He is off-base in his reasoning for opposing the elimination of user fees as a source of funding for FDA activities. See his article in the NEJM. While I tend to agree that user fees are becoming increasing unwieldy -- and should be replaced by public-private partnerships to advance Critical Path -- the implication that companies can't work with FDA to advance science is absurd.
Mark McClellan's editorial in the NEJM saying we have one last chance to get it right on FDA reform is on point. Pair Avorn's Circ article with Mark's NEJM and we have a sensible consensus that is Critical Path focused.
Links to all follow: