Edward C. Lawrence
While some progress has been made in addressing the inflow of counterfeit drugs into the U.S. with the FDA Safety and Innovation Act (FDASIA) signed into law on July 9, 2012, there is still much more to be done. The recent news of fake anti-cancer drug Avastin has again put the issue of drug safety under the media spotlight. The latest estimates of counterfeit pharmaceuticals in the global market place the value between $75 billion and $200 billion a year. To put this issue in perspective, the World Health Organization (WHO) estimates that 100,000 Africans die each year as the result of fake anti-malarial drugs, which make up an estimated 15 to 30% of the market. Furthermore, this black market reduces government revenues by 2.5 to 5%. Even though high safety and regulatory standards in the U.S. have traditionally kept fake drugs below 1% of the total national pharmaceutical market, the percentage is expected to rise as improving technological sophistication allows counterfeiters to exploit potential shortcomings in the supply chain.
While some progress has been made in addressing the inflow of counterfeit drugs into the U.S. with the FDA Safety and Innovation Act (FDASIA) signed into law on July 9, 2012, there is still much more to be done. The recent news of fake anti-cancer drug Avastin has again put the issue of drug safety under the media spotlight. The latest estimates of counterfeit pharmaceuticals in the global market place the value between $75 billion and $200 billion a year. To put this issue in perspective, the World Health Organization (WHO) estimates that 100,000 Africans die each year as the result of fake anti-malarial drugs, which make up an estimated 15 to 30% of the market. Furthermore, this black market reduces government revenues by 2.5 to 5%. Even though high safety and regulatory standards in the U.S. have traditionally kept fake drugs below 1% of the total national pharmaceutical market, the percentage is expected to rise as improving technological sophistication allows counterfeiters to exploit potential shortcomings in the supply chain.
The recent Avastin case
is not the first time a complex medication has been counterfeited. In 2008,
Chinese subcontractors for Baxter International’s injectable blood-thinner
heparin substituted the active ingredient with a cheaper, toxic substance.
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