The US Food and Drug Administration (FDA) is reviewing a proposal by drugmaker Perrigo to sell its decades-old contraceptive pill, Opill, over the counter. The application, if successful, would allow consumers to access the pill without a prescription for the first time. However, the FDA has raised multiple concerns over the proposal and has cast doubt over the application’s success. A meeting of FDA advisers is set to consider the request, although no binding decision will be taken. Amongst the issues raised by the FDA are concerns over the data used to support the application, the accuracy of the labelling instructions, and whether those with certain medical conditions will be able to correctly use the drug. The FDA also raised concerns about the abilities of teenagers to understand and follow the instructions provided. If the application is accepted, Opill would bridge the gap for many of the 15 million US women of child-bearing age who do not currently use birth control.
The FDA’s concerns centre on the accessibility of the pill to women of all ages, and how effective and reliable the drug will be outside the confines of a pharmacy. The FDA has said that documents submitted by Perrigo lack detail in some areas and contain inconsistencies that need to be addressed before the application can be approved. Rampant opposition to the proposal has also emerged from groups such as the United States Conference of Catholic Bishops, who argue that women should be evaluated by doctors before receiving the pill.
Perrigo has countered the objections by insisting that its proposed product could be a valuable option for the estimated 15 million US women currently using no form of birth control or inadequate methods, such as condoms. The company has emphasised that the administration of contraceptive pills has been the most common form of birth control since the 1960s and has long been used as a safe and reliable method of preventing unwanted pregnancy. With the additional advantage of being easily accessible off the shelf, Perrigo’s Opill would offer many women the chance to take control of their reproductive choices more easily than ever before.
While Perrigo has highlighted potential advantages and risks, it is ultimately the FDA who will determine whether making Opill available as an over-the-counter product is the right decision. The meeting of FDA advisers considering the matter is set to take place next week, and should provide further illumination on the objections, counterarguments, and likelihood of a successful outcome. The consideration of making birth control pills available over the counter is part of a bigger debate over women’s reproductive rights, access to contraceptives, and the efficacy and safety of widespread over-the-counter use of medications.
