Yes, but the costs are sufficiently high that it discourages researchers from trying to create new medicines which would be broadly helpful but unprofitable. Such as better treatments and preventative medicine for diseases that only afflict poor people in underdeveloped regions.
It doesn’t have to be all or nothing. We could have a scaled back paranoia around risk, and thus allow the FDA to pass medication for vastly decreased process costs.
The question then is about trade-offs. Given that there will be QUALYs lost on either side of the decision boundary, we should seek to minimize regret. Instead we are seeking to minimize Copenhagen-ethics-style culpability, and thus incurring a lot of regret. Getting rid of the FDA entirely would shift the decision boundary, but probably too far in the opposite direction. That doesn’t mean the status quo is near optimal.
It is true that most pharma companies concentrate on indications that supply returns to offset the cost of development. The FDA does have a mechanism for Orphan Drug approval, for rare diseases, where the registration requirements are significantly lowered. According to this site 41 orphan drug approvals were made in 2023. Whether this mechanism is good enough allow the promototion of rare disease in the larger pharmaceutical industry is a good question. I wonder how many of these drugs, or their precursors, originated in academic labs,, and were then spun out to a start-up or sold on?
Orphan drugs, yes. But no program for “drugs to more cheaply prevent conditions common in poor people but completely absent in rich people.” That’s the program I’d like to see.
Yes, but the costs are sufficiently high that it discourages researchers from trying to create new medicines which would be broadly helpful but unprofitable. Such as better treatments and preventative medicine for diseases that only afflict poor people in underdeveloped regions. It doesn’t have to be all or nothing. We could have a scaled back paranoia around risk, and thus allow the FDA to pass medication for vastly decreased process costs. The question then is about trade-offs. Given that there will be QUALYs lost on either side of the decision boundary, we should seek to minimize regret. Instead we are seeking to minimize Copenhagen-ethics-style culpability, and thus incurring a lot of regret. Getting rid of the FDA entirely would shift the decision boundary, but probably too far in the opposite direction. That doesn’t mean the status quo is near optimal.
It is true that most pharma companies concentrate on indications that supply returns to offset the cost of development. The FDA does have a mechanism for Orphan Drug approval, for rare diseases, where the registration requirements are significantly lowered. According to this site 41 orphan drug approvals were made in 2023. Whether this mechanism is good enough allow the promototion of rare disease in the larger pharmaceutical industry is a good question. I wonder how many of these drugs, or their precursors, originated in academic labs,, and were then spun out to a start-up or sold on?
Orphan drugs, yes. But no program for “drugs to more cheaply prevent conditions common in poor people but completely absent in rich people.” That’s the program I’d like to see.