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Rather than wait to see which ePedigree legislation becomes law, biotech firm Genzyme has taken the initiative and implemented an electronic track-and-trace program to clamp down on fake meds.
In an effort to cut off counterfeiters at the knees, Genzyme announced on Monday that it is implementing an ePedigree system to keep tabs of its entire pipeline.
While many pharma companies have gone on record with their track-and-trace projects, Boston-based Genzyme is one of the first biotechs to tackle counterfeiting and diversion head-on, whether there is a nationwide mandate for ePedigree or not.
According to Genzyme, the January 2011 deadline for compulsory ePedigree in California was merely an accelerator to implement the technology. The company began evaluating its supply chain three years ago, evaluating each drug's risk and quickly deciding to establish its security program.
"Genzyme did not purchase ePedigree specifically to comply with California—they purchased it because they have identified either counterfeiting or diversion issues that they are going to serialize their product to combat it," said Kim Loughead, director of healthcare solutions at Axway, the ePedigree software provider for Genzyme.
Traditionally, oncology and renal treatments—Genzyme's two top specialties—are not thought of as targets for counterfeiters, but the company said that the high cost of biologics is driving a black market for these types of drugs. Genzyme's Vice President of Security David Kent told Pharm Exec Genzyme does not have these problems, but is being proactive to keep its drugs out of the black market.
The company said that it has been involved in raids in third-world countries where fake Genzyme packaging has turned up, but no product was evident.
Peter Norton, serialization project manager at Genzyme, told Pharm Exec on Tuesday that its supply chain security is different from traditional pharma companies, particularly because of the limited number of drugs running through it. This allows the company to have added control for regulation of the product temperature.
The company installed an EPCIS-compliant database that creates a digital signature every time a product passes a particular point on the supply chain. The package can be tracked throughout the entire process.
As for serialization, Genzyme chose to go with the more affordable 2-D barcodes, but not because of price. While some pharma companies, such as Pfizer and Purdue, are using radio-frequency labels for increased security and easier scanablility, Genzyme noted that the technology still hasn't been proven when affixed to containers of liquid. Since many biologics are in liquid form and often shipped in vials and syringes, the radio frequencies might be negated by the moisture. There is also concern that the exposure to the radio signal could possibly modify the drug.
"By the time the drug gets to the end user, it could have had five to ten exposures—and who knows what the long-term effect will be on efficacy," Norton said.
Genzyme is currently building and testing the system and plans to go live well in advance of the Cali deadline. Says Axway's Loughead: "We work with organizations like Genzyme and AstraZeneca that see the value of serializing the product and have a specific problem that they are dealing with. The other group [of pharma companies] is dealing with complying with legislation and doing the lower-cost option. We believe that going forward, the market will continue to be fragmented."
This article was updated on May 14, 2008, to include additional comments and clarifications from Genzyme.