3 ms·
I am very interested in improving approval times, approval costs, and accelerating as much as possible and improving the current situation. But having done one
by epistasis 3y ago
I am very interested in improving approval times, approval costs, and accelerating as much as possible and improving the current situation.
But having done one filing and read tons of filings and talking to others, I don't have many complaints with the current setup.
The closest I have to a complaint is the attitude of a single person who served on an approval committee who wrote advice to those making applications, and that person seemed to have little acceptance of their own role in the process, specifically the high cost of saying "no" unnecessarily.
As with any approval body, their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no". But the FDA, of all the approval bodies I have dealt with, such as IRBs, has managed the best in my experience.
My experience may not be representative though.
Edit: thinking again, I do have one request, pandemic related. I think the FDA should rely more heavily on artificial standards for evaluating diagnostic tests for infectious agents. A key bottleneck in Covid19 diagnostics was obtaining clinical samples to validate new tests, and allowing more validation is synthetic samples would have greatly expanded testing capacity more quickly.
- roflc0ptic 3y ago> their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no". The FDA acting out this incentive scheme _is_ the problem. The issue is the opportunity cost: "I default to no, because while that may cost millions of lives, I don't incur responsibility for their deaths." The incentives should change to "I am responsible to take informed risks to maximize the wellbeing of the population." There is a literal death toll from their inaction, and it doesn't get counted in the equation. It's possible to design a system that takes that into account; that's what's being argued for.
- epistasis 3y agoI would agree that these sorts of agencies should take a proper risk/benefit analysis. And I would argue that the FDA is by far the best at taking this approach, despite lawmakers not yet officially making it their mandate. They have been responding to criticism over the past few decades.
- roflc0ptic 3y agoThat’s a perspective I haven’t heard; I’ve generally heard the opposite. Would love to hear more about that - any reading recommendations?