1 / 14

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

bernad
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related