Comments on Drug Channels: Pedigree and Obscenity

FYI, here is a press release from Secure Symbology...

2008-02-05T16:16:00.000-05:00

FYI, here is a press release from Secure Symbology that was released after my blog post.

Catalent And Secure Symbology Partner To Meet E-Pedigree Mandate

Adam

Adam,
Key issue for all should be public safety...

2008-02-01T07:09:00.000-05:00

Adam,
Key issue for all should be public safety. The board has not provided data on the route cause of counterfeits detected. They extrapolate WHO global data from countries that don't have as a controlled regulatory system and supplychain. Question-will increased cost and potential interuptions in supply force people outside the supplychain and into Caveat Emptor.
In regard to recall control, lot system exists but not used by all trading partners. Guess longer and more numerous digits will be easier to control.

Jon,

Thanks for the thoughtful comments.
2008-01-29T12:43:00.000-05:00
Jon,

Thanks for the thoughtful comments.

You may be right about the outcome. Nonetheless, you paint a very disturbing and cynical picture of our system for regulating drug distribution.

Adam

One of the most important decisions seems yet to b...

2008-01-28T17:57:00.000-05:00

One of the most important decisions seems yet to be made: what happens when one drug manufacturer decides not to ship to California? Or they simply don’t comply? In the meeting, the Board kept asking what consequences the FDA considered or will consider for non-compliance. No reply. It doesn’t take a long history in supply chain to guess what happens if a manufacturer says, "hey, not going to play on these particular drugs in California.” Will California residents have to buy them online? Can you imagine the alarmist reactions from the press and consumers? No more ED drugs shipped to the coast! Town hall meetings in every city and county.
Or maybe noncompliance results in $50k penalty payable to the Board? If that is the case, manufacturers might find it cost-efficient to pay the penalty.
If a doctor prescribes a drug, does a pharmacy board really have the right to determine what drugs are available to California residents (recent rulings say heck no)?
The proposal creates a supply chain control system of a scale the world has never seen. Yet, the pharma industry is endeared to legacy distribution systems. Pharma just implemented barcodes – decades behind other consumer categories. Now, California proposes they leap forward a couple of decades and become the world’s premier distribution channel with unprecedented data content. The operational affect is unknown. The impact on consumer health, unquestioned. Improvements to anti-counterfeiting and recalls, untested. The penny costs to the system, insurance providers, government, and consumers is undisclosed or likely, unknown. The effect on large proteins, unpublished. The ePedigree vendors allowed to play, undetermined. And our hearts certainly go out to small business because we DO know what will happen to them.

It seems the Board sees themselves as visionaries with drug suppliers as their constituents and worker bees. They have waved their magic wand and blindly expect the nasty details to fall into place. Manufacturers and suppliers will align (maybe even hug). Standards will write and publish themselves with full agreement among the players. IT systems will be replaced - and new systems installed where they never existed. Print production lines upgraded. Vendors will be ready with open systems and aligned with their offerings. Tests run and rerun.

I predict the board will be replaced by a new operationally-focused one. The new board will then begin the years of planning needed to execute such a supply chain control system. The current board will be allowed to keep their wand.

I have a couple of questions.

Excluding the...

2008-01-28T10:09:00.000-05:00

I have a couple of questions.

Excluding the associations, if a drug manufacturer or wholesaler submitted a letter for the record stating they are not prepared to meet the requirements of California Law addressing 'public safety', and grandma dies as a result of a counterfeit drug between now and a delay date, what is the drug company defense when they are sued for contributing to the death of grandma by negligently not taking what is recognized by the CA State Legislature as a requirement for ensuring public safety in California ?

Basicaly, a previous delay or pending delay is not the determination of the Board that the Law is not credible, or the basis for the law is not proper.

The delay would be recognition the industry is not prepared to meet minimum requirements.

What may appear to be a sound argument by the defense, can still be a distinct argument by the plaintiff.

Can drug companies be compelled to 'prove' the drugs they sold in California are not counterfeit in a wrongful death or injury medical suit ?

Without the legislation, the presumption of authenticity is in favor of the drug supply chain. But, with the legislation in California does the burden not shift to the drug company or drug wholesaler ?

Adam: You are being much too kind to the board. I...

2008-01-25T15:28:00.000-05:00

Adam: You are being much too kind to the board. I was there and some of the presentations got very heated - like the professor from florida. I don't think the board trusts wholesalers or manufacturers, so can there be any evidence that will satisfy them?