The pharmaceutical industry urged the US Food and Drug Administration (FDA) to take a more “assertive and forward-leaning” approach in assisting pharmaceutical manufacturers prepare their track and trace systems for full implementation of the Drug Supply Chain Security Act (DSCSA) once these systems go live in November 2024.
The Healthcare Distribution Alliance (HDA) also asserted that FDA has not provided any further direction to industry since a stabilization policy went into effect in the summer, and that in the absence of agency direction, some trading partners are “delaying making any necessary investments and commitments necessary for DSCSA compliance.”
These comments are in response to FDA’s request for information (RFI) in November 2023 on industry’s progress in implementing the interoperable systems and processes for enhanced drug distribution requirements under DSCSA. In August 2023, FDA announced it would be giving firms a one-year reprieve or “stabilization period” from DSCSA track and trace requirements to give companies more time to prepare.
The agency received 17 comments on the notice; the public comment deadline was 20 February.
Industry groups urged FDA to take a more proactive approach in the stabilization period and to closely monitor companies’ progress in implementing these systems.
HDA wrote that “five months after the issuance of the Stabilization Policy, stakeholders need FDA to take an assertive and forward-leaning approach to lead industry into the final phase of DSCSA implementation.”
The group requested that FDA use the information collected from the RFI to develop a “comprehensive picture of supply chain readiness.” The group would also like for FDA to “acknowledge the reality of readiness in the supply chain and advise industry of FDA’s intention to use enforcement approaches following the end of the Stabilization Policy.”
HDA urged FDA to develop an “intensive” communication strategy during the remainder of the stabilization policy, including issuing targeted “Dear Trading Partner” letters.
The group further asserted that “FDA has provided no further direction to industry on these phases” since the stabilization policy went into effect. In the absence of FDA involvement, some trading partners are continuing to transact sealed cases and either cannot or will not provide product identifiers for each package in the sealed case. Or in other cases if trading partners are able to provide serialized data for some transactions, the transaction data provided are incomplete or inaccurate.”
In other cases, “trading partners are viewing November 27, 2024, as the only relevant compliance date, and are therefore, delaying the investments and commitments necessary for DSCSA compliance.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) similarly urged FDA to take a more activist approach to enforcing DSCSA prior to next November 2024. The group urged FDA to “publicly reinforce the need for trading partners to collaborate during the stabilization period.” The group states that “onboarding trading partners in an interoperable environment requires communication and collaboration amongst trading partners.”
PhRMA member companies “have experienced challenges in working with certain trading partners to identify and address data discrepancies during the stabilization period. The ability to manage data discrepancies is critical to ensuring the intent of the DSCSA and this functionality must be in place prior to the end of the stabilization period.”
The Pharmaceutical Distribution Security Alliance (PDSA) similarly urged FDA to be a more involved partner during the stabilization period. “We have a concern that some trading partners are using the stabilization period as an opportunity to pause implementation efforts. Without FDA’s immediate action, implementation is at risk and could interrupt patient access, cause drug shortages, and overall supply chain challenges.”
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