1. New Developments in International
Cooperation
Partnership for Safe Medicines Interchange 2013
October 24, 2013
Washington, D.C.
Moderator: Linda I. Marks
Senior Litigation Counsel
Consumer Protection Branch
U.S. Department of Justice
linda.marks@usdoj.gov
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Views offered in this presentation are my own views, and not necessarily views of the Department of Justice.

2. Panelists
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J. Scott Ballman, Jr.: Technical Expert for IP
Program - North America, World Customs
Organization
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Dr. Patrick Lukulay: Vice President, Global
Health Impact Programs, USP, and Program
Director, Promoting the Quality of Medicines
Program
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John Roth: Director, Office of Criminal
Investigations, U.S. Food and Drug
Administration

3. THE PROBLEM
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Large quantities of prescription drugs coming
from “Canada” and other countries create
challenges for Customs and Border Protection &
FDA.
“Prescription drug abuse is the Nation’s fastestgrowing drug problem.” (United States Office of
National Drug Control Policy, 2011)
Trade/B2B sites: anyone with a computer
can now become a drug wholesaler.

4. THE PROBLEM
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Physicians are ordering directly from unlicensed
brokers/wholesalers
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Receiving drugs not approved for U.S.
market
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Receiving drugs not properly stored and
shipped
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Receiving counterfeits

5. Unapproved/Counterfeit Drugs
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Drugs can be
counterfeit, unapproved, misbranded:
■ Contains API – too much/too little
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Different API (sildenafil vs. tadalafil)
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No API
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Harmful/toxic ingredients

6. Direct Customer Orders

7. Direct Customer Orders

9. Physicians looking for cheaper
suppliers
UNAPPROVED & COUNTERFEIT

11. Global Challenges
Tracing money
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Phony or shell names
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Intermediaries
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Bank and wire transfer details

12. Global Challenges
Tracing packages
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Phony names/addresses
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False customs declarations
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Drop shippers/re-packagers
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Multi-jurisdictional businesses

13. Global Challenges
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Identification of key players
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VOIP telephones
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New websites

15. Global Challenges
FORMAL REQUESTS
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Mutual Legal Assistance Treaties/Letters
Rogatory
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Requests made for bank records, corporate
records, e-mail/server records, phone
records, identifications, interviews
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Can take many months, or years

16. Global Challenges
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Will foreign country notify account holder?
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Will foreign country open own investigation?
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Once received, will we need to translate?

17. Global Challenges
OTHER MEANS TO GATHER EVIDENCE:
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Tracker warrants – ok with foreign country?
Assistance with surveillance?
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Are there informal ways to receive
information?
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Industry assistance: purchasing product,
testing product, identifying subjects,
introducing agents to subjects; international
resources

18. Charging Decisions
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Can we extradite from defendant’s country?
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From another country where defendant is found?
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Do we have extradition treaty?
Does foreign country have similar laws?
Can we seize assets?

19. Global Initiatives: International
cooperative enforcement operations
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Operation Mercury I & II (2009 - 2010)
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Looked for drugs shipped via international
mail facilities, express consignment hubs
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2010: included a system to exchange data
between Customs administrations

20. Global Initiatives: International
cooperative enforcement operations
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Operation Pangea (2008 - 2013)
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Initiated by
PFIPC, INTERPOL, WHO/IMPACT
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Targets the illegal advertising, sale and
supply of medicines over the Internet
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In 2013, 99 participating countries, 10.1
million illicit and counterfeit pills
confiscated, more than 13,700 websites shut
down

21. Global Initiatives: Support to
Developing Countries
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USP’s Promoting the Quality of Medicines
in Developing Countries (PQM) program
Funded by USAID
■ Strengthens QA and QC systems
■ Increases the supply of quality-assured
medicines
■ Combats the availability of substandard and
counterfeit medicines
■ Provides technical leadership and global
advocacy
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22. Panelists
■
J. Scott Ballman, Jr.: Technical Expert for IP
Program - North America, World Customs
Organization
■
Dr. Patrick Lukulay: Vice President, Global
Health Impact Programs, USP, and Program
Director, Promoting the Quality of Medicines
Program
■
John Roth: Director, Office of Criminal
Investigations, U.S. Food and Drug
Administration