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.
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.
ReplyDeleteWhile 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.
Question is whether the governor will provide a formal approval/veto or will the answer come by a no response the 31 Dec.
ReplyDeleteMarket reaction to the change will be interesting.
Once again big pharma has avoided pedigree/serialization. It's a true shame they value shareholders and operating costs
ReplyDeleteversus the consumer (patient).
Pharma spends over $22 billion in sales/marketing yet will not spend a dollar to protect the integrity of their supply chain, since there is no ROI since their is no increase in sales like physician lunches/dinners.
They are missing the true ROI (saving patients and improving their quality of life). How come no one has asked them to reallocate the money spent on physician/staff lunches, shirts, pens, mugs, etc to protect the supply chain.
It's sad legislation thinks the pharma companies don't have the money to protect the supply chain. PHARMA is supposely cutting all trinkets in 2009. Why can't they reallocate the money spent on trinkets to protect the supply chain?
Pharma has played the game well. They tell the technology providers it's self-serving if they claim they can help protect the supply chain since they would profit. Yet it's self-serving for pharma since they don't have to spend additional money to protect their patients.
Pharma says the technology is not mature. How can the technology mature if no one is willing to allow it to grow? The only way technology evolves is if the technology is used and has user feedback to improve the weaknesses. Just imagine if no one tested the new medications. How would medications evolve or mature?
Hopefully the FDA steps in and moves up the date. I would hate for the big one to come and a lot of patients are affected as in Maryland. How about that for a ROI? No law suits or effects to patients QOL/well being.
The high costs of this system would most heavily affect pharmacies and other small businesses in the supply chain - not "Big Pharma".
ReplyDeleteThe costs of implementation can easily be swallowed by "Big Pharma", but not by smaller companies.
In fact, if "Big Pharma" was being purely Machiavellian, they should support this legislation - as it would act as a barrier to entry and prevent them from facing future competition.
Also, the claim that "Big Pharma" have nothing to gain by protecting patients from counterfeits (as made by "Anonymous") is absolutely bizarre. Pfizer alone has lost over $2 billion solely due to Viagra fakes, and the reputational harm at stake from counterfeiting is enormous. Purely in terms of self interest, "Big Pharma" should be (and, in fact, is) constantly looking for new ways to protect their brands.
Sorry, just to clarify - my comment above is in response to the comment made by "Anonymous", not the original post (which is entirely sensible).
ReplyDelete