A presentation by J. Aaron Graham, Executive Director of Brand Safety & Security at Boehringer Ingelheim Pharmaceuticals, Inc., about the threat of imported counterfeit prescription drugs.

1. J. Aaron Graham
Executive Director – Brand Safety & Security
Boehringer Ingelheim Pharmaceuticals, Inc.
aaron.graham@boehringer-ingelheim.com
March 7-8, 2016
Protecting Patients from Counterfeit Medicines
ABCD

2. “Protecting patients and America’s prescription
drug supply is more than a profession.”
Protecting Patients from Counterfeit Medicines

3. January 13, 1938 – May 5, 2013
Protecting Patients from Counterfeit Medicines
“It’s a passion because it’s personal.”

4. “In October 2014, The NABP found that 96% (of more than
10,000) Internet drug outlets reviewed were operating out of
compliance with United States pharmacy laws.“

5. “US residents account for 80% of all Rx medicines purchased from
illegal online pharmacies”

6. “US residents account for 80% of all Rx medicines purchased from
illegal online pharmacies”“85% of all rogue online Internet pharmacies are targeting patients
and consumers in the US”

7. OK
Doctor
OLP
Credit Card Processor
Affiliate
Customer
Brick-and-Mortar
Pharmacy
Shipper
Complex Rogue Online Pharmacy Schematic

8. Center for Safe Internet Pharmacies
COMMUNICATIONS ROUNDTABLE
EDUCATING CONSUMERS ON THE DANGERS OF
ILLEGITIMATE ONLINE PHARMACIES
December 3, 2015

9. Counterfeit Investigational New Drugs
The Next Global Threat

10. • Criminals sold API with a DIY package to
instruct doctors on how to make the drugs,
• The Do-It-Yourself package included:
 API ,
 Excipient (lactose),
 Electronic scale,
 Empty capsules,
 Detailed DIY guide
• To avoid detection by Customs officials,
the criminals labeled the distribution as
follows:
Investigative New Drugs - The Criminal Scheme
“For study or research use only, not
allowed to use for other purposes.”

11. In August 2015 – Chinese law enforcement officials raided the
suspect lab and:
• Seized 700gm of chemicals and 1,650gms of Patented API,
• Recovered $8.2 million in proceeds from illicit activity,
• Arrested 40 suspects
ENFORCEMENT ACTION

14. “U.S. government prosecutors are accusing an online Canadian
pharmacy of selling $78 million worth of unapproved, mislabeled
and counterfeit drugs to doctors across the United States”

15. “An indictment filed in the US District Court in Montana charges
Canada Drug Ltd. and its affiliates in the UK and Barbados with
smuggling, money laundering and conspiracy.”

16. “Thirteen of the 14 companies and individuals names as
defendants are located outside the U.S….”

17. Illegal Rx medicines smuggled into and sold in the US

18. Illegal Rx medicines smuggled into and sold in the US

19. Illegal Rx medicines smuggled into and sold in the US

20. Illegal Rx medicines smuggled into and sold in the US

21. Illegal Rx medicines smuggled into and sold in the US

22. Illegal Rx medicines smuggled into and sold in the US

23. Illegal Rx medicines smuggled into and sold in the US

24. Illegal Rx medicines smuggled into and sold in the US

25. Illegal Rx medicines smuggled into and sold in the US

26. Illegal Rx medicines smuggled into and sold in the US

27. “Criminals have moved into the area of prescription
drugs and similar treatments because the profits to
be made far outweigh those to be made from
narcotics such as cocaine, heroin and cannabis.”

28. “In 2010, the World Customs Organisation estimated
that the global market for counterfeit drugs was
worth $200bn. The combined heroin and cocaine
markets are worth $160bn.”

29. Illegal Rx medicines sold on the Internet via Social Media

30. Illegal Rx medicines sold on the Internet via Social Media

31. Illegal Rx medicines sold on the Internet via Social Media

32. Illegal Rx medicines sold on the Internet via Social Media

33. “While common in Mexico, Neo-Melubrina has been banned in in
the United states since 1977. It has been found to cause
agranulocytosis, or a marked suppressant of white blood cells.”

34. “If agranulocytosis is left untreated, the risk of dying can be high.”

35. “Kolowich, 45, also known to neighbors and in cyberspace
as the go-to guy for Viagra”

36. “Today, a judge is scheduled to sentence him for
assembling what authorities call possibly the largest
Internet-based pharmaceutical distribution ring ever
broken.”

37. ”When he was arrested in March, Kolowich had just
hatched a deal to purchase a commercial pill-pressing
machine to ramp up production of his generic Viagra in
Tijuana, authorities say.”

39. “law enforcement investigators received a lab
analysis of 40 pharmaceutical –mimicking tablets
containing heroin in lieu of oxycodone.”

40. Dangerous Counterfeit Medication Trend Growing in LA County

41. Dangerous Counterfeit Medication Trend Growing in LA County
“Esmeralda Mendez was grieving her sister, who suffered from chronic
pain, bought unlicensed pharmaceutical medication as an affordable
alternative and died within hours of taking the drugs.”

42. “CITY ATTORNEY FEUR DETAILS LATEST CRACKDOWN, WARNS PUBLIC
ABOUT DANGERS OF ILLEGAL SALE OF PHARMACEUTICAL DRUGS”
Public – Private Sector Collaboration

43. Public – Private Sector Collaboration

44. Public – Private Sector Collaboration

45. Public – Private Sector Collaboration

46. Public – Private Sector Collaboration

47. J. Aaron Graham
Executive Director – Brand Safety & Security
Boehringer Ingelheim Pharmaceuticals, Inc.
aaron.graham@boehringer-ingelheim.com
March 7-8, 2016
Protecting Patients from Counterfeit Medicines
ABCD