"counterfeit medicines: threat to public health and safety," congressional briefing march...
TRANSCRIPT
Counterfeit MedicinesThreat to Patient Health and Safety
John P ClarkVice President and Chief Security Officer
March 2016
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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
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What Do These Medicines Have in Common?
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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
2014No active ingredient
2012No active ingredient
2015Considered unsafe by FDA
Internet Threat: “Canadian” Websites
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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).
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Internet Threat: “Canadian” Medicines
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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
As We Launch Initiatives to Mitigate the OLP Threat…
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… Counterfeiters Turn to Social Media …
Strategic Private-Public Partnerships Succeed
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Counterfeit MedicinesPose a Real and Present Threat
to Patient Health and Safety
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Manufactured Under Conditions Like This…
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… Containing …
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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!
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