Dr. Sharfstein’s Departure

This week, the news came out, ironically via Twitter, that Dr. Joshua Sharfstein was going to be departing as Deputy Commissioner from the FDA, effective almost immediately, to take on duties at the state level in Maryland.  When he and Dr. Hamburg came to FDA barely two years ago, together they presented a public health dynamic duo – both having been former major metropolitan health commissioners.

The appointment of these two individuals said that the agency was effectively turning a corner – that public health was the driving force and if you wanted to communicate effectively with the agency, framing a discussion -whether a drug approval or safety considerations or a policy decision – should be in public health vernacular.

The announcement seems to have taken many by surprise – perhaps even inside the agency.  While Dr. Sharfstein did schedule a statement, there was no official press release from the agency itself.  As a result, the story is being driven not by the FDA, but by the media and the blogosphere.  Still, the agency may want to weigh in on matters beyond those of who will replace Dr. Sharfstein in the interim until another Deputy Commissioner is identified.

Dr. Sharfstein served many roles at the agency.  Last April I had the opportunity to sit down with him and record a podcast on the new levels of transparency at FDA, an area he was clearly spearheading.  One of the things he stated at that time was the fact that changing the agency took time – a great deal of it – and that things simply could not change as fast as he would like.

The transparency initiative is pretty broad, including an FDA Transparency Blog and, the subject of my interview with him, the publication of various metrics by which each part of the agency tracks its progress called FDA Track by making public the divisional reporting dashboards – wholly unprecedented then and now I believe when considering any federal agency.

The transparency initiative is one of the important ways that the agency regains some of its credibility under its new leadership.  What happens with that initiative is important because the work is far from complete.  The dashboards still have a considerable time lag involved with the reporting of the numbers, and even something as simple as providing links to the background information of advisory committee members on the FDA’s Web site is still not at a level where it needs to be (how hard is a link?).

At some point, therefore, so that we know what is going to happen going forward with this and other important areas in which Dr. Sharfstein was involved, it is important for the FDA to open up and have a a more guiding hand in shaping the story about the departure of Dr. Sharfstein, and not leave it to the media and bloggers.

In the meantime, goodbye and good luck Dr. Sharfstein.

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