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From Health Law Daily, February 28, 2014

Rogue internet pharmacies pose challenges to prosecution and education efforts

By Melissa Skinner, JD

Rogue internet pharmacies are, for the most part, operated abroad and many are suspected of selling illegal, counterfeit drugs and violating a variety of federal laws. The GAO Report acknowledged that many of these pharmacies sell drugs that are not approved by the FDA or are counterfeit or substandard and sell prescription drugs without the necessary prescription. These sales are often executed by illegally importing the drugs into the country. Since the rogue internet pharmacies are often complex, global organizations that employ sophisticated marketing techniques to appear legitimate and in compliance with federal laws, investigation and prosecution efforts as well as consumer education on the topic face many challenges (GAO Report, No. GAO-14-386T, February 27, 2014).

Rogue internet pharmacy characteristics. Although no official numbers are available, the GAO report notes that some sources have estimated that over 36,000 rogue internet pharmacies were in operation as of February 2013. According to interviews of federal officials and other industry stakeholders, these online pharmacies, many of which are fraudulent, operate abroad and ship drugs into the U.S. Often, the products imported into the country by the rogue pharmacies are not approved by the FDA or are counterfeit or substandard in that the products contain too much, too little, or no active ingredient or the products contain the wrong ingredient. Many of the drugs are misbranded or adulterated in violation of the Food, Drug and Cosmetics Act (FDC Act). Evidence has shown some of these products have also contained dangerous ingredients such as yellow highway paint, heavy metals, and rat poison. Additionally, these rogue internet pharmacies are known to provide prescription drugs to consumers without requiring the prescription from a provider.

Investigation and prosecution. Investigation and prosecution of the operators of rogue internet pharmacies has proven difficult to federal authorities for several reasons. First, because the operations are global and complex, officials face challenges in pinpointing the true operators. The websites for these pharmacies are often complicated, composed of several different but related sites, and can easily be disassembled and reorganized. Thus, the identities of the operators are easily hidden from U.S. authorities. Moreover, the organizations are often located abroad and are scattered among several foreign countries. This poses problems for officials not only in terms of identifying and locating the operators but also in regard to the investigation and prosecution of the individuals since jurisdictional limitations are often at play. Even when foreign officials cooperate with U.S. authorities in those investigations, the assistance is often slow and ineffective. Despite the challenges, the FDA and other federal agencies, such as U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement, have conducted investigations that have resulted in arrests, fines, and seizures of assets.

Educating consumers. The GAO asserted that according to a recent FDA survey, one in every four adult internet consumers in the U.S. reports purchasing prescription drugs online. In addition, the report also noted that 30 percent of the respondents claimed to lack confidence in purchasing drugs online. The GAO also related the results of a National Association of Boards of Pharmacy’s (NABP) survey, which revealed that 97 percent of over 10,000 online pharmacies investigated were in violation of laws and industry standards. The NABP publishes guidelines for determining the legitimacy of internet pharmacies for consumers and is currently creating a special domain name that will be reserved for pharmacies that are in compliance with laws and regulations.

MainStory: TopStory DrugBiologicalNews AdulterationNews FDCActNews ControlledNews InspectionNews GenericDrugNews ImportNews MisbrandingNews PrescriptionDrugNews SafetyNews

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