Senators Press FDA on Estrogen Patch Shortage, Demand Supply Plan

Three Democratic senators are turning up the heat on FDA to explain its response to widespread shortages of estradiol transdermal patches used to treat menopause symptoms, questioning why the agency has not formally declared a shortage and demanding details about plans to expand manufacturing capacity.

Last month, FDA said it was working with manufacturers to increase patch supplies after reports that some patients are having difficulty finding their usual products at pharmacies. The 9/3 update said the agency was engaging with all six manufacturers of FDA-approved estradiol transdermal patches to increase supply.

The supply difficulties are related to increased demand for menopausal hormone therapy, with more women seeking treatment for symptoms associated with menopause following FDA’s 11/2025 action requesting that manufacturers revise labeling for menopausal hormone therapy products to remove Boxed Warnings concerning a probable risk of breast cancer, cardiovascular disease and probable dementia in patients receiving hormone therapy for menopause.

In a 10/20 letter to acting FDA commissioner Kyle Diamantas, Sens. Kirsten Gillibrand (D-N.Y), Tammy Duckworth (D-IL) and Adam Schiff (D-CA) said supply disruptions have affected nearly 20 estrogen patch formulations over the past year, forcing patients to switch pharmacies, change products, ration doses or discontinue treatment.

The senators questioned why FDA has not listed estradiol patches in its official Drug Shortage Database and asked what criteria would trigger such a designation, potentially enabling additional regulatory measures to address supply disruptions.

They also requested information about FDA's efforts to expedite manufacturing expansions, including applications for new production lines, larger batch sizes, additional facilities and specialized equipment. The letter asks whether FDA is considering temporary imports from foreign manufacturers and expedited inspections of overseas facilities.

Additionally, the lawmakers asked whether FDA anticipated increased demand following its hormone therapy labeling changes and whether CDER evaluates supply-chain impact assessments before major safety labeling revisions.

The lawmakers requested a written response to their questions, including production forecasts, drug-shortage staffing levels and a timetable for restoring adequate supplies.