From: Gross, Mary
Sent: Thursday, August 08, 2002 11:37 AM
To: Butler, Jennie C
Subject: FW: Presentation Notes 26 July Public Meeting

Barcoding rule.

-----Original Message-----
From: Laurence.Edzenga@gsk.com [mailto:Laurence.Edzenga@gsk.com]
Sent: Thursday, August 01, 2002 3:54 PM
To: grossm@cder.fda.gov
Cc: efrench@oc.fda.gov; mdotzel@fda.gov; ayne.gilbert@chiron.com;
james.mundt@merck.com; david.dwight@chiron.com; BARRYJ@labs.wyeth.com;
lori.easterday@aventis.com; FANS@labs.wyeth.com; katie.maher@merck.com;
jose.blairon@gsk.com
Subject: Presentation Notes 26 July Public Meeting


Re.:  VISI Industry Member Company Presentation

Mary,

Please see my presentation notes below presented at your FDA 26 July 2002
Public Meeting, Bar Code Labeling Requirements for Human Drug Products.
Please include these notes as part of the FDA 26 July Public Meeting
Minutes.

Thank you for your cooperation.

Laurence Edzenga
VISI Representative
Aventis Pastuer, Chiron, GlaxoSmithKline, Merck and Wyeth Laboratories



         VISI Vaccines/Biological Products Manufacturers Position
    for Automatic Identification of Unit of Use Labeling by Bar Coding

We represent Vaccine Manufacturer Member Companies for VISI from Aventis
Pasteur, Chiron,
GlaxoSmithKline, Merck and Wyeth Laboratories, working in conjunction with
Centers for Disease Control and Prevention.

In an effort to reduce medication errors, VISI member companies align with
PhRMA Statement, as a co-contributor to the development of the document.

However, vaccines have substantial challenges different from
pharmaceuticals. VISI member companies have researched bar code technology
available in the market today and supplier capabilities to meet the very
small available space to print on vaccine labels and high running speeds in
production for base labels, not including the tear-off detachable portions.
There is a very limited number of vaccine base labels where space is
available to fit RSS-14 linear code. There is no available space for bar
coding 2 or 3 part tear-off portions of vaccine labels without relief from
the Agency     to eliminate copy,  i.e.,      company address, company
name.

VISI member companies conclude that reduced size bar code symbology is
required and specifically two-dimensional DataMatrix is the selected code
to bar code vaccines labels.

VISI member companies feel it has met the objective for vaccine standard
bar code identification for users from affordable scanning technology now
available and ability to read multiple bar code symbologies. This present
scanning technology allows scanners to be programmed to read both RSS-14
and DataMatrix codes.

VISI member companies are concerned the Public Health Organizations and
physician offices use of bar codes provided on labeling by industry. And as
indicated earlier during this FDA Public Meeting, only 1% of all vaccines
are dispensed in hospitals.

Government agencies will need to educate and 'pull' the medical health
community for appropriate use to meet the objectives bar code are intended.

VISI member companies want to continue our work with the CDC, the Agency
and healthcare stakeholders of this process in the effort to reduce
medication errors.
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