Last week’s post discussed industry reactions to the delay of California’s ePedigree implementation deadline from 2011 to 2015 for pharmaceutical manufacturers. This week, PharmTech Talk caught up with Arvindh Balakrishnan, vice-president of the Life Sciences Industry Business Unit at Oracle, to get his thoughts on the California Board of Pharmacy’s decision.
In a July 2008 column in Pharmaceutical Technology magazine, “ePedigree: Using the Gift of Time Wisely,” Balakrishnan described the steps companies could take to prepare during the extra two years given under the deadline extension from 2009 to 2011 that was announced this spring. Here, he talks about factors behind the decision to extend the deadline to 2015.
PharmTech Talk: What do you think of the delay to 2015 for manufacturers? Was it a good idea?
Balakrishnan: We think that the delay to 2015 was the only feasible path out. Different companies have different complexities and problems of scale when getting to ePedigree compliance. Reasons include the reasonable cloudiness of the product portfolio in the future, erosion of patent-protected portfolio (in the case of research-based pharma) and the increase in portfolio (in case of generics), number of packaging lines, types of packaging, channels of distribution and contract manufacturing, shifting of manufacturing operations to low-cost economies, globalization, ascent of Tier 2 and 3 markets (such as Asia and Africa), and the potential of the Chinese market. When trying to be fair to all parties without penalizing the most complex (and large) pharmaceutical manufacturer, the least-common-denominator approach dictated a delayed ePedigree compliance date. In the absence of better (and uniformly fair) ideas, this seems like a good one!
PharmTech Talk: Seven months ago, the deadline was extended from 2009 to 2011. Now it’s been pushed back to 2015. Will we see another delay?
Balakrishnan: We believe this date is achievable by all parties and will be adhered to; however, decisions like these are made through a combination of industry forces, legislative bodies, and executive support, and we cannot clearly read into this crystal ball. Several of our customers have indicated that they intend to be fully compliant with the recent date, and we believe this is a telling industry indicator.
PharmTech Talk: What should companies do with this extra time?
Balakrishnan: Companies should start off implementing serialization in their supply chains. Some immediate benefits could be reaped, including better traceability of drugs in hospitals, better return-handling, and identification of counterfeit or diverted drugs. Most importantly, manufacturers will benefit from the experience in detecting supply-chain anomalies and errors from large volumes of serial number data. Manufacturers should then engage in collaborative supply-chain pilots with their key 3PL’s [third-party logistics partners], distributors, and pharmacy outlets. Finally, manufacturers should avoid the issues of grandfathering when possible by using the extra time to minimize the amount of nonserialized products in the supply chain by 2015.
PharmTech Talk: What will we see implemented first: California’s serialized ePedigree law in 2015 or a national plan developed by FDA?
Balakrishnan: We believe that the FDA’s support for the California Board of Pharmacy initiative has been clear and consistent. While a national plan for ePedigree will eliminate state-to-state inconsistencies (and is hence preferable), we believe that such a plan will need to be aligned with the new government’s vision and strategy for healthcare and healthcare IT in the United States.