FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua Sharfstein

No kidding.  I mean it.

Photo sharfsteinTransparency is one of those buzz words that doesn't really mean much to people, because it means so many things to so many people.  As a result, in some ways, the word has lost its relevancy.  So one is hesitant to even use the word "transparency" to describe the new effort launched by FDA earlier this month called FDA Track.  It is transparency, but it is so much more.  And to those of us whose lives and livelihoods revolve around the workings of this agency, FDA Track is an incredible new tool filled with a great deal of promise.

This is more than transparency, it is really about program accountability.  With FDA Track, you will be able to look in on your pertinent parts of the agency to see how they are tracking by checking out one of the many dashboards that has been formed for the many FDA program offices that will be reporting through the program.  For example, I zeroed in on CDER, which has ten reporting dashboards, including one for the Office of New Drugs.  Using this, one can track investigational new drug applications as well as NDAs and BLAs to see the numbers on how the FDA is doing.  Here is a screenshot of what that looks like and some of the metrics involved:

CDER FDA Track Metrics

Not interested in new drugs, but more interested in generics?  There is a dashboard for that as well.   In fact, there are a few dozen dashboards that convey a lot of information on the progress of the agency over time.  

You can see that there are a lot of N/A's and TBD's, but the numbers should start rolling in soon. And if there is a metric not there that might be useful, the agency is apparently open to suggestion at any rate, on the possibility of adding new measurements.   

In looking it over, I had to wonder if any other federal agency has gone so far in publishing some of the areas in which it was already collecting data on  how the agency itself is doing.  That is why I think this might be somewhat pioneering.  

I had the opportunity last Friday to sit down with Dr. Joshua Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration to discuss FDA Track. We talked about the genesis of the program, how they are doing it, what those of us in the public who are interested can expect of the program, and the process and timeframe for bringing it entirely up and running.  Check it out.

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1 Response to FDA Pioneers New Level of Transparency – An Interview with Dr. Joshua Sharfstein

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