Food and Drug Administration (FDA), along with regulatory agencies from 81 countries, participated in this year’s International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products. Dubbed Operation Pangea IV, the week of action ran September 20-27, 2011, and focused on Web sites supplying illegal and dangerous medicines. An FDA news release describes the goals of the effort as follows:
- increasing public awareness of the dangers and risks associated with purchasing medicines and medical devices from Web sites,
- identifying the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, and targeting these individuals or businesses with civil or criminal action, and
- seizing counterfeit and illegal products and removing them from the supply chain.
During Operation Pangea IV, FDA focused its efforts on Web sites selling unapproved drugs, such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. FDA explains that “Although some drugs containing these active ingredients are approved by FDA for use under the supervision of a licensed medical practitioner, the drugs offered for sale on these websites were not FDA approved, and were offered for sale without requiring a valid prescription.” FDA’s Office of Criminal Investigations, in conjunction with the Center for Drug Evaluation and Research, and the Office of Enforcement targeted 997 Web sites that are engaged in the illegal sale of unapproved and/or misbranded medicines to United States consumers. FDA sent Warning Letters to the operators of 717 identified Web sites, "all of which appear to be associated with the same individuals and corporate entities located outside of the United States." FDA reports that a total of 578 of these sites “have been suspended or no longer offer pharmaceuticals for sale,” and the agency is working with its international partners to address the remaining Web sites.
According to an INTERPOL news release, as a result of the efforts of all international partners “almost 13,500 websites engaged in illegal activity were shut down. In addition, some 45,500 packages were inspected by regulators and customs authorities, of which almost 8,000 were seized and 2.4 million illicit and counterfeit pills originating from 48 countries were confiscated – including antibiotics, steroids, anti-cancer, anti-depression and anti-epileptic pills, as well as slimming or food supplement pills. Some 55 individuals are currently under investigation or under arrest for a range of offences, including illegally manufacturing, selling and supplying unlicensed or prescription-only medicines.”
The IIWA 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, as well as national health and law enforcement agencies from the 81 participating countries.