Women nationwide are struggling to fill these critical prescriptions
WASHINGTON, DC – Today, U.S. Rep. Kelly Morrison (MN-03) joined a letter with her colleagues from the Democratic Women's Caucus (DWC) calling on the Food and Drug Administration's (FDA) Acting Commissioner Kyle Diamantas and Health & Human Services Secretary Robert F. Kennedy Jr. (RFK Jr.) to immediately address the ongoing shortage of estradiol transdermal patches (estrogen patches), which help manage menopause symptoms.
Over the past two years, partly due to the removal of the black box warning label, prescriptions for estrogen patches have risen by 162%. Now, 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 the FDA, women nationwide are struggling to fill their prescriptions. Without access to estrogen patches, not only will women have to mitigate ongoing menopause symptoms, the risk to their long-term bone and cardiovascular health will increase.
“Millions of women use estrogen patches to manage their menopause symptoms – and it can be truly life-changing. As an OB-GYN, I know how disruptive it is when patients can’t fill a prescription they rely on,” said Congresswoman Kelly Morrison. “No one should have to wonder whether the medication their doctor prescribed them will be available when they need it. The FDA and HHS need to investigate and inform patients and providers what is causing this shortage, when supply will stabilize, and what they are doing to help solve this immediately.”
Earlier this month, Rep. Morrison joined Senators Kirsten Gillibrand (D-NY) and Rick Scott (R-FL) in a bipartisan request for a Government Accountability Office (GAO) report on menopause care and research. The lawmakers requested GAO examine federal research and funding, access to evidence-based treatments, and how prepared health care professionals are to diagnose and treat menopause and perimenopause. The report would help identify remaining gaps in research, education, and care. Read the full request here.
Members of Congress, led by Senate Liaison and Caregiving Task Force Co-Chair Debbie Dingell (D-MI), first notified HHS and the FDA of the shortage in July, but have seen no significant assistance by the FDA to aid manufacturers and help women facing continued and unnecessary suffering.
The Members begin by outlining the impact estrogen patches have on women’s health and the dangers a shortage poses:
“Estradiol patches are used by millions of individuals to manage menopause symptoms and protect long-term health, including bone density. Patients nationwide are reporting significant, ongoing difficulty filling estradiol patch prescriptions their doctors have written for them. Interrupting treatment can mean the return of debilitating symptoms for women and real risk to their long-term bone and cardiovascular health.”
The Members highlight the concerns of their constituents who are unable to fill their prescriptions:
“However, the resulting surge in demand has outpaced the supply chain’s ability to keep pace. We have heard directly from constituents who have been unable to fill their prescriptions and are given no clear timeline on when their medication will be back in stock.”
In their letter, the Members also highlight the FDA’s failure to address this crisis and help manufacturers increase production:
“While the FDA has reported they are offering assistance to manufacturers seeking to increase production, we are many months into this disruption and patients continue to report significant, ongoing difficulty accessing this medication with no clear end in sight.”
Lastly, the Members ask the FDA to outline its plan to address the shortage and make sure the millions of women who rely on this medication can fill their prescriptions:
“1. A detailed explanation of the specific factors contributing to the ongoing delay in resolving this disruption, including any regulatory, manufacturing, or supply chain bottlenecks that continue to prevent supply from meeting patient demand.
2. A current, specific timeline for when supply is expected to stabilize.
3. What interim guidance, if any, the FDA is providing to prescribers and pharmacists to help ensure patients have access to alternative formulations during the disruption.
4. Data on which specific brands and dosages remain most affected.
5. Information on how the FDA is considering whether additional manufacturers could be utilized to help close the supply gap and whether the agency is providing technical assistance to enable that.
6. Whether or not the FDA is considering adding estradiol transdermal patches to its Drug Shortage Database.”
Read the full letter here.
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