You now have less than one week to provide a group of Congresspeople with your thoughts on their latest discussion draft for a bill that would attempt to make our U.S. drug supply chain less susceptible to criminal attacks and errors.  See my two earlier essays, “The Congressional Draft Proposal to Improve Drug Distribution Security” and “Congressional Legislation Development: Mad Libs Edition!” for more specifics.

Perhaps the aggressiveness of the response date is a reflection of how important this piece of proposed legislation is.  That is, if you think it is important, then you will immediately drop whatever it was you were doing and get right to the task of providing a detailed reply so they can make sure the final draft reflects your preferences.  I don’t know what you’ve been up to, but this is my third essay about it.  😉

There are still a few things that I wonder about.

DISPENSERS, CRIME AND REGULATIONS

In the initial pedigree phase that is defined by the discussion draft, less is required by dispensers than manufacturers and wholesalers.  While companies in the two upstream segments would need to retain copies of all Transaction Information, Transaction Histories and Transaction Statements (see page 15-16 of the draft for the definitions), dispensers would need to retain only the Transaction Information.

I assume that difference stems from concern that small pharmacies can’t afford the kind of systems that would be necessary to hold all that extra data.  But that would be despite the fact that the draft also allows wholesalers to hold the dispenser’s data on their behalf as a service.

I’m more than a little surprised at this difference in data retention considering the kind of crimes we have heard about at the pharmacy level in the last few years.  Let’s see, there was the pharmacist in Baltimore that was dispensing drugs she and an accomplice had diverted from the Catholic Medical Mission Board that were supposed to go to poor people in Africa.  Then there was the illegal importation of counterfeit and mis-labeled Avastin and subsequent purchasing of it by over 20 dispensers.  Plus, the California Board of Pharmacy has reported finding at least one pharmacy where the drugs on the shelves were bought illegally in Canada or on the internet.

I’ll even include the stolen Levemir case where a national chain pharmacy was found to have bought the drug at an unrealistic discount and failed to check the lot numbers which were in recall at the time due to the theft.  In this case the pharmacy apparently didn’t break any laws but it also doesn’t seem like they were practicing in the best interests of their customers.

In all of these cases a requirement for the pharmacy to validate and retain a pedigree (cough… I mean, Transaction Information, Transaction History and Transaction Statements) would have helped to expedite the investigation and prosecution, and probably would have helped prevent the crime or the dangerous situation in the first place.

I also dispute that the amount of information a full pedigree retention regulation would require is an unjustifiable burden.  The amount of drugs that pass through a national wholesaler is massive, and their data retention needs would be huge, but those drugs are spread across more than 166,000 dispensing points, according to the Healthcare Distribution Management Association (HDMA).  The amount of data an independent pharmacy would need to retain is a very tiny fraction of the whole.  The typical teenager can now retain more data in their portable music collection than a typical independent pharmacy would likely need to retain for pedigree purposes.  Only the national pharmacy chains would need to retain really large quantities of information, but the size and extent of their business (being national), their available IT resources and the greater benefit to patients easily justifies that too.

In my view if any segment needs to retain the full supply chain history of the drugs they buy and sell then the pharmacy segment should too.  However, keep in mind that I’m also a proponent of a phased implementation where companies in each segment would be required to make some deployment toward building the full capability in each phase, not a “big bang” deployment.

Today, dispensers are regulated by each state.  I understand why they would be opposed to new federal regulations, but the point of the regulation proposed in the discussion draft is a reflection of the fact that both the pharmacy segment of the supply chain and the effects of crimes that occur there have grown to a national scale.

 BLOCKING BOTH THE FDA AND THE STATES

There are a couple of troubling restrictions that I think should be re-thought.  From page 71 of the draft:

“[ (2) RESTRICTIONS.—In promulgating the regulations under paragraph (1), the Secretary shall— ]

[(A) not require the adoption of specific business systems for the maintenance and transmission of data; and ]

[(B) not impose any new requirements on dispensers that are in addition to the requirements set forth under [ subsection (d) of such section 582 ] ]”

It seems to me that the wording of restriction (A) would leave just about any regulation the FDA proposes open to challenge.  If the regulation would require the adoption of a system that is specifically needed to interpret, maintain and transmit pedigrees, would that conflict with this section?  It also may block the FDA from selecting ePedigree or track and trace models that only work if everyone adopts a specific kind of business system.  That would be true of all the models I am aware of.  Perhaps a wording change should be made so that the intent of this clause is more clear.

Restriction (B) just seems flat wrong.  A protection agency like the FDA should never be blocked from imposing new requirements on anyone touching our national drug supply if changing conditions justify those requirements.  I’m thinking of national security events like a serious terrorist attack on our drug supply chain, but even certain criminal attacks that penetrate deeply into our national supply chain before they are detected, could justify quick action by the FDA with dispenser requirements that would save lives.  We should not limit our national patient protection agency so severely from protecting patients nationally in our modern national drug distribution system.

When adopting restrictions like these don’t forget that this draft, as written, would preempt all state pedigree and track and trace laws.  There is good reason for that because it fixes the patchwork of existing laws, but all the more reason the regulation should not simultaneously eliminate dispensers from participating in the protection of the supply chain that they are an integral part of.  Note that the preemption provision on page 116 is just about the only thing that isn’t a “policy option” (it’s not in brackets).  In other words, everyone already agrees on it.

It will be interesting to watch how long it takes before we see the final draft, when we will finally get to see which policy options hit the cutting room floor and which ones remain.

Dirk.