Issue 186  /  October 30, 2026  /  Feature

FDA Explores Over-the-Counter Vaginal Estrogen

A line in Friday's HHS release says the FDA is exploring over-the-counter vaginal estrogen. A switch would change who reaches treatment, who pays and who profits.

FDA Explores Over-the-Counter Vaginal Estrogen

The FDA is working with drug sponsors to explore selling vaginal estrogen without a prescription, according to a release the Department of Health and Human Services published Friday.

The line sits under the day's headline action, new labeling for three estradiol patches, and names no sponsor and no timeline. Any switch, the release says, would need FDA approval backed by evidence that women can choose and use the product safely without a clinician.

Kelsey Gallo, Ekene Enemchukwu and three co-authors from Stanford, City of Hope, Endeavor Health and the University of Michigan measured how few women reach the drug today. Using a 20% random sample of fee-for-service Medicare beneficiaries from 2006 to 2018, they identified 1,838,732 women aged 66 and older with a diagnosis indicating genitourinary syndrome of menopause, the vaginal and urinary condition caused by falling estrogen (JAMA Network Open, December 2025). Over a median of eight years, 165,530 of them (9.0%) filled a prescription for vaginal estrogen. Those who did waited a median of 15 months after diagnosis.

Claims data miss symptom severity and patient preference, and the condition has no validated diagnostic criteria. Fills through Medicare Advantage or online pharmacies were not counted, so use may be understated. The National Institutes of Health funded the study. Enemchukwu reported research funding from AbbVie, which markets Estrace vaginal cream.

The FDA has already set vaginal products apart on safety labeling. Its November 2025 request to manufacturers kept an endometrial cancer statement in the boxed warning only for systemic estrogen-alone therapy, which leaves vaginal estrogen with no boxed statements at all and a safety section condensed around local use. Of the nine products relabeled so far, from submissions by 29 companies, Estring is the only vaginal one. Vagifem, Novo Nordisk's 10 microgram tablet, has not been relabeled.

Britain moved that exact dose off prescription four years ago. In July 2022 the Medicines and Healthcare products Regulatory Agency approved Novo Nordisk's application to sell Gina, a 10 microgram estradiol tablet equal in strength to Vagifem, from pharmacies without a prescription. It was the first hormone therapy the UK had taken off prescription-only status. A pharmacist supplies it using a company checklist, only to women 50 and older who have gone a year without a period, with a check-in at seven weeks and every three months after. Women with a history of breast cancer or blood clots cannot buy it. The regulator's documents report no uptake figures, and Britain switched the tablet, not the cream.

Cream is the US form, making up 90.3% of vaginal estrogen claims in the JAMA Network Open cohort, and it is the form now running short. On October 28, Reuters reported that the American Society of Health-System Pharmacists lists vaginal estradiol creams from Viatris' Mylan unit, Padagis and Teva as backordered or on allocation, as women who cannot find patches move to other forms. Viatris told Reuters it is meeting its current supply plans and adding equipment and a production line. HHS says the FDA is monitoring gels and creams and sees no imminent risk of a nationwide shortage.

Unlike Britain, the US has no pharmacy-only category. Its nearest equivalent is a rule finalized in December 2024 that lets a company sell a drug over the counter behind an added step, such as an online questionnaire.

The most recent women's health switch took a year. HRA Pharma, now part of Perrigo, filed to move the progestin-only pill Opill over the counter in July 2022, and the FDA approved it in July 2023 after its advisers voted 17 to 0.

Under the Hatch-Waxman Act, a switch backed by new clinical studies essential to approval, usually an actual-use trial, earns three years of marketing exclusivity. Estradiol has been sold in the US for decades. Those three years are what would pay a sponsor back for the consumer studies the FDA requires.

The main US brand approvals for vaginal estrogen sit with four companies. Novo Nordisk sells Vagifem and ran the British switch. Pfizer holds Estring and Premarin vaginal cream. AbbVie holds Estrace cream, the reference product for generic estradiol cream. Mayne Pharma sells Imvexxy, a softgel insert it licensed from TherapeuticsMD in 2022, and reported $29.3M in US Imvexxy net sales for its fiscal year ended June 2026. HHS did not say which companies the FDA is talking to.

The last full public count of the category's dollars is eight years old. A November 2019 investor presentation from TherapeuticsMD, then Imvexxy's owner, put 2018 US gross sales of vaginal atrophy drugs at $1.7B using Symphony Health data. Estrace cream and its generics accounted for $554M, Premarin for $461M, Vagifem and its generics for $455M and Estring for $114M, which comes to $1.58B for the four estrogen lines by The Luteal's sum. Those figures are company-stated and measured before rebates.

Medicare claims add a trend line for part of that market, and it points down. Alexandra Tabakin, Wai Lee, Harvey Winkler and Dara Shalom of Hofstra/Northwell found that Part D spending on Estrace, Estring, Vagifem and Yuvafem fell from $277.9M in 2016 to $106.7M in 2020, as beneficiaries using them fell from 439,210 to 123,318 and spending per beneficiary rose from $689 to $1,028 (Urogynecology, 2024). The study left out Premarin vaginal cream, and the authors suggest cost may be part of why use fell.

Federal law bars Medicare Part D from covering over-the-counter drugs, a point the HHS Inspector General restated in an August 2026 audit. If a prescription version stayed on the market, as Vagifem did beside Gina in Britain, women could keep using insurance, and those buying off the shelf would pay out of pocket. Menopause care companies would lose a reason for a visit, since a woman who can buy vaginal estrogen after a questionnaire no longer needs an appointment for it.

The prescription is the step fewer than 1 in 10 diagnosed Medicare patients ever completed. A shelf version removes it, and the insurer with it. The first sponsor through gets three years to set the price.

This article is for informational purposes only and is not medical advice.

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SOURCES

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Company-stated

Secondary (used for confirmation only)

— Keisha, Editor of The Luteal