April 14 2004 fda hhs importation meeting docket 2004n 0115
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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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April 14 2004 fda hhs importation meeting docket 2004n 0115

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

Lewis Kontnik

www.LewKontnik.Com

www.SafeMedicines.Org


Lew kontnik

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


What is the issue

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


Importation sensible

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


Importation risk

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


Counterfeiting real

Counterfeiting Real?


Counterfeiting real1

Counterfeiting Real?


Counterfeiting real2

Counterfeiting Real?

  • .


Counterfeiting real3

Counterfeiting Real?


Security systems adequate

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


Security systems adequate1

Security Systems Adequate?

  • Closed system

    • Company responsible

    • FDA has oversight

  • Open system

    • Who is responsible?

    • Who verifies?

    • Customs/FDA all over-stretched now


Bep approved approach

“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?


Importation a solution

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


Thank you for your interest

Thank you for your Interest

Lewis Kontnik

www.LewKontnik.com

www.SafeMedicines.org


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