three of those medications and incorrect use still doesn’t appear to have problematic issues,” she said.
The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to make a decision on whether to approve the over-the-counter pill this summer.
Opill is a “mini-pill” that uses only the hormone progestin.
The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.
Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended and rates are especially high among lower-income women, Black women and those who haven’t completed high school.
In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.
“This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.
A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.
About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.