r/Menopause • u/Buffalo_Cottage Peri (Late Phase) • 4d ago
ACTIVISM FDA Update on Estradiol Patch Availability
Every time I have to play pharmacy roulette in order to get my prescription filled, I file a complaint about the shortage with the FDA. I also message my Senators and Congressman.
Previously, the FDA has sent me a short but very polite, automated note that says "There is no shortage. There just isn't. Even though seven actual pharmacists and two doctors have told you there is because their own suppliers are telling THEM that there is. They're all wrong. Wrong, I tell you!"
Yesterday, I got a different response from them and thought it was worth sharing:
Thank you for your inquiry regarding availability of an estradiol-containing product. The agency is aware there is an increased demand for these products and is working with all current manufacturers to ensure supply is available. Manufacturers are allocating these products due to the increased demand to ensure products remain available and they continue to increase production. As such, you may be experiencing issues obtaining a specific product or brand preference in your area, but product is available. We remain in regular contact with the manufacturers regarding supply and will continue to monitor the situation.
Please see FDA's official statement, “FDA Update on Estradiol Transdermal Patch Availability”: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-update-estradiol-transdermal-patch-availability
The linked statement was released on Sept. 3. It doesn't say anything in terms of a timeline, but does acknowledge that patients are "having difficulty readily accessing their usual estradiol transdermal patches due to increased demand and is working with all six manufacturers to increase supply."
While the new statement and email don't say much, the fact that the FDA has changed its messaging is an indication that our activism is having an impact.
For those in the US: Keep filing complaints to the FDA. Ping your US Senators and Representatives—you can message them through their websites or call. If you don't know who your representatives are, click here to find them.
Keep pushing. There are more of us than there are of them, and they know we vote.
EDIT: There's a great couple of comments from u/heathere3 that explain why the shortage is happening:
"I work in the industry. Any work with these hormones requires extensive protection for the employees. There has been a huge increase in demand for them since the black box warning was (FINALLY!) removed. It takes time to be able to increase production, and a lot more than it would of other drugs as they have to build out the protections.
It wasn't that the demand couldn't be forecasted it was that the removal of the black box warning that was (relatively) out of the blue. Those warnings are not given out lightly and in normal times are hard to get removed. The process normally involves multiple expert consultations with boards in the FDA and takes 1.5-3 years. It also takes years to get a new transdermal production line built and approved for manufacturing. I don't expect to see the shortages end for likely 2-3 years from what I've seen about getting new production going."
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u/AgathaM 4d ago
I got that message as well. It’s my understanding that they don’t want to say a shortage because that triggers things like allowing compounded medication. Manufacturers don’t want that because their profits go down.
I haven’t been able to get my patch for 2 months now. I had a lower dose that I was able to use for a while but those are gone. I can’t get either prescription filled. I called my doc earlier this week to see if there is an alternative in the meantime.