Friday, January 16, 2009

FDA Commissioner Update: Califf's Name Emerges But Is Sharfstein the Pick?

We know you've been waiting on the edge of your seat so we thought we'd send you an update. We've heard that Duke researcher Robert Califf and Baltimore Commissioner of Health Joshua Sharfstein have been tapped, at the very least, for interviews. 

In fact, multiple sources say Sharfstein may have been offered the job. But we're not quite ready to confirm that just yet. 

Califf as we understand it has the support of senior FDA officials who would be very happy if he were named FDA Commissioner. Califf knows the folks at the agency quite well. In September 2006, Duke entered into an agreement with FDA to serve as a warehouse for electrocardiograms to serve as tools for drug safety research through the Critical Path Initiative. In addition, he's served on FDA advisory committees. 

As we've said before (click here), if the Administration chose to go with a big name who was less controversial, Califf would fit that description. His ties to the drug industry would be a hindrance in the vetting process, but as we understand it, Duke has among the strictest, most transparent guidelines when it comes to running their clinical trials for drug developers. 

The choice of Sharfstein would indicate the transition knew exactly who they wanted to head the agency from the beginning. Sharfstein is leading the FDA review team for the HHS transition. We'd heard Sharfstein had encountered resistance from different stakeholder factions but clearly he's been able to overcome those concerns. 

To read the likely picks for FDA Chief Counsel and HHS General Counsel, see our previous post here. We'll let you know as soon as we find out more. 

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