August 18, 2011

Repeat After Mike: Dear FDA...

Mike Ratrie left a new comment on the post "Repeat After Me: Dear FDA..." that I think is so good it should be a stand alone post. He wrote:

Bennet,

Here is a copy of the what I posted on the FDA comments link you provided. I also sent it along to my Congressperson (Mica) and Senators (Nelson, Rubio).

Cheers,
Mike


"Having read the draft guidance regarding Investigational Device Exemption (IDE) and Pre-Market Approval Applications (PMA) for Low Glucose Suspend (LGS) Device Systems, there are at least two areas that stand out for me.

The first and most obvious one is why is the FDA putting together this lengthy and dense type document when these devices have been approved in over 40 countries AND have been in use for over three years. Surely in this time of near instantaneous communication of results, the companies who market these devices have already answered most if not all of the questions and concerns raised by the FDA. If not, the remaining questions and concerns should be relatively minor and not worth the time and expense of undergoing full-blown trials.

Note that by time and expense, I refer to not only the time and expense for both the FDA and the LGS manufacturers, but also the time and expense to the patient community that would benefit by having these devices immediately available. Indeed, delays like this strike at the heart of the public's confidence in the FDA's ability to follow its mandate.

The second issue that stands out is the HB1AC guideline for a successful trial. It seems to me that the FDA is being overly technical here and is missing the bigger picture - the avoidance of hypoglycemic events. In other words, a T1DM patient who has a 0.4% lower HB1AC without using a LGS system, doesn't just have a lower "number" without meaning to their quality of life, and in all likelihood they are not "healthier", because this lower number means they are spending more time with blood glucose levels that are too low. I urge the FDA to revisit this parameter of trial success, with a more expanded, less technical view.

There are other minor issues with the draft such as spelling and grammar, inappropriate links (there is one that literally links the reader to the very next paragraph) and language that just cannot be followed."