Counterfeit Drugs : A CLEAR AND PRESENT DANGER State Senator Marvin Riegsecker, R.Ph.

Counterfeit Counterfeit DrugsDrugs::

A CLEAR AND A CLEAR AND PRESENT DANGERPRESENT DANGER

State Senator Marvin Riegsecker, R.Ph.

Prevalence of Drug CounterfeitingCounterfeit drugs are more prevalent in developing countries.

According to the World Health Organization (WHO):

A. Industrialized Countries: 22%

B. Developing Countries: 78%

Africa: 50-60%

China: 50%

Mexico, Argentina, Columbia: 40%

Brazil: 30-40%

India: 15-20%

6 4 6 6

20 22 22

58

32

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10

20

30

40

50

60

1997 1998 1999 2000 2001 2002 2003 2004 2005

Trends in Counterfeit Drug Cases

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FD

A C

ases

Where drug incidents occur

Countries with the most incidents in 2004:

Fake Diversion1 Theft Total

USA 32 30 14 76

Colombia 41 15 4 60

China 56 3 0 59

Russia 40 8 2 50

India 36 3 0 39

Peru 21 4 0 25

Ukraine 23 1 0 24

Brazil 3 4 12 19

Israel 17 1 0 18

Mexico 6 5 6 17

U.K. 14 2 1 17

1 — Drugs which have been illegally diverted to a different market, population or region than was initially intended.

Source: Pharmaceutical Security Institute

What is a Counterfeit Drug?

According to WHO: “[A] product that is deliberately and fraudulently mislabeled with respect to identity and source.”

Where is the problem?

Drug counterfeiting isn’t a manufacturing problem, it is a distribution problem.

Red arrows indicate secondary (gray) market

Example 1: Lipitor

According to WHO: “ [A] product that is deliberately and fraudulently mislabeled with respect to identity and source.”

Lipitor: Which pill is authentic?

Epogen Trail to

Timothy Fagan

AmerisourceBergen3,363 boxes2,000 U/mL

J&M PharmacareFL Pharmacy

Bought 12,294 boxes2,000 U/mL

Cardinal8,931boxes2,000 U/mL

AmgenDrugmaker2,000 U/mL

Armando Rodriguez FL Go-between12,294 boxes2,000 U/mL

Playpen SouthFL Strip Club

Nick Just/ Paul Perito

Tradewinds TradingTX Wholesaler

135 BoxesLot 2970

Rebel DistCA Wholesaler

Grapevine TradingOH Wholesaler

Coastal MedicalVA Wholesaler

135 BoxesLot 2970

AD PharmaceuticalFL Wholesaler

2 BoxesLot 2970

Medix IntlCarlos Luis

TX Shell Co.180 Boxes Lot 2970

Armin Medical24 Nashua, NH 129 BoxesLot 2970

Premier Medical GroupGA Shell Co.

460 Boxes Lot 1091 812 Boxes Lot 2970

Express RXEddie Mor

Texas Shell Co.180 Boxes Lot 2970

Y W ConsultantsUnlicensed FL

Wholesaler

Double JUnlicensed FL

Wholesaler

Ivan VillarchaoFL

45 BoxesLot 2970

CSGTN Wholesaler

460 BoxesLot 1091

AmeRxSusan CavalieriFL Wholesaler

182 BoxesLot 2970

CSGTN Wholesaler

812 BoxesLot 2970

Optia MedicalMark NovoselUT Shell Co.

45 BoxesLot 2970

Jemco MedicalFL Wholesaler

16 BoxesLot 2970

Dialysist WestAZ Wholesaler

461 Boxes, Lot 1091

Dialysist WestAZ Wholesaler

1056 Boxes, Lot 2970

AmerisourceBergen KY Distribution Center1517 Boxes

Timothy Fagan

CVS, NY

MANUFACTURER

NATIONAL WHOLESALER

PHARMACY

GRAY MARKET

REGIONAL WHOLESALER

NATIONAL WHOLESALER

PHARMACY

PATIENT

probable sales

unknown sources and sales

confirmed sales

Silvino Cristobal Morales

Relabeled Vials

Printer in Hialeah Made Counterfeit

Labels

Jose GrilloAlleged FL Counterfeiter

2,000 U/mL 40,000 U/mL

Example 2: Epogen

Example 3: TamifluFighting Fake Flu Pills

What can be done?Federal Regulation of Wholesale Distributors: Prescription Drug Marketing Act (PDMA) of 1987, Prescription Drug Amendments (PDA) of 1992

Banned the Sale of Drug Samples and Drug Coupons

Banned Reimportation (limited exceptions)

Set Requirements for Sample Distribution and Storage

Required State Licensing of Wholesale Distributors

Required Identity Statements for Sales (pedigree) by Unauthorized Distributors of Record

What can be done?

State Licensing of Wholesale Distributors: State Boards of PharmacyRenewal Schedule: One to Two yearsOut-of-State Wholesale DistributorsRegulatory Challenges

Limited Board of Pharmacy Resources

Lack of Uniformity of States’ Regulation

Lack of Communication Between Regulators

Indiana’s New WDD Law

Increases penalties for counterfeiting Rx drugs Increases penalties for counterfeiting Rx drugs and distributing contraband drugsand distributing contraband drugs

Creates rigorous licensing requirements Creates rigorous licensing requirements including mandatory accreditation for all including mandatory accreditation for all wholesalerswholesalers

Determines a “Normal Chain of Distribution” Determines a “Normal Chain of Distribution” (NCOD)(NCOD)

Requires pedigree for all drugs distributed Requires pedigree for all drugs distributed outside of NCODoutside of NCOD

Indiana’s New WDD LawMandatory National Accreditation

VAWD® or other Board Approved Accreditation

Accreditation will ensure compliance with relevant state and federal laws

Newly issued licensees must obtain Accreditation prior to issuance

Existing license holders must obtain prior to next license renewal ( 9/30/06)

Negligible fiscal and operational impact on state