> I'm actually on Marc's side on this one, in that I suspect current FDA approval processes are overkill.

As I understand it FDA didn't approve Pandemrix, while EU regulators did give it fast track appeal.

Pandemrix causes narcolepsy in 1 in 60,000 people who take it. (so, for the entire US that's about 5000 with a life long debilitating illness that requires constant care.) The risk is very low, but it's there and we need to be careful about exposing a population of hundreds of millions to these risks just because we have an ideological opposition to any form of government regulation.