Drugs

Democratic Women in Congress Want Action on Estradiol Patch Shortage

David McFarland

— 1 min read
Share

Some 44 members of the congressional Democratic Women’s Caucus have written to FDA acting commissioner Kyle Diamantas and HHS secretary Robert F. Kennedy Jr., asking that they immediately address the ongoing shortage of estradiol transdermal patches that help manage menopause symptoms. A caucus statement (contains a link to the letter) says prescriptions for the patches have risen by 162% over the past two years, partly due to the removal of the Boxed Warning from the labeling. “Now,” the legislators say, “millions of women use these patches daily to mitigate painful menopause symptoms like hot flashes, urinary tract infections, and mood swings. Unfortunately, due to a lack of manufacturing capacity, a surge in demand, and continued inaction from FDA, women nationwide are struggling to fill their prescriptions.”

The members write that while FDA has said that it is offering assistance to manufacturers seeking to increase production, the disruption is several months long, and patients continue to report significant, ongoing difficulty accessing the medication with no clear end in sight.

The letter asks FDA for information on:

  • a detailed explanation of the specific factors contributing to the ongoing delay in resolving the disruption, including any regulatory, manufacturing, or supply chain bottlenecks that continue to prevent supply from meeting patient demand;
  • current, specific timeline for when the supply is expected to stabilize;
  • what interim guidance, if any, FDA is providing to prescribers and pharmacists to help ensure patients have access to alternative formulations during the disruption;
  • data on which specific brands and dosages remain most affected;
  • information on how FDA is considering whether additional manufacturers could be used to help close the supply gap and whether the agency is providing technical assistance to enable that; and
  • whether FDA is considering adding estradiol transdermal patches to the drug shortage database.

Read more