By: Sarah Varney
The announcement by the Food and Drug Administration last week that sixteen California clinics and physicians were sold bogus vials of the cancer drug Avastin did not surprise regulators and researchers who study the counterfeit drug trade.
Indeed, it was after fake AIDS drugs were discovered in California that state legislators passed the “e-pedigree law“ mandating that all prescription drugs carry an electronic tag. The tag could be scanned to show where the drug was first manufactured and every stop along its way to market.
Since the law passed in 2004, biotech and pharmaceutical trade groups fought to delay its implementation. They argued, successfully, that the electronic track-and-trace system would up-end global drug manufacturing.
Finally the system is going into effect, says Virginia Herold, head of the state Board of Pharmacy. But it will still be awhile. “In January 2015, 50 percent of a manufacturer’s products that will be sold into California have to have this unique serialized number of each container,” she says.
The remaining half must have the serialized numbers by the following year — and in subsequent years the system will become more robust. Herold says the the electronic tags can stop incidents like the recent sale of the adulterated Avastin.
“The wholesaler, when it purchased the product would have had to certify, ‘Yes, I just bought this from Roche.’ Well, Roche didn’t manufacture the product. Somebody else did.”
But Brian Liang, Director of the Center for Patient Safety at UC San Diego, says electronic tags won’t end the fake drug business, because counterfeiters often avoid wholesalers. “These are people who are coming at it from a completely different underground approach,” he says.
Liang says counterfeiters will try to sell directly to clinics and doctors by bombarding them with faxes advertising cheap drugs. But there are resources available now, he says, that clinics and patients can turn to.
“We have authorized wholesalers who are in fact listed by the government and National Association of Boards of Pharmacy, they also list wholesalers. If it’s a source you’re not familiar with you really should find out: Is this source legitimate?”
State regulators say about 1 percent of the 400 million prescriptions dispersed in California each year are fake. That’s about four million prescriptions that have too little or too much of the right active ingredients or no active ingredients at all.
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