The alert over fake Avastin may light a fire under a dormant U.S. plan to create an international tracking system for pharmaceuticals.
While the idea has been kicking around for many years, agreement on the specifics has been hard to come by among the many constituencies, which include manufacturers, suppliers and providers. Until now, the discovered incidents of counterfeit drugs have not been terribly compelling. Reports of fake Viagra or weight loss drugs being sold over the Internet lack the drastic elements of the Avastin case. The cancer drug is medically critical, worth billions of dollars, and the fakes made it into the approved supply chain.
The FDA and Roche ($RHHBY), whose U.S. unit Genentech manufacturers Avastin, last week were contacting 19 medical practices in California, Texas and Illinois believed to have purchased the phony vials. Roche said tests confirmed the counterfeits contained none of the active ingredient for the cancer drug.
Those backing the idea of a tracking system say using special identifiers on bardcodes or tags, like those used in Belgium, Sweden and Turkey, could screen out fakes. Manufacturers are legitimately concerned about the cost of a mandated system and note the sophistication of computer printing allows for barcodes to be counterfeited.
As the Associated Press points out, pharmaceutical manufacturers prefer the idea of a uniform national system. But California, a state known for leading in consumer concerns and often setting standards higher than the feds, was one of the three states in which the fake Avastin was acquired by medical practices, and that fact could influence the debate.
Still, the episode clearly points out that given the current system of global manufacturing and distribution, relying on poorly funded state inspections may no longer cut it. It is a system that is just too easy to game, Tom Kubic, president of the industry-created Pharmaceutical Security Institute, points out to the AP.
"Even when the state system is regulating effectively, they've usually got one guy looking at 600 licenses," Kubic points out. "It's a really easy system for the crooks to beat."
- get the AP story
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