California Debates a Tougher Drug Supply Chain Law

Implications: State Senator Mark Ridley-Thomas’ editorial argues California needs its own pharmaceutical supply chain security laws because the Federal government has failed to implement the Prescription Drug Marketing Act (PDMA). However, it does not necessarily follow that every individual state pharmacy board should establish unique documentation requirements for manufacturers, wholesalers and pharmacies operating within each state. This approach has already created a disparate patchwork of inconsistent regulations for tracking pharmaceuticals in the U.S. supply chain. In the absence of federal standards, ambitious local politicians around the country are establishing their own incompatible systems, raising costs, reducing product availability, and lowering patient safety. 

Analysis:

Senator Ridley Thomas is the sponsor of SB1307, a bill that proposes a new phased-in timeline for California’s e-pedigree requirement. See CA Sets More Realistic Pedigree Deadline, but Timeline Still Uncertain (Council Site) for details, although the bill has changed slightly since my last write-up.

Senator Ridley-Thomas’ editorial also represents a response to the Schwarzenegger’s Administration new legislative proposal for California pedigree regarding an “accredited distribution chain,” which is similar to the “Normal Channel of Distribution” rules implemented in many states. California’s current legislative session ends in August, so any action on SB1307 will happen over the summer. Read the first draft proposal here.

California’s current legislative session ends in August, so any action on SB1307 will happen over the summer.

Note that there is currently a bill before Congress regarding national standards.  See National Supply Chain Security Standards Will Benefit Everyone (Council Site).