Comments on FDA Drug Security Act Meetings
Several stakeholder groups have submitted comments thanking FDA for its three public meetings on implementation of the Drug Supply Chain and Security Act (DSCSA) and suggesting improvements to the program. The American Society of Healthsystem Pharmacists asked the agency to consider its recommendations on stakeholder engagement, hospital- and health system-specific concerns, and education and awareness.
Genentech provided some comments on specific sections of the law and said it is actively collaborating with other industry members to explore technology solutions that could enable creation of a closed system to ensure that only authorized trading partners can request verification.
The Pharmaceutical Distribution Security Alliance said it appreciated the agency’s openness in communicating its expectations for DSCSA implementation and looked forward to continued open dialog on the topic. It listed a number of topics for which it has appreciated the approach FDA is taking.
The Healthcare Distribution Alliance gave comments on two issues: certain components of the 10 points on “enhanced security needs” that the agency disseminated in advance and during the public meeting, and FDA’s request for more information on where and how it might aid DSCSA implementation.
The Association for Accessible Medicines said it is concerned about an over-reliance on a manufacturer’s aggregation data used to realize the FDA vision of an interoperable network in 2023. “We suggest FDA attempt to strike a balance between allowing inference in the supply chain to preserve efficiency, while understanding the parent-child (case-to-unit relationships) aggregation data is far from perfect, due to a relatively high error rate…. If downstream trading partners can infer the contents of shipping containers without ever ‘seeing’ a package, can they be certain that they have ever owned that specific package simply by inferring? And if they cannot, unless the package was verified by a downstream trading partner, this error might not be discovered. One ramification of this scenario is that if such a package was later determined to be suspect product, that trading partners downstream in the supply chain after the manufacturer, could not be certain that they ever owned that package.”
The National Association of Chain Drug Stores provided comments for developing future policy on tracking transaction data history upstream, in response to agency comments on the importance of deadlines, on open questions on verification, and regarding the association’s desire for FDA guardrails on various DSCSA policy topics.