U.S. Sen. Tammy Duckworth, D-Ill., has joined two Senate colleagues in pressing the Food and Drug Administration over its plan to address a nationwide shortage of estradiol transdermal patches, a treatment many women rely on to manage menopause symptoms.

Duckworth joined Sens. Kirsten Gillibrand, D-N.Y., and Adam Schiff, D-Calif., in a letter sent Thursday to the FDA's acting commissioner. The senators said the patches are the clinically preferred, first-line treatment for menopause symptoms such as hot flashes and night sweats, but that the drug supply chain has failed to keep up with rising demand over the past year.

The senators wrote that reports from the American Society of Health-System Pharmacists indicate nearly 20 distinct estrogen patch formulations have been severely impacted by supply disruptions over the last calendar year. As a result, they wrote, thousands of women are "bouncing between competing pharmacy chains, transferring prescriptions between locations, switching formulation brands, or resorting to stretching doses or splitting patches." In some cases, the letter said, patients have been forced to stop the therapy altogether.

The letter cited a Sept. 16, 2026, hearing of the Senate Special Committee on Aging that highlighted gaps in menopause care. It said the FDA's November 2025 removal of boxed warnings on hormone replacement therapies was a positive step that, combined with increased awareness and research, surged demand and drove a dramatic year-over-year increase in prescriptions nationwide.

The senators acknowledged the FDA issued an update on Sept. 3, 2026, addressing patch supply, but said they remain concerned about the agency's delay in responding. They wrote that it took four months of inquiry for the FDA to issue basic advice telling patients to contact their pharmacist or healthcare provider, and called passive monitoring and generic advice inadequate for a nationwide manufacturing deficit.

What the senators are asking

The letter requests written responses by Nov. 16, 2026 to a series of questions, including:

  • What criteria must be met for the FDA to declare an official estradiol patch shortage on its Drug Shortage Database, which would unlock emergency regulatory tools.
  • What metrics the FDA uses to monitor manufacturer capacity, and when staff first identified an imbalance between demand and production.
  • What remedial steps the agency has taken to increase supply long-term, including baseline production levels from late 2025 compared with current capacity, and when production will meet full demand.
  • How many production-expansion submissions the FDA has received since November 2025 and the average review time.
  • What interim regulatory tools the agency is considering, including whether it would temporarily allow supplies from countries not previously approved for import.
  • How many staff work on drug shortages and how many are focused specifically on the estradiol patch issue.
  • Whether the FDA's Center for Drug Evaluation and Research performs supply chain impact reviews before issuing major safety labeling changes such as removing boxed warnings.

Background

According to the FDA's Sept. 3, 2026, "Update on Estradiol Transdermal Patch Availability," the agency said the patches "remain available" while acknowledging that availability of certain products or brands may vary by pharmacy or location. The FDA has not added estradiol patches to its official shortage database and has said it is working with all six manufacturers to increase supply, which it says has nearly doubled over the past year. The American Society of Health-System Pharmacists has listed an estradiol patch shortage since Jan. 30, 2026, according to its reporting.

Source: the original release