FDA Considers Over-the-Counter Vaginal Estrogen to Expand Menopause Treatment Access
The Food and Drug Administration (FDA) is exploring the possibility of making vaginal estrogen available over-the-counter (OTC) for women experiencing menopause symptoms. This initiative aims to provide easier access to treatments for conditions such as vaginal dryness, burning, irritation, and painful intercourse, which are caused by declining estrogen levels. Currently, these treatments require a prescription in the U.S., unlike in some other countries like Britain, Sweden, and Norway, where certain vaginal estrogen products are available without a prescription or with pharmacist assessment. The American College of Obstetricians and Gynecologists (ACOG) supports OTC access to hormonal contraception and has advocated for removing boxed warnings from low-dose vaginal estrogen, arguing that these warnings, based on systemic hormone therapy studies, unnecessarily deter clinicians from prescribing effective treatments. The FDA has not yet approved a switch or set a timetable for this change, but it is engagin...
