Some months back, as part of its greater transparency efforts, FDA launched FDATrack which has set up a number of metrics that are being tracked on FDA performance. At the time, I had the pleasure of doing a podcast here on Eye on FDA with Dr. Joshua Sharfstein about the program, which provides dozens of dashboards where data is tracked. At the time, while the dashboards were designed, and up on the FDA site, there wasn't much data yet plugged into the fields.
However, data is finally beginning to emerge. One of the first I've looked at is the dashboard on FDA Advisory Committees. Here the data is still spotty. While the dashboard goes back to October 2009 and there is data that goes back that far, data for December 2009 and January 2010 are missing. After that, there is data again from February 2010 through June 2010, and nothing after that date. (There doesn't seem to be a dashboard for seeing how well FDA is doing about entering data into the dashboards.)
The dashboard for advisory committees has a measure for vacancy rates overall, and then breaks it down by the various advisory committee divisions – everything from the Center for Biologics Evaluation and Research (CBER) to the Center for Tobacco Products t the National Center for Toxicological Research (NCTR).
For purposes of medical product approvals, it seemed best to focus on four of the categories to see how the vacancy rates were running. First, of course, the overall vacancy rate, the rate for CBER, the rate for the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).
What was found was that the overall vacancy rate for the most recent period of consistent data entry was around 34-35%, though it dropped down in June to 31%. Interestingly, however, the vacancy rate for both CBER and CDRH hovered above the overall rate, while the rate for drug evaluation (CDER) was below the overall rate, even though the number of committees to be filled on CDER outnumbers by far those of CDRH and CBER combined. The CBER vacancies appear to be concentrated in specific committees. The vacancies on CDRH are a little more complicated as one committee is subdivided into specialty panels.
The target vacancy rate identified in the FastTrack dashboard for each is 10%, so needless to say, while there appears to be some modest movement by June, the FDA still appears to be a far way away from meeting its goal.
There are two things that make reaching that goal important. First, the high vacancy rate in CBER is not good given the fact that biologics are such a fundamental part of the future of medicine. Secondly, the advisory committee structure and process is a lynch pin for FDA credibility.
One other interesting point – the dashboard states that overall there are 608 advisory committee member positions in total. And if you think you are qualified, here is how you can apply for a position.