Serious question: does anyone in this community know anyone in a relevant position at the FDA, and if so, have / could they have this conversation with that person? Meaning a deep face-to-face discussion.
It would be very interesting to understand the private viewpoint of individuals at the FDA (as opposed to the official viewpoint of the organization): do they recognize that the tradeoffs being made here are bad? Do they honestly believe that it is somehow necessary / for-the-best? If so, are their reasons at least somewhat plausible?
Is it simply that their hands are tied, and if so, how? (Formal rules, concerns regarding public opinion, directives from above...)
Or do they honestly not see that the tradeoff is bad? This might be the most optimistic scenario, as then it might at least in principle be possible to effect change by helping them to see it.
There is another ciunterfactual world that looms large in the ethos of the FDA.
If drug makers were allowed to start selling without any testing at all, that would be bad. If they could sell based of efficacy without concern for safety, also bad. If they only tested on otherwise healthy 25-50 year old men, that would still be bad.
So, the question becomes "who gets to decide how much testing is necessary, and how to prove it was done?"
Regulations are written in blood. And have to account for adversarial interactions with bad actors.
Serious question: does anyone in this community know anyone in a relevant position at the FDA, and if so, have / could they have this conversation with that person? Meaning a deep face-to-face discussion.
It would be very interesting to understand the private viewpoint of individuals at the FDA (as opposed to the official viewpoint of the organization): do they recognize that the tradeoffs being made here are bad? Do they honestly believe that it is somehow necessary / for-the-best? If so, are their reasons at least somewhat plausible?
Is it simply that their hands are tied, and if so, how? (Formal rules, concerns regarding public opinion, directives from above...)
Or do they honestly not see that the tradeoff is bad? This might be the most optimistic scenario, as then it might at least in principle be possible to effect change by helping them to see it.
There is another ciunterfactual world that looms large in the ethos of the FDA.
If drug makers were allowed to start selling without any testing at all, that would be bad. If they could sell based of efficacy without concern for safety, also bad. If they only tested on otherwise healthy 25-50 year old men, that would still be bad.
So, the question becomes "who gets to decide how much testing is necessary, and how to prove it was done?"
Regulations are written in blood. And have to account for adversarial interactions with bad actors.
This is all true - medical regulations are indeed written in blood.
Bearing that firmly in mind, a key difference is that families can sue drug manufacturers, but cannot sue the FDA.
(That’s probably sounds quite cavalier - it’s not my intent.)
Neither extremes resurrect the dead, but the possibility of remedy can lead us to err toward approvals rather than delays.