[ericb]

I fundamentally lack respect for bureaucracies because although they may be made up of minds far brighter than mine, they are subject to organizational dysfunctions and well documented psychological failings like group-think. The Peter Principal is another problem, as well as the influence of outside money. Additionally, the incentives are wrong for individual scientists--making bold calls is a career risk. Going with the flow is career enhancing.

Further, the FDA doesn't operate on the precautionary principle.

References:

http://en.wikipedia.org/wiki/Thalidomide

Distorting effects of authority (this applies both within the FDA, and regarding listening to the FDA)

http://en.wikipedia.org/wiki/Milgram_experiment

Conformity and group-think: http://en.wikipedia.org/wiki/Asch_conformity_experiments