FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA

Regulatory NewsRegulatory News
| 17 November 2021 | By Joanne S. Eglovitch 

The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing its guidance on standards for the interoperable exchange of product information.
 
Doing so would help improve industry’s uptake of exchanging product data well ahead of the November 2023 deadline when these systems go live, say trading partners weighing in on the implementation of Drug Supply Chain Security Act (DSCSA) at a 16 November public meeting on DSCSA held by FDA.
 
Anita Ducca, senior vice president of regulatory affairs with the Healthcare Distribution Alliance (HDA), told FDA that without this endorsement, some manufacturers are “deciding to wait to commit to EPCIS, which is critical for both data exchange and tracing.”
 
The law mandates that by November 2023, prescription drug products must be electronically tracked though the supply chain to ward off counterfeiting. In November 2014, FDA issued draft guidance on standards for this interoperable exchange of information. It is yet to be finalized.
 
The draft guidance recommends the use of EPCIS, which is a global GS-1 standard for creating and sharing transaction data about the movement of products though the supply chain. Manufacturers can also use other methods, such as paper of electronic versions of invoices; or electronic data interchange (EDI) standards, such as 856 Advance Ship Notice (ASN). GS-1 is a neutral, non-profit global organization that develops and maintains global supply chain standards. DSCSA is silent on which type of data system to use for tracking products.
 
Lack of endorsement hurting implementation
 
Maryann Nelson, regulatory manager with Cardinal Health, a large drug distributor in the US, discussed the company’s efforts at onboarding manufacturers to test such data exchanges using the EPICS system. She said these onboarding efforts are “not new, we have been building capabilities for this for over five years now.”
 
She said that it is important for manufacturers to onboard early to test these systems to allow any glitches to be ironed out before systems go live. It takes about four to six weeks to onboard trading partners.
 
“As we saw in 2015 when manufacturers started to send DSCSA transaction data to wholesale distributors via the ASN 856, establishing connections between trading partners requires significant time, effort, and resources,” said Nelson. “To that end, Cardinal Health has asked manufacturers to send us aggregated serialized data one year in advance of the deadline beginning in November 2022. We made this request because it is important to allow adequate time for set up, testing, stabilization, and evaluating data quality.”
 
Still, Nelson said that Cardinal’s efforts at onboarding manufacturers have fallen short. The company works with 500 trading partners, yet only 42, or 8%, are sending serialized EPCIS data to Cardinal.
 
Nelson surmised that FDA’s delay in issuing a final guidance may be prompting the slow uptake as manufacturers may be reluctant to adopt a system which has only been recommended in a draft guidance. “We believe FDA’s support of EPCIS as a valid format for serialized data exchange would help improve the adoption rate.”
 
Join the bandwagon
 
Scott Mooney, vice-president of distribution with McKesson, a distributor, concurred with Nelson. He said that McKesson started building their system five years ago based on using EPCIS to exchange transaction information (TI) and transactions statements (TS) with manufacturers and to respond to tracing requests.
 
Mooney said that “we have heard a lot of people discuss the need for EPCIS standards to be able to communicate the TI and TS. We want to join that bandwagon. To prepare for 2023, we ask that FDA endorse that decision, that EPCIS will carry the minimum requirements of DCSCA in an international manner.”
 
Mark Hendrickson, of Leavitt Partners, an advisory body to the Pharmaceutical Distribution Security Alliance (PDSA), agreed. He said that FDA should “recognize the GS-1 suite of standards” for data exchange.
 
Dave Mason with Novartis, supply chain compliance and serialization lead, weighed in as well, noting that “GS-1 is very important to us.” Mason said if FDA finalizes a guidance which is different than the draft version, this “will jeopardize the 2021 implementation.”
 
Ducca concurred that “FDA’s support to the supply chain’s direction would provide the ‘go ahead’ that some trading partners are waiting for.”
 
FDA public meeting on DSCSA
 

 

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Tags: DSCSA, FDA

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