Folks - This is not a news item but a chance to think together about issues of shared concern.
The following are often asserted by defenders of preemption:
1. Litigation stifles new drug development.
2. Litigation raises drug costs.
3. Litigation leads to danger "over-warning."
We have already heard from some FDA senior people that the last claim does not appear supported by the evidence. But let me ask you about the first two:
1. How would you design a study - what could and would you look at - to prove or disprove either proposition 1 or 2? Obviously, defendig lawsuits cost money. But that cost could impact a lot of different things.
How would we know, how _could_ we know, whether that cost impacted new drug development or drug costs? It would be nice to go from articles of faith and talking points - on all sides - to something resembling evidence.
Thanks for your good thoughts!