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RE: [IP] FDA stops sale of insulin pumps

I'm with you Michael and I'm one of the victims of what I consider to be
another FDA debacle.
They let Rezulin into this country knowing that it was banned in Europe and
why, and this seems to be just another STUPID move on their part.

I don't suppose you can purchase used D-Tron Plus pumps somewhere, right?


-----Original Message-----
From: email @ redacted
[mailto:email @ redacted]On Behalf Of Michael
Sent: Thursday, June 19, 2003 12:56 PM
To: email @ redacted
Subject: Re: [IP] FDA stops sale of insulin pumps

> NewsFlash:

My interpretation of this based on conversations with the people
involved is that the FDA has its tail in a knot over differencex in
the EU vs US standards and reporting and that Roche / Disetronic is
an innocent victim. Frankly I think it is an example of heavy
handedness on the part of the FDA over paperwork issues.
Roche/Disetronic is in full compliance with ISO standards that all
pump makers adhere to. While I don't champion any particular
manufacturer, I think it's a shame that a fine company has to suffer
from the incompetency of our own government agencies.


> FDA Stops Sale of Insulin Pumps!
>  Senior Disetronic representatives reported that the FDA has issued
>  an embargo
> on importation of new Disetronic insulin pumps into the United
> States. On Monday an official letter was issued, however private
> conversations with a high level Roche representative indicated that
> they knew about this previously.
>  In fact Diabetes in Control has learned that Roche has already sent
>  members of
> their manufacturing teams to Switzerland to take over operations.
> The embargo is seen as a result of continuing problems with
> documentation of the manufacturing processes, and back end
> procedures of the company.
>  The FDA has in no way indicated that there is a safety issue with
>  any of the
> pumps that Disetronic makes. Although the embargo means that new
> patients cannot be started on Disetronic insulin pumps. The FDA
> action does not affect the ability of Disetronic to provide support
> to existing pump users.
>  I met in private with Disetronic representatives at the ADA meeting
>  last week
> to find out what they will be doing and was informed that they will
> continue servicing current customers and will help patients waiting
> for Disetronic pumps select an alternative pump from another
> company. ----------------------------------------------------------
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