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

2. 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. 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. 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. 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

6. 6 www.LewKontnik.Com Counterfeiting Real?

7. 7 www.LewKontnik.Com Counterfeiting Real?

8. 8 www.LewKontnik.Com Counterfeiting Real? ..

9. 9 www.LewKontnik.Com Counterfeiting Real?

10. 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. 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. 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. 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

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