FDA, Industry Experts Urge DSCSA Action at HDA’s 2023 Traceability Seminar
In late August, HDA convened more than 400 healthcare supply chain stakeholders, technology experts and regulatory officials for the association’s Traceability Seminar. This highly anticipated event, provided a forum to discuss implementation challenges and strategies for Drug Supply Chain Security Act (DSCSA) compliance as the industry faced a November 27, 2023, deadline to establish a framework to trace pharmaceuticals across the supply chain.
Just days before the seminar, the Food and Drug Administration (FDA) announced its decision to exercise enforcement discretion on the DSCSA’s final requirements. Ahead of the agency’s guidance, HDA shared the association’s concerns with FDA on the uneven state of industry readiness for November 2023, underscoring that the progress of implementation and the law’s single compliance date for all trading partners could lead to supply chain disruptions and interruptions to patient care. FDA’s action "[Put] the health and safety of Americans first," HDA President and CEO Chip Davis subsequently said in a statement, indicating that "The agency heard the concerns of distributors, manufacturers and pharmacists and provided guidance that will ultimately minimize the potential for disruptions in the short term."
Given the backdrop of activity, HDA’s sold-out forum provided a unique opportunity for continued private- and public-sector collaboration and served as a call to action for continued work on implementing the remaining DSCSA requirements. Read more about key industry insights and event highlights below.
The FDA intends for 2024 to be a “stabilization period.” Supply chain partners should continue working diligently toward compliance.
In the “FDA DSCSA Overview and Update” session, the audience heard from the agency’s Director of the Office of Drug Security, Integrity and Response, Leigh Verbois, and Senior Advisor for Policy, Dr. Connie Jung. Verbois and Dr. Jung gave a detailed discussion of the agency’s enforcement plans moving forward, explaining the agency is framing November 27, 2023–November 27, 2024, as a “stabilization period” for trading partners to build and validate DSCSA systems to ensure the continued delivery of prescription medicines across the supply chain.
“This [stabilization period] should not be viewed as justification to stop implementation … We want this implementation to be done by 2024,” said Verbois. Moreover, Dr. Jung explained, “We are only intending for the stabilization period to apply to [FDA’s final guidance for Enhanced Drug Distribution Security Requirements Under Section] 582(g)(1),” and emphasized, “This does not mean to stop anything.”
Industry panelists reiterated FDA’s message throughout the event. Gregg Gorniak, VP, Manufacturer Operations and Data Services and Secure Supply Chain Lead, Cencora, encouraged attendees to prioritize meeting the interoperability requirements as early as possible, stating, “The point of the stabilization period isn’t to take your foot off the gas.”
Additionally, Verbois and Jung indicated that following delays due to the COVID-19 response, FDA is using the next few months to work on DSCSA-related guidance. Of note, the agency is continuing efforts related to wholesaler/3PL provider licensure standards and planning a survey on small dispenser readiness. Further, the agency plans to host several DSCSA-related public meetings this year.
Effective collaboration and data management are crucial in this final phase of implementation.
As industry speakers reflected on their own experiences setting up DSCSA compliance programs, they urged companies to send and receive data as soon as possible since having complete, accurate data is paramount. In her remarks, Riya Cao, CEO, LSPedia, said, “For those of you sending data, just because it left your four walls doesn’t mean it’s good [quality] … we need to take that next step to use the data” to resolve errors and discrepancies.
Speakers emphasized there are inevitably challenges when establishing connectivity. Therefore, beginning the process sooner provides trading partners more time to resolve the issues. Furthermore, panelists stressed that upstream data errors inhibit downstream parties from completing their requirements, and because of this issue, industry sectors must be accountable in establishing connectivity.
Dispensers, especially independent pharmacies, need additional support to reach the finish line.
The dispenser community also weighed in on their state of readiness. Ilisa Bernstein, SVP, Pharmacy Practice & Government Affairs, American Pharmacists Association, remarked on the challenges facing small, independent pharmacies, “If you look at most of the larger chains, they're ready, or they [would have been ready] to flip this on in November, but not necessarily be getting data because their trading partners may not be ready to send data,” she said. “But for the small dispensers, the independent pharmacies ... they were just not ready.” Further, Dr. Bernstein, who previously worked on DSCSA implementation at the FDA, recognized HDA and the pharmaceutical distribution community’s leadership in advancing a dialogue that ultimately resulted in FDA’s decision to establish additional time to stabilize DSCSA processes and systems.
Boards of Pharmacy representatives discussed these challenges further and emphasized continued partnership with all entities in the supply chain to ensure compliance with the DSCSA requirements. During a dispenser-focused panel discussion, Alexandra Blasi, Executive Secretary, Kansas Board of Pharmacy, said, “The goal here is to support everyone in the [supply] chain. Just getting in the room with all of you has been a huge help.” Moreover, Josh M. Bolin, Associate Executive Director, Federal Affairs and Strategy, National Association of Boards of Pharmacy®, added, “The small dispenser community are the ones who need DSCSA the most.”
Bottom line: Make the most of this next year.
Overall, FDA and other DSCSA experts made clear the requirements of this law should be taken seriously and are critical to enhancing the overall safety of the healthcare supply chain. As Gorniak reminded the crowd, “This whole thing is around the safety of the patient... We need to make sure we get it right.”
Looking ahead to another crucial year of DSCSA implementation, HDA will continue to lead and support industry stakeholders as the supply chain works throughout the stabilization period to achieve full compliance with the law's final phase.
A special thanks to the 2023 HDA Traceability Seminar sponsors, including our service and technology provider exhibitors, as well as the speakers and attendees that made this year's event a success. For additional DSCSA and traceability-related resources, visit hda.org/pharmaceutical-traceability/.