Download - "Counterfeit Medicines: Threat to Public Health and Safety," Congressional Briefing March 7-8, 2016

Counterfeit MedicinesThreat to Patient Health and Safety

John P ClarkVice 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


3

What Do These Medicines Have in Common?


Counterfeit Versions Breached U.S. Legitimate Supply Chain

2003Coating affected efficacy

2008Contaminated, toxic ingredient

149 deaths; 81 in US

2012No active ingredient

2012, 2013No active ingredient



2015Considered unsafe by FDA

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjapI-5nPDKAhVFPz4KHceVA5AQjRwIBw&url=http://www.breastguide.com/breastcancerblog/category/breast-cancer-drugs/herceptin/&bvm=bv.113943164,d.cWw&psig=AFQjCNHbYdLyOZoiICFzbX37nj9pq3Kqcw&ust=1455297664587108

http://www.slady.com.hk/Botox.html

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwi83cO8nvDKAhWBeT4KHXi0A4oQjRwIBw&url=http://www.ensferium.com/demo/anket/&bvm=bv.113943164,d.cWw&psig=AFQjCNHo7YVPvKf5p9uSBvxct_lcc04Thw&ust=1455298214624632

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwic7JOAn_DKAhXLdz4KHaTFBBcQjRwIBw&url=http://design-by-debbie.com/Logos&bvm=bv.113943164,d.cWw&psig=AFQjCNE0AnjPwWlmeo6caKl5mBw8Dj85cg&ust=1455298271362098

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiMwY-in_DKAhXGND4KHURzApYQjRwIBw&url=http://www.specialtypharmajournal.com/medical-news/oncology/4045-nice-issues-final-guidance-recommending-against-avastin-for-advanced-ovarian-cancer&bvm=bv.113943164,d.cWw&psig=AFQjCNGsjxaLP5UnQ--1w5OcOpnmVGC8vw&ust=1455298420074748

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwi7_tOEoPDKAhVKPT4KHRDuAXIQjRwIBw&url=http://www.labelvalue.com/labels/pre-printed-stock-labels/medical-and-healthcare-labels/chemistry-labels/heparin-medical-labels-p-612.html&bvm=bv.113943164,d.cWw&psig=AFQjCNEKSay9tJRZnkiQWROmIMTF88bW9w&ust=1455298622691625

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiwgumQovDKAhVEGD4KHW1vBrYQjRwIBw&url=http://www.freelogovectors.net/lipitor-logo-pdf-file/&bvm=bv.113943164,d.cWw&psig=AFQjCNGv45ZOLgKmlQSGxTdibCO-4BwCnA&ust=1455299186454105

Internet Threat: “Canadian” Websites

4Copyright© Pfizer 2016

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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).


Internet Threat: “Canadian” Medicines

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Internet Threat: FDA Warning to Patients


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

As We Launch Initiatives to Mitigate the OLP Threat…

Copyright© Pfizer 2016 7

… Counterfeiters Turn to Social Media …

Strategic Private-Public Partnerships Succeed

Copyright© Pfizer 2016 8

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&ved=0ahUKEwidj6OZ95XLAhXKcj4KHUNDCVAQjRwIBw&url=https://postalinspectors.uspis.gov/aboutus/History.aspx&psig=AFQjCNEt8w3StymJP4QlMU90eNX2sEy6Cw&ust=1456593305401046

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwj_tpOF-JXLAhVJOz4KHUE5DlAQjRwIBw&url=https://www.hsfgiftshop.com/ProductDetails.asp?ProductCode%3D500&psig=AFQjCNE9DX_iqtbxw_wnZLXX6Nr6asroDQ&ust=1456593568212066

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&ved=0ahUKEwjPuLm_-JXLAhVBcD4KHcYSB08QjRwIBw&url=https://en.wikipedia.org/wiki/CBP_Office_of_Field_Operations&psig=AFQjCNGylcS11kKYSjzQrHxFi66G5Ctr-w&ust=1456593669695179

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Counterfeit MedicinesPose a Real and Present Threat

to Patient Health and Safety


Manufactured Under Conditions Like This…


… Containing …


Wallboard

Brick dust

Commercial Paint Highway Paint

Pesticides

Chalk

NO API

WRONG API

INCORRECT DOSE OF API

… But Virtually Indistinguishable


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Thank You!


Download - "Counterfeit Medicines: Threat to Public Health and Safety," Congressional Briefing March 7-8, 2016

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