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

2 Lew Kontnik  Author, Counterfeiting Exposed (Wiley 03)  Publisher, Protecting Medicines: A Manual of AntiCounterfeiting Solutions  Pharmaceutical Facilitator, (FDA anticounterfeiting project)  AntiCounterfeiting advisor

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