U.S. Sen. Kirsten Gillibrand and two Senate colleagues are asking the Food and Drug Administration for a detailed plan to improve access to estradiol patches, including production targets, manufacturing reviews and possible temporary imports.
The New York Democrat joined Sens. Tammy Duckworth of Illinois and Adam Schiff of California in an Oct. 20 letter to the FDA, released Wednesday. They requested written answers by Nov. 16.
The patches deliver estrogen through the skin and are used to treat menopause symptoms. The senators said unpredictable supplies have led patients to search multiple pharmacies, change brands, stretch doses or stop treatment. Citing the American Society of Health-System Pharmacists, their letter said nearly 20 formulations had experienced supply disruptions over the past year.
Production, imports and shortage criteria
The senators asked what conditions must be met for the FDA to formally list estradiol patches in its Drug Shortage Database, how the agency measures manufacturers’ capacity and when staff first identified a gap between supply and demand.
They requested production figures comparing late 2025 with current capacity, a forecast for when production will meet demand and an account of steps taken to increase supply.
The letter also seeks the number of manufacturing-expansion submissions received since November 2025, covering new production lines, larger batches, added sites and specialized equipment, along with average review times for expedited requests.
Because new patch manufacturing can take time, the senators asked whether the agency is considering temporary imports and expedited inspections of overseas factories not previously examined. They also want staffing figures for the FDA’s drug-shortage work and the employees assigned specifically to estradiol supply.
Gillibrand, the ranking Democrat on the Senate Special Committee on Aging, and her colleagues criticized what they described as a four-month delay in patient guidance. They asked how the agency will improve public communications and inventory reporting.
FDA says supply has increased as demand rises
In its Sept. 3 availability update, the FDA said it was working with all six manufacturers and that the supply of FDA-approved estradiol patches had nearly doubled over the previous year. Products remained available, the agency said, though individual brands and strengths could vary by pharmacy or location.
Manufacturers were adding shifts, production capacity, larger batches, specialized equipment and manufacturing lines, according to the FDA. The agency said it was offering help and expedited review when appropriate, while larger expansions could take longer because patches require specialized equipment and processes.
The FDA said demand increased as more women sought menopause treatment and after its November 2025 request for manufacturers to change labeling to remove certain boxed warnings. It described those changes as supporting individualized discussions of hormone therapy’s benefits and risks.
The senators asked whether the FDA had anticipated the demand associated with that labeling action and whether its drug-review center routinely assesses supply-chain effects before major safety-label changes.
For patients unable to obtain their usual patch, the FDA advises contacting a pharmacist about available products and a health care provider about appropriate alternatives. It advises patients to discuss any change or interruption with their provider before changing or stopping medication.
Related menopause-care efforts
The letter follows a Sept. 16 Senate Aging Committee hearing on menopause care. Gillibrand has also joined a bipartisan request for a Government Accountability Office report on federal menopause research and care.
She is a cosponsor of the Advancing Menopause Care and Mid-Life Women’s Health Act, which would authorize $275 million over five years for research, health care workforce training and education.
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