In Sync with California - Pharmaceutical Executive

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In Sync with California
Pharma Ramps Up for E-Pedigree Mandates


Pharmaceutical Executive


"We view RFID simply as the data carrier, and what it is carrying is a serial number," Staver says. "From a compliance viewpoint, whether we choose RFID or 2D bar codes is not as critical as it is to move forward with serialization." Pfizer is currently piloting Gen2 UHF chips for Viagra (sildenafil) at the case level. At the item level, Pfizer is tagging packages with HF tags. The company is now beginning to implement RFID on its Celebrex (celecoxib) packaging, although the tagged product won't be on the market until 2008.

In the United States, several of Pfizer's trading partners have expressed interest in RFID over 2D bar codes because of the operational efficiencies associated with RFID. "We've been trying to work with our trading partners to understand what the cost/benefit is," Staver says. "But we still aren't there yet."

Rather than waiting for a standard to be ratified, manufacturers such as Pfizer are using a risk-based approach to serialization. High-cost items are getting an RFID tag, while the bulk of the products are receiving traditional paper bar codes. For example, of Pfizer's 100-plus prescription drug products, only five or six either have been counterfeited in the past or have high revenue capabilities. Those items are more likely to receive a higher level of serialization.

The serialization of individual packages is a serious endeavor, Staver says. "Because of the cost and complexity involved in implementing serialization on packaging lines across the US market, this is not an insignificant event that can be done in a short amount of time," she adds.

The race to meet California's e-pedigree deadline is tight, but it's only the first leg of a marathon. More than 20 other states, including New York, are currently signing off on legislation mandating pedigrees. The big question: When is the federal government going to step in? Fifty different supply chain pedigrees for 50 different states is not the answer, says one industry expert. As of right now, FDA is waiting and watching what happens in California. "It's only a matter of time before FDA comes out with a mandate, but I think the government is giving the pharma industry some time to develop products and solutions that are workable for the industry," says Bill Allen, group director for RFID at CMP Technology, a publisher and media company.

There is also the chance that the California deadline might get pushed back to 2011—after all, the date has already been moved once from 2007 to 2009. At press time, neither FDA nor the California Board of Pharmacists could be reached for comment.

"The California legislation anticipates that by 2009 there will be serialized products being sold in California," says Paul Fowler of Axway Software. "Realistically, you are talking to manufacturers that are just now looking at pilots, and none of those [programs] are anywhere near production. Many are questioning how this is going to work by 2009. If no one is able to comply with California's law, they might have to rethink the plan."


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