A major decision has been made by a U.S. Food and Drug Administration (FDA) advisory panel, voting unanimously on Wednesday to endorse the over-the-counter sale of daily birth control pills, according to an Axios report.
This follows two days of deliberation over potential patient misuse and increased unintended pregnancies and could lead to a significant shift in the accessibility of contraceptives, widening the availability of birth control and intensifying political divisions over reproductive health in a post-Roe America.
The 17-0 vote by members of two FDA advisory committees determined that patients can safely follow Opill’s labeling instructions, including taking the pill at approximately the same time every day, without the need for consultation with a health care provider.
Throughout the two-day meeting, FDA staff argued that patients receive detailed screening and counseling when accessing birth control pills through their provider, ensuring they choose the most suitable method for their needs.
However, FDA scientists have expressed concerns about the potential risks of making a birth control pill available without a prescription, The News York Times reports.
The scientists have raised questions about the reliability of the data from a company study intended to show that consumers would follow the label’s directions to take the pill at roughly the same time every day and use another form of contraception or abstain from sex if they missed a dose.
The FDA analysts also raised concerns about whether women with medical conditions that should preclude them from taking the pill, primarily breast cancer and undiagnosed vaginal bleeding, would avoid the product.
For example, a recent peer-reviewed study found “new evidence that current or recent use of progestagen-only contraceptives is associated with a slight increase in breast cancer risk.”
A 2018 National Institutes of Health (NIH) publication also found that breast cancer risk is slightly increased in women who have ever used oral contraceptives, with current use being associated with a 24% increased risk.
Cervical cancer risk is higher in women who have used oral contraceptives for 5 or more years, with risk doubling after 10 or more years of use.
Additionally, the FDA analysts questioned whether younger adolescents and people with limited literacy could follow the directions.
The FDA is now tasked with determining whether women will use the product safely and effectively in the nonprescription setting.
