Industry calls for withdrawal of FDA electronic tracing guidance

Regulatory NewsRegulatory News | 10 September 2021 |  By 

Pharmaceutical distributors urge the US Food and Drug Administration (FDA) to immediately withdraw its guidance setting parameters for establishing electronic systems to trace products through the supply chain. A trade association for distributors claims the agency overreached its statutory authority in seeking access to private electronic tracing information among trading partners.
The guidance, published in June, laid the groundwork for the data architecture systems needed to build the electronic, interoperable systems called for in the Drug Supply Chain Security Act (DSCSA), scheduled for implementation on 27 November 2023. In August, the agency granted the industry a 30-day extension to comment on the guidance. (RELATED: FDA details plans for DSCSA implementation in four guidances, Regulatory Focus 4 June 2021; Updated: FDA grants industry 30-day extension to comment on track and trace guidance, Regulatory Focus 2 August 2021).
The Healthcare Distribution Alliance (HDA), which represents pharmaceutical distributors, submitted 37 pages of comments enumerating “serious concerns” with the guidance. Among other concerns, HDA asserted that the draft guidance does not clearly articulate the essential requirements for 2023 compliance and is “inconsistent” with the systems that the supply chain has already been implementing.
“For the first time in guidance, FDA describes a ‘system’ that, we believe, is fundamentally counter to the plain language of the DSCSA and, as such, is not what industry has collectively spent the last 7 years investing in and building,” wrote HDA. “Indeed, there is an immense gap between what the draft guidance seems to assume industry is implementing and what industry is actually doing.”
Too Much Big Brother
The group took issue with a provision of the guidance stating that electronic tracing information should be available to FDA and other state officials. The guidance states that “the enhanced system should allow FDA and other federal and state officials to communicate with trading partner’s individual systems and receive relevant information upon request.”
“We have serious concerns with the draft guidance’s assumption that trading partners will open up their proprietary systems for a direct connection with a government authority or with other trading partners,” wrote HDA. “We do not see wholesale distributors or any other trading partners allowing federal or state government officials or other third parties direct, system-to-system connections to their records of every prescription drug product transaction in the US pharmaceutical supply chain.”
Data architecture models questioned
HDA also took issue with the data architecture models proposed in the guidance, which specify how data can be stored, managed and integrated among trading partners. These include the centralized model, the distributed model or a mixture of the centralized and the distributed model. FDA supports use of either a distributed or semi-distributed data architecture model, because either allows trading partners to maintain control over the data.
HDA said that such a such a distributed or semi-distributed model does not exist. The group states that “no system or networks exist with this capability and none is currently being built. What does exist is a collection – an ecosystem – of thousands of privately owned and maintained systems that are all different.”
The comment also highlighted other “particular areas of concern” including aggregation and inference, reconciliation and discrepancies, verification, validation, integration, and alerts.
HDA concluded by urging immediate withdrawal of the draft guidance, maintaining that the “enhanced system” called for in the document “is not what Congress intended or enacted in the DSCSA.  “The ‘enhanced system’ does not exist and, even if the agency did have the authority to implement it as described in the draft guidance, it could not be built by November 27, 2023,” wrote HDA.
McKesson wants more clarity on government access  
FDA received 11 other comments from a pharmaceutical manufacturer, pharmacy groups, dispensers, and a pharmaceutical distributor, and others.
McKesson  concurred with HDA that the guidance overreaches the statutory intent of DSCSA by allowing FDA to access trading partners’ electronic systems. “The draft guidance could be interpreted to impose requirements that do not appear in the DSCSA, are unnecessary, and would be highly intrusive,” wrote the firm. “One could interpret that guidance to mean that a trading partner must allow governmental entities to (1) directly communicate the trading partner’s individual data systems and (2) retrieve transaction information through that direct interface.”
”We respectfully request FDA to clarify this ambiguity and make clear that the DSCSA does not require a trading partner to allow governmental entities to directly access private data systems and retrieve transaction information through direct automated response,” wrote McKesson, underlining the point for emphasis.
McKesson is a member of HDA and said it endorses HDA’s comments.
Thirty days not enough time 
One pharmaceutical manufacturer, Boehringer Ingelheim, weighed in. The company took issue with a provision stating that manufacturers must respond to notifications of recalls and illegitimate products within one day.
The company said that FDA should allow more time in the event there are issues with the electronic system.
There is already much work ahead for industry to develop and implement the systems called for in the guidance. FDA has already announced it has no plans to extend the deadline for establishing these systems. (RELATED: FDA official: Agency will not extend 2023 DSCSA interoperability deadline, Regulatory Focus, 11 August 2021)
HDA comment
McKesson comment
Boehringer Ingelheim comment


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