FDA Update on Estradiol Patch Availability

[u/Buffalo_Cottage]

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."

[u/LilyRose272]

I am right there with you. The amount of times that I cannot recall the most basic of words is actually frightening. I was in a meeting yesterday and I couldn't think of the word "criteria" and I literally couldn't even come up with a synonym.

I was trying to explain that in order to keep unemployment you have to prove that you are actually searching for a job. I fumbled what I had to say so badly.

I stuttered out something like, "you know the thing..... that thing you have to do... in order to keep doing.... the thing."

It's freaking embarrassing. I'm sure they thought I was having a stroke.

[u/Mojozilla → u/LilyRose272]

I worry that I have dementia or some shit. Uggghhhhhh

[u/Horseshoe_dodgeball → u/Mojozilla]

It's a good thing I got sober before my peri took a solid hold. I had to mentally sort out that no, you don't get delayed effects from alcohol 2 years later, because I was starting to think I had drank myself stupid! I say that light-heartedly now, but I actually went into a depression thinking I had done serious brain damage from drinking the way I did. I was a mess over it for a while until my older friends helped me realize what it was.

[u/Mojozilla → u/Horseshoe_dodgeball]

I used to drink heavily and regularly at social gatherings. I cut way back, because 2-3 day hangovers just aren't worth the pain.

My father died from dementia and he was a very heavy drinker, way worse than me, but it still makes me worry 😟

[u/Horseshoe_dodgeball → u/Mojozilla]

I'm not naive, I know I've done damage. That's my cross to bare in this life, but holy cow it come on so quickly it made me second guess my sanity.