http://www.fiercepharma.com/manufacturing/shortage-injected-hormone-falling-hard-transgender-women … Why would their supplier literally just *stop making it*
-
-
Replying to @ZJemptv
We need a long-term plan for reliable manufacturing of HRT drugs at high volumes in order to ensure immediate and continued access
5 replies 5 retweets 19 likes -
Replying to @ZJemptv
So, I have a bit of FDA experience, mostly in medical devices, not pharma, but its similar....
1 reply 1 retweet 1 like -
Replying to @EmilyGorcenski @ZJemptv
On 3/10, Par filed a notice with the FDA for a "manufacturing change or addition". They use contract manufacturers overseas, so...
1 reply 1 retweet 1 like -
Replying to @EmilyGorcenski @ZJemptv
There is a good chance this is to change manufacturers or to modify the process in some way that isn't supposed to affect the drug
1 reply 1 retweet 2 likes -
Replying to @EmilyGorcenski @ZJemptv
In a 2014 SEC filing, Par acknowledges the risk of mfg delays due to using overseas suppliers, so this couls be related.
1 reply 1 retweet 0 likes -
Replying to @EmilyGorcenski @ZJemptv
*could. Anyhow, contract mfg is tricky because they're subject to FDA regulations. Hard to spin up a new one. Takes > 6 mos.
1 reply 1 retweet 0 likes -
Replying to @EmilyGorcenski @ZJemptv
So the mfg is at least aware of the risks of single point of failure. Overseas mfg can be affected by stuff we don't hear about.
2 replies 1 retweet 1 like -
Replying to @EmilyGorcenski @ZJemptv
Perfect example is hard drives in 2009 or so... a flood wiped out like 33% of global mfg capacity. Drugs are similarly vulnerable.
1 reply 1 retweet 1 like -
Replying to @EmilyGorcenski @ZJemptv
I remember that (I work with repairs). It was hell for a bunch of years :/
1 reply 0 retweets 0 likes
I saw the news and told my IT guy. Same day we bought $1000s worth of hard drives before prices doubled.
-
-
Thanks. Twitter will use this to make your timeline better. UndoUndo
-
Loading seems to be taking a while.
Twitter may be over capacity or experiencing a momentary hiccup. Try again or visit Twitter Status for more information.