FDA participates in "International Internet Week of Action'
The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action ( IIWA ), a coordinated, cooperative effort to curb online sales and distribution of counterfeit and illicit medical products. IIWA took place between October 5-12, 2010.
The IIWA is an initiative sponsored by INTERPOL, the World Health Organization's International Medical Products Anti-Counterfeiting Task Force ( IMPACT ), and the Permanent Forum on International Pharmaceutical Crime, as well as national health and law enforcement agencies from 40 participating countries.
The goal of the IIWA is 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 IIWA also provided an excellent opportunity for the FDA to enhance cooperation with international and domestic regulatory and law enforcement partners to effectively target those involved in the manufacture and distribution of illegal medications.
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.
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Buying Medicines over the Internet