FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids – Drug Information Update

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 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. For more information, please visit: Operation Pangea XI.