Tuesday, November 27, 2018

A New Normal...

For many of us who have worked in the pharma serialization space for many years today represents a unique milestone- for the first time the US market will be operating under a "live" serialization regulation.   

I put "live" in quotations for the simple fact that the industry is largely unaware of how the FDA and other governance bodies are going to enforce the regulation going forward.   Just last week I received great input from a 30+ year FDA auditor who noted the agency tends to have a policy of "educate while you regulate".   Interpret that as you may.

I likely take an unpopular viewpoint which is I hope the FDA enforces DSCSA to the fullest-swiftly and forcefully.  While I don't fully expect this to be the reality, I firmly believe that after a decade+ of regulatory delays, including the most recent year delay of the DSCSA serialization deadline, the FDA needs to give some indication that serialization is the 'new normal' in the pharma industry.   Conversely, I think it’s time for the industry to be held responsible (or maybe better said- liable) for the efforts put forth and decisions made about how to best meet these regulations.   

And so, waking up this morning I didn’t quite know what to expect- the chatter on LinkedIn seems to be fairly minimal in fact.  For most in the industry knowing if they would be in a compliant position today was something determined long ago- so it makes sense that today is largely a non-event.  Undoubtedly there will be packaging runs done today/tomorrow/...  which are not serialized.  It's not out of pure ignorance for the regulation but likely folks who simply couldn't get batches done in time and are willing to take the risk the FDA will show leniency.  

Certainly, the true measure of how well the industry has achieved serialization compliance will be measured from this point forward.   Eventually the FDA can't turn a blind eye to unserialized batches and, moreover, if the FDA does want to make an example of some manufacturers, they won't have to look too hard for findings.    For example, we know the state of DSCSA-compliant barcoding is still woefully bad based on the most recent GS1/Big 3 surveys.   And I have often stated, and still happy to be viewed in the minority with this opinion, that the data being gathered by companies in their serialization solutions is woefully inadequate- and what we will soon find out- is if in some cases will also lead to compliance issues under DSCSA.   Of course, going back to my opening point, this is only a problem if the FDA decides to enforce and, moreover, knows how to interpret the data. (e.g. if a tree falls in a forest and no one is around to hear it, does it make a sound?)   

So, I'll toss an easy one out there for the FDA to look for and for manufacturers to check in their own systems in case they are concerned someone will come looking.     

Look at the instances in your serialization data where you indicate a 'change of ownership' has occurred.  This is often veiled under the labels "From Business" and "To Business" but make no mistake, the underlying data shows a change from a source owning party to a destination owning party.    Of course, we all know under DSCSA that 'change of ownership' also requires the existence of a T3 document- which for years now has tracked the sale of items from seller to buyer at a lot level (and still is required even once your product is serialized).   So, the simple question becomes- do you have, or can retrieve, a T3 document for every instance where your serialization data is showing a 'change of ownership' occurred?  I'm quite intimately aware that many manufacturers out there would not be able to produce corresponding T3s if they paid attention to all of the occurrences where their serialization data claims a change of ownership- and the reason for this is because their data will erroneously claim a change of ownership when one never actually happened, and thus no T3 will ever exist.

So now If I'm the FDA and I want to give my auditors an 'easy' intro question to interrogating a manufacturer's serialization data it wouldn’t be far-fetched for them to say, “Provide all serialization data for product X or Lot Y and all corresponding DSCSA T3s where you show a change of ownership has occurred."  In that one question an auditor would get a very clear idea of where a manufacturer stands with both the new serialization requirements as well as the long-standing Lot Level T3 requirements.

Why is this important?   As the industry now moves past this big milestone of DSCSA which largely centered around the ability to physically apply a unique identifier to items, attention will increasingly turn to data- as data is the single most important component to ensuring compliance with all future DSCSA milestones- whether it be product verifications, saleable returns or eventually full supply chain serialized data exchange. The example above is not likely to stop product supply, but it does represent the importance of having consistent and accurate data (and certainly most manufacturers will want to avoid FDA findings whenever possible)

If you are a manufacturer and happen to check your data and find yourself in an unfavorable position- I will say it’s likely not entirely your fault.   The data scenario described above is most often seen due to limitations in enterprise serialization platforms- whether it be the one you are using or even the one a partner, like your CMO, is using.  Said another way- its more than likely your vendor made a data decision without you even knowing.  Up until yesterday that didnt cause any issues.  Today and going forward you are now solely liable.

You don't need to know every nitty-gritty data detail but, as of today, you are now responsible for what that data says.  The only interpretation of DSCSA that matters is your own- not your vendors.  And starting today, a system limitation is certainly no excuse for being put in an unfavorable compliance position. And thus, my longstanding mantra remains-   maintain oversight of your serialization/traceability programs and leverage the readily available (and often free) tools and services to help ensure your serialization implementation is on track (and now- meets DSCSA compliance).

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