Lack of Leadership at the FDA
In preparing for a talk recently about the FDA and drug development, I looked at the timeline for FDA Commissioners over the last nine years (since David Kessler). Ends up that for six of the last nine years or 66% of the time the FDA was without someone to head up the agency. Just look at the FDA’s own website: Jane Henney served from 1/17/99 - 1/19/2001 two days past two years; Mark McCellan served from 11/14/2002 - 3/26/2004 or just a little more than 16 months, and then Lester Crawford served from 7/18/2005 - 9/23/2005 or just a few days over 2 months. So in the last 108 months (9 years), there has been someone heading up the FDA for only 42 months or 39.2% of the time. Now having spent 14 years in the industry, I know there have been acting commissioners but my point is, can someone in the acting position truly make a difference, lobby congress and set a culture and view of the future?
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