From: ReconnUSA@aol.com
Sent: Saturday, April 12, 2003 7:15 PM
To: fdadockets@oc.fda.gov
Cc: ffricke@ora.fda.gov; Kwolnik@ora.fda.gov; mculbertson@psl.nmsu.edu;
LTKontnik@Reconnaissance-Intl.com
Subject: Comments Docket 02N-0528-CDER/CBER Risk Assessment

Docket No. 02N-0528
Dockets Management Branch (HFA-305) 
Food and Drug
Administration 
5630 Fishers Lane, rm. 1061
Rockville, MD 20852; 
e-mail: fdadockets@oc.fda.gov

Dear Sirs:

The Three Risk Assessment Document, Docket No. 02N-0528 with comment deadline 
April 30, 2003, focus on:

* Pre-release risk assessment,

* Post-release/use pharmacovigilance (monitoring, reporting etc.) to pick up 
unanticipated issues, and 

* Risk management.

All of the documents appear prepared in the belief that all the product 
moving through the system is exactly what it appears to be and that criminal 
(economically or politically motivated/terrorist) substitution/counterfeiting 
or tampering is not possible and is not to be considered as part of the 
analysis.

As the history of pharmaceutical counterfeiting shows--this assumption is not 
correct. There are incidents of fakes (material that is dispensed and used 
believing that it is one chemical but in fact is something different).

For example, take the recent cases of counterfeit Serostim and Procrit, both 
of which caused publicly documented cases of apparent 'adverse reactions.' 
Subsequent analysis revealed that the patients in question were suffering 
pain and other symptoms not because of adverse reactions to the named drugs 
but as the result of adverse reactions to chemicals that were NOT THE 
PRESCRIBED MEDICINES but were packaged to look like those drugs and were 
successfully passed off through the US drug distribution system as 'genuine.' 

It appears at a minimum that these draft risk documents should acknowledge 
this possibility--and maybe (depending on the scope of and resources 
available to the project) should be expanded to take account of this 
additional, currently ignored, risk.

The FDA is currently executing the Product Surety Project 
(www.ProductSurety.org) through New Mexico State University to identify and 
examine the areas of counterfeiting and tampering risk in the US 
pharmaceutical supply and to facilitate industry/agency discussion of 
possible countermeasure approaches. Hence, recognition of these risks within 
the agency's pharmacovigilance plan would seem appropriate.

It may be useful to include some aspect of counterfeiting detection, planning 
and management as a part of the Risk Management document. Maybe manufacturers 
for 'high risk products' should be asked to consider this risk as part their 
risk management plan.

Respectfully,

Lewis T. Kontnik
Principal
Reconnaissance Intl
5650 Greenwood Plaza Blvd #225K
Greenwood Village, CO 80111
USA
303 779 1096
Fax 303 779 3647
www.pharma-anticounterfeiting.info
www.productsurety.org
www.holopackholoprint.info
www.Reconnaissance-Intl.com