This is part 2 of my Supply Chain Security Rivalry story.
In Friday’s post (Part 1), I described the pedigree vs. track-and-trace division that has emerged among advocates of better supply chain security. I got a lot of private feedback on my comments. Many people gave me additional insight about the behind-the-scenes machinations, although it’s getting harder and harder to tell truth from spin. (Also check out the posted comments.)
As I see it, the battle will increasingly be fought via legislation, where track-and-trace is at a disadvantage relative to pedigree. This gives more influence to wholesalers and pharmacies, although their supply chain interests are not aligned on the implementation issues. No one wants to admit this obvious reality, creating uncertainty for everyone else and making me wonder whether the drug supply chain can ever be truly secure.
Pedigree not Track-and-Trace?
As I noted in California Dreamin’, the U.S. is many, many, many years from a workable track-and-trace security solution based on serialization. This practical reality is forcing HDMA to shift tactics away from track-and-trace in favor of federal pedigree standards.
At the 2006 RFID Adoption Summit (note the omission of “track-and-trace” in the event’s title), Mark Parrish issued a “call to action” for “the creation of a broad coalition to establish a target date for industry-wide implementation of a consistent track and trace system.”
Well, things change. In his remarks at the 2007 HDMA Leadership Meeting last month, Mr. Parrish stated: “Rx SafeTrack has fallen short of our ambition to have a date for when track-and-trace systems would be implemented.”
Translation: the HDMA and RxSafeTrack have now shifted toward a much more meaningful and achievable goal: “Rx SafeTrack will shift focus and drive efforts for uniform federal pedigree requirements.” So, we're now talking about Federal preemption of state pedigree requirements, which has the intuitive appeal of avoiding 50 different standards.
And as I have pointed out repeatedly on this blog, various pieces of Federal legislation have pedigree and serialization requirements buried in the details, including PDUFA. The primary House importation bill (HR 380) includes detailed requirements about pedigree and track-and-trace systems. Presidential candidate John Edwards has even made pedigree into a campaign issue. And let’s not forget the still-unimplemented pedigree requirements of the Prescription Drug Marketing Act?
Local Roadblocks
Unfortunately, I fear that lobbying will reduce any Federal pedigree to a lowest-common-denominator standard, putting us right back to where we started with the PDMA in 1987. And despite all the happy talk about collaboration and idea-sharing, I don’t think we can easily gloss over the challenges of federal preemption.
Most boards of pharmacy are composed of independent pharmacists who will want to maintain local control. Some states would gladly give up responsibility (blame?) for pedigree/counterfeits -- but other states now have pride of authorship (CA?). Florida has even been able to levy large fines for non-compliance against some wholesalers (like PSSI), giving states a financial incentive to maintain local authority.
Federal pedigree would make it harder for pharmacy to leverage local control unless the legislation is written to suit their needs. I presume that pharmacy associations will use their newfound political influence to shape supply chain standards. For example, chain pharmacies do not want to absorb the costs of reading pedigree or serialized data. They also recognize that these data have monetary value, which will throw a monkey wrench into the data sharing aspects of fee-for-service agreements.
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I wrote these two posts to stimulate more public discussion about the real issues at stake. We risk having the supply chain security debate evolve from a technology competition into a legislative quagmire. Who will win if safety becomes a legislative issue? Will patients really be safer?
What do you think?
The problem with all of the proposals is all of the proposals. With 40 state requirements, multiple federal proposals and requirements, conflicting lobbying efforts, multiple competing technologies, inconsistent definitions, multiple or nonexistent standards and dozens of data architects; it is not likely industry will every come to a conclusion. If the industry cannot, then we must leave ePedigree, TNT, and RFID to the federal government. And given they passed the first pedigree legislation when I was in high school, I am sure most of your readers will be retired before we have any momentum there.
ReplyDeleteBut far worse than a lack of cohesiveness is that most of these programs are not patient-centric. Brand-centric, yes. Security-centric, absolutely. Brand's want to protect profits. Security wants to catch the bad guy. Consumers want prevention, not a top-notch after-the-fact reporting system. A similar approach is used by our Consumer Product Safety Commission that is interested in recalls, not prevention, and those heads have just started to roll. Talk about sticking your neck out.