2011: Progress on the Pedigree Front?

In last year’s “The Path to Epedigree: Manufacturers Chart Their Course,” we looked at how drug manufacturers were gearing up to meeting California’s mandate of pedigree compliance by 2015, and how drug product serialization efforts were coming along in general. In the year since, has there been any progress? We put the question to Scott Dicks, practice manager at Maxiom Group.PhM: What does the e-pedigree landscape look like today from a regulatory standpoint, as opposed to one year ago? While "California 2015" hasn't changed, are there still global shifts taking place?S.M.D.: Pretty much the same. The U.S. had some movement, in March 2010, releasing the guidance that we discussed in “FDA’s New Supply Chain Guidance: A (Necessary) First Step,” but has since failed to address pedigree, serialization, or track-and-trace in their “strategic priorities for 2011–2015,” as reported by Adam Fein in Is Track-and-Trace a Priority for the FDA?. There was some recent movement at the FDA with a public workshop in February, but it’s too early to know what, if anything, will come from that meeting. While new global developments have slowed down considerably (from the torrid pace of 2009), a number of significant laws are already on the books (Brazil, China, Turkey, France, etc.).  PhM: Where are manufacturers in their pedigree/serialization readiness, as compared to a year ago? (Are there any examples of companies that have made significant leaps?)S.M.D.: I believe manufacturers, especially ones targeted to the U.S. supply chain, have stayed on the sidelines. Larger companies, with wide-reaching global supply chains, have continued on the path that many of them had started prior to 2010 to outfit their global supply chains to meet requirements in Turkey, France, Brazil or China.  Nevertheless, I haven’t seen any major announcements of companies completing their implementation. Some companies have even put on hold programs that were in-process or in the exploration phase.PhM: What hiccups or unforeseen hurdles are they encountering as they develop global programs?S.M.D.: As mentioned above, some companies have put on hold programs that were in-process or in the exploration phase. This was mainly due to deprioritization of the projects due to the lack of impending regulations (and this includes at least one company with a global supply chain who is currently using workarounds to label product for Turkey and other European countries).PhM: One hope has been that e-pedigree and product serialization will not be "regulatory burdens" but rather essential components of healthy brand security and supply chain strategies. Are you seeing this among drug manufacturers?S.M.D.: Not as much as we would have hoped. While some large manufacturers have moved forward to generate increased supply chain visibility or further secure their products and brands, many smaller manufacturers, launching their first or second products, are choosing other supply chain security measures, such as covert markings and other packaging characteristics.  This seems to be due to both the added cost of the hardware, software and operations (ongoing marking and scanning) as well as the complexity of the communication with partners.               PhM: Last spring, I wrote, after speaking with you: Currently, there's no single and easy way to do electronic pedigree with serialization, since the decisions that need to be made-where to initiate a pedigree, how to reconfigure packaging lines, what software to use, how to integrate with one's enterprise systems, and how to establish greater visibility and cooperation between supply chain partners-differ by product and market."There are no standards," says Maxiom's Scott Dicks. "It's a manufacturer's nightmare." A year later, has the nightmare improved at all? If so, in what areas?S.M.D.: As I discussed in my blog entry, “Oracle Launches Major Pedigree and Serialization Product,” 2010 saw the release of a major new player in the enterprise system category, though since that initial burst in July/August there hasn’t been much publicity.Additionally, as we discussed in “FDA’s New Supply Chain Guidance: A (Necessary) First Step, and Dirk Rodgers discusses in his “Attributes Of A Global Track & Trace Application,” there has been a continued path towards the use of GS1 standards like the sGTIN. Nevertheless, the lack of implementation progress, especially in the U.S., means that pedigree and serialization are not high priority in discussions between manufacturers and their supply chain partners.All told, we’re making some minor progress but firm steps need to be taken by the FDA for many manufacturers to start or restart their projects.  However, during this period of uncertainty, we encourage manufacturers to take proactive steps to understand their product’s risk brand security profile and to make minor “readiness” investments, such as reserving space for barcodes on packaging.  For manufacturers that want to be able to spring into motion once the climate clears, we recommend conducting serialization feasibility studies and/or a conceptual design.