Fake Avastin case highlights need for supply-chain controls

Global pharma police have few weapons against fly-by-night drug distributors that deal in counterfeits. This is no secret to drugmakers; Pfizer ($PFE), for instance, has a vast security force focused on cracking down on fake versions of its meds, including--perhaps especially--that little blue pill, Viagra. And before phony Avastin surfaced in the U.S., Roche ($RHHBY) teams tracked fake versions of the company's drugs in the Middle East.

Now, that phony Avastin has cast a spotlight on the pharma supply chain. The fake cancer drug--which contained none of the real thing's active ingredient--had passed through several countries and half a dozen companies before the FDA warned U.S. doctors about it. "The business about counterfeit Avastin really demonstrates how easy it is to be fooled," Sandra Kweder, deputy director of FDA's Office of New Drugs, said, as quoted by Reuters.

Complicating matters is distributors and customers themselves ignore red flags--such as markedly discounted prices, as in Avastin's case--which only feeds the counterfeit trade. In other cases, import/export rules prohibit middlemen from opening boxes to inspect their cargo; Switzerland's Hadicon, for instance, blamed such rules for its unwitting participation in the Avastin fraud. Plus, experts say, many counterfeiters are simply good at faking it.

"The perpetrators certainly acted in a highly professional manner and knew that drugs would not be allowed to be opened once smuggled into the delivery chain," Hadicon CEO Klaus-Rainer Toedter told Reuters. And one anonymous buyer said the U.S. Avastin distributor was "a good con man" with documentation and licenses that appeared authentic.

What's to be done? Drug-tracking systems have been proposed, and Europe starts requiring unique identifiers on all drug packages beginning in 2016. But even RFID tags can be circumvented, especially if customers are willing to look the other way, Reuters' sources said. And drug shortages have healthcare providers casting about for new suppliers, which could aid counterfeiters. Some U.S. lawmakers have proposed harsher penalties for counterfeiters and increased tracking along the supply chain.

- read the Reuters analysis