FDA's Crude Tools

The FDA makes binary decisions in the main while medical science is quantum knowledge --  which means it's capacity to regulate drugs and devices by adding language to labels or simply pulling a drug because it doesn't benefit -- on average -- all patients relative to risks is outdated.  From Avandia to Avastin the old school view of FDA regulation -- from the right and left -- is prehistoric.    Why is the FDA frittering away millions on discovery work masked as regulatory science and playing footsie with CER when the future is in digitizing and personalizing product development and treatment selection?  And why is the industry funded NIH Foundation lauded for promoting Alzheimer's advances through collaboration and the Reagan-Udall Critical Path Institute is attacked?     I just don't get it. 

marketplace.publicradio.org/display/web/2010/08/16/am-fda-may-revoke-breast-cancer-drug-q/