april 14 2004 fda hhs importation meeting docket 2004n 0115
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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

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april 14 2004 fda hhs importation meeting docket 2004n 0115

April 14, 2004FDA/HHS Importation MeetingDocket 2004N-0115

Lewis Kontnik

www.LewKontnik.Com

www.SafeMedicines.Org

lew kontnik
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
what is the issue
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
importation sensible
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
importation risk
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
security systems adequate
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
security systems adequate1
Security Systems Adequate?
  • Closed system
    • Company responsible
    • FDA has oversight
  • Open system
    • Who is responsible?
    • Who verifies?
    • Customs/FDA all over-stretched now
bep approved approach
“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?
importation a solution
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
thank you for your interest

Thank you for your Interest

Lewis Kontnik

www.LewKontnik.com

www.SafeMedicines.org

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