HDA Seeks to Limit FDA Enforcement Discretion of DSCSA Come November, Raising the Burden on Some Manufacturers

When it comes to compliance with the US Drug Supply Chain Security Act (DSCSA), trade associations involved with the pharma supply chain, like the Healthcare Distribution Alliance (HDA), usually sought two things from FDA: more specific guidance on how to comply; and more time to fulfill compliance requirements. Indeed, another group involved in DSCSA compliance—the American Pharmacists Association—has just made a request for delay in meeting the deadline for a fully functioning tracking system from the manufacturer to the dispensing pharmacy; and others are likely to follow as the November deadline approaches.

In a response to FDA, HDA recently asked for flexibility in enforcement as well—but with a twist. Rather than providing blanket “enforcement discretion” (the mechanism by which FDA can overlook a Congressionally mandated deadline without actually defying Congress), HDA suggests that the agency should only grant product-by-product discretion to manufacturers who fail to provide the necessary data about their products to trading partners. “[N]arrow exemptions will be far less disruptive and costly to the supply chain than a grant of broad enforcement discretion that effectively extends the compliance date for interoperable data exchange beyond November 27, 2023,” writes HDA. In this way, noncompliant manufacturers will be forced to accelerate their compliance efforts, rather than simply waiting for another deadline to be missed and then seeking yet another delay.

IT interoperability

In early February, another industry group—the Partnership for DSCSA Governance (PDG)—issued four new chapters to its ongoing “Foundational Blueprint for 2023 Interoperability.” PDG is notable in that it represents all key participants in the pharma supply chain: manufacturers, distributors, third-party logistics providers; and hospital and retail pharmacies, with support from consulting organizations and IT vendors. FDA is a collaborating partner as well.

The new chapters follow an initial chapter updated in 2022. They comprise: functional design (for interoperability); TI/TS exchange; product identifier verification; and tracing architecture. Another chapter on credentialing of trading partners is apparently forthcoming. The documentation is quite technical; for example, there are pages of notes on how to write messages in JSON (JavaScript object notation), an open-source standard for data exchange. The bulk of these chapers are focused on the EDDS (enhanced drug distribution security) system, FDA’s goal for DSCSA compliance; however, FDA is still in the process of clarifying how the EDDS system will perform. PDG is careful to note that its guidance does not have the force of law.