Dan Carpenter, in the October 18, 2005 issue of Health Affairs, proposes financing post-marketing drug safety studies by augmenting FDA user fees. That’s just PDUFy. Why add (by Carpenteré¾ own calculation) 25% increased cost to the process when a more expeditious route is to empower FDA with the enforcement authority required to compel post-market commitments made during the initial approval process. Carpenter’s modest proposal would certainly provide a lot of work for idle academics, but not much in the way of enhanced patient safety. Maybe its time that we kept our powder dry and kept sponsors to their NDA-phrase promises. For more thoughts on the Carpenter article, please click on “comments” below for a thoughtful response from Bob Goldberg of the Manhattan Institute.
Carpenter Rants
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