HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’

In a lengthy comment submission to the FDA’s recent publication of draft guidance on Standardization of Data & Documentation Practices for Product Tracing (see “DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing”), the Healthcare Distribution Alliance (HDA) called on the FDA to move on and focus on requirements for deadlines in the future, not those in the past.  HDA’s comments on this guidance was the most strongly-worded submission of any they have made yet related to the Drug Supply Chain Security Act (DSCSA).

This is the first time I can remember HDA considering a draft guidance to be so bad that they called for its withdrawal in its entirety.  They are not even asking the agency to re-write it.  They feel that the guidance it contains is aimed at supply chain operational activities for which companies needed guidance back in 2014, but FDA failed to provide it at that time.  In its absence, companies were forced to make decisions on their own and they notified the FDA of those decisions.  Trying to revisit and second-guess those decisions now will only take attention away from efforts needed to meet the next series of DSCSA requirements, thus jeopardizing those deadlines.

In their comment to the FDA, HDA argues:

“We also believe the supply chain has been very transparent in its DSCSA interpretations and implementation. Stakeholders repeatedly sought advice from FDA on data elements during the ASN development process and thereafter. HDA provided its Transaction Scenarios to FDA which set out what we believe are the data exchange requirements for various types of DSCSA transactions; the Transaction Scenarios have been widely disseminated and used throughout the supply chain for more than the last three years. Repeatedly, stakeholders informed the Agency that systems and processes were being built in reliance upon these many good faith interpretations of the DSCSA and, in the absence of any feedback, trading partners had to proceed. To the extent FDA’s new interpretations in the Draft Guidance can even be operationalized for today’s transactions (and we believe many cannot), those developing the systems to accommodate them would have needed these interpretations from the Draft Guidance by early 2014.”

“Now, many of the data and document “standardization” practices the Draft Guidance espouses are flatly contrary to what trading partners have been doing – and have told FDA they would be and are doing – for over three years. The Draft Guidance raises enormous state licensure and inspectional risks as we do not believe that the many currently used data practices, systems and processes can be swiftly changed, or even changed at all, to align with the Draft Guidance.  Updating the ASN Guideline to reflect these new interpretations would require months of work stakeholders cannot afford. Supply chain experts and scarce resources are all now fixed on meeting 2019 serialization and verification requirements and preparing for 2023 compliance. There is no capacity, time or will to go back and change what was implemented between trading partners in 2015 and has been working ever since. Attempting such changes now, even assuming they are possible, would entail severe disruption and expense to the supply chain with no meaningful security enhancement. We believe pausing now to implement the Draft Guidance will set back DSCSA readiness by months or years and actively harms the pathway to 2023 compliance.”


“We do not believe that business and data processes can be aligned with the Draft Guidance without imperiling 2019 and 2023 DSCSA readiness.”

And finally:

“Given the many difficulties the Draft Guidance poses to current, established practices, we strongly urge FDA to immediately withdraw the Draft Guidance in its entirety.”  (emphasis by the HDA)

Wow.  That’s bold.  In their comments, HDA considers the likelihood that the FDA might not withdraw the draft guidance as they prefer.  In that case, HDA provides their thoughts on how the FDA should immediately address the risks that the draft guidance poses for the supply chain.  They propose that the FDA immediately issue a statement to indicate that the draft guidance does not apply to or change current compliance obligations and should not be the basis for any enforcement actions by the FDA or state regulatory bodies.  And if the FDA does that, HDA’s comment submission offers thirty pages (that’s right…30 pages!) of commentary and recommended changes to fix the draft.  If FDA takes this approach, the changes to the draft would be so significant, that HDA proposes the draft guidance be re-published with another comment period, before it is finalized.

HDA has never been shy in their submissions to the FDA during public comment periods, but in this response they take their strongest stand yet.  I highly recommend you read through their comment submission.  The comment period for this draft guidance ended on the day after HDA submitted their comments (April 30, 2018), an indication of just how much time and effort it took HDA to analyze the draft and construct this response.  It will be very interesting to see how the FDA reacts.

I don’t always agree with HDA’s interpretation of the DSCSA, including some of their arguments in this comment submission.  When we disagree on the DSCSA, it’s usually not over major things.  But I agree with HDA’s argument that it is too late for FDA to try to establish a different interpretation for requirements that went into effect in 2013, 2014 and 2015.  The industry called out for this kind of guidance at that time but the FDA was silent.  In my view, by that silence, the FDA forfeited their opportunity to determine how the early DSCSA requirements would be interpreted and implemented (see “FDA Forfeits Opportunity To Guide Industry”, “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” and “In Absence Of FDA Guidance, Follow PDSA Recommendations”).

Instead, the FDA should put their precious time into decisions that must be made now for the 2019, 2020, 2021 and 2023 requirements.  Looking backward is a waste of everyone’s time and it is just a setup for the same thing to happen again in these future deadlines.  But the difference is, these future deadlines include requirements that are much more important.  Much more is at stake for patients and industry stakeholders.  FDA should take HDA’s advice on this one, and immediately focus on the future requirements that companies need guidance on right now.

If all that weren’t enough, on the same day, HDA submitted separate comments regarding the reopening of the comment period for the FDA Pilots.  The comment period for the reopened docket closed on that same day.  This one isn’t quite as exciting as the other submission, but companies interested in DSCSA pilots should read it.