Drugmakers still struggling to keep up with spiking estrogen patch demand

The pharmaceutical industry is warning that estrogen patches continue to be in shortage in the U.S. as manufacturers struggle to keep up with increased demand linked to federal policy changes issued earlier this year, even as regulators have yet to recognize a lack in supply. 

Manufacturers first reported issues with supplying demand earlier this year after the Department of Health and Human Services (HHS) in November lifted the black box warning on estrogen patches containing estradiol that had suggested the medications could accelerate preexisting breast cancers. 

Transdermal estradiol is used to treat symptoms of menopause like hot flashes, prevent osteoporosis or replace estrogen in patients who are naturally deficient. 

In March, manufacturers cited the lifting of the black box warning by the Food and Drug Administration (FDA) as having spurred heightened demand.  

The American Society of Health-System Pharmacists (ASHP) tracks supply disruptions and shortages at the manufacturing level and currently lists more than a dozen products from five manufacturers as being in shortage. 

Products made by Sandoz account for the largest share of patches that are in shortage. 

“Unfortunately, the market is currently experiencing supply challenges affecting HRT patches, driven by external factors including a global shortage and a significant rise in demand for this menopause treatment,” Sandoz said in a statement to The Hill, referring to hormone replacement therapy. “Recent changes in prescribing behavior due to the FDA’s removal of boxed warnings on these products have created an unprecedented demand that cannot be fully met at present.” 

Viatris, another maker of the patches, told The Hill that it is “committed to supporting patient access to this needed treatment.”

“While we continue to meet our current supply plans, we know demand for this product has increased,”........

© The Hill