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FDA’s recommended guidance is for a system that ‘does not exist, cannot be built by 2023, and poses unacceptable security and compliance risks,’ says alliance
At first glance, the guidance that FDA issued in early June* for the so-called “enhanced drug distribution system” (EDDS) that will codify the requirements of the 2013 Drug Supply Chain Security Act (DSCSA) by 2023 looked like a positive step: Pharmaceutical Commerce called it a “gold mine of guidance that industry had been seeking for years.” But a hint of future trouble could be seen when the Healthcare Distribution Alliance (HDA) requested, and was given, additional time to comment on the draft document this summer. At the end of August, HDA filed its comments, which basically blow up the entire document; the trade association of wholesalers and distributors requests that “the Draft Guidance be withdrawn in its entirety.”
In the comments which go on for 37 pages, HDA sees “catastrophic impacts,” “unprecedented in federal law” and “contrary to the plain language of the DSCSA and not legally defensible,” among other choice criticisms. The comments also cite prior case law involving federal agency enforcement restrictions; this could be looked on as presaging the legal battle that would begin should FDA finalize the draft guidance.
The main point of HDA’s comments, however, is a fairly straightforward technical disagreement over what is implied in the term “interoperable.” While FDA allows for “distributed” or “semi-distributed” data repositories for the transaction information that DSCSA requires trading partners to maintain, the language in the guidance implies a central data repository, or what HDAA calls a “a centralized system that every trading partner must subscribe to and participate in, and/or some type of network or global overlay that connects all the systems of every pharmaceutical trading partner.” Such a system is not only technically challenging; its security is uncertain regarding protecting the highly proprietary trading information that wholesalers, especially, would want to protect. FDA would like, as HDA puts it, a “a single, centralized database or blockchain(s) that can be queried with a ‘one-button’ request” with near-instantaneous response; the reality is that dozens of distinct software systems exist, with tens of thousands of trading partners, across the US pharma supply chain. Manufacturers, wholesalers and some other trading partners have created linkages among some of their databases, but in nearly all cases, the linkage is established through tedious, time-consuming processes. More importantly, each trading partner controls access to the data it stores; for the most part, the linkages do not flow freely from one organization to another.
FDA’s goals are clear; it wants to be able to find, or cause to be found, suspect or illegitimate product flowing through the pharma supply chain, and to rapidly effect a product recall. It would be easy, if everything were connected on one system, to do this; but in reality, FDA will need to manually trace such products by querying each database (in the current, distributed setup) individually. Here, it’s worth noting that (with the debatable exception of counterfeit opioid products that are bought and sold illegally), the instances of counterfeit or illegitimate products showing up in routine pharma distribution are rare. Product recalls are a real issue of patient safety, and while most of the time these recalls take weeks to months and are rarely comprehensive, after 2023, this process should move a lot faster whether or not FDA gets the EDDS system it seems to be looking for.
The casual observer of this dustup between FDA and industry might wonder what all the fuss is about, when in Europe, under the Falsified Medicines Directive, there are national, central databases, and trading partners are connected to them. But FMD only serves to authenticate the barcode on an item of sale in a pharmacy; it does not track products as they move from trading partner to trading partner. DSCSA was intended to be much more comprehensive and to provide much more detailed information of value both to manufacturers and to their trading partners. That vision is still possible to achieve, but industry and FDA will have to collaborate more productively to make it happen.
*Draft Guidance for Industry: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, Dkt. No. FDA-2020-D-2024, 86 Fed. Reg. 30053 (June 4, 2021)