Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar. It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers. In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace. The sessions are helpful, but the real goldmine are the hallway conversations. Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).
Normally I write a lot more about the event after it occurs, not before, but this year I am unable to attend due to an unfortunate scheduling conflict. So I won’t be able to write about what I learn there. So instead, I’ll write about what I was looking forward to investigating at this year’s event so maybe you can do the investigating. Here are the things to look into:
GS1 US Barcode Assessment
For the last two years, GS1 US has announced the results of their annual DSCSA Barcode Assessment along with the Big 3 wholesale distributors (see “Wholesalers Find Troubling Results In DSCSA Barcode Assessment”). This, the third year, will be very interesting because drug manufacturers have been operating since last November under full enforcement of their serialization requirement and wholesale distributors will have to start being very careful about which non-serialized drugs they buy and sell this November. Initially there would have been a lot of grandfathered, non-serialized product still entering the supply chain but by the time of this year’s assessment, we should see big gains in the percentage of serialized products in wholesaler inventories. GS1 US likes to hold the full results back until their session at the Fall HDA event. I’ll have a look at it and write about it when I get back from my travels.
I keep hearing positive and negative things about the state of the Verification Router Service implementations that will be used by some manufacturers to help the Wholesale Distributors to meet their 2019 (before the FDA announced “enforcement discretion”) saleable returns verification requirement (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?” and “No Surprise: DSCSA Verification Delay”). It’s a voluntary solution that was originally proposed by the HDA and I’m sure they will have one or more sessions with updates on its progress (see “DSCSA: Verification Systems Draft Guidance”, “GS1’s Messaging Standard For Verification Of Product Identifiers” and “GS1 US Publishes New DSCSA VRS Implementation Guide”). Also, a lot of the vendors in the trade show room will be showing their VRS-based solutions. You should be able to shop around and compare features, capabilities, and find out who else is using which vendor, all in one place.
FDA Pilots Initial Results
There should be one or more sessions about initial results from some of the individual pilots that are part of the FDA DSCSA Pilot program. There are a lot of companies and groups of companies doing pilots of various sorts and they are all going to want to speak about their results. It will be interesting to see how HDA sorts them out because I doubt if they will have time/space for every company to speak. Maybe they will have concurrent sessions?
A lot of the pilots revolve around blockchain, and I see HDA has a session dedicated to that technology. I don’t know about you, but I think it’s about time to start treating blockchain like any other technology used in traceability solutions. Would you want HDA to offer a session on relational or cloud databases, or the latest barcode technology? Of course not. These are just tools in the solution toolbox. Sometimes blockchain should be used, sometimes not. Yes it’s cutting edge. Yes it’s important. Just not necessarily HDA-Traceability-Seminar important (see “Could Blockchain Technology Be Used For DSCSA Compliance?“, “Blockchain Reigns At GS1 Connect 2017” and “Blockchain Will Not Be Used For DSCSA Data Exchange“).
HDA’s Annual Serialization Readiness Survey
Every year for the last three or four years HDA Research Foundation has conducted a fairly scientific poll of drug manufacturers to assess their readiness for the serialization and other DSCSA requirements and options. You might think that all the interesting results are behind us since manufacturers have been under the full serialization requirement since November 27, 2018 but I’m curious to see what’s happening with grandfathering, aggregation and other things HDA is likely to ask. I will definitely get ahold of the document and write about it soon. Here are some essays about earlier results (see “HDA’s 2016 Serialization Readiness Survey”, “HDA’s 2017 Manufacturer Serialization Readiness Survey Results” and “2018 HDA Traceability Seminar Recap”).
What’s up with DSCSA Master Data Exchange?
HDA’s Origin master data exchange solution is still happening, GS1 US still offers their Global Data Synchronization Network (GDSN) approach for master data exchange. I’m curious to hear what’s happening between HDA and Tracelink since they settled their disagreement and agreed to cooperate going forward (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”, “What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data” and “Simple, Standard, Low Cost Product Master Data Synchronization for DSCSA”. (Full disclosure: when mentioning the former lawsuits of friends in a competitive environment, the reader should be aware that the author was recently employed by Systech International, a competitor of TraceLink in one product area. Systech International was then a solution provider member of the HDA. Back in 2007 and 2008 the author was employed by SupplyScape, the predecessor company to TraceLink and run mostly by the same people. From 2002 to 2007, and then from 2008 to 2012 the author was employed by Cardinal Health, one of the “Big 3” wholesale distributors who is an important member of the HDA. During 2013 and 2014 the author’s own consultancy was a solution provider member of HDA. The author has also been a long-time active member of GS1 and GS1 US. RxTrace is wholly owned by Dirk Rodgers Consulting, LLC and is not owned or controlled by any other company.)
What’s happening with the DSCSA Interoperability Governance non-profit that PDSA is kicking off?
This is the month that the Pharmaceutical Distribution Security Alliance targeted for formally registering and starting operations for the new non-profit company composed of members of the US pharma supply chain aimed at helping to establish and govern DSCSA interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”, “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability”, “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders” and “PDSA Releases Prospectus To Prospective Governance Group Members”). I’m sure they’ll do a session with the organizers to provide an update on their progress. Once the event is over I will try to get my own update and write about what I’ve heard.
I don’t know what the FDA has planned going forward but I see the Dr. Connie Jung, Senior Advisor for Policy with the FDA is the first substantive speaker on Tuesday. These sessions are always very enlightening and highly anticipated (see “FDA Speaks About DSCSA At HDA”). I’m really sorry I’m going to miss this one because it may be hard to get the information she will present after the event. It’s one of those things where you kind of have to be there. My hope is that she will lay out a detailed schedule for FDA DSCSA activities that lead to agreement between the Agency and the industry about how to meet the DSCSA 2023 requirements—particularly the interoperability requirement. If all she does it recap what the Agency has been doing for the last two years, with only vague mentions of future deadlines—as opposed to an actual roadmap to get to those deadlines—I think the industry should get real nervous. It’s time for the FDA to step up and collaborate with the industry to establish that roadmap. We’ll see.
It’s also very enlightening to hear what the HDA lawyers think about what the FDA just said in the very next session. In fact, this session is usually more informative than the FDA session.
November 27, 2023 is supposed to be the start of the DSCSA Enhanced Drug Distribution Security (EDDS) phase, but the DSCSA itself fails to provide enough detail about how the industry is supposed to meet the significant requirements spelled out in the law (see “EDDS: The New Data Exchange Requirements”). That’s why there are lots of details in the text about what the FDA is supposed to do to work it out with the industry: pilots, public meetings, studies, etc. This year’s event should continue the trend of the last two years to escalate the attention on this issue. This is the event to learn what people are thinking and get a sense for where things are headed. Will the HDA and the FDA recognize the importance of the new non-profit company that PDSA is kickstarting? Will they ignore it, thinking that company is stepping on their toes? Or will they embrace that company and their goals, make room for them to take on some of the needed activities and help them hit the ground running? Oh I wish I was going to be there to see how it all unfolds.
Not everything I’ve listed above will have a dedicated session, but you will find lots of people willing to talk about them during the sessions or in the halls during the breaks.
I won’t be there, but if you are going, please send me your observations to help fill me in. Don’t worry, .I won’t quote you in RxTrace unless you wish to be named.