Rising demand for estrogen patches prompts FDA action

The news: The FDA is working with six manufacturers to boost supplies of estradiol patches as growing demand makes the hormone replacement therapy (HRT) products harder for patients to find. The FDA said it is expediting manufacturing reviews tied to increasing supply, while drugmakers expand production and prioritize patch production.

The FDA has not officially designated the patches as being in shortage. But the American Society of Health-System Pharmacists’ shortage list, updated August 12, identifies 17 affected patch products.

Why it matters: Difficulty filling estradiol patch prescriptions has persisted even as the FDA said patch production has nearly doubled over the past year. ASHP first listed the products in shortage in January.

The limited availability is disrupting treatment and daily life. Forty-four percent of women had difficulty filling an estrogen patch prescription, according to a May Midi Health survey of 7,730 women. Of those, 40% said their menopause symptoms returned or worsened, 26% lost sleep worrying about obtaining their medication, and 13% said they were less productive at work.

The FDA characterized the rising demand as progress in menopause care. It linked the surge partly to its November request to revise hormone therapy labels, including removing black box warnings about cardiovascular disease, breast cancer, and dementia.

Implications for pharma and telehealth marketers: The biggest risk is that a temporary supply problem becomes a lasting treatment interruption. Eleven percent of the Midi respondents who couldn’t source patches say they stopped hormone therapy rather than pursue an alternative, undercutting recent efforts to expand access to menopause treatment. Pharma brands with alternate HRT formulations can make those options more visible and explain how they differ, while telehealth platforms can direct patients to providers who can assess an appropriate switch.

The shortage also gives marketers an opportunity to reinforce and explain the FDA’s updated safety guidance. That education could help women understand their options amid continued confusion: 38% said they had received conflicting advice about menopause treatments, particularly HRT, per a July ThisIsMenopause survey.

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