Home > Transparency Posts > Comment on the Sentinel Initiative

Comment on the Sentinel Initiative

In line with FDA’s Transparency Task Force efforts, FDA is encouraging public comment on the Sentinel Initiative. The Sentinel Initiative is an FDA collaborative effort to develop a national electronic system (Sentinel System) that will transform FDA’s ability to track the safety of drugs, biologics, medical devices—ultimately all FDA-regulated products—once they reach the market.  By seeking public comment via an open discussion room, FDA is expanding its ability to get new ideas and guidance from the public in near real time. To contribute ideas on the Initiative and related documents, please visit http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

We look forward to your participation.

Erik P. Mettler, MPA, MPH

FDA Transparency Blog Managing Director

 

 

  1. July 23, 2009 at 4:30 am

    Eric,
    Don’t you have any more capital letters behind your name?
    Gee Whiz! It never occurred to anyone to look around our government and see if there are already other agencies who have such a system. You know what I mean. Letting the left hand know what the right hand is doing. Hmmm, maybe the Veterans Health Administration has such a system called VistA? Nah, that would be too easy and would reduce our budget for next year. We need to spend money to help speed the recovery of the economy. Besides, VistA software is already Public Domain Software and is going to be incorporated into the new National Healthcare Plan. We need to reinvent the wheel and then create a new agency to integrate all the seperate softwares into one system. WE WILL NEED A NEW “IT” CZAR in 2011! Hire a Vet!

  2. TSC
    July 24, 2009 at 4:51 pm

    To be fair to the FDA, it seems to me that they did look at what other agencies “have such a system”. They just looked across the pond, and found that MHRA (the UK counterpart of the FDA) runs something similar (for example, see here http://findarticles.com/p/articles/mi_m0EIN/is_2005_July_22/ai_n14813770/ ). MHRA system is also called Sentinel, and MHRA seems to be quite happy with it (see http://www.publictechnology.net/modules.php?op=modload&name=News&file=article&sid=19286&mode=thread&order=0&thold=0 and http://www.dgra.de/fortbildung/pdf/kongresse/2007/kongr2007-wheeler.pdf )
    On the other hand, VistA is just an electronic health record system, and it is not at all clear how it could serve the agency needs. It will probably require extensive customization. Why reinvent the wheel?

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  14. July 28, 2011 at 3:28 pm

    I hope the comments that the FDA are asking for are listened to. Too often this is a process that organisations go through to show what good listeners they are, and then ignore what they are told and just carry on as before

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    I agree with the fact that outstanding efforts in the right direction. True change takes time and trust issues still must be resolved, but this appears to be moving in the overall right direction to me.

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