Presented by John P. Clark, VP and Chief Security Officer, Pfizer, Inc.

1. Counterfeit Medicines
Threat to Patient Health and Safety
John P Clark
Vice President and Chief Security Officer
March 2016
Copyright© Pfizer 2016

2. Importation Places Patients at Risk
A closed supply chain protects patients
An open supply chain, which permits importation,
is only as strong as its weakest link
Copyright© Pfizer 2016 2

3. What Do These Medicines Have in Common?
Copyright© Pfizer 2016 3
Counterfeit Versions Breached U.S. Legitimate Supply Chain
2003
Coating affected efficacy
2008
Contaminated, toxic ingredient
149 deaths; 81 in US
2012
No active ingredient
2012, 2013
No active ingredient
2014
No active ingredient
2012
No active ingredient
2015
Considered unsafe by FDA

4. Internet Threat: “Canadian” Websites
4Copyright© Pfizer 2016

5. 5
Major seizure at London Heathrow included 13,500 counterfeit Lipitor® tablets. Investigation showed
complex route of entry into UK (black arrows) together with likely onward route to US patients (red arrows).
Copyright© Pfizer 2016
Internet Threat: “Canadian” Medicines

6. Internet Threat: FDA Warning to Patients
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FDA warned patients not to buy or use from Canadian pharmacies including RxNorth
At time of warning, preliminary tests had confirmed counterfeit
Subsequent tests confirmed counterfeits
contained no API, insufficient API and heavy
metals

7. As We Launch Initiatives to Mitigate the OLP Threat…
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… Counterfeiters Turn to Social Media …

8. Strategic Private-Public Partnerships Succeed
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9. Counterfeit Medicines
Pose a Real and Present Threat
to
Patient Health and Safety
Copyright© Pfizer 2016 9

10. Manufactured Under Conditions Like This…
10
Copyright© Pfizer 2016

11. … Containing …
11
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Wallboard
Brick dust
Commercial Paint Highway Paint
Pesticides
Chalk
NO API
WRONG API
INCORRECT DOSE OF API

12. … But Virtually Indistinguishable
12Copyright© Pfizer 2016

13. Thank You!
13Copyright© Pfizer 2016