Hi BCO,
yes, you are correct, A PRV can be used for any human drug application.
Regarding the 2024 and 2026 sunset scenarios, make of it what you will.
I consider that historically it's a bureaucratic aspect, regarding government funding and politics, and also efficacy.
To me, it's a repeat of the 2020/2022 sunset scenario, which simply got rolled over.
I liken it somewhat to the US government debt ceiling that nearly "stops" the country each time it is met, only and forever, to be rolled over.
PRVs aren't as big or dramatic as the debt ceiling and halting US payments, but still politically I don't think either party wants to be responsible for canceling what seems to be stimulating to get treatments to market for children with rare diseases.
That said, 2020/2022 was looking at being rolled over, and then COVID came along and possibly got some extra inertia, and easily rolled over.
My thoughts are that history will most likely repeat, but that's not a given, and it is up to Congress.
If someone in Congress can portray that the program is ineffective at stimulating new drug development or expedited access to patients then the Sun may set. But who is motivated to do that?
I do know one thing, they are well sought after by Pharmaceutical companies and if any group has a strong lobbying system it is them
So although I know it's not a given, I strongly suspect there will be no Sunset when its currently deemed and there may be a new Sunset set for 2028/2030.
But I could be wrong, time will tell.
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