William Hyman: Another Visit to the FDA’s Action Plan

In a January 2014 blog post, I reported on a third visit to the FDA’s own scorecard for its 2013 Action Plan. As of Jan. 1, 2015, this page showed a last updated date of Sept. 17, 2014. As shown on the scorecard, the 2013 Action Plan had 14 elements with completion set for three time frames: June, September, and December 2013. The scorecard currently shows completion of five of these elements—the same number as one year ago.

As I have previously noted, four of these elements relate to the unique device identification (UDI) initiative. My favorite among these is the UDI expert workshops which were set for completion by June 2013. The associated posted “completion” references a report from Brookings on workshops completed in October 2012, December 2012, and March 2013. Thus, the claimed completion occurred before the 2013 Action Plan was promulgated, and in turn before the June 2013 deadline the FDA set for itself. Creating future dates to complete things already completed is a good strategy for meeting your own self-imposed deadlines. Interestingly, the scorecard has not recorded another recently announced UDI product from Brookings which is the release of its Roadmap for Effective Implementation.

The other completed effort is the poorly designed MedWatcher software and website for capturing voluntary device reports. Do any professionals use this? Does anyone look at the reports received?

With the FDA claiming completion of five elements, this still leaves nine not completed as 2014 came to an end. There is no transparency associated with the progress, or the lack of progress, of these nine. Did they ever get started? Are they underway but significantly delayed? Were they started and abandoned? Does anyone at FDA still care about its 2013 Action Plan? If not, they should say so.

It may be that people and resources at FDA for this effort have been lost or diverted, and that as 2015 begins the 2013 Action Plan has become ancient history while living on as an active website—a relic of the digital age where some things last forever. It may also be that the FDA is easily distracted, and that it suffers from a phenomenon I observed in academia. This is that all new initiatives are much more exciting and important than all old initiatives, no matter how important the old initiatives were said to have been at the time they were created, and no matter how well they are working. It may also be that the FDA lacks effective management controls to assure that the launch of new initiatives is consistent with the resources to complete them, and to assure that old initiatives need to be either completed or officially declared dead in the water.

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union.

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