After Heparin: - The Pew Charitable Trusts

—Chapter 3—
3.2.2 Risks originating outside the United States
The U.S. drug supply also is vulnerable to counterfeit drugs produced overseas, smuggled into the United
States and sold into normal distribution. Estimates of counterfeit drugs in other parts of the world
run as high as 30 percent. 503 In 2003, counterfeit Lipitor ® from Central America was illegally imported
and sold into U.S. distribution. 504 In 2009, a Chinese national was sentenced to prison for distributing
counterfeit and misbranded pharmaceuticals in the United States. His counterfeits contained low levels
of active ingredient, and many had impurities. 505
As international pharmaceutical trade grows, traders may take advantage of free-trade zones where scrutiny
of broker and trader behaviors is low, thereby enabling, for example, the repackaging or relabeling
of products to conceal their origins, according to the World Health Organization. 506 This practice may
help hide the provenance of counterfeit drugs as well as drugs and drug ingredients that are not made
at approved manufacturing sites, as discussed in section 1.3.2. Wholesalers and pharmacies that use or
are willing to ignore these suspicious chains of custody risk passing on potentially unsafe products to
consumers.
Online pharmacies are another way that problematic products can make their way into the United
States. While not examined in depth in this paper, there is no doubt that by indiscriminately purchasing
drugs from online sources, consumers expose themselves to a large safety risk. While many legitimate
online pharmacies exist, there have also been documented sales of counterfeit, diverted, misbranded or
adulterated medicine through online pharmacies. In the summer of 2010, the FDA alerted the public
that counterfeit Tamiflu ® was being sold online. 507 When the FDA staff ordered samples of the advertised
antiviral drugs, they received a shipment from India. The agency determined that the medicine contained
the wrong active ingredient, and that this substituted material, similar to penicillin, could cause
severe reactions in allergic patients. 508 In March 2009, the FDA discovered that consumers received
counterfeit Xenical ® , an FDA-approved diet drug, from at least two different Web sites. The counterfeits
did not contain any active drug. 509 In the spring of 2009, a man in Dallas was convicted of buying and
selling counterfeits online. The counterfeits were traced to China. 510 In November 2009, the FDA issued
22 warning letters to online pharmacies that appeared to be selling unapproved or misbranded drugs to
U.S. consumers. 511
The National Association of Boards of Pharmacy (NABP) has created the Verified Internet Pharmacy
Practice Sites (VIPPS), an accreditation program for U.S.-based pharmacies to guide consumers to safe
online options. 512
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Pew Health Group