Ed, keep up the good work.

PV

I agree with Christopher that impact of FDA timing–within certain limits–is pretty hard to quantify re: both good and bad results for pts. And, yeah, each side finds what it needs. (Or, in lieu of data, finds stuff to make up–see again, Hilts…)

Also agree that joint ventures, not competitive ones, would be very good. My understanding (admittedldy based on the reporting of Gardiner Harris here) is that there used to be more of that before PDUFDA steered most of CDER’s funding to new drug review–that is, using collaborative data bases, and so on.

I understand that some of that has been restored.

Fixing the FDA is important but if resources are at the heart of it - including their availability and effective deployment - perhaps more could be achieved through cooperation.

I’m not supporting this hypothesis but it makes for an interesting discussion; I said at the beginning it won’t work for political reasons. However, if beyond resources, the quality of safety evaluations pre and post-marketing continue to be important, perhaps two heads would be better than one, so to speak.

Whether harmonization helped can also be debated, but regardless of whether more drugs were approved faster, the oversight made possible by a collective review may well have improved the quality of evaluations and that is what maybe the prize here, not quantity.

It is appalling that even under PDUFA the FDA has consistently failed to meet its time-critical obligations to get NDA’s approved more quickly. I would prefer to concentrate on fixing the FDA to get the NDA’s cranked out more quickly and not worry about what EU does. As far as I’m concerned I think way too many years were wasted on the the “Harmonization” proceess, essentially a busy work exercise that diverted attention from the regulatory mission of actually approving drugs. Prior to ICH, the rate of drug approvals was actually faster via the individual country route. To me it was a problem that didn’t need fixing.