The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.

This effort was 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.

"The sale of potentially dangerous and counterfeit drugs by criminal networks on the internet is a large and growing threat to the public health. The illegal online pharmacies that we’re taking action against are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including potentially counterfeit medicines and controlled substances both on the surface and dark web. Consumers go to these websites believing that they're buying safe and effective medications. But consumers are being put at risk by individuals who put financial gains above patient safety," said FDA Commissioner Scott Gottlieb, M.D. "I'm particularly concerned about the ease with which consumers can gain access to controlled substances and prescription opioids online. This is one reason why we’ve stepped up our efforts, both from a policy and enforcement standpoint, to take these bad actors down. Today's major operation by FDA, together with our international regulatory and law enforcement partners, demonstrates that we’ll aggressively pursue those who place patients at risk and seek to profit from illegal products."

The agency's 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, FDA's Office of Criminal Investigations (OCI) special agents initiated several criminal investigations involving illegal online pharmacies. One recent investigation resulted in the recent arrest and indictment of a San Diego 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 United States using the dark net and other means.

During Operation Pangea XI, the FDA sent warning letters to seven different networks that were operating a total of 465 websites offering misbranded and unapproved drugs to U.S. 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 http://www.nextdaypills.com, http://www.top-meds-discounts.com, and http://www.bestgenericstore.com. This year's Operation Pangea also took place at three of the nine international mail facilities (IMFs) in the U.S., as well as at other facilities around the world. 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, 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 U.S. Sixty-two products were identified as being purchased from internet sites operating in the United Kingdom, 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. The 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, the FDA sent warning letters to the Canada Drugs Online Pharmacy Network. 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, and to 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 to the U.S. thousands of domain names and websites from their businesses and to cooperate with the U.S. Department of Justice and the FDA in ongoing and future criminal investigations conducted by the agencies.

The FDA provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. In addition to health risks posed by these products, illegal online pharmacies can pose other risks to consumers. These include the risk of credit card fraud, identity theft and computer viruses.

The FDA is also working with other government agencies, a variety of internet stakeholders, social media and internet platforms, academic researchers and advocacy groups to pursue efforts that will curb the illegal sale of prescription opioids online and through social media. In many cases, products illegally marketed online as opioids are counterfeit drugs that can contain potentially lethal doses of illicit compounds like fentanyl. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigations. Consumers are encouraged to report any unlawful sale of medical products online to FDA.

The IIWA ran from Oct. 9 to Oct. 16, 2018, with the participation of the 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 the FDA, the U.S. 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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