The Partnership for Safe Medicines
Weekly UpdateOctober 25, 2010
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 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 international 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.
Top News


Microsoft IP Addresses Hijacked by Illegal Online Pharmacies


A group of Russian criminals have been using internet addresses belonging to Microsoft to re-route consumers to more than 1,000 sites, including a number of illegal online pharmacies that may be selling counterfeit drugs, according to The Register. The news source reports search results from Microsoft's own servers show that since at least September 22, 1,025 unique websites with names like "seizemed" and "yourrulers" have been using one of two Microsoft IP addresses to host their official domain name system (DNS) servers. Researcher Ronald F. Guilmette made the discovery and the news source said that it had independently verified his findings. The Register along with a number of researchers who specialize in DNS and the take-down of criminal websites were able to determine that the two Microsoft IP addresses, and, are housing dozens of DNS servers that "convert the pharmacy domain names into the numerical IP addresses that host the sites." (PSM, October 25, 2010; Link here)

World News

Missouri: Counterfeit Lifestyle Drug Seller Facing Prison Time


A St. Louis County man pleaded guilty to federal charges Monday and admitted selling thousands of counterfeit pills over the last several years. Mark Hughes, 47, ordered counterfeit versions of the popular lifestyle drugs online from China and India, and sold them either in an illegal, unlicensed pharmacy or via word of mouth, Assistant U.S. Attorney John Bodenhausen said. Hughes' last shipment, of 1,000 pills, was intercepted by U.S. Customs and Border Protection in 2009 and delivered by investigators. Hughes house was then searched and he admitted buying roughly 11,000 pills. He sold them for $5 each, roughly one-third of the wholesale price, Bodenhausen said. Bodenhausen also stated that the pills either did not contain the correct drug or contained a less potent dose of the drug. Hughes could face at least two years in prison. ("Fake Lifestyle Drugs Mean Prison for St. Louis County Man," St. Louis Post-Dispatch, October 18, 2010; Link here)



Eastern Europe Confronts Counterfeit Drug Problem


Eastern Europe is a key route in a multi-billion-dollar trade in often-dangerous counterfeit medicines that has grown exponentially on the Internet, experts said at a regional meeting this week. More than 120 anti-counterfeit specialists from six Eastern European countries met in Romania on Wednesday and Thursday to step up the fight against a risky business estimated to be 75 billion dollars (54 billion euros) worldwide in 2010. "There is an important Balkan route for fake medicines, which is the same as for heroin and other narcotics," Hungarian customs officer Karolyi Szep told AFP at the meeting called by the world's leading pharmaceutical company Pfizer. Such drugs can contain no active ingredients at all or 8,000 times the required amount, or heavy metals such as arsenic, lead-based paint, brick dust or floor wax -- content that poses major health risks and can lead to death. ("Eastern Europe Confronts Fake Medicines Trade," AFP, October 21, 2010; Link here)



Philippines Doctor Facing Counterfeit Drug Charges


A doctor in the Philippines is facing charges of expired, smuggled and counterfeit drugs.

Edwin Pinili of the Pinili Clinic in Calumpang village is facing charges from the National Bureau of Investigation (NBI) and the Bureau of Food and Drugs (BFAD), according to the Philippine Daily Inquirer. Dominic Cerro, special investigator of the NBI's Sarangani District Office, told the news source that Pinili is facing a number of charges including a violation of RA 8203, which is the Special Law on Anti-Counterfeit Drugs. Cerro said that a civilian informed law enforcement officials about the illegal activities allegedly being perpetrated by Pinili, prompting a surveillance investigation, which resulted in the counterfeit drug charges. (PSM, October 22, 2010; Link here)


PSM Interchange

If you missed our recent conference, you can catch videotaped versions on C-SPAN, read the remarks of our keynote speaker, FDA Commissioner Margaret Hamburg, and view photos from our flickr archive. Visit our archives here.

Anti-Counterfeiting Americas (Boston, USA)

Monday, Nov 8, 2010
Description: PSM Executive Director Scott LaGanga is speaking at this conference.


Building Pharmaceutical Anti-Counterfeiting Programs (Los Angeles, CA)


When: Wednesday, Nov 10, 2010

Where: University of Southern California (map)

Description: A one day course from the USC Regulatory Science Program and the Food and Drug Law Institute. For more information or to register see the USC page



International Conference of Drug Regulatory Authorities (Singapore)


When: Tuesday, Nov 30, 2010

Where: Singapore (map)

Description: Website

About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. For more information, please visit