HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS

Man in camelhair business suit wearing Question Authority button on left lapelOnce again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).  The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments.  The seven issues include:

  1. HDA urges greater appreciation for and recognition of the ‘distributed model’…
  2. HDA recommends topics to address at the February 28 public meeting
  3. We expand upon certain data standard and exchange issues from the December public meeting
  4. …we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
  5. We summarize our understanding of the aggregation and inference discussion at the public meeting…
  6. HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA
  7. …various other issues raised during the public meeting…

As usual, I highly recommend you read HDA’s original comments in their entirety because you won’t find a more concise discussion of the vital issues facing the industry today regarding the DSCSA.

I was particularly interested in HDA’s comments regarding the first issue.  They were pleased that the FDA included a discussion of the distributed model in the December meeting, but, based on the discussion that occurred, they believed that further elaboration was necessary.

HDA submitted a four-part discussion of this issue, and nailed it, in my view.  And long-term readers of RxTrace know, I am not particularly a fan of the distributed model for data exchange.  But this isn’t a question of which architecture is the best in theory, it is a question of what is sufficient for enhancing patient safety and also has the least financial and operational impact on legitimate members of the supply chain.

So in response to the FDA representatives’ expression of doubts at the public meeting that a distributed model for 2023 would be an improvement over existing processes, and would not advance supply chain security and patient safety, HDA wanted to explain why that model of data exchange, “…coupled with other DSCSA requirements, constitute an enormous enhancement of the current system”.

HDA starts out explaining how, by 2023, the use of unit and homogeneous case serialization by all members of the supply chain will result in

“…a level of information and insight that does not exist with current lot-level traceability”.  And, “[w]ith this visibility, each trading partner will be able to quickly produce a product’s TI in order to facilitate the FDA or other appropriate official’s gathering of the product’s TI back to the manufacturer in recalls and suspect and illegitimate product investigations.


“Furthermore, each product identifier and other important data will be exchanged electronically, in a consistent, standardized manner, between trading partners. […]  Here we emphasize that the point-to-point connections to provide transaction data, including the important product identifiers, do not exist today between all trading partners. Without these critical connections, trading partners would likely be unable to realize the full potential of item-level serialization. Connecting manufacturers to all their wholesale distributors and wholesale distributors to all their dispensing customers, though complex and costly, will allow trading partners to consistently and accurately send, receive, and promptly retrieve, in accordance with international standards, unit-level purchase and sale information.”

Clearly, the authors of this HDA document are intimately familiar with the language of the DSCSA.  They use terminology and phrases found directly in the law itself in the exact sections that cover the Enhanced Drug Distribution Security (EDDS) phase that will begin on November 27, 2023 (see “EDDS: The New Data Exchange Requirements”).  This is fairly solid ground.

HDA then goes after the centralized model directly, concluding:

“We believe there are serious questions regarding FDA’s authority even to mandate participation in a centralized-type system or the posting and updating of product status information given that § 582(g)(4)(A)(i) does not permit promulgation of regulations ‘requiring the adoption of specific business systems for the maintenance and transmission of data.’ This potential statutory bar should be thoroughly explored before any attempt to implement a centralized-type system is considered further.”


In the fourth and final part of the first issue, HDA’s argument remains strong, though their facts are not quite right.  This section talks about the importance of GS1’s Electronic Product Code Information Services (EPCIS) standard.  They say:

“When it is fully implemented, EPCIS will provide seamless, stable, consistent, compatible, electronic connections between trading partners throughout the pharmaceutical supply chain.”

They make the common mistake of implying that GS1’s standard is a full data exchange architecture.  It is merely a standard that establishes an XML-based data format for documenting a wide range of events that occur between trading partners in a supply chain.

I use the word “merely”, not to insult the standard or GS1, but to deflate the excess attributes of it that are implied by HDA’s comments.  To get to the full data exchange architecture they describe will require the help of a standard, secure, point-to-point data transmission sub-system (such as AS2) (again, see “EDDS: The New Data Exchange Requirements”).  But this is still minor nit-picking by a perennial nit-picker (me) and does not have any impact on the virtue or power of HDA’s argument here.  I agree with the core of their summation in this section:

We believe EPCIS is the appropriate, and only, technological standard suitable for supporting compliance by 2023. This is not an ‘either/or’ proposition but, rather, a foundational prerequisite.”

All I’ve covered here are selected parts of the first of seven issues discussed in their comments.  It’s highly recommended reading.