US FDA Participates in Pangea III – 274 Websites Closed Down
The U.S. Food and Drug Administration and a number of other regulatory and international bodies recently completed International Internet Week of Action (IIWA), which took place to help limit the sales of counterfeit drugs by illegal online pharmacies.
A wide range of internationl bodies helped to sponsor IIWA including INTERPOL, the World Health Organization's International Medical Products Anti-Counterfeiting Task Force (IMPACT) and the Permanent Forum on International Pharmaceutical Crime, in addition to national health and law enforcement agencies from 40 participating countries.
According to the FDA's news release, IIWA is intended to, "protect the public health by increasing the public's awareness about the dangers and risks associated with purchasing drugs and medical devices from internet websites, to identify the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, to target these individuals or businesses with civil or criminal action, and to seize counterfeit and illegal products and remove them from the supply chain."
The FDA participated in this year's IIWA, code named OPERATION PANGEA III, in two ways. First, the FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Enforcement within the Office of Regulatory Affairs, targeted 294 Web sites that appeared to be engaged in the illegal sale of unapproved/misbranded drugs to U.S. consumers.
The FDA sent Warning Letters to the operators of these Web sites, all of which appear to be associated with the same individuals and corporate entities located outside the United States. As a follow up, the agency sent notices to the corresponding Internet Service Providers (ISP) and Domain Name Registrars (DNR), informing them that these Web sites were selling products in violation of U.S. law. In many cases, conducting illegal activities also violates ISP and DNR policies and agreements, giving the hosting companies the opportunity to terminate the Web sites and suspend the use of the domain names. Of the 294 websites addressed in the warning letter, a total of 274 have been suspended or no longer offer pharmaceuticals for sale. The FDA is working with its foreign counterparts to address the remaining 20 Web sites which continue to offer unapproved prescription drugs to U.S. consumers.
In addition, OCI and the FDA’s import specialists joined with U.S. Immigration and Customs Enforcement, U.S. Customs and Border Protection, the Drug Enforcement Administration, and the U.S. Postal Inspection Service to target and interdict shipments of violative pharmaceutical products transiting certain International Mail Facilities and express courier hubs.
A list of websites that received warning letters from the FDA is available on their website.