It is actually the retailers that are upset. The law is beneficial to the drug producers and the wholesellers. It was not so for the retail chains such as Walgreens and CVS and smaller chains. For the wholesalers and the drug producers the cost is past directly to the consumers, in their case the retailers. It is the retailers who face the dillema of the final price as that is determined by insurance contracts; higher cost from suppliers and fixed sales price means less profit.
 

The articles in the papers cited manufacturers and distributors as being opposed. The LA Times story, for instance, cites McKesson as claiming they can't do it. They can do it, of course, as tracking items throughout the distribution chain is done in other industries, such as blood donations an airplane parts. It's just a question of money.
 

Eric,

I know that you and I share a desire to protect consumers from counterfeits. However, I think you are too glib regarding the ease of establishing serialized e-pedigree.

Existing technology can be used to comply with California’s law, but current product identification and supply chain practices are not sufficient for CA e-pedigree. For example, many products have the familiar bar coded UPCs to identify a specific product. Every package of a particular product/size combination can have the same bar code.

In contrast, serialization (under CA law) requires a *unique* identifier on each individual package. The volume of data is much, much, much greater b/c each specific package gets it own bar code.

Thus, complete serialization with e-pedigree requires at minimum: affixing a unique number during the packaging process; capturing and managing the data; adding pedigree information as the product moves down the supply chain; and then making these data easily (but securely) accessible. It also requires substantial lead time since serialization must happen during the drug manufacturing process, which can be months (or longer) from the time that the product is dispensed to a patient. Standards must also be developed and adopted by literally thousands of independent participants in the supply chain — manufacturers, wholesalers, pharmacies, and technology providers. Plus, the whole system must also be flexible enough to deal with all of the supply chain variations from manufacturer to patient.

As I have noted in my blog, this is (becoming) feasible but neither easy, cheap, nor fast. And to put the pharma industry’s challenge in perspective, there were more than 4 billion prescriptions filled in the US 2007.

While counterfeit drugs remain an ongoing threat, I don't understand how patients would benefit by rushing ahead with a law that is still susceptible to interpretation.

IMO, the CA Board of Pharmacy has been opaque and arbitrary throughout this process. In fact, he Board itself was not ready for 1/1/09. (See Can CA's e-pedigree law be Implemented?.

Hopefully, the CA Board of Pharmacy will now put aside their pharma-bashing and get on with the hard work needed over the next 33 months.

Adam J. Fein
Drug Channels