The US Food and Drug Administration's advisory board unanimously voted on Wednesday to make the birth control pill Opill available without prescription, stating that the benefits outweigh any risks.
Two FDA advisory panel agreed that the Opill would be used safely and effectively. They also said that groups, including adolescents and people with limited literacy, would be able take the pill every day at the same time without assistance from a healthcare worker.
They were asked to vote if they thought people would use the tablet correctly, and if so, a majority of them said yes. Seventeen voted yes. Zero voted no or abstained.
This would be the first pill to be available in the United States that can be purchased over-the-counter.
This would help kids avoid unintended pregnancy, said Dr. Leslie Walker Harding, an adviser from the University of Washington. She added that it was equally important for those who have limited literacy to also be able to access this medication.
Walker-Harding stated that Opill is as safe as other drugs available in stores.
She said, 'The safety profile of this medicine is so good, that we would have to remove all other medicines from the market, like Benadryl and ibuprofen and Tylenol which cause deaths. And people can get as much of it without any oversight. This is very safe, safer than those three medications, and incorrect usage still does not appear to be problematic.
It is not mandatory for the FDA to follow its advisors' advice. However, it does so quite often. The FDA is expected to decide whether or not to approve this over-the counter pill by the end of summer.
Opill is an'mini pill' that only uses the hormone progestin.
Health care providers and lawmakers have urged the FDA to make Opill available over-the-counter.
Unwanted pregnancy is a major public health concern in the US. Nearly half of all pregnancies occur unintentionally. The rates are particularly high for women with lower incomes, Black women, and women who have not completed high school.
In March 2022 59 members sent a letter about OTC contraception to FDA Commissioner Robert Califf.
This is a crucial issue for reproductive rights and justice. The lawmakers stated that despite decades of safety and effectiveness being proven, many people face enormous barriers in getting birth control because of systemic injustices in our healthcare system.
Recent research shows that women have found it harder to access services related to reproductive health, such as birth control and routine screenings.
In 2021, 45% of women reported at least one obstacle to accessing reproductive health services. This is an increase of 10% from 2017. In 2021, nearly 19% of women reported experiencing at least three barriers to reproductive health care services. This is up 10% from 2017.