Consider the source: Mr. Walker is co-founder and chief adviser for the Abigail Alliance for Better Access to Developmental Drugs.
Mr. Walker’s write-up in the WSJ is a highly biased view of the FDA, in my opinion.
I agree that the Abigail Allaince is a group that is dangerous as heck. And most WSJ articles about the FDA absolutely stink (I was appalled when, several years ago, I read the WSJ editorial that clinical trials in cancer were needless since historical comparison were obviously good enough.)
But you have to admit that is one of the more reasonable editorials - given the sources.