Now the Vote is Over

Avonechenbach2_2The confirmation of Dr. Andrew C. von Eschenbach after such a long wait for a new FDA Commissioner should be a beginning, not an ending.  The FDA has long been in need of leadership, a fact long neglected.  Given that there has been a vacuum for so long, the vote to confirm that leadership does not alone fill it.

Two things lacking has been a pronouncement of vision, and as often stated here, a dedicated plan to restore the image of the agency.  The confirmation serves as an opportunity to do both. 

The agency has sent some mixed signals about the future lately.  Earlier in the year, Dr. Scott Gottlieb stated a desire to embrace adaptive clinical trial designs and then, in the wake of a workshop on the same topic, the agency signaled a slower, evolutionary approach to same. 

On another note, the agency has positioned itself as a model of transparency, but the PDUFA negotiations are occurring behind closed doors, with information coming out in piecemeal fashion.  What is the agency’s plan for the future and how is it being communicated to those who need the information – those companies both in the U.S. and outside the U.S. who are actively engaged in research for new drugs. 

Personalized medicine has been pronounced by Dr. von Eschenbach as a future imperative, but what is the path for getting there?  Is it the Critical Path Initiative?  If so, then the agency needs to make that a roadmap that has clear goals, objectives and timelines.  To date, it does not seem to be there, or if it is, that hasn’t been convincingly communicated.

In short, Dr. von Eschenbach should use the opportunity of the next few months to lay out not only a vision, but communicate the means as well – and get past the ribbon cutting speeches.  It is one thing to say we are going to go to the moon.  It is quite another to build the apparatus that gets you there.  Lofty goals have to be backed up by sound planning and good communications to restore credibility. 

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