April 14, 2004 FDA/HHS Importation Meeting Docket 2004N-0115

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

• Lewis Kontnik
• www.LewKontnik.Com
• www.SafeMedicines.Org

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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

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What is the Issue?

• Demand for Travelto obtain medicines?
• Demand for Internet useto obtain medicines?
• The Issue is Affordable Access to Medicines, and
• Safety

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Importation Sensible?

• Canada 10 of US population
• Canadian medicine supply 7 of US demand
• The numbers dont work
• The system is bassakward
• We are adding expense and complication

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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

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Counterfeiting Real?
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Counterfeiting Real?
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Counterfeiting Real?

• .

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Counterfeiting Real?
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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

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Security Systems Adequate?

• Closed system
• Company responsible
• FDA has oversight
• Open system
• Who is responsible?
• Who verifies?
• Customs/FDA all over-stretched now

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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?

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Importation a Solution?

• Misses the real issue-Affordable Access
• Destroys system integrity
• Increases complexity and burdens
• Deal with the real issuesdont depend on chance
  and foreign systems

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Thank you for your Interest

• Lewis Kontnik
• www.LewKontnik.com
• www.SafeMedicines.org