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Weekly Update | May 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."
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The inspection and
subsequent media coverage highlights four key barriers to mitigating the threat
of counterfeit drugs:
- 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."
- 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.
- 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.
- 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.
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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)
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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) |
Events
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 info@irishpatients.ie. 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. |
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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 SafeMedicines.org.
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