FDA issues warnings to websites selling counterfeit drugs, devices

The FDA has taken action against more than 1,050 websites that sell unapproved prescription medications and medical devices to U.S. consumers, according to a press release.

The FDA’s action is part of Operation Pangea VIII, which aims to identify illegal prescription drug and device manufacturers and distributors, as well as eliminate these products from the supply chain, with the help of law enforcement, customs and regulatory authorities across 115 countries.

The FDA’s action is also part of Interpol’s Eighth Annual International Internet Week of Action (IIWA), a cooperative effort that works to fight against the sale of illegal and counterfeit medications and devices on the internet. The collaboration includes the FDA, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry, and international health and law enforcement agencies from 111 countries.

As part of the operation, warning letters were sent to almost 400 website operators, whose sites sell unapproved or misbranded prescription medications, along with nine firms offering unapproved or uncleared medical devices to U.S. consumers. During the IIWA, federal agencies, along with FDA inspectors in Miami, Chicago and New York, screened and seized illegal drugs and devices that had been received through International Mail Facilities. These searches resulted in the confiscations of 814 parcels, which will be referred to various FDA offices for follow-up. If any of the products are found to violate the Federal Food, Drug and Cosmetic Act, they will be denied entry into the U.S.

Confiscated parcels that were destined for the U.S. included antidepressants, hormone replacement therapies, sleep aids, erectile dysfunction treatments, and high cholesterol and seizure treatments, according to preliminary findings.

According to the FDA, targeted counterfeit products include generic Nolvadex, generic Meridia, generic Valium, generic Truvada, generic Advair Diskus, the Ondamed System, Colon Care products of PA Open System Colon Hydrotherapy Device (Grace), Interfall Hydrogel polyacrylamide dermal filler, Dermafil hyaluronic acid dermal filler and Teosyal hyaluronic acid dermal filler.

The FDA warned that in addition to the health consequences these sites and products pose, accessing the sites could also lead to computer viruses, credit card fraud and identity thefts.

“Our efforts to protect the health of American patients by preventing the online sale of potentially dangerous illegal medical products will not cease. Operation Pangea VIII provides yet another avenue for the FDA to engage with our international law enforcement partners on these critical issues. We are not only pleased to be a part of this strong international enforcement effort, but resolved to do everything we can to ensure that the global problem of illegal internet drug and device sales is deterred as a result,” George Karavetsos, director of the FDA’s Office of Criminal Investigations, said in an FDA press release.