The US Food and Drug Administration (FDA) has started working with six drug-device manufacturers involved in the production of transdermal estradiol patches to bolster supplies to the American public amid an ongoing shortage.
By speeding up the review of submissions linked to increasing the supply of such drug-device hormone replacement therapies (HRTs), the agency hopes to enhance their near-term production to meet demand.
On top of its efforts in the shorter term, the FDA is also looking to secure the long-term supply of HRTs by calling on manufacturers to expand their production infrastructure over time. Currently, manufacturing transdermal patches requires specialist processes, equipment and know-how.
The FDA makes these efforts as estradiol-based HRTs remain in short supply across the US – primarily due to a notable increase in demand. This uptick, the agency says, is mainly down to their growing use in pre- and postmenopausal individuals, who can apply transdermal HRTs like estradiol to the skin to treat its negative symptoms. This includes hot flashes, night sweats and – in the case of some approved products – bone density loss.
Transgender and non-binary communities also often use these hormone therapies for gender-affiming care, which can allow for gradual feministation. However, the Trump administration has recently taken active efforts to shift federal policy around gender-affirming medical care by withdrawing federal support through Medicare and Medicaid.
While the current US government is taking active steps to curb the use of gender-affirming care, it has been vocal on the positive potential of HRT in individuals going through menopause. This led to the FDA removing the long-standing ‘black box’ warning labels linked to products like estradiol transdermal patches back in November 2025, which had long been implemented to inform users of their increased risk of cancer, cardiovascular disease and dementia.
At a press conference around the time of the black box warning’s removal, US health secretary Robert F Kennedy (RFK) Jr said: “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT.”
The FDA looks ahead to further growth of HRT use
With the use of HRTs potentially set to rise further, the FDA notes that availability of certain estradiol-based products and brands will vary between pharmacies and locations, but the regulator clarified that these products remain available.
In order to increase the supply of estradiol to American individuals, the FDA recommends that manufacturers should focus on adding production shifts, while expanding capacity, increasing batch sizes and adding specialised equipment and manufacturing suitable for this task.
As the situation evolves, the FDA notes that it will continue to monitor the supply of estradiol patches in the US by communicating closely with manufacturers, while also finding ways to increase availability as demand continues to grow.
