FDA bureaucrats see the role of their organization as that of a shield, removing as much risk as possible from medicine. Since it is impossible to remove all risk from any medicine, what this mission means in practice is that no individual bureaucrat ever wants to be held accountable for approving a therapy that later turns out to have unexpected consequences. It doesn’t matter if those consequences occur in just a few individuals, while countless others benefit, or even if the medicine in question is actually responsible: the fickle press will rise up in arms; the lawyers will flock. Thus those FDA bureaucrats will always move in the direction of requiring ever greater proof from companies – the cost of commercial development has doubled for no reason other than this in the past decade. Along the way, they also remove the right to choose from patients, the ever-present authoritarian side to the goal of protection. No-one is permitted their own risk assessment, and no organization is permitted to help those patients willing to take educated risks.
There are more subtle, reaching, and harmful effects beyond the obvious ones noted above. The structure of regulation has