September 2, 2011

A Grievance

I have a Grievance with the FDA
It take them too darn long to approve better stuff for diabetes care. Someone should do something about that...
... and there is an opportunity to do something right now. The FDA docket on Low Glucose Suspend (LGS) is open for just a few more weeks. Take advantage of this chance to share your views with the regulators and congress.
You may feel that you are not qualified. You may fear that you do not know all the ins and outs of medical studies and that is what this seems to be about.
I think this is about more than ins and outs of studies. This is about timely approval of devices that can help manage diabetes. You may not use a CGM, you may not pump,  you may have doubts about artificial pancreas but if you live with diabetes regulatory delay puts you at risk. 
I think we should have an expectation that the FDA will preform their regulatory duties with alacrity.  That doesn’t seem to be the case with LGS. Here is a product that is in use in 40 different countries and the FDA still doesn’t have a process for considering applications to approve it here. That is more than a little late to the party.
If nothing else the FDA should hear from people with diabetes saying that devices should not come to the US market years after they are approve else where. The FDA needs to do its thing in a timely, citizen friendly and focused manner.
I think LGS can save lives. Particularly lives lost to sever overnight lows. I
That could mean fewer blue candles on Facebook. There are few things I hate seeing more than that symbol of grief and remembrance of a life lost to diabetes. Further delay moving forward on devices to that may keep kids alive is unacceptable. 
LGS is not a magic bullet. It is no cure. 
It does offer a means of lowering potentially tragic risks. What there is NOT is a means of the FDA will considering these and other pump / sensor advances as they are created.
Please comment on the Docket. I view it is one way of avoiding blue candles. I hope it is only ONE of MANY ways of avoiding blue candles. We need all the ways we can get to keep them out. The FDA should be our ally not an impediment in those efforts.
Comment to the FDA and share those thoughts with your member of Congress. Be someone who does something. As it says in the first amendment, “petition the government for a redress of grievances.” 


  1. I find these huge large corporations good for nothing at times. They sit on millions, and make trouble rather then approving the good that people need.

  2. Bennet. I finally posted on this topic. Talking to the FDA.

    The individuals in the FDA are generally great, the bureacracy and leadership is a large part of the problem. Plus if you keep punishing a group for failure the easiest way to avoid the failures is to not approve anything.