The Healthcare Distribution Alliance (HDA) Traceability Seminar is always a great event to find out about the current industry response to the Drug Supply Chain Security Act (DSCSA), and ideas for where it is headed in the future. This year was particularly valuable for those who attended. Sessions included a DSCSA update from the FDA, HDA perspectives on DSCSA guidance, manufacturer perspectives on serialization, an update on HDA’s Verification Router Service (VRS) and other technology issues, and in a pre-conference meeting, how blockchain may be used to meet the 2023 requirements of the DSCSA.
As you might expect, the update from the FDA was the most anticipated session. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spent most of her session talking about what the FDA is working on right now and what they expect to do in the future regarding the DSCSA. They have a number of new guidance documents that she expects to be published very soon, including those on grandfathering, licensure of wholesale distributors and 3PLs, waivers, exceptions and exemptions, product identifier Q&A, and verification systems, among others. With all those publications coming up, the FDA is very busy right now and the pace will only quicken. She also talked about the FDA’s vision for supply chain security after the full DSCSA is in effect on November 27, 2023. For more about the FDA and the DSCSA, see their DSCSA web pages.
The HDA perspectives on DSCSA guidance session was a panel with three attorneys who are each affiliated with the HDA. The panel discussed the legal nuances and implications of the DSCSA guidance documents that the FDA has published over the last year, exposing where additional clarifications are needed. HDA responds to each major guidance document and most of the discussion was a recap of comments they have already submitted to the FDA. Their recommendations are always comprehensive. For more on HDA’s feedback to the FDA, see their website.
The session on manufacturer perspectives on serialization was a panel of executives from a large drug manufacturer, a biotech manufacturer and large contract manufacturer. They discussed their respective experiences with preparing for the serialization requirement of the DSCSA. Despite the enforcement delay, all three said they ready to serialize now and they intend to begin on the original deadline. This will allow them to have their processes operating smoothly and accurately before the new regulatory deadline of November 26, 2018.
The VRS update session was a panel of drug manufacturers and wholesale distributors, moderated by KPMG, the VRS design facilitator. Each participant explained their interest in the VRS and some of the characteristics the system would have. The VRS is one of two ways the HDA found last year as the best way for the industry to meet the 2019 wholesaler saleable returns verification requirements of the DSCSA. The other way is for manufacturers to provide lists of serial numbers included in each shipment to the wholesalers. The VRS is currently being designed through a series of HDA-sponsored industry workshops and should be ready to pilot early next year. For more on the VRS, see the HDA’s DSCSA Webinar: HDA 2019 Saleable Returns Requirements Pilot Update Webinar.
Other sessions covered supply chain technologies like barcodes, aggregation and inference, data exchange and integrity and the sharing of supply chain master data. Each session was moderated by an expert in the field.
The sessions offered at the HDA Traceability Seminar are presented by experts and are always informative, but the best feature of the annual event is the networking opportunities. It starts at breakfast, continues through a morning break, lunch, a mid-afternoon break and then a networking reception at the end of the day. These may seem like nothing more than rest periods but they are really your opportunity to chat one-on-one with one of the speakers or panelists, or find an industry veteran and get their perspective on some topic. In short, you can get your burning questions answered by those who know—whether they are on the agenda or are just another attendee with lots of experience. For example, after concluding the Q&A in her session, Ilisa Bernstein spent every break answer a long line of questions asked in one-on-one conversations. Of course, because she’s with the FDA, she cannot provide information beyond what has already been published in guidance, but most people get at least some satisfaction from speaking with her directly.
The HDA is one source of information we use to help us keep our Systech Global Serialization Regulatory Update documents up-to-date every quarter. The Traceability Seminar offers a wealth of knowledge to those who attend. And we do attend, every year.