Being in a position where I work with regulators on a routine basis, I do not find it unusual that people like John Jenkins and Janet Woodcock have repeatedly stated on the record that there has been no change in FDA policy on drug approvals. It is totally conceivable that they did not want to call attention to the executive branch issuing policy guidance that is a departure from decades of past FDA practice. There are numerous examples of good soldiers in the Bush administration. This is an administration that praised loyalty above all else throughout the ranks. It is very easy to point to a subjective reason (i.e., the quality of the applications as being the reason for a denial or an approvable letter).
I consider myself an Independent so I hope not to sound to much like a Bush conspiracy freak).
Alternatively, Jenkins and Woodcock may not have totally agreed with the policy memo and decided ro adopt the much more conservative approach until clarification was provided thru either the executive, legislative or judicial branches.
Why did the FDA have to be sued by NVS for approval of omnitrope? I think just about everyone will agree that it occurred because there was a vacuum since no approval process was provided by legislature. I think the same kind of mindset applies here. I believe the FDA bureaucrats may have followed the policy memo to the letter, either out of allegiance or possibly to point out the shortfalls (i.e., increased burden of proof placed on the FDA).
I still think FDA will bear watching to see if this the Supreme Court clarification on this matter provides them a little more lattitude and reduces the hyper conservative nature of the past few years. I find the change in the level of review scrutiny in the past three years after several decades of relative consistency a little to coincidental.
Thanks
FL
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