From: Gross, Mary
Sent: Friday, August 09, 2002 12:49 PM
To: Butler, Jennie C
Subject: FW: Speaking at the July 26 Meeting on Bar Code Label
Requirements



-----Original Message-----
From: Robert Rack [mailto:rrack@rdgguys.com]
Sent: Thursday, July 11, 2002 3:48 PM
To: grossm@cder.fda.gov
Subject: Speaking at the July 26 Meeting on Bar Code Label Requirements


Dear Ms. Gross:

I am writing to inform you that I would like to speak at this meeting. An
outline of my presentation will be forwarded on Friday. I presume that is
within the deadline for submission. I would also appreciate it if you could
give me an idea of how much time may be available to make a presentation.

I have a unique perspective on the issues at hand. My company is a solutions
provider to the pharmaceutical industry providing primarily packaging floor
solutions, printers, bar code reading systems, vision systems. In addition I
understand and have delivered systems for product control throughout the
distribution chain. But between 1987 and 1992 I was one of the people
working with the PMA that developed the bar code labeling standards and did
the actual lab testing that determined what was and was not printable, and
what were the optimum ways to accomplish the task, and in so doing created
many of the labeling standards that exist to this day. During that period, I
was working for Bristol-Myers Squibb. At this time my company also runs one
of the largest On-Line stores for Automatic Identification equipment, so
ultimately we deliver the systems that the end users will require to read
these codes. Whether RSS or Datamatrix is selected, readers are required,
and therefore unlike many others, we can provide an unbiased technical
reasoning for adoption of a particular technology, rather than that we have
only one technology to sell. Frankly I merely want to see it done right this
time because I believe this to be the last opportunity to get it right.

I believe that the tasks at hand can be accomplished, but am concerned that
a one size fits all approach is being employed, when with the use of the
proper reading technologies, either RSS or Datamatrix can be employed. Their
are obvious instances where RSS does not fit on the smallest packages. I
also believe that all the information that has been requested can be fit,
(including lot & date codes, and package ID serialization) and that by
employing the proper methodology we can not only reduce the instances of
medical errors, but also eliminate the growing product counterfeiting
problem. I can also demonstrate cost effectiveness for these technologies.
Costs that have been cited for implementation at the point of use are far
too high and there are novel ways to reduce the costs at the point of use. I
am also concerned that the technology chosen must be able to produce the
quality of codes that can be printed with on-line real time methods, allows
real world high speed reading verification on line speeds of up to 450
bottles per minute, and whose quality can be maintained in real packaging
conditions.

My ability to address the technical and cost issues will be determined by
the time that is allotted to me. I am concerned about some of the
misinformation that I have seen that has been spread by some of the
"experts", particularly as regards the use and adaptation of Datamatrix. I
am equally concerned that while the pharmaceutical industry has expressed
concerns about the issues associated with adaptation of some of these codes,
that this not be turned into a long period for adaptation since the
technologies to implement a solution do exist, and are available today if
the right technical selections are made. I also believe that we should look
forward to how technologies can be used to insure that the efficacy of the
drugs dispensed are adequate, and that the drugs have not been aged beyond
their usefulness by either age or thermal abuse. In addition, I feel that
this is the time to put in place the standards that will reduce
counterfeiting, and that this period of change is the best time to
accomplish that task. It may never come again.

Robert W. Rack
President
Rack Design Group, Inc. / BarCodeAmerica.com
973-377-8182 Office
201-220-1092 Cell