From: Gross, Mary
Sent: Friday, August 09, 2002 3:39 PM
To: Butler, Jennie C
Subject: FW: Bar Code Public Meeting



-----Original Message-----
From: Craig Weingarten, Big Fish [mailto:cweingarten@beabigfish.com]
Sent: Friday, July 12, 2002 5:18 PM
To: grossm@cder.fda.gov
Subject: Bar Code Public Meeting


Below is a short summary of the presentation Stephen Polinsky of GenuOne,
Inc. would like to give at the Bar Code Label Requirements for Human Drug
Products Public Meeting on July 26.

I understand you are out of the office today, so I will contact you on
Monday, July 15, to confirm your receipt of this email.

Best regards,

Craig S. Weingarten
Director of Public Relations and Planning
Big Fish Communications
www.BeaBigFish.com
cweingarten@beabigfish.com
W: 617.713.0252


Authentication and Tracking of Medical Devices,
Human Drug and Biologic Products

Stephen Polinsky
GenuOne

In May 2001, investigators from Columbia’s National Institute for the
Supervision of Medications and Food discovered a thriving drug business in
Bogotá.  What they originally thought was a cocaine or heroin factory
instead turned out to be a factory producing the flu drug Dristan and
Ponstan 500, a painkiller made by Pfizer.  The Columbian official in charge
of the investigation said the pills contained boric acid, cement, floor wax,
talcum powder and yellow paint with high levels of lead, all in an effort to
replicate the drugs genuine appearance.  This is not an isolated incident.

Medical product manufacturers and pharmaceutical companies spend millions of
dollars per year to create some of the world’s most sophisticated products
and drugs; yet often the quality and integrity of packaging is overlooked.
Companies are feeling the financial and social pressures to raise the
sophistication of their packaging and coding to ensure consumer confidence
and safety, while mitigating industry risks of product liability and
negligence.  New regulations require a lot of effort to be born, therefore
the FDA should ensure, if they are creating guidelines for bar-coding, that
they consider all product tagging and tracking implications.