Tuesday, September 02, 2008

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.

6 comments:

  1. So Adam - how does this play out against HR 5839? If pre-emption moves forward, arent we back in the 2011 boat for high risk products?

    ReplyDelete
  2. Hi Adam - Re: Ridley-Thomas bill passing in California.

    As I write this today (9/2), I believe this bill is not yet law - pending some action (or long enough inaction) by the Governor. Like many large states, California faces a serious budget deficit - the resolution of which creates some uncertainty on what will happen with this. Right now, manufacturers are in a tough position as the 1/1/2011 date is still on the books.

    As an eventual end result, it would be much easier to comply with one national standard and compliance schedule rather than a myriad of state regulations.

    Thanks once again for following this critical - and extremely costly - issue. Is there any current news on what is happening with other state laws?

    ReplyDelete
  3. man, I missed you! I guess this is the last Spinal Tap post if the deadline won't be going to 11. Too bad for us!

    ReplyDelete
  4. Brian --

    California's budget deficit should make it more likely for SB 1307 to pass. As I noted earlier this tear, the CA Board of Pharmacy has a limited budget ($10 million) and had no personnel to implement or enforce the 2009 deadline prior to the delay to 2011. Moving the deadline to 2015 allows money to be allocated in a future budget -- and perhaps allows a federal solution to emerge that would take the pressure off CA.

    Adam

    ReplyDelete
  5. One comment I can't beleive no one has made. What about the major companies that have embraced this, have moved off of a compliance strategy and focused on patient safety and a secure supply chain strategy.
    What about the countless number of people hours and dollars invested to meet the original CabOP deadline. CaBOP - sorry guys we were only kidding. Thanks for stepping up, spending your companies money, investing you time, caring about our not so noble cause - CABOP was only kidding. See you folks in 2015 - bring your pcket books and precisous time again or are we only kidding CABOP!

    ReplyDelete
  6. Reason why they moved from compliance to securing the supply chain (improve visibility) is because they need to be able to provide a ROI to the business.

    ReplyDelete

Related Posts Plugin for WordPress, Blogger...