april 14, 2004 fda/hhs importation meeting docket 2004n-0115
DESCRIPTION
April 14, 2004 FDA/HHS Importation Meeting Docket 2004N-0115. Lewis Kontnik www.LewKontnik.Com www.SafeMedicines.Org. Lew Kontnik. Author, Counterfeiting Exposed (Wiley 03) Publisher, Protecting Medicines: A Manual of AntiCounterfeiting Solutions - PowerPoint PPT PresentationTRANSCRIPT
1
www.LewKontnik.Com
April 14, 2004 FDA/HHS Importation Meeting
Docket 2004N-0115
Lewis Kontnik
www.LewKontnik.Com
www.SafeMedicines.Org
2
www.LewKontnik.Com
Lew Kontnik
Author, Counterfeiting Exposed (Wiley 03)
Publisher, Protecting Medicines: A Manual of AntiCounterfeiting Solutions
Pharmaceutical Facilitator, www.ProductSurety.Org (FDA anticounterfeiting project)
AntiCounterfeiting advisor www.SafeMedicines.Org
3
www.LewKontnik.Com
What is the Issue?
Demand for Travel—to obtain medicines?
Demand for Internet use—to obtain medicines?
The Issue is Affordable Access to Medicines, and
Safety
4
www.LewKontnik.Com
Importation Sensible?
Canada 10% of US population
Canadian medicine supply 7% of US demand
The numbers don’t work
The system is “bassakward”
We are adding expense and complication
5
www.LewKontnik.Com
Importation Risk?
Moving from Closed System
Already under attack by criminals
Procrit,Serostim,Zyprexa
To Open System
Open to attacks by All
Lipitor, Evra, Viagra
WHO 40% fakes in Asia/Africa
10
www.LewKontnik.Com
Security Systems Adequate?
Use security feature to authenticate
Holograms, watermarks, taggants
Barcodes, RFID tags
Bureau of Engraving and Printing does in for money-right?
Useful but consider the reality
11
www.LewKontnik.Com
Security Systems Adequate?
Closed system
Company responsible
FDA has oversight
Open system
Who is responsible?
Who verifies?
Customs/FDA all over-stretched now
12
www.LewKontnik.Com
“BEP” Approved Approach?
Money
One manufacturer (BEP), full-time security focus, security top priority, banks/Fed check bills “daily”
Still counterfeits
Pharmaceuticals
100s manufacturers, 1000s packagers, security PART of production, who checks/how?
13
www.LewKontnik.Com
Importation a Solution?
Misses the real issue-Affordable Access
Destroys system integrity
Increases complexity and burdens
Deal with the real issues—don’t depend on chance and foreign systems