ABSTRACT
There are three underlying precepts that together provide a foundation for and an understanding of all the myriad FDA actions: (1) proximal causality, (2) risk assessment, and (3) self-regulation. Those three principles can be used heuristically as well, providing a basis for prediction of future FDA actions and a projection of interpretations and emphases. Since the FDA’s inception, these three principles have governed the ebb and flow of debate between proponents of the industry promotion and protection (providing more medical options) and the proponents of public health and safety (providing fewer but safer options).
