FDA officials resist calls to further delay DSCSA enforcement

WASHINGTON – US Food and Drug Administration’s (FDA) officials say they are aware of industry’s concerns about complying with the track and trace requirements of the Drug Supply Chain and Security Act (DSCSA) yet insist that the agency will stick to its 27 November 2024 implementation timeline. They also urged experienced companies who have track and trace systems in place to assist those with less experience at a 27 August meeting sponsored by the Healthcare Distribution Alliance (HDA).

Leigh Verbois, director of the Office of Drug Security, Integrity, and Response (ODSIR) within FDA’s Center for Drug Evaluation and Research (CDER), told the attendees that “it is time to implement and continue to implement and troubleshoot” these systems. She noted that companies have less than 90 days to get these systems ready.

FDA continues to hear readiness concerns

Verbois told the meeting that officials are aware of industry concerns that trading partners will not have their systems up and running by the time the law is implemented this November.

The agency “heard loud and clear that you are still having concerns with data quality, those concerns with data quality will impact product movement,” she said. These concerns were also raised at FDA’s public meeting on DSCSA implementation in June.

Verbois added that “we are taking those concerns under advisement. We are talking to a number of individual organizations through the Partnership with DSCSA Governance and we want to make sure that you know we are hearing you loud and clear. We want you to understand that ensuring access to product is of paramount importance.”

Through the public meeting, FDA also learned that “communication and collaboration are key to bringing in those organizations that were not previously communicating.” She added that “we do need to continue on this pathway of making sure we are bringing along others with us.”

Abha Kundi, team lead at ODSIR, reiterated that these concerns are being heard. Following the June meeting, FDA decided that small dispensers would not be ready for the November deadline and granted this group a two-year extension from meeting the enhanced tracking requirements for drugs. (RELATED: FDA grants small dispensers two-year delay for DSCSA tracking rules, opens door for exemption requests, Regulatory Focus, 13 June 2024)

Kundi said that “based on our engagement and outreach what we have heard from industry it was clear that we needed to do something, and we understood that.”

Other concerns were raised in response to FDA’s request for information issued last November.

Respondents expressed concerns with data quality and the transmission of inaccurate or incomplete data to trading partners. FDA heard the need for best practices for data aggregation and standardizing data, as well as concerns with respect to trading partner connections and communications. FDA also heard concerns with how the new NDC form may disrupt data exchange between trading partners.

Through the RFI, industry also wants FDA to provide additional information and to clarify the use of waivers, exemptions or exceptions (WEE), conduct more outreach with how to be compliant with DSCSA, and provide additional guidance on how to confirm the identity and status of an authorized trading partners (ATPs).

Regulators pressed on additional delays, standardizing waiver

Throughout the question-and-answer period of the panel, industry members asserted that trading partners are not ready for November, and pressed FDA for an additional extension in their enforcement of DSCSA.

One attendee told the FDA officials that “shortages are going to occur because we as distributors are not getting EPCIS [Electronic Product Code Information Services] data from manufacturers” and asked what he could do to resolve the problem.

In response, Verbois told them to request an exemption until the issue is resolved.

Dave Mason, serialization lead for Novartis, said 25-30% of the industry is not ready and is not sending serialized data to their trading partners. He said that despite the one-year stabilization period, “Progress has been very slight. Everyone should have should be exchanging data now.” He also said he has grave concerns about the quality of the serialized data.

Verbois acknowledged that “there are different levels of industry readiness. This is what we have heard from our conversations and through the public meetings.” She added that “there has been some progress made in the stabilization period in bringing stakeholders to the table and ensuring the data connection.”

With respect to the data quality issue, Verbois told Mason that “it is our understanding that there has been some progress” yet acknowledged that “we understand that there are still concerns with data quality, and we are taking that under advisement.”

A representative of the National Association of Chain Drug Stores (NACDS) told FDA that the stabilization period has been “helpful” and asked FDA to offer “some insight in what FDA may be able to do within the next 90 days?”

Verbois responded that FDA is continuing to “have conversations with industry including your organization, we understand the complicated nature of supply chain security. We are thinking through what that might look like, and we are having conversations with lots of organizations to really understand the true nature of implementation and those data quality issues.”

Another audience member asked whether FDA could establish a broad category of exemptions for WEE requests that are similar, instead of granting individual exemptions. For example, grouping together the requests seeking a 6-month delay, a one-year delay, or a two-year delay.

Verbois replied that “I think there are varying ways this exemption authority can be exercised. That is probably the clearest answer.”

FDA officials resist calls to further delay DSCSA enforcement

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