The French drug maker HRA Pharma is seeking approval from the Food and Drug Administration (FDA) to sell its birth control pill, which contains a single synthetic hormone, progestin, over-the-counter (OTC) in the U.S.
Since their introduction in the 1960s, hormone-based birth control pills have been prescription-only in the U.S. The rationale for this has been that medical professionals can then evaluate individual patients for conditions that raise the risk of rare, but dangerous, blood clots.
HRA Pharma is trying to convince the FDA that women can screen themselves in order to use its product, called Opill.
The year 2020 marked an end to a long drought in switching of prescription-only drugs to over-the-counter status. In 2020, five products with four separate active ingredients switched in four different therapeutic classes, which was reminiscent of the most recent heyday of switches in the mid 1990s.
However, the increased switch activity in 2020 appears to be an anomaly. In 2021, the tepid pace of switches resumed with only two switches, and only one switch thus far in 2022. All switches in 2021 and 2022 are in the allergy space, an area in which there had already been switches for decades.
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