FDA’s Generic Drugs – FDA Tracker Status Update

FDA Track

 A month ago I was able to sit down with FDA's Deputy Commissioner Dr. Joshua Sharfstein to discuss the FDA's new effort at transparency and accountability called FDA Tracker, resulting in a podcast on the subject.  FDA Tracker is a program that collects data from all parts of the FDA and plots them so that one can see how various functions are doing.  There are a number of dashboards set up that one can look at to measure progress, or lack thereof.  While many of these dashboards had yet to be populated with data, Dr. Sharfstein said that the grids would start filling up in weeks to come.  

I thought it time to check in and see how FDA Tracker is doing.  Some of the dashboards I was most interested in still have no data, such as the Office of New Drugs.  But one that did was the Office of Generic Drugs.  Let's look and see how it's going.   

According to the dashboard, which is complete through February 2010, the rate for new generic approvals would appear to slow down as 2010 began.  It is interesting to note that there are a large number of "Not Approvables" each month.  

Generic Drug Approvals Dashboard 1
Because the program just started, there is not much data to demonstrate a true long-term trend and what we see here is too short term to come to any conclusions, but it is nonetheless interesting to view.  I was not aware, for instance, that there were so many applications that the agency had to review.

That led me to look at a different metric where a short-term observation may be more revealing and that is with respect to the number of cumulative pending applications.

Generic Drug Pending Applications Dashboard 1
 Here is what the agency says about this particular metric.  The pending review queue is affected by the number of new applications submitted, the number of amended applications needing additional review cycles, and the number of applications that cannot be approved due to patents, exclusivities, complex issues or the need to address matters raised in citizen petitions.  Overall review capacity affects the capability to address the queue.  

So there are a number of variables that affect this particular measure.  But the trend is definitely upwards raising the matter addressed in the last sentence of FDA's description of this metric – is review capacity sufficient to address this trend?  I may be getting into the realm where a little knowledge is a dangerous thing, but it seems a reasonable question.  

As more metrics become available, we'll begin to post some of the more interesting ones here.  

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