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Download Trends in Counterfeit Drug Cases Number of open FDA Cases
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Counterfeit Drugs: A CLEAR AND PRESENT DANGER State Senator Marvin Riegsecker, R.Ph. Prevalence of Drug Counterfeiting Counterfeit 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% Trends in Counterfeit Drug Cases Number of open FDA Cases 60 58 50 40 32 30 20 20 22 22 2001 2002 2003 10 6 4 1997 1998 0 6 1999 6 2000 2004 2005 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? Example 2: Epogen Epogen Trail to probable sales Amgen Drugmaker 2,000 U/mL MANUFACTURER unknown sources and sales confirmed sales NATIONAL WHOLESALER Cardinal 8,931boxes 2,000 U/mL AmerisourceBergen 3,363 boxes 2,000 U/mL PHARMACY Timothy Fagan J&M Pharmacare FL Pharmacy Bought 12,294 boxes 2,000 U/mL GRAY MARKET Armando Rodriguez FL Go-between 12,294 boxes 2,000 U/mL Silvino Cristobal Morales Relabeled Vials Coastal Medical VA Wholesaler 135 Boxes Lot 2970 Jose Grillo Alleged FL Counterfeiter 2,000 U/mL 40,000 U/mL Optia Medical Mark Novosel UT Shell Co. 45 Boxes Lot 2970 REGIONAL WHOLESALER AD Pharmaceutical FL Wholesaler 2 Boxes Lot 2970 Grapevine Trading OH Wholesaler Armin Medical24 Nashua, NH 129 Boxes Lot 2970 Ivan Villarchao FL 45 Boxes Lot 2970 Jemco Medical FL Wholesaler 16 Boxes Lot 2970 Double J Unlicensed FL Wholesaler Playpen South FL Strip Club Nick Just/ Paul Perito Tradewinds Trading TX Wholesaler 135 Boxes Lot 2970 Rebel Dist CA Wholesaler Printer in Hialeah Made Counterfeit Labels Express RX Eddie Mor Texas Shell Co. 180 Boxes Lot 2970 AmeRx Susan Cavalieri FL Wholesaler 182 Boxes Lot 2970 Premier Medical Group GA Shell Co. 460 Boxes Lot 1091 812 Boxes Lot 2970 CSG TN Wholesaler 812 Boxes Lot 2970 Dialysist West AZ Wholesaler 1056 Boxes, Lot 2970 Dialysist West AZ Wholesaler 461 Boxes, Lot 1091 NATIONAL WHOLESALER AmerisourceBergen KY Distribution Center 1517 Boxes PHARMACY CVS, NY PATIENT Y W Consultants Unlicensed FL Wholesaler Medix Intl Carlos Luis TX Shell Co. 180 Boxes Lot 2970 Timothy Fagan CSG TN Wholesaler 460 Boxes Lot 1091 Example 3: Tamiflu Fighting 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 Pharmacy Renewal Schedule: One to Two years Out-of-State Wholesale Distributors Regulatory 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 and distributing contraband drugs Creates rigorous licensing requirements including mandatory accreditation for all wholesalers Determines a “Normal Chain of Distribution” (NCOD) Requires pedigree for all drugs distributed outside of NCOD Indiana’s New WDD Law Mandatory 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
