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3.7 Auto_ID — Value Creation from Big Data and Serialization 193
chain impacts what hazards they are exposed to. For example while Viagra
still is the most counterfeited product in the world today, cancer drugs now
represent an increasing share of that market as reported in the Wall Street
Journal. 1 It is not surprising to see that those willing to put people’s lives in
danger to make money see greater potential in counterfeiting a vial of Avastin
that sells for $2,400, than manufacturing a $15 or $20 bottle of fake Viagra.
An integrated financial risk management system is required for curating and
valuing data assets.
3.7.1.7 Regulatory oversight
Automating FDA inspection/data collection processes is but one example of
where changes from manual to automated data collection processes is needed.
Using today’s onsite inspection methodology, according to the FDA budget
request to Congress in 2013, the Agency said it’s inspections of foreign manufacturers
jumped 10% last year to 813 inspections in 62 countries. The Agency
said nearly half of the 46 warning letters issued to foreign manufacturers
resulted from these inspections. What might those tallies look like if the FDA
were able to inspect (200,000) pharmaceutical ingredient production sites in
Asia? To quantify the size of the problem, working with FDA partner agencies
International Criminal Police Organization (Interpol) and the World Health
Organization (WHO), approximately 20 million pills, bottles and sachets of
counterfeit and illegal medicines were seized in a five-month operation in
China and nearby Asian countries in 2009 [29 WHO, 2010]. Asia has the
largest amount of counterfeit medications but these illegal acts can be found
worldwide. Automated mechanisms for manufacturing and supply chain compliance
reporting is an area requiring further collaboration.
3.7.1.8 Product lifecycle management data
In the US healthcare market, the lack of visibility over the product lifecycle
of drugs results in a $11 billion in “revenue leakage,” according to a
study by IDC, that could be reduced by better drug tracking [30 IDC Tech
Insight, 2010]. In addition to chargeback’s, reverse chargeback’s, duplicate
1 “Counterfeit Cancer Medicines Multiply;” By JEANNE WHALEN And BENOIT FAUCON; (December
31, 2012, WSJ) http://online.wsj.com/article/SB100014241278873233204045782114924523530