I don't understand how there can even be a shortage of "drug for half the population when they age".
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Replying to @ZJemptv
http://www.fiercepharma.com/manufacturing/shortage-injected-hormone-falling-hard-transgender-women … Why would their supplier literally just *stop making it*
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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
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Replying to @ZJemptv
So, I have a bit of FDA experience, mostly in medical devices, not pharma, but its similar....
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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...
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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
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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.
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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.
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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.
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Replying to @EmilyGorcenski @ZJemptv
FWIW, perrigo shut down their 20mg/mL dose to move up to 40. That should be available in 8-10 weeks.
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This is all public but hard to find. Just query 'delestrogen' at this database: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm …
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Replying to @EmilyGorcenski
Would you be willing to like, maybe Skype at some point and we can do a little Gender Analysis interview about this?
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Replying to @ZJemptv @EmilyGorcenski
This is a big thing for a lot of trans women and I feel like this inside look could help put people at ease
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