September 17, 2012


Following a contentious an unproductive meeting at FFL with the FDA, for which I am as responsible as anyone else. I set out to try to have a less contentious exchange with the agency. This is one in what will probably be a series of posts based on their replies. 

The FDA’s representative at FFL suggested that if consumers are unhappy that a devices is available overseas and not in the US that we should ask industry if they have submitted it for review. I have suggested this is a little simplistic if the agency is still in the process of creating guidance for review - or at least which comes first the chicken and egg deal but with guidance and submissions. In addition there were statements that seemed to prejudge artificial pancreas. Specifically that AP would, not could, would kill somone. With that background here we go:
Q - Can you reconcile statements (at FFL) about AP and mortality with the deaths of adolescents due to nocturnal hypoglycemia our community has mourned this year. Specifically does the agency see that the lack of LGS guidance in the US market may have played a role in these cases of mortality that LGS may have prevented? 
A - The FDA is acutely aware of the struggles of diabetics, especially in children, adolescents and their parents and makes every effort to encourage and enhance the development of breakthrough medical devices, including those that suspend basal insulin delivery when blood glucose levels are thought to be in or approaching low glucose concentrations. Although guidance documents are one way of doing that, it is often challenging to provide guidance on a topic which the FDA has not yet developed the expertise necessary to do this. Recognizing the importance of cooperative efforts, the FDA has an open-door policy, and in fact encourages all manufacturers to work with us as they develop and conduct studies to evaluate new devices. The pre-submission, also referred to as the pre-Investigational Device Exemption or pre-IDE process, allows manufacturers to present the FDA with their plans for developing their products and obtain guidance.  This process is often more valuable than a generic guidance document as it is specific to the strengths and limitations of that manufacturer's product and can be developed to support the specific claims that are sought by that manufacturers for that device.

My Comments.
Here the FDA says they are open to paths to approving a device other than guidance. Specifically the pre-submission process. 

That is a timely issue for the diabetes public to consider as the FDA currently has a docket open on “Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings with FDA Staff; Availability.”

When I looked there were three public comments. So if this is path to get diabetes devices in the market here in the USA, that are already available widely outside the US. It seems that it would be in the DOC’s interest to comment. 

Want to comment but don't know what to say? 

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Lastly it is somewhat disheartening to hear the FDA say, “... it is often challenging to provide guidance on a topic which the FDA has not yet developed the expertise necessary to do this.” I trust that the nuance here is about creating guidance not considering applications for the regulation innovative care. That the agency will use the pre-sub process to gain access to experts before creating wider guidance. This is how I think they meant what they said.

It does beg a comment on expertise.

We certainly didn’t have the option to develop the expertise necessary to be the parents of a T1D child before diagnosis. I worry that the FDA as an institution is never rewarded for doing well and only beat up in blogs and congressional hearings for mistakes and so becomes risk adverse to the point that lives are lost pursuing perfection beyond the good of safe and effective. How can that change? 

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