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The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.
On Oct. 23, 2018, FDA announced that it targeted 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology, and antiviral prescription drugs to consumers in the United States.
The effort was done in partnership with international regulatory and law enforcement agencies as part of Operation Pangea XI, the eleventh annual International Internet Week of Action (IIWA). This is a global cooperative effort led by Interpol to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products sold on the Internet.
During Operation Pangea XI, FDA sent warning letters to seven different networks that were operating a total of 465 websites offering misbranded and unapproved drugs to US consumers. In addition, more than 450 domain names were brought to the attention of search engines and the appropriate domain name registries and registrars. These include domains such as www.nextdaypills.com, www.top-meds-discounts.com, and www.bestgenericstore.com.
FDA reports that its multi-pronged enforcement strategy under Operation Pangea XI was aimed at identifying the makers and distributors of illegal prescription drugs and removing these products and their sources from the supply chain. As part of this operation, the agency’s Office of Criminal Investigations (OCI) special agents initiated several criminal investigations involving illegal online pharmacies. One recent investigation resulted in the arrest and indictment of a San Diego, CA resident known as “The Drug Llama” on a dark net marketplace. The suspect in this case is alleged to be responsible for shipping more than 50,000 tablets containing fentanyl throughout the US using the dark net and other means, according to FDA.
The most recent installment of Operation Pangea also took place at three of the nine international mail facilities in the US, as well as at other facilities worldwide. During three- and four-day screening sessions at Chicago’s O’Hare International Airport, New York’s John F. Kennedy International Airport, and in San Francisco, CA, FDA investigators found products attempting to make their way into the country from places such as India, the United Kingdom, China, and El Salvador. Of the 626 packages examined, 794 products were refused entry into the US. Sixty-two products were identified as being purchased from Internet sites operating in the UK, Canada, and India.
To target the infrastructure supporting the illegal online sales of drugs, a series of recent OCI cybercrime investigations focused on credit card processors involved in an arrangement known as ‘transaction laundering’ or ‘factoring’. Under this scheme, the business operations process payments for illegal online drug networks through shell companies such as clothing stores or florists that are seemingly not related to online pharmacies. FDA’s investigation of these payment schemes led to a federal indictment charging a complex conspiracy related to transaction laundering for online pharmacies.
Another aspect of this year’s operation is a continuation of an effort that started back in 2012. As part of Operation Pangea V conducted in 2012, FDA sent warning letters to the Canada Drugs Online Pharmacy Network. The agency reports that after the network ignored these letters, OCI began an investigation that culminated in April 2018 when Kristjan Thorkelson, a resident of Manitoba, Canada, together with several Canadian companies associated with Thorkelson, including Canada Drugs, admitted to widespread illegal sales of misbranded and counterfeit prescription drugs in the United States.
The Canadian companies were sentenced to forfeit $29 million of the proceeds of their illegal scheme, to pay a fine of $5 million as well as five years of probation. The court sentenced Thorkelson individually to pay a fine of $250,000 and to five years of probation with the first six months in home confinement. Thorkelson and the associated companies were also ordered to permanently cease their illegal operations, surrender thousands of domain names and websites from their businesses to the US, and to cooperate with both the US Department of Justice and FDA in ongoing and future criminal investigations conducted by the agencies.
IIWA ran from Oct. 9–16, 2018, with the participation of FDA’s Office of Regulatory Affairs’ OCI and Office of Enforcement and Import Operations, and the Center for Drug Evaluation and Research. The operation is a collaborative effort between FDA; the US Department of Homeland Security; the National Intellectual Property Rights Coordination Center; Interpol; the World Customs Organization; the Permanent Forum of International Pharmaceutical Crime; the European Heads of Medicines Agencies Working Group of Enforcement Officers; the U.S. Drug Enforcement Administration; the pharmaceutical industry; and national health and law enforcement agencies from 115 participating countries.