The Partnership for Safe Medicines
Weekly UpdateMay 24, 2010
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U.S. Agents Search Mail for Counterfeit Drugs

On May 13, the U.S. Food and Drug Administration (FDA) led a foreign mail inspection in West Miami-Dade, Fla., designed to weed out thousands of counterfeit and unapproved medicines and stop them from entering the country.

The three-day search had agents poring over packages of illegal pharmaceutical drugs, dietary supplements and home remedies mailed from foreign countries. Reporting on the inspection, the Miami Herald noted that many medications are "purchased from foreign suppliers over the Internet, an increasingly risky shopping place for pharmaceutical drugs with unsafe ingredients, inaccurate dosages and false expiration dates."

The inspection and subsequent media coverage highlights four key barriers to mitigating the threat of counterfeit drugs:

  1. Regulation of Internet pharmacies. Online pharmacies should be subject to the same rigorous oversight and standards that govern their offline counterparts. "In addition to requiring licensure through a national internet pharmacy licensing program such as Verified Internet Pharmacy Practice Sites (VIPPS), said PSM Vice President Bryan Liang, MD, PHD, JD, "We need new legislation that prohibits financial transactions for drug sales of unlicensed online pharmacies and creates substantive criminal penalties for any party, including websites and search engines, who engage in the illegal sale of contraband or counterfeit drugs."
  2. Lack of regulation for products trans-shipped through foreign countries. While the West Miami-Dade inspection weeded out medicines shipped from Latin America and the Caribbean, even "safe" countries like the Canada and the United Kingdom pose threats due to lax regulations on medicines earmarked for other countries. For example, fake or low-quality drugs made in countries around the globe could ship through Canada to the U.S. without Health Canada's oversight.
  3. Additional FDA agents for Internet investigations, including foreign assignments to source countries. Criminals selling counterfeit or unapproved drugs over the Internet are beyond the reach of FDA regulators and investigators. As we told the Office of Intellectual Property Enforcement Coordinator (IPEC) earlier this year, by exploiting the anonymity of the Web and the complex jurisdictions of international criminal laws, purveyors of these unsafe medicines remain outside the reach of domestic law enforcement.
  4. Additional onshore support and authority. The U.S. has 300 customs ports, but the FDA has only 200 port inspectors and a mere 17 inspectors to cover all international mail centers. We must hire more inspectors and grant the FDA and other agencies the authority to destroy unapproved drugs entering the U.S. rather than returning them to the criminals who sent them here-a sentiment echoed by one FDA supervisor who told the Miami Herald that the vast majority of intercepted pharmaceuticals were returned to sender: "We have no authority to destroy them. We have to send them back."

According to the Miami Herald, the Miami Customs facility processed about 36 million pieces of foreign mail last year. Of that total, inspectors relayed between 8,000 and 10,000 foreign pieces containing unapproved medicines to the FDA for further assessment-showing that the threat of counterfeit drugs may be hitting closer to home than many are aware of.

Top News

United States: Officials Intercept Unapproved Drugs Sent through the Mail


In a three-day operation, the US Food and Drug Administration (FDA) worked with colleagues at the US Customs and Border Patrol and Postal Service to weed out illegal medicines at the Miami International Mail Facility. Officials netted hundreds of packages containing unapproved and potentially counterfeit drugs, according to the FDA. The operation uncovered a broad range of pharmaceuticals, such as including antibiotics, cardiovascular drugs and products to treat diabetes, which were not registered for use in the US. According to the FDA's director of enforcement, David Elder, many of the drugs were "clearly unapproved, unsafe and ineffective." ("US Federal Operation Nets Illegal Meds Sent via Mail," Securing Pharma, May 16, 2010; Story here)

World News

Increases in Counterfeit Drugs Threaten Public Health


Counterfeiting is growing in complexity, scale and geographic scope, Margaret Hamburg, head of the U.S. Food and Drug Administration (FDA), said in a speech to the annual ministerial meeting of the World Health Organization (WHO). In wealthy countries, counterfeiting often involves pharmaceuticals related to lifestyle, a WHO report said. But in developing countries, especially Africa, counterfeit medicines are commonly available to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS. Margaret Chan, WHO director-general, said that illicit products had also increased the problem of drug resistance, including to vital anti-malarials and HIV/AIDS drugs. ("Counterfeit drugs on rise, pose global threat: WHO," Reuters, May 19, 2010; Story here)

Finland: Organized Crime behind Counterfeit Drug Trafficking


Finnish customs investigators said Tuesday that international organized crime is behind a vast traffic in counterfeit drugs which dozens of Finns are illegally buying each day. Most of the fake drugs are made in Asia and reach Finland through Russia and the Baltic states. Hannu Sinkkonen, from the Western District Office of Finnish Customs, said several hundred people had already been caught as part of an inquiry into internet purchases with dozens of new cases emerging every day. "Importing medicines over the Internet is prohibited because of the risks involved," Sinkkonen said. ("Finnish customs investigates fake drug imports," Asia One, May 18, 2010; Story here)


The Partnership for Safe Medicines (PSM) Counterfeits Dialogue Breakfast

When: Friday, Jun 4, 2010

Where: Shelbourne Hotel Dublin Ireland

You are cordially invited as a guest to this important event. Please confirm your attendance / non attendance by the 25th May 2010 as places are strictly limited. You can confirm by calling our office 01-2722555 or by sending an email with your information to Link here.

The Drug Information Association 46th Annual Meeting

When: Sunday, Jun 13, 2010

Where: Washington D.C.

Description: Link here


5th Global Pharma Manufacturing Summit

When: Monday, Jun 14, 2010

Where: Boston, MA

Description: Link here


Global Pharma Authentication

When: Monday, Jun 14, 2010

Where: Munich, Germany

Description: Link here


4th Annual Pharmaceutical Anti-Counterfeiting Strategies Conference

When: Tuesday, Sep 7, 2010

Where: London, UK

Description: Link here

PSM's Inaugural 2010 Interchange
When: Friday, Oct 8, 2010
Where: Washington, D.C.
Description: The Partnership for Safe Medicines invites you to save the date for an intimate conference bringing together patient groups, providers, pharmaceutical company quality experts, enforcement personnel, policymakers, regulatory agency experts and other interested parties to discuss key issues around counterfeit drugs and other unsafe medicines. Link here.
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