Whatever else is going on… the FDA has never been graded on speed, and plenty of ink has been spilled in non-covid times about how many people die, and how many QALYs are lost, because of delays that make little difference to the eventual outcome, but look to the general public like Serious People Making Decisions Carefully. They permit themselves the time, and with it buy a mantel of authority in the public eye.
Also… looking at the VRBPAC online meeting calendar, it looks like they plan out their meetings several months in advance. I assume normally this is to ensure that members can align their schedules. Does anyone know how far in advance the seemingly-weeks-delayed-meetings were scheduled? Before or after the data from trials gets officially submitted? I’m wondering if they just have recurring meetings on the topic and wait to talk at the next one, or if their standard practice is to always schedule meetings at least a few weeks out for their own convenience, or what.
This past year we removed many but hardly all of the more useless regulatory barriers to testing and approval the vaccines. Is there any reason the FDA couldn’t have been auditing the data and the trial process all along (other than “they’re not set up to do that or aren’t allowed to”)? “We need weeks to confirm the data are authentic and check your math” just isn’t plausible during a pandemic when there’s no scientific reason that has to wait until the very end.
Whatever else is going on… the FDA has never been graded on speed, and plenty of ink has been spilled in non-covid times about how many people die, and how many QALYs are lost, because of delays that make little difference to the eventual outcome, but look to the general public like Serious People Making Decisions Carefully.
The FDA is effectively never graded at all. At the same time, politicians do something push for the FDA to just approve a drug. Big Pharma who hires FDA officials likely also rewards officials for approving their drugs faster.
They permit themselves the time, and with it buy a mantel of authority in the public eye.
This is essentially a conspiracy theory. It might be true that’s what happens but as rationalists I don’t think we should believe in conspiracy theories without understanding the underlying dynamics. I asked this question because I believe the underlying dymamics are important to judge whether or not it makes sense to believe in that conspiracy theory.
Fair enough, maybe it is a conspiracy theory, though to me it seems like the default adaption of what I would expect to happen. It’s a good question regardless.
Also RE: pharma companies wanting their drugs approved faster: yes, they do, too slow lowered their ROI, but also limits their pool if competitors to those already prepared to navigate the approval process. They may not want it to be too fast either.
Whatever else is going on… the FDA has never been graded on speed, and plenty of ink has been spilled in non-covid times about how many people die, and how many QALYs are lost, because of delays that make little difference to the eventual outcome, but look to the general public like Serious People Making Decisions Carefully. They permit themselves the time, and with it buy a mantel of authority in the public eye.
Also… looking at the VRBPAC online meeting calendar, it looks like they plan out their meetings several months in advance. I assume normally this is to ensure that members can align their schedules. Does anyone know how far in advance the seemingly-weeks-delayed-meetings were scheduled? Before or after the data from trials gets officially submitted? I’m wondering if they just have recurring meetings on the topic and wait to talk at the next one, or if their standard practice is to always schedule meetings at least a few weeks out for their own convenience, or what.
This past year we removed many but hardly all of the more useless regulatory barriers to testing and approval the vaccines. Is there any reason the FDA couldn’t have been auditing the data and the trial process all along (other than “they’re not set up to do that or aren’t allowed to”)? “We need weeks to confirm the data are authentic and check your math” just isn’t plausible during a pandemic when there’s no scientific reason that has to wait until the very end.
The FDA is effectively never graded at all. At the same time, politicians do something push for the FDA to just approve a drug. Big Pharma who hires FDA officials likely also rewards officials for approving their drugs faster.
This is essentially a conspiracy theory. It might be true that’s what happens but as rationalists I don’t think we should believe in conspiracy theories without understanding the underlying dynamics. I asked this question because I believe the underlying dymamics are important to judge whether or not it makes sense to believe in that conspiracy theory.
Fair enough, maybe it is a conspiracy theory, though to me it seems like the default adaption of what I would expect to happen. It’s a good question regardless.
Also RE: pharma companies wanting their drugs approved faster: yes, they do, too slow lowered their ROI, but also limits their pool if competitors to those already prepared to navigate the approval process. They may not want it to be too fast either.