Last month, California regulators passed a bill that would postpone the state’s electronic pedigree requirements until 2015 (for drug manufacturers). This is the third time that the state, which has the most advanced requirements in the U.S. so far, has applied the brakes. I’m sure that this is very welcome news for many companies, given the complexity and cost of item-level serialization and the technical challenge of integrating serialization with electronic pedigrees.
Then there are the practical considerations of who pays for what, who gets access to what information, how to set up contracts with the numerous technology providers and the like. We hear that a growing number of pharmaceutical companies are proactively developing compliance plans, selecting technologies and working to develop internal processes, some of which may be up and running before the deadline.
You recognize the names: Purdue Pharma, Pfizer, AstraZeneca and others. Late this month, we’ll hear from one such company, Procter & Gamble Pharmaceuticals, in a webcast on the topic. But how about the companies that we don’t hear from—the generic drug manufacturers, for instance, or the smaller companies, for whom e-pedigree costs seem astronomical, and contractual terms fuzzy at best?
To dismiss the need for electronic pedigree would be akin to attacking parenthood. But, why is it that all these years after the PDMA was first proposed, the law still has not been enacted? Many see the law as unenforceable; FDA has not gotten involved in spelling out its vision of how it should work, while Congress hasn’t passed legislation to take the term pedigree out of the land of the theoretical. Many companies still don’t even have “pedigrees” of any sort in place, or even the templates or basic foundations for them. The problem with any complex requirement is that it becomes increasingly tempting for some to ignore it.
With “suggestions” or “guidances,” that course becomes even more tempting, as FDA has probably discovered with initiatives such as PAT and risk-based compliance. E-pedigrees have been under discussion for so many years now that they may be losing credibility in some circles. Companies already face 30 different state regulations in the U.S. alone, while those who do business abroad face a whole different set of requirements, with different timelines, most of which are also theoretical. The net effect has been one of uncertainty, says Todd Applebaum, vice president of strategy and operations practice for Maxiom Group (Boston).
As jaded editors, we can recall the heady days three or four years ago when RFID dominated the airwaves. Debates and discussions raged on frequencies, technical challenges, implementation challenges, and how many angels could fit on the head of a pin. RFID remains the ultimate track and trace solution, but how often do we hear it discussed at length now? It seems to be taking a back seat to more practical solutions such as 2-D barcoding.
Could the same thing happen to e-pedigree requirements? Will we see sweeping plans be scaled back drastically, and a grand technical roadmap broken down into very practical, incremental measures, each with a practical, and inflexible, deadline? I hope that we do see something. Soon. Drug counterfeiting is a booming business, and boundaries between the fake and the substandard are blurred in much of the world today.
FDA could offer more concrete guidance in this area, just as it could in the area of contractor oversight, subject of our cover story and a survey on drug supply chain safety. Enforcement requirements that have teeth could help ensure public safety and see to it that a critical concept doesn’t remain just another interesting idea, but that it takes shape within the industry.