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

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

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  1. April 14, 2004FDA/HHS Importation MeetingDocket 2004N-0115 Lewis Kontnik www.LewKontnik.Com www.SafeMedicines.Org

  2. 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. 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. 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. 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

  6. Counterfeiting Real?

  7. Counterfeiting Real?

  8. Counterfeiting Real? • .

  9. Counterfeiting Real?

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

  12. “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. 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

  14. Thank you for your Interest Lewis Kontnik www.LewKontnik.com www.SafeMedicines.org

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