Operation Pangea V: A Global Attack on Online Prescription Drug Pharmacies
The U.S. Food and Drug Administration (FDA), in partnership with multiple international regulatory and law enforcement agencies, targeted over 4,100 internet pharmacies that allegedly sell potentially dangerous, unapproved drugs to consumers. On October 4, 2012, the FDA announced the details of Operation Pangea V, a global effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. (For the full text of the FDAs press release, please click here.) In executing Operation Pangea V, the FDA collaborated with INTERPOL, the World Customs Organization, Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the Medicines and Healthcare products Regulatory Agency of the United Kingdom, the Irish Medicines Board, the London Metropolitan Police, the U.S. Department of Homeland Security, the Center for Safe Internet Pharmacies, and the national health and law enforcement agencies from 100 other participating countries. The cooperative investigations conducted by these law enforcement, customs, and regulatory authorities resulted in civil and criminal charges, seizure of illegal produces, and removal of websites.
According to the FDA, the goal of Operation Pangea V, which took place between September 25 and October 2, 2012, was two-fold: first, to identify producers and distributors of illegal pharmaceutical products and medical devices and, second, to remove these products from the supply chain. In its press release, the FDA stated that the majority of medicines at issue pose potential health concerns for consumers because “they contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.” Some of the medicines identified through Operation Pangea V were Domperidone, Isotretinoin, Tamiflu, and Viagra.
During Operation Pangea V, regulators and customs authorities across the globe inspected over 133,000 packages and confiscated over 3.75 million illicit and counterfeit pills. In total, approximately $10.5 million worth of pharmaceuticals were seized worldwide and over 18,000 pharmacy websites were ordered to shut down its operations. (To read INTERPOLs brief summary of Operation Pangea V, click here.) The FDA referred to the online sale of illegal, unapproved, counterfeit, or potentially adulterated or substandard drugs as an “inherently international crime problem.” To that end, INTERPOL estimates that roughly 80 individuals are currently under investigation or under arrest for criminal offenses, including operating a clandestine laboratory producing counterfeit medicines, membership in a criminal group selling illicit medicine online, and operating websites selling illicit medicines.
Pursuant to its enforcement authority in the United States, the FDA issued a Warning Letter to Canadadrugs, which listed over 4,100 identified websites that purportedly sell illegal or counterfeit drugs or medical devices to American consumers. The operators of each of these 4,100 websites received a copy of the FDAs Warning Letter to Canadadrugs, which explained that these online pharmacy websites “offer unapproved and misbranded new drugs for sale” and requested each website to “immediately cease marketing violative drug products to United States consumers.” (To read the FDAs Warning Letter to Canadadrugs, please click here.) Furthermore, the FDA sent notices to Registries, Internet Service Providers (ISPs), and domain Name Registrars (NDRs) informing them of the websites allegedly violative practices.
The FDA has stated that it will continue to work with international groups to investigate websites that sell potentially unapproved, counterfeit, or adulterated drugs and medical devices. Within the last week, alone, the FDA launched BeSafeRx”Know Your Online Pharmacy, a national campaign to provide consumers with information about the risks of purchasing prescription drugs online.
Fuerst Ittleman David & Joseph, PL will continue to monitor the regulation of online pharmaceutical drug companies. The attorneys in the Food, Drug, and Life Sciences practice group are well-versed in the complex regulatory framework for prescription drugs and medical devices. For more information, please email us at firstname.lastname@example.org or call us at (305) 350-5690.
This entry was posted on Friday, October 5th, 2012 at 2:32 pm and is filed under FDA.
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