RxTrace Preview of 2016

It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability.  As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  You don’t have to be a subscriber  to respond and the results will also be open to everyone in the coming months.

So what about 2016?  I think it is going to be a busy year for everyone.  Even busier than 2015.  Here are my predictions by country:

United States:
We can expect the FDA to finally publish their four overdue guidance documents in the coming weeks (see “FDA DSCSA Deadline Passes Quietly“).  I do not have any inside information about their publication schedule but I think the agency is unlikely to ignore these mandated documents.  If they do, they will risk providing the industry with the excuse, “Why should we be on time when you couldn’t get your mandated documents out on time?

Will the FDA provide dispensers with a third four-month delay in the enforcement of their obligation to receive, store and retrieve the three types of transaction documentation?  (See “FDA Extends Dispenser Delay in DSCSA Enforcement“, and “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“.)

Right now I have to give that one a less than 50% chance.  Now that enforcement has been delayed a total of eight months, each potential additional delay gets harder and harder to invoke.  Companies should assume the agency will begin enforcing those requirements on March 1, 2016.  If another delay does come, they will not announce it until the last minute.

2016 will be the year of the first FDA Drug Supply Chain Security Act (DSCSA) pilot with the participation of industry.  We know this is in the works because of the Request For Proposal (RFP) that the FDA issued back in the summer of 2015 looking for help with it (see “FDA Looking For Consulting Org To Run DSCSA Pilots“).  Part of that pilot will also include at least one public meeting regarding the DSCSA.  The last meeting on that topic was held in May of 2014 (see “The 2014 FDA DSCSA Workshop“.  Keep in mind that both the pilot and the public meeting(s) will be aimed at exploring options for the operation of the Enhanced Drug Distribution Security (EDDS) phase that begins in late 2023.

European Union:
In 2016 we should get more details about exactly how to communicate with the European Medicines Verification Organization (EMVO) hub and the regional hubs.  The communications specification is due to be published sometime in the first half of the year.  More than likely, companies will be able to begin pushing data into that repository by the end of the year so that they may begin including the E.U. unique identifier barcode on the drug packages they introduce into markets other than Germany (see “The ‘Unique Identifier’ in the EU Delegated Act“).  Hopefully the EMVO will get their own informational website soon too.

Of course, the obvious prediction is that the E.U. Delegated Act (EUDA) associated with the Falsified Medicines Act (FMD) will finally be “published” in its final and official form in the first two months of the year.  That publication date will start the clock on the final date that the industry must meet its requirements (see “Breaking News: The EC Has Published The Delegated Act“).  That will be three years after the date of official publication for most E.U. member states.

We should get a better idea of the revised drug serialization and tracing requirements from ANVISA in the first few months of the year.  Almost everything I heard about Brazil and their reconsideration of their original requirements seems to indicate that the move will result in a more rational design and timeline.  That is what I am expecting to see when they begin releasing drafts or actual regulations.  I am reasonably confident that the current date of December 10, 2016 for full serialization and traceability will be pushed out once the redesign is formally published (see “The Official Suspension of the Three-Lot Pilot in Brazil“).

Other countries:
It appears that we will see final requirements issued in 2016 for drug serialization and tracing from Russia and Pakistan.  Several other countries will probably join them before the end of the year.  I predict that South Korea will back off on their proposed requirement that certain drug packages have RFID tags attached to them.

Other wild predictions:
I predict that Justin Bieber will become legally married in 2016 but it will be kept a secret until his new wife’s 18th birthday, sometime after 2016.

The Big Short” will win Best Picture in the 2016 Academy Awards, and the attention the movie receives as a result will cause a big boost to Bernie Sander’s campaign for President.  I then predict that Bernie Sanders will win the Democratic nomination for President (and Donald Trump will win the Republican nomination).  Sanders will win the general election with 38-42% of the vote with the remainder split between Trump and Ted Cruz who will run as an independent.  I further predict that the Democrats take back the Senate but not quite the House of Representatives.

Whew!  That’s enough for now.  What are your predictions?  Happy New Year!