A panel of experts who advise the Food and Drug Administration unanimously recommended allowing women to obtain HRA Pharma's birth control pill, Opill, without a prescription. The FDA is not obligated to follow the recommendations of its independent advisors, but HRA Pharma expects a final decision on its application for non-prescription sales of Opill this summer. If approved, women could obtain Opill without first having to visit a doctor or other healthcare provider. The FDA originally approved norgestrel, the drug in Opill, in 1973 as a prescription drug. Still, the company stopped US sales of the pill in 2005 for business reasons.
Medical associations such as the American College of Obstetricians and Gynecologists have been urging over-the-counter sales of birth control pills for years. More than half of all pregnancies in the US were unintended in 2011, according to a New England Journal of Medicine study published in 2016. And 75% of all pregnancies among girls aged 15 to 19 years old were unintended, according to that study.
However, FDA scientists raised concerns about whether the general public, particularly adolescents and people with lower literacy levels, will understand norgestrel's drug label and use the medication the right way. The FDA also found that a third of participants in HRA Pharma's study reported taking more norgestrel pills than were actually dispensed. FDA committee member Dr. Karen Murry said the agency understands the importance of increased access to effective contraception for women. But Murry said HRA Pharma submitted a study that was difficult to interpret.
Despite the study's data problems, the benefits of over-the-counter birth control clearly outweigh the risks, according to Kathryn Curtis, a scientist at the Centers for Disease Control and Prevention and an FDA committee member. Dr. Anna Glasier, an expert on reproductive medicine, told the committee that most women do not consult a doctor about unexplained vaginal bleeding because these episodes are common and typically resolve spontaneously. Glasier also testified on behalf of HRA Pharma.