[Previous Months][Date Index][Thread Index][Join - Register][Login]   Help@Insulin-Pumpers.org
  [Message Prev][Message Next][Thread Prev][Thread Next]   for subscribe/unsubscribe assistance

Re: [IP] FDA stops sale of insulin pumps

Dear List Members,

As one who has worked in FDA regulated industry for the last 27 years, let
me offer a possible explanation to this apparently irrational actions of the
In order to get a medical device or drug licensed by the FDA for sale in the
US the manufacturer must meet the US laws for what are called current Good
Manufacturing Practices (cGMP's).  The company agrees to meet these
regulations when they obtain their license. These regulations establish
standards for the Quality requirements for drugs and medical devices.  Some
of these regulations may seem like trivial paperwork requirements to the
lay-person, but they are very important to maintain high standards of
Quality.  While there are some differences, the ISO (European) requirements
are largely the same.  If during one of the periodic inspections conducted
of FDA regulated firms, the FDA finds that the company is seriously in
violation of the cGMP's they have certain options to enforce the law.  These
options are more limited by international law when the company is not
manufacturing the device on US soil.  Usually, a customs embargo is a last
ditch effort of the FDA to get the attention of an overseas company's

Perhaps it is the management of the company that is deserving of the anger
of the list members and not the FDA?


M.L. Ehrlich
email @ redacted
----- Original Message -----
From: "Jon Wagner" <email @ redacted>
To: <email @ redacted>
Sent: Thursday, June 19, 2003 4:44 PM
Subject: Re: [IP] FDA stops sale of insulin pumps

> Michael wrote:
> > > 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.
> I called Roche/Disetronics yesterday to complain about their embargo, and
> did not get what I thought were very good answers.  They must have
> thought the same upon review as I was called today by a patient (a pumper
> herself) advocate who made it clear that the embargo only affected new
> sales, there was nothing in the FDA stuff about stopping supplies or even
> 2nd pumps to people that had already bought them.  I must agree with
> Michael that it certainly appears as though the FDA is just throwing it's
> weight around to show that it can, rather than having a legitimate gripe
> here.  IE, if there is a problem, why does the FDA allow them to continue
> to supply the pumps and warrenty work upon the pumps they have previously
> sold?  And we wonder why the rest of the world resents us :(
> Jon Wagner
> Proud to be wearing a Dtron+
> type something or other :)
> or bad type'er :)
> ----------------------------------------------------------
> for HELP or to subscribe/unsubscribe, contact:
> HELP@insulin-pumpers.org
for HELP or to subscribe/unsubscribe, contact: