California Delays Drug Tracking Law to 2011

Implications: As predicted, the California Board of Pharmacy announced its decision to extend the deadline for implementation of e-pedigree laws to 2011.  The timing was unexpected but not the outcome.  The Board now avoids the embarrassment of having a legislative or legal solution imposed on them.  Let's hope that the Board members can put aside their pharma-bashing and get on with the hard work needed over the next 33 months.

Analysis:

Even though the CA Board of Pharmacy has been insisting for months that there would be no delay, I correctly predicted a delay in a January post.  (See CA e-pedigree: Delay to 2011 -- Council Site.)

Here is the official announcement: DECISION OF THE CALIFORNIA STATE BOARD OF PHARMACY PURSUANT TO BUSINESS & PROFESSIONS CODE SECTION 4163.5

Best sentence: “For the moment, the Board concludes tha its primary duty to protect the public is better served by a delay permitting a less disruptive implementation, than by a rush to secure industry compliance.

While counterfeit drugs remain an ongoing threat, there was little logical or fact-based rationale for rushing ahead with a law that is still susceptible to interpretation.  An executive from McKesson (MCK) told the Board that most manufacturers were not going to ready for e-pedigree by the arbitrary deadline of January 1, 2009.

Nonetheless, I remain surprised at “leading edge” role that California has assigned to itself. As a point of historical fact, Florida’s pedigree laws were prompted in part by a 2003 Grand Jury report that documented widespread problems with the wholesale distribution of pharmaceuticals in the state. Most of these secondary market excesses have been corrected by national, industry-wide efforts such as new data sharing practices and the major wholesalers’ renunciation of secondary trading. I am not aware of a similar grand jury report for the state of California nor have I seen any California-specific research on counterfeiting.

BTW, the Heparin example in the announcement is completely misleading because the contamination allegedly occurred overseas. Pedigree would have had no value or role in preventing this tragic situation.