FDA Shuts Down More Than 1,000 Websites Selling Drugs, Medical Devices Illegally

Over the past several weeks, the FDA and other international regulatory agencies have worked together to shut down more than 1,000 websites distributing illegal and potentially counterfeit medications and medical devices, which may pose a serious risk for patients. 

The international effort, known as Operation Pangea VIII, is a part of the 8th annual International Internet Week of Action (IIWA). This is a global cooperative effort led by INTERPOL focusing on taking action to protect consumers from potentially harmful medicines and devices sold online illegally.

Operation Pangea VIII sought to identify the manufacturers and distributors of illegal prescription drug products and devices and removed those products from the supply chain.

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Between June 9 and 16, action was taken against 1,050 websites unlawfully selling and distributing illegal or counterfeit medical products. This included the shutdown of numerous websites, and the screening of products. In some cases the products were seized through International Mail Facilities in Chicago, Miami and New York.

“Our efforts to protect the health of American patients by preventing the online sale of potentially dangerous illegal medical products will not cease,” said George Karavetsos, director of the FDA’s Office of Criminal Investigations. “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.”

Over the past year, Operation Pangea VIII has sent warning letters to more than 400 website operators selling unapproved or misbranded prescription medications to U.S. patients. Nine warning letters were sent to distribution companies selling unapproved medical devices.

Following the issuance of the regulatory warnings, 814 parcels were detained and referred to FDA offices for follow up, which may also include seizure of the illegal products from worldwide distributors. Those which were deemed to be in violation of the U.S. Food and Drug Administration Cosmetic Act were refused entry to the country.

A total of 115 countries worked with the U.S. in partnership with international regulatory and law enforcement agencies.

Wide Variety of Drugs, Medical Devices, Seized

Agents seized drugs sold as FDA approved generic versions of brand name medications, including generic Nolvadex, generic Meridia, generic Valium, generic Truvada and generic Advair Diskus.

Medical devices that were seized included Ondamed System, Colon Care products of PA Open System Colon Hydrotherapy Device (Grace), Interfall Hydrogel polyacrylamide dermal filler and Dermafil hyaluraonic acid dermal filler.

After the products were detained, screenings of the packages revealed many medications from abroad, like antidepressants, hormone replacement therapies, sleep aids, and erectile dysfunction medications were en route to U.S. consumers.

The FDA warns this is not only potentially harmful considering the risks of taking illegal and unapproved medication, but they may also pose a threat to consumers as credit card fraud, identity theft, and computer viruses.



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