No Delay Announced for California Pedigree Laws
The California State Board of Pharmacy wants item-level serialization by January 2009.
By Daphne Allen, Editor
Despite requests for a delay to its epedigree requirements for prescription drugs, the California State Board of Pharmacy appears to be standing firm with its January 1, 2009, deadline. “To delay implementation is not on our agenda—2009 is the date,” said board member Stanley Goldenberg at a September 20 epedigree meeting in Los Angeles. Goldenberg added, “None of us wants to be here to do body-count legislation if something bad happens. We are putting the stake in the ground today—move forward vigorously.”
Drug manufacturers are continuing to move forward with electronic pedigree pilots, often involving radio-frequency identification (RFID), reported Marjorie Powell from the Pharmaceutical Research and Manufacturers of America (PhRMA). “My guess is that all companies are engaged in pilots at some level,” she said.
However, RFID pilot results are not yet demonstrating a validatable system, industry seems to suggest. Read rates, for instance, are “still a variable experience,” reported Tim Kvanvig, vice president, U.S. pharmaceuticals, for GlaxoSmithKline, which has been RFID-tagging pallets, cases, and units of Trizivir. When speaking of challenges, he described RFID as “not ready for vigorous validation.” Nonetheless, GSK is working to expand its pilots to other high-risk drugs, he said.
Also speaking on behalf of PhRMA was David Albrecht of TAP Pharmaceuticals. “Industry-wide implementation by 2009 is not feasible,” he said. “Manufacturers have to rework all their labels, redo all their packaging lines, and revalidate.”
When asked by PMP News whether the board was considering industry’s validation efforts when deciding to stand firm, Joshua Room, California’s deputy attorney general, replied: “Industry has to validate to meet FDA’s good manufacturing practices, but that is not the board’s bailiwick.”
PhRMA suggested a phased-in approach that starts with electronic pedigrees using whatever serialization is currently in place (item, case, or lot numbers) and then moves toward product-level serialization on a risk-based approach. “Such transactional-level security would be an enormous step forward,” said Albrecht. “Counterfeiters are not interested in one or two bottles.” He said that the phased-in approach is needed because “standards are still in development, and ratification for some is not expected until 2008, even 2009.”
The board did not seem receptive. “PhRMA’s timeline doesn’t sit well with me,” said Goldenberg. “Serialization by 2012? Evidence for a delay is needed.”
Powell added that “a number of companies are waiting to see what [technologies] trading partners are using before making final investments.”
Some of those trading partners spoke at the board meeting. They, too, are waiting. “Today, only three products are item-level serialized,” said Emily Stamos, RPh. PharmD. She serves as associate category manager, pharmaceutical strategy, for Walgreens. “We are waiting on upstream partners to explain what technologies they will use. Once we know what they are and parameters are set, it will take us 15 to 18 months to implement. If we started today, we would just make it.”
Added David Vucurevich, RPh, Rite Aid’s general vice president of pharma purchasing and clinical services: “Few active suppliers are engaged. We are also concerned that generics manufacturers will abandon California sales.”
“Pilots seem to be a well-kept secret,” said Goldenberg. “We need someone to coordinate these pilots.” Added fellow board member Robert Swart: “We need more pilots from manufacturer to pharmacy.”
The board encouraged the pharmaceutical industry—and PhRMA in particular—to provide specific pilot data that could better characterize industry progress. “We want evidence from pilots,” Goldenberg said earlier. “Start getting data so we can understand the challenges. We seek evidence-based [delay] requests.”
Added Room: “The board needs presentations from industry on why or why not it cannot meet the deadline. It cannot make its decision without them.” When asked whether the next board meeting, to be held in December, was time enough to provide such data, the resounding answer was, “We need it much sooner—how about tomorrow?”