Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”. I don’t have any special or inside knowledge but, as usual, I do have a theory about that. I offer it to you here as one possible outcome. You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again?
[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 15, 2010. See “Return Of Two Classics” for an explanation.]
In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance with the California Pedigree Law would be decided solely by the pharmaceutical manufacturers. I pointed out that most of them would end up choosing 2D barcodes because their ongoing costs for Radio Frequency IDentification (RFID) would be too high.
Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice. If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages. I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.
But what about the pedigree model that the supply chain will use for compliance? Can we apply similar logic to determine who will get to choose the technology that defines what a compliant pedigree is? Yes we can! And here it is. Continue reading Who Will Decide Which Pedigree Model You Will Invest In?
Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee. That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill. See “’Track And Trace’ On Ice For Now” in Politico PULSE.
According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”
Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates. The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal. The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC
In this time of potential Congressional legislative action on drug track and trace I think it is time to take a closer look at the specific provisions contained in the current California pedigree law regarding Federal preemption. As I recall, this language was added in the most recent update of the law, the same update that pushed it out to 2015 – 2017. It is an invitation to the federal government to create their own national pedigree regulation and, if that happens, would cause the California pedigree law to become “inoperative”, thus preempted.
Here is the full text of section 4034.1 from the California Business and Professions Code: Continue reading The Preemption Provisions Built Into The California Pedigree Law
During the California Board of Pharmacy, Enforcement Subcommittee meeting on Wednesday the members voted unanimously to recommend to the full board the approval of a regulation that would require the use of the Food and Drug Administration’s (FDA) Standardized Numerical Identifier (SNI) as the unique identifier that is required on all drugs packages as part of their pedigree law. That law currently requires pharmaceutical manufacturers to apply unique identifiers to 50% of all their prescription drug packages by January 1, 2015 and the remainder by January 1, 2016.
The approved text reads as follows: Continue reading California Enforcement Subcommittee Moves To Require FDA SNI
The California pedigree law will have a surprising influence on how the pharmaceutical supply chain operates in another state. I’ll get to that in a minute, but first, the law will change some things about the way the supply chain operates in all states. Prescription drug manufacturers who want to continue offering their products to patients within California after 2015-2016 must add unique serial numbers to each drug package and start an electronic drug pedigree.
California is the only state that requires both of those things but most manufacturers are forced to treat the California state law as if it applies nationwide. That’s because most drug manufacturers sell through distributors in the United States and so they have no way of knowing which drug package will end up being shipped into California and which ones will not. Voila! Pharma manufacturers end up having to serialize and create a pedigree for every single package that enters the U.S. supply chain.
This almost certain outcome will likely affect the full nationwide supply chain in a couple of interesting ways.
AFTER 2015: ALL DRUGS IN THE U.S. SUPPLY CHAIN ARE SERIALIZED AND PEDIGREED BY THE MANUFACTURER
That will be a big change, even outside of California. Here are some of the things I think we will see happen: Continue reading The Surprise Consequence of the California Pedigree Law
For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7. Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011. It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly. Here is the item as it actually appears on the agenda: Continue reading California Board of Pharmacy Re-awaken
“…[C]ommencing on July 1, 2016, a wholesaler or repackager may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.
…[C]ommencing on July 1, 2016, a wholesaler or repackager may not acquire a [prescription] drug without receiving a pedigree.
…[C]ommencing on July 1, 2017, a pharmacy may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.
…[C]ommencing on July 1, 2017, a pharmacy may not acquire a [prescription] drug without receiving a pedigree.”
With these words the State of California introduced a significant change to the way the pharmaceutical supply chain works (see section 4163 of the California Business and Professions Code) and has written a new page in the history of commerce. It brings pharmaceutical commerce fully into the computer age. Adam Smith would not recognize it. Today, and up to the effective dates of these provisions, the value of a legitimate pharmaceutical in the legitimate U.S. supply chain is determined by the physical condition of the product and its package. After July 1, 2016, the value of a legitimate pharmaceutical in the supply chain in California will be determined by the combination of the physical condition of the product and its package, and the sellers ability to provide the buyer with an electronic pedigree.
The intended effect of this new regulatory requirement is to place a significant roadblock in front of counterfeiters, diverters and others who would try to scam patients and the legitimate participants in the supply chain. This is a noble cause. By requiring sellers to provide buyers with a pedigree at each change in ownership in the supply chain, illegitimate parties will find it very hard to inject illegitimate drugs without exposing their actions and, at the same time, creating evidence that can be used against them in their own prosecution. By providing a pedigree at each change in ownership, supply chain buyers will be able to check the authenticity of the full supply chain transaction history provided by the seller, maximizing the likelihood that any suspicious activity would be detected long before a patient would receive the drugs.
But I’m more interested today in exploring a surprising unintended effect of these requirements. I’ve touched on this briefly in past essays but I’ve recently concluded that the implications of these requirements are much more significant than I realized before. This may be the first time in the history of commerce that Continue reading California Pedigree Law: Historic Change to Commerce
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“…[C]ommencing on July 1, 2016, a wholesaler or repackager may not sell, trade, or transfer a [prescription] drug at wholesale without providing a pedigree.