Former FDA Commissioner and NCI director Andrew von Eschenbach has a good editorial in the WSJ about how the FDA needs to modernize to help patients and the medical industry.
I was particularly struck by his point that the FDA regulatory responsibility covers $.25 of every dollar in consumer spending - from tobacco products to vaccines. In essence, the FDA's mission applies as much to sprouts (which have been subject to e.coli breakouts) as stem cells.
von Eschenbach does't propose it, but what if the "D" part of the FDA was spun out into its' own agency? With an organization built specifically for regulating modern medicine, we might end up with regulations and processes optimized for 21st century medical innovation.