So, releasing the data is hard by default because of what it would require - you are talking hundreds of thousands of pages for a single drug.
It would take a very large permanent staff to do it.
Or a new set of requirements placed on pharma for how data is submitted to reduce that burden.
I'm not opposed, mind you, just saying what happens now would make it hard for the FDA to achieve "release by default" in practice[1]
Changing the rules here would also make things more adversarial in practice than they are now (for better or worse).
I think the value in the end is probably worth it, but i don't think it's as obvious a win as it is on paper. It's very easy to say how things should be abstractly. It's very hard to make systems that work in practice, and it's never as theoretically nice as we want them to be, nor can you really force them to be (which is often the proposed solution).
[1] you will also likely have to play whack-a-mole for a while
(not saying it's not worth it mind you, just that it's not easy). IE you will now be given 5x the data just because they know it will take you a while to sort through it. It will take a few iterations and lawsuits to get regulation/etc right to cause this not to happen.
It would take a very large permanent staff to do it. Or a new set of requirements placed on pharma for how data is submitted to reduce that burden. I'm not opposed, mind you, just saying what happens now would make it hard for the FDA to achieve "release by default" in practice[1]
Changing the rules here would also make things more adversarial in practice than they are now (for better or worse).
I think the value in the end is probably worth it, but i don't think it's as obvious a win as it is on paper. It's very easy to say how things should be abstractly. It's very hard to make systems that work in practice, and it's never as theoretically nice as we want them to be, nor can you really force them to be (which is often the proposed solution).
[1] you will also likely have to play whack-a-mole for a while (not saying it's not worth it mind you, just that it's not easy). IE you will now be given 5x the data just because they know it will take you a while to sort through it. It will take a few iterations and lawsuits to get regulation/etc right to cause this not to happen.