A few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA). The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”). The second docket was opened shortly after the Public Meeting to continue collecting the same kind of information from anyone who had already conducted their own pilots or was planning future pilots. Both dockets are now closed so here is a look at the responses.
The FDA apparently received 23 responses to the first docket, but they made only six of them public. None of those are very pertinent. Most were from vendors attempting to attract the FDA’s attention to their wonderful proprietary technology. They’ve missed the point of the DSCSA. The FDA apparently received ten responses to the second docket but only three were made public. Two of those three were from the Healthcare Distribution Management Association (HDMA). HDMA public comments are always interesting, but their April 21 comments are the best I’ve seen. I strongly recommend that you read the original document. The May 16 comments add very little of value to the April 21 comments and repeat some of it.
HDMA’s APRIL 21, 2016 COMMENTS TO THE FDA
So much of the 13 pages of HDMA’s comments were so right on and well-written that I have to resist the urge to quote every sentence. I will try to extract the best samples here.
“A common understanding of the DSCSA’s statutory requirements is necessary before any pilot is developed.”
Right on. HDMA enumerates some of the many things we need the FDA to clarify. And then, this gem:
“Without clear statements from FDA of what must be done and what key terms mean, much of FDA’s time, and that of pilot participants, will be consumed with determining (and possibly disputing) ‘who has to do what’ and what the DSCSA requirements mean, rather than on actually developing the pilots. Without this essential groundwork, it will not be possible to develop useful pilots that will instruct on methods to establish a secure, interoperable, electronic system.”
“The ‘scope creep’ of any proposed pilot must be curtailed.”
“Given the uncertainties of what we know we must accomplish by November 27, 2023, this long, careful process will undoubtedly be hindered if FDA’s pilot development includes what might have been in the DSCSA or what could be achieved in some future state.” (emphasis by HDMA)
HDMA then actually ridicules some inaccurate and ill-informed statements made by some participants during the recent FDA DSCSA Pilots Workshop, just like something you might read in RxTrace!
“Despite what was often assumed at the Workshop, the DSCSA does not require dispensers to verify product identifiers with manufacturers or repackagers at the time they dispense. Further, the DSCSA does not require wholesale distributors to verify product identifiers with manufacturers when they receive or sell product (other than with saleable returns).”
“It appeared that some Workshop attendees made similar broad assumptions about an interoperable system being one in which it is possible to scan (or otherwise read or ‘look up’) a product identifier and immediately see and access every previous transaction for that product, from when the manufacturer affixed the product identifier, forward. Frequently couched as intended to ‘facilitate gathering the information’ and using the product identifier to ‘enhance’ traceability, these hopes ignore the explicit mandate of the DSCSA – the requirement to pass TH sunsets on November 27, 2023.”
“The DSCSA does not create or contemplate an ‘electronic pedigree’ such as that in the prior California electronic pedigree law that required a record in electronic form containing information regarding each transaction resulting in a change of ownership of a product going back to the manufacturer. The DSCSA does not contemplate or require that someone, including individual supply chain members, have the ability to trace a product all the way back to the manufacturer’s commissioning of the product identifier by simply scanning or looking up that identifier at any point in the pharmaceutical supply chain. This theoretical ‘electronic pedigree’ is not the 2023 end-state set forth in the DSCSA.”
“HDMA states emphatically that, for now, it is imperative that FDA-supported pilots focus upon what the statute actually requires and have a direct relationship to compliance with 2023 requirements. We believe the supply chain would be ill-served by pilots that needlessly complicate what is already a lengthy, difficult, and expensive process by testing things because they would be ‘nice to know’ or that could likely only be implemented by amending the DSCSA, such as validation on receipt or at time of dispensing, product authentication, or the creation and passing of an electronic pedigree.”
Well said, even though I might have a tiny quibble over exactly what Congress intended the passing of TH to be replaced with after it is sunset on November 27, 2023. Watch for an exploration of that in a future essay.
“FDA should carefully consider how pilots can be designed and managed to yield useful, practical, actionable information.”
“…[G]iven the many broad and disparate ideas put forth at FDA’s Workshop, we urge resisting both the temptation to pilot every possible scenario and the expectation that a single pilot will result in a single system that will answer all DSCSA needs. We have observed an inclination to push boundaries further and further in the hope that a pilot could address, for example, not just product identifier verification, but also notifications, investigations, and recalls. There is also a proliferation of ever-more-unlikely scenarios for the entry of illegitimate product into the U.S. market – and then a scramble to try to design a pilot that could protect against these highly improbable scenarios.”
“Rather than increasing the burdens upon the part of the supply chain that is working – the controlled, documented transactions between authorized trading partners – we believe scarce resources would be better expended upon either piloting ways to make the existing, secure and DSCSA-compliant supply chain more efficient, or focusing upon those places where FDA is actually observing the entry of illegitimate product into the U.S. supply chain.”
“Many elements discussed at the Workshop reflect a need for FDA guidance or FDA affirmation, not a pilot.”
HDMA makes an excellent point here. There are many things on the list of pilot attributes that the FDA collected at their recent workshop that are present only because there are questions about ambiguities in the law, and not because they need to be piloted. People just need an explanation from the FDA. HDMA lists:
- “The [GS1] Global Trade Item Number (GTIN)”
- “Exceptions Handling”
- “The [GS1] Global Location Number (GLN)”
- “Use of Master Data”
- “Special Scenarios”, like “…340B transactions, drop shipments, and investigational drugs.”
- “[GS1] EPCIS”
HDMA then lists some pilot elements for which it had some special commentary to deliver.
Regarding the DSCSA Product Identifier…
“HDMA urges FDA to revise the Final Guidance: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages and specifically endorse the SGTIN, lot number, and expiration date as the product identifier under the DSCSA.”
That’s an interesting way of minimally implementing my proposal, as expressed in “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”.
Regarding Interoperability, HDMA provided some thoughts on the attributes of a truly interoperable system, and then they expressed what they believe does NOT constitute “interoperability” under the DSCSA.
“Specifically, HDMA rejects any assumption or argument that the DSCSA’s contemplated secure, interoperable electronic system is, in fact, an electronic pedigree-type system that allows a user to scan (or otherwise read) a single identifier and obtain a product’s entire history back from point of manufacture. The DSCSA is explicit that the provisions requiring transmission of TH sunset on November 27, 2023. The DSCSA also limits when trading partners and government officials may obtain transaction data.”
“…[W]e see no benefit to pilot testing an electronic pedigree-type of system that is explicitly outside the statute. Trading partners might, on their own, explore such systems but the already complex process of DSCSA implementation should not become mired in FDA-supported pilots testing theoretical systems that are contrary to the DSCSA.”
Regarding Aggregation and Inference,
“The entire supply chain is significantly aided by aggregation and inference and we do not believe that implementation of the DSCSA’s interoperable vision is possible without it. We believe aggregation and inference is so important to the entire supply chain, and so widely recognized as such, HDMA does not see the utility of any pilot that does not incorporate these processes.” (emphasis by HDMA)
As you can tell, I am very impressed with these ideas and the way they were delivered. When I worked for Cardinal Health, one of the larger members of HDMA, I was always in favor of making statements that acknowledged the existence of supply chain security regulations and demonstrated a solid understanding of their implications as well as the ambiguities they contain (but I had little-to-no influence on those kind of decisions back then). That’s what this document does, and does well.
I particularly like the firm—actually bold—tone because it is backed up with a solid understanding of the regulation. It delivers the important message that, with the missing guidances (see “FDA DSCSA Deadline Passes Quietly”), the FDA is holding the industry up and if they squander the opportunity offered by the pilot(s), things will not get better. The FDA risks causing the industry to miss the DSCSA 2023 deadline by its obvious lack of interest and inattention to their needs (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “The Many Faces Of The FDA”).
To the authors of the HDMA document, congratulations on crafting a bold statement that delivers a much-needed message to the FDA. You are welcome to write for RxTrace anytime!