FDA Part of International Effort to Curb Online Counterfeit Drug Sales

This past week FDA participated in Operation Pangea IV, a coordinated international program to root out online sales of counterfeit and illegal medical products. The operation was this year's International Internet Week of Action (IIWA), which is coordinated by INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the Heads of Medicines Agencies Working Group of Enforcement Officers, and national health and law enforcement agencies from 81 participating countries.

According to a press release posted on FDA's Web site, this year’s IIWA, which ran September 20-27, was conducted in support of the International Medical Products Anti-Counterfeiting Taskforce.

“The FDA will continue to work closely with our domestic and international law enforcement and regulatory partners to protect consumers from unapproved and potentially harmful products sold over the internet,” said Dara Corrigan, associate commissioner for regulatory affairs, in the press release. “We will continue to aggressively pursue those who sell products which may pose a significant risk to consumer health.”

FDA reported that its Office of Criminal Investigations, the Center for Drug Evaluation and Research, and the Office of Enforcement targeted 997 websites that are engaged in the illegal sale of unapproved and/or misbranded medicines to U.S. consumers. During the operation, FDA sought out Web sites selling unapproved drugs, such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin, the agency reported.

FDA sent warning letters to the Web site operators and then notified the Internet Corporation for Assigned Names and Numbers, Registries, Internet Service Providers (ISPs), and Domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S. law, FDA reported.

"Of the 717 websites addressed in the Warning Letters, a total of 578 have been suspended or no longer offer pharmaceuticals for sale," FDA reported in the release. It is working with its foreign collaborators to address the remaining sites.

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