I know that I promised to take a blogging break, but I just can’t help myself.
Today’s Capitol Weekly, the “newspaper of California government and politics,” has an editorial by state Senator Mark Ridley-Thomas, sponsor of SB1307. As e-pedigree fans (?) know, this bill proposes a new phased-in timeline for California’s e-pedigree requirement. See CA E-Pedigree Timeline in Flux for details, although the bill has changed slightly since my last write-up.
Here is today's editorial: Time To Protect The Pharmaceutical Supply Chain.
Note this paragraph, which is clearly a rebuke to critics (like me) who argue that a national standard would be better:
“Other e-pedigree opponents have argued that California should defer to the federal government since drugs are manufactured, shipped and sold across the county. However, it has taken the federal government 20 years to adopt regulations required to implement the federal Prescription Drug Marketing Act (PDMA), which was passed to protect consumers from counterfeit or adulterated drugs. California did not wait for the federal government to act on environmental issues - why should we wait for them to act on this?”
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. (Read the first draft proposal here.)
I presume that Senator Ridley-Thomas is also not a fan of H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008.
California’s current legislative session ends in August, so any action on SB1307 will happen over the summer.
I know that I promised to take a blogging break, but I just can’t help myself.
1 comments:
When you return, 1307 is likely to have emerged from the Legislature be on its way to The “Governator” Based on its amended form, which seems to be more closely suited to the wishes of the commercial supply chain, phase in period will likely phase in period will be 50% of drugs by January 2015 and the final 50% by January 2016 for manufacturers. Wholesalers and repackagers will have until July 1 2016 to provide pedigrees and pharmacies will have until July 1, 2017 to comply.
While this may seem like a message telling everyone to take break for the next 2 to 3 years, it is actually the date forecasted by the likes of JnJ and Pfizer as the earliest they could be ready if they started implementation last year (see mins of California Board of Pharm).
Is the legislation finally getting to a realistic time table?
The revised version of 1307 is also likely to put final responsibility for pedigree regulations on the Fed Gov.
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