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Three Takeaways from the FDA Public Meetings on DSCSA

March 26, 2018

On February 28, FDA hosted its third and final public meeting in a series focused on "Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act [DSCSA],” bringing together a broad group of stakeholders, including manufacturers, distributors, dispensers, hospitals and service providers.

Overall, the series provided a great opportunity to hear from FDA — including Commissioner Dr. Scott Gottlieb, who delivered the final meeting opening remarks — as well as check in on overall industry progress. While each meeting had its own focus, when examining all together there are three key takeaways.

The meetings provided insights into areas of industry consensus — and confusion.

Through the meetings, consensus emerged on a distributed data architecture and the operational importance of aggregation and inference, with the need for continued work to resolve issues related to exceptions. However, there is confusion on the details around terms or phrases in the law (e.g., “facilitate the gathering”) and interoperability. We know the 2023 system is standards based and some foundational work will be done in 2019, but many specifics still need to be developed — including further details around the system(s) FDA and the supply chain envision in 2023. Some issues that appeared to be straightforward, like verification requests, also are undergoing additional interpretation.

FDA’s initial expectations for a 2023 system are aspirational and differ from what is in the process of being built.

It was great to hear from the FDA on its vision for 2023, and it is clear that patient safety and access are shared goals of the industry and the Agency as they collaborate to achieve DSCSA milestones. But what became apparent is that the system FDA would like industry to build, and what the industry currently is building, differ in key ways. For example, supply chain stakeholders have not focused on predictive analytics, red flags or interoperability with the global marketplace, among other features. These functionalities presented at the meetings typically fell outside of the scope of the law and are not currently possible based on a distributed architecture with today’s technology.

The technology and process changes required to comply with the law are a major undertaking. Given the challenge to meet milestones on time, there is an overall industry opinion that our scope should remain sticking to the original requirements laid out in the law in the short term. As the industry and technologies evolve, some of the more aspirational system attributes may be able to be considered.

Understanding the perspectives and challenges of FDA and trading partners is crucial.

Time spent at these meetings was educational (with agenda topics shifting over the series based on where questions were raised or where additional discussions were needed) and demonstrated that it is worth taking the time to comment and participate. While HDA participates in — and convenes — many groups around DSCSA compliance, it was helpful to hear from a larger group, and to share the hard work HDA and distributors are completing with a broader audience. Equally important was the overall opportunity to hear concerns, as well as understand thinking and current approaches and challenges to achieving DSCSA compliance. What is clear is that reaching 2023 remains a highly collaborative endeavor and these meetings provided a unique forum to discuss across sectors.

Read HDA’s comments on the August 23 and December 5-6 public meetings; comments on the February meeting are due March 30.

Learn more about HDA efforts surrounding DSCSA here.

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

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