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April 14, 2004 FDA/HHS Importation Meeting

Docket 2004N-0115

Lewis Kontnik

www.LewKontnik.Com

www.SafeMedicines.Org

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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

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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

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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

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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

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Counterfeiting Real?

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Counterfeiting Real?

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Counterfeiting Real?

.

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Counterfeiting Real?

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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

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Security Systems Adequate?

Closed system

Company responsible

FDA has oversight

Open system

Who is responsible?

Who verifies?

Customs/FDA all over-stretched now

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“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?

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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

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Thank you for your Interest

Lewis Kontnik

www.LewKontnik.com

www.SafeMedicines.org