Admin_Adham
Jump to Key Points Sept 29 (Reuters) - The Democratic Women's Caucus in the US House of Representatives has asked Health Secretary Robert F. Kennedy Jr. to address a shortage of estrogen patches to ensure a stable supply of the widely used hormone therapy, according to a copy of the letter seen by Reuters.
The 96-member caucus' letter sent to Kennedy and FDA Acting Commissioner Kyle Diamantas on Monday evening seeks details on the prolonged supply disruption, a timeline for stabilization, and for the agency to consider adding the patches to its list of drugs and treatments in shortage.
Reuters has reported that women have faced issues acquiring the patches and been forced in many cases to reduce or switch estrogen dosages or change brands or types of therapy.
"Estradiol patches are not in shortage. FDA continues to monitor supply and, if the product falls into shortage nationally, the FDA will then post that information on our website," a spokesperson for the agency said.
- House Democratic Women’s Caucus urges HHS/FDA action on estradiol patch shortage.
- Estradiol transdermal patches widely used for menopause symptom control.
- Supply disruption forcing dose reduction, brand switches, or therapy changes.
- FDA says it is working with 6 manufacturers to increase patch supply.
- Lawmakers requested bottleneck data, affected brands/doses, and shortage-listing consideration.
The estradiol transdermal patches, which deliver estrogen directly into the bloodstream, are used to ease menopause symptoms such as mood swings, hot flashes and sleep disturbances.
Representative Debbie Dingell of Michigan and seven other Congress members sent a letter to Diamantas in July regarding the disruption.
There have been no meaningful actions taken, the members said in the letter sent on Monday.
"This goes again to the priority of women's health in the American healthcare system," Representative Val Hoyle of Oregon told Reuters, saying the issue is not getting enough attention.
Earlier this month, the FDA said it was working with all six manufacturers to increase supply of the patches.
Hoyle said she would like to see health officials address their concerns before Congress returns to session on November 9, after the midterm elections that will decide which party controls the US House and Senate.
"If we don't have an answer, we will make a plan to make sure that we highlight this problem in whatever way we need to in order to be able to get a response," Hoyle said.
The lawmakers requested details on manufacturing or supply chain bottlenecks adversely impacting supply, data on which specific brands and dosages remain most affected and whether the FDA is considering additional manufacturers to help address the supply gap.
(Reporting by Sriparna Roy in Bengaluru; Editing by Bill Berkrot)
