After Heparin: - The Pew Charitable Trusts

—Chapter 3—
Counterfeits may originate wholly outside the regulated system, or they may be illicitly procured medicines
that have been diluted, falsely labeled or otherwise adulterated and sold by unauthorized entities.
In 2002, counterfeit high-dose Epogen ® (see case study 7) was actually low-dose Epogen ® that had been
relabeled to resemble a higher strength, and successfully sold to legitimate distributors and pharmacies.
Overt pharmaceutical theft, particularly cargo theft, is a substantial problem, with a number of reports
of patient adverse events from stolen drugs—likely due to improper storage and handling. 477 In 2009,
thieves stole 129,000 vials of insulin and likely stored them under improper conditions, according to an
FDA report. 478 According to an FDA affidavit, the stolen drugs resurfaced at retail chain pharmacies in
Texas, Georgia and Kentucky. 479 The stolen goods were sold by at least three wholesalers before reaching
pharmacies. 480 One of the wholesalers was discovered to have additional stolen and diverted goods. 481
Two months after this crime was discovered, the FDA had recovered only 2 percent of the missing
vials. 482 In March 2010, more than $70 million worth of pharmaceuticals was stolen from an Eli Lilly
& Co. warehouse in Connecticut 483 —the single-largest cargo theft on record. 484 The fate of these stolen
drugs has not been determined.
Although there were fewer pharmaceutical cargo thefts in the first six months of 2009 than in the same
period in 2008, the average value of loss increased dramatically from $704,685 to $6.7 million. 485 The
average loss value in 2010 was $3.78 million, which was the highest average loss value of all stolen commodities
that year. 486
A 2006 report by the FDA’s Counterfeit Drug Task Force expresses concern that U.S. drug distribution
may be increasingly vulnerable to the introduction of sophisticated counterfeits. 487 During fiscal year
2010, the FDA’s Office of Criminal Investigations opened 72 counterfeiting cases—more than in any
prior year. 488 Fiscal year 2009 had also been a record for counterfeit investigations with 65 cases (see
figure 16). 489 In 2006–2007, the first year after Florida enacted new legislation to improve the safety of
distribution, Florida’s Diversion Response Team opened 50 new cases on drug diversion. 490
Figure 16
Counterfeit cases opened by the FDA’s Office of Criminal Investigations,
1997–2009
80
70
60
50
40
30
20
10
0
9 5 11 6 21
27
30
FY97 FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10
58
32
54
31
56
65
72
8
7
6
5
4
3
2
1
Source: FDA. 491
66
Pew Health Group