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Risk and Potential in FDA-TRACK Initiative

April 9, 2010


  • Deputy Commissioner Sharfstein Briefing to Alliance Membership and Membership Meeting.   Deputy Commissioner Sharfstein has agreed to brief the Alliance on FDA’s new performance measurement initiative called FDA-TRACK on April 15, 2010 at 11:00 am.  The quarterly membership meeting will be held immediately following Dr. Sharfstein’s briefing rather than the previously scheduled date of April 27.  
  • Alliance Press Release on FDA-TRACK Initiative. Earlier this week the Alliance issued a press release regarding the agency’s performance measurement initiative called FDA-TRACK.  (See also Alliance Applauds FDA-TRACK Initiative.)


Earlier this week, the FDA announced the initiation of FDA-TRACK, an accountability management tool to be implemented across the agency. Eventually, there will be hundreds of metrics covering every aspect of agency activity. Even getting started is a substantial accomplishment.

Yet, for all of the glory of being a “leader,” there is also a risk to the agency of being among the first federal agencies to implement a system this large and detailed. In addition, FDA-TRACK is intentionally transparent, meaning that any shortcomings or failures of the agency will become public knowledge quickly. FDA doesn’t want to be an example of what not to do.  

The Alliance believes that risk is worth taking because FDA should become a more effective agency as a result of this effort. The benchmark should not be “Are we ahead of other agencies?” nor “Are we at greater risk than other agencies?” The only metric of success for FDA-TRACK is whether it helps FDA to better carry out its public health and regulatory missions.

When I work with an organization or company on shaping their future, I almost always start with the question: Five years from now (or three years from now), what will you wished you had started today? This empowers groups to think beyond immediate limitations (substantive, political, emotional) and, especially, beyond the pain of short-term risks and failures.

The pay-off from FDA-TRACK will not be achieved until some time has elapsed. FDA-TRACK is not primarily about the agency 6 months or a year from now, but where it will need to be in 3 and 5 years. By then, the metrics will be refined through experience, meaningful baseline date will have been collected, and all of FDA will be thoroughly knowledgeable about what is expected of them. To me, FDA-TRACK is the epitome of good planning.

The agency will  face critics who see the early results from FDA-TRACK as ammo for assaulting the agency. It will take time for the metrics to be refined. Accountability can’t be judged from quarterly reports. We should commit to being patient, knowing that there will be bumps, maybe even some outright failures. I might even go further and say: we need to be a little protective of FDA because it is doing the right thing by creating and implementing FDA-TRACK.  

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.


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