CA E-Pedigree: Going to ... 2015

Sorry, Spinal Tap fans. Implementation of California’s e-pedigree law has (probably) been pushed back to 2015. Only 2,312 days to go!

Nevertheless, advocates of a secure supply chain should not feel stuck in a hell hole. The widespread industry support for the bill makes me believe that the 2015 date might actually stick. The more realistic timeline should encourage pharmaceutical manufacturers to get serious about mass serialization for their products – a necessary first step for California’s vision of serialized e-pedigree.

Thus, I expect that “mass serialization” will become increasingly important for supply chain security efforts at multinational drug makers, especially given the new serialization requirements in countries such as Belgium, Italy, and Turkey. However, it's still not clear whether global standards will lead us to “serialize” or “serialise.” (Full disclosure: I am on the Advisory Board of leading serialization vendor Secure Symbology.)

Tonight I’m Gonna Stop You Tonight

The new CA timeline comes from SB1307, a bill sponsored by CA state Senator Mark Ridley-Thomas and passed by the state assembly on August 19 by a vote of 58-1. Technically, the bill still needs to be signed by Governor Schwarzenegger to become law in California.

Here are the new deadlines for compliance:

• Manufacturers: 50% of product lines serialized by January 1, 2015; 100% by January 1, 2016
  
• Wholesalers: January 1, 2016
  
• Pharmacies: January 1, 2017
  

In an ironic twist of fate, there was a recall of some PEDIGREE brand dog food in California during the same week as the vote. I guess some people on the West Coast really don’t like pedigrees

(Listen to the) Flower People

As many of us in the industry are aware, there was extensive lobbying from all sides throughout the summer as everyone raced to meet the end-of-session deadline. Senator Ridley-Thomas described the process in a press release (State Assembly Aproves Ridley-Thomas Measure to Protect Public from Bad Medicine), saying:

“All vested parties, including consumer protection advocates and pharmaceutical manufacturers and distributors have reached resolution and have identified a reasonable and workable solution that will allow additional time and flexibility to comply with current requirements.”

I suggest that you read the official Senate Floor analysis for a good summary of the bill’s evolution. When you get to the bottom, you will be rewarded with a list of the 13 associations and 22 companies that formally supported SB1307. Curiously, only 2 of the big 3 drug wholesalers are listed. Que pasa, AmerisourceBergen (ABC)?

Note that SB1307 clears the way for a Federal approach to serialized e-pedigree by setting strong federal pre-emption language. As you may know, I support a federal approach to the pharmaceutical supply chain – see my op-ed Securing America’s Pharmaceutical Supply Chain. I’ll have more to say on the Federal situation tomorrow.

Um, Adam, what's a Pedigree?

I recently attended the National Council for Prescription Drug Program's education work group for Pharmaceutical Pedigree and Traceability. The group is hosting a free "Pedigree 101" webcast. (I am not involved in the webcast.) Sign up here if you want to get up to speed on this complex subject.