Data is what distinguishes the dilettante from the artist.
– George V. Higgins
In another move on its transparency initiative, the FDA has recently announced a new program to publicly track its own performance. It’s called FDA-TRACK and, in the FDA’s own words, its objectives are:
- Transparency – provide interested parties an unprecedented look into how FDA performs its work.
- Results – highlights performance measures and results with relevance to the agency’s public health mission.
- Accountability – requires senior managers to develop, track, and report performance measures that will improve the agency’s accountability to the public; holds the program offices accountable for their priorities, plans and results.
- Credibility – encourages sharing of information about FDA performance which is essential for the agency’s credibility; provides the opportunity to submit suggestions which will be considered as part of the continuous improvement efforts.
- Knowledge-sharing – enables the identification of common issues and interdependencies among program offices to improve FDA’s operational effectiveness through better collaboration and sharing of ideas.
So, that certainly sounds good, but what data (i.e., tracking metrics) are the FDA going to be presenting? Well, it’s not finalized quite yet, but it looks like rather a lot. After each quarterly briefing by the centers within the FDA, updated metrics will be posted to various dashboards on the FDA-TRACK site. The dashboards include both center-specific and cross-agency metrics.
I’ve already bookmarked CDER’s OND dashboard, so let’s use that one as an example of the kinds of data you’ll (eventually) be able to find there:
Investigational New Drug Applications (IND)
- Number of Commercial INDs received in the month
- Number of Research INDs received in the month
Marketing Applications (New Drug Applications (NDA) and Biologics License Applications (BLA))
- Number of marketing applications received in the month
- Total number of actions taken on marketing applications during the month
- Number of actions taken on marketing applications in the month that were within goal deadlines
- Number of actions taken on marketing applications in the month that were past goal deadlines
- For those actions taken past goal deadlines, median number of days past deadline
Efficacy Supplements to NDAs and BLAs
- Number of efficacy supplements received in the month
- Total number of actions taken on efficacy supplements during the month
- Number of actions taken on efficacy supplements in the month that were within goal deadlines
- Number of actions taken on efficacy supplements in the month that were past goal deadlines
- For those actions taken past goal deadlines, median number of days past deadline
Postmarket Requirements (PMR) and Commitments (PMC)
- Number of PMRs and PMCs established during the month
- Number of PMR and PMC final reports received during the month
And that’s just OND! As of this writing, there are 10 dashboards for CDER, 3 for CBER, and 6 for CDRH (not to mention DVM, CFSAN, ORA, etc). 100 offices within the FDA will eventually participate in the program.
As far as one can be excited about data (which is pretty far, actually), I’m excited about this. Previously, some of these data were available through other sources (e.g., FDA presentations, internal corporate tracking) of course, but this is the first time that everything is going to be compiled together in an organized and accessible way.
What will the FDA get out of this effort? By increasing transparency into its activities, it should help the public understand how the FDA serves public health (translation: PR). It will certainly also be used by the public to give (hopefully constructive) feedback to the FDA; this could have an added benefit of helping the FDA secure more funding if the public recognizes a need within the FDA.
I’m sure you’ll hear more about this from me in the future. Personally, I look forward to checking in on these dashboards regularly.
