HDA’s 2016 Serialization Readiness Survey

Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers.  In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results.  The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny.  So here is my coverage, better late than never.

But first, while researching for this essay I discovered that the HDA has just published the final report of the Saleable Returns Pilots conducted last year.  You can get a free copy of that report here.  I don’t think I am likely to write about its contents but I will review it and let you know if I see anything that changes my mind.

Most RxTrace followers will recall that I used to do an annual survey similar in direction to the one that HDA has now done (see “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”, “2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!”, and “The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report”).  I stopped doing that survey annually because I began working for Systech International about a year ago.  Fortunately, the HDA jumped in and conducted a much more professional and accurate survey shortly after I stopped.  Their survey was conducted between August 10, 2016 and September 15, 2016, which means that the results reflect information that is now about six months old.  And the Drug Supply Chain Security Act (DSCSA) deadline for full serialization of drugs is about nine months away.  Keep that in mind when you read the results.  You can download a copy of the HDA report here.

The document is titled as an “executive summary”, and it does contain one of those, but it also appears to include all of the actual results of the survey.  I’m not going to pull out individual results because I think the HDA report does a great job of that and I want to encourage you to download and read it.  But I will say that I find it interesting that there is little difference between the responses they received from branded drug manufactures and generic drug manufacturers.  Over the years I have heard predictions that generic drug manufacturers will not serialize their drugs or otherwise prepare for the DSCSA because they do not have enough margin in their pricing.  The results of this survey shatter that theory.

OK, one more result that I want to call out.  That is the percentage of respondents who are waiting for FDA guidance before they decide whether or not to aggregate their products.  More than one quarter of the respondents are in that category.  First, it is unfortunate that the FDA is under-spending on preparing itself and the industry for the DSCSA, but second, I really don’t think we are likely to see any guidance from the FDA that is directly related to aggregation (for a complete listing and explanation of each of the overdue FDA guidance documents, see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”).  Not only that, but aggregation has been well-established as a DSCSA-triggered business requirement, and not a regulatory requirement, so the decision should be based on the requests/requirements coming from your trading partners, not the FDA (I have recorded a webinar on this very topic, see “Strategies For Meeting DSCSA-Triggered Business Requirements”).

I hope the HDA plans to conduct more surveys like this one on an annual basis between now and 2023.  The questions asked in this particular survey only dealt with the November 27, 2017 serialization requirement, so, at most, they will be pertinent for only one more survey.  But HDA could start asking additional questions related to the Enhanced Drug Distribution Security (EDDS) phase that will begin in November of 2023.  Properly constructed, it would be very interesting to see how the responses change over the years as we get closer to that deadline.  And I also recommend that the HDA include wholesale distributors and perhaps even dispensers in their annual survey to make it even more interesting.  But even if this is the last year they do it, don’t miss reading this one.