Transcript Trends in Counterfeit Drug Cases Number of open FDA Cases

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