I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar every year because it is where the a very large number of the key members of the US supply chain meet to discuss implementation of the Drug Supply Chain Security Act (DSCSA). Organizations like the HDA, GS1 US and the FDA often save up their significant news and publications throughout the fall so they can release them with big fanfare at this event. This year was no exception. All three of those organizations made news with their announcements this year.
The news from the FDA was announced in the middle of the first presentation on the first day by Dr. Ilisa Bernstein, PharmD, JD, Deputy Director, Office of Compliance, Center For Drug Evaluation and Research, FDA. Dr. Bernstein announced that the FDA will not offer any more extensions in the enforcement of the manufacturer’s serialization and verification requirements. The original extension–announced by the FDA in early July of 2017 (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means“)–delayed enforcement of those provisions until November 27, 2018. Until her announcement at the HDA Seminar, everyone, including me, was wondering if the FDA might announce another extension. Now we know…nope.
If you need more time, better file for an exemption, exception or waiver, as applicable to your situation. Only trouble is, according to Dr. Bernstein, if you filed for one today, you won’t receive the FDA’s response by the November 27 deadline.
FDA has been very productive in 2018 with the publication of an impressive number of draft and final guidance documents (see “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations“, “DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing“, “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption” and “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document“) and it sounds like their feet are still on the ground and still running. Dr. Bernstein mentioned the following guidance documents/programs they are working on right now that we should see in the coming months:
- “…another guidance related to verification…”. Dr. Bernstein could not tell us what’s in it, but it should be out very soon;
- FDA will finally initiate, through a future announcement in the Federal Register, the FDA DSCSA Pilot Program that is mandated by the DSCSA and was initially discussed in a public meeting in early April, 2016, and then information collected back in July 2017 to convince the Office of Management and Budget to allow them to proceed under the Paperwork Reduction Act (PRA) (see “The 2016 FDA Pilots Workshop” and “What Should FDA Pilot?“);
- FDA will hire a DSCSA Program Manager to help coordinate the FDA team and move things forward. The position has been posted for some period of time now and they expect to make a hire very soon. This will likely make 2019 and beyond even more productive for the FDA, which is just what is needed to have any chance of meeting the 2023 deadline;
- FDA will publish a proposed rule soon that finally establish the DSCSA-mandated FDA Wholesale Distributor and 3PL licensing program. FDA has been busy building the IT infrastructure necessary to implement that program, and to collect registration fees from those entities;
- As promised by the FDA Commissioner, Dr. Scott Gottlieb, during the third FDA DSCSA Public Meeting on February 27, 2018, FDA will soon revise its guidance to state governments about DSCSA preemption. Gottlieb admitted during his comments at that meeting that FDA may have introduced confusion in State governments by the vague language they used in that original draft guidance (see “FDA DSCSA Public Meeting #3: A Difference?” and “The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA“);
- FDA will hold a Public Hearing on November 5, 2018 to collect public input into the possible new format of the National Drug Code in the next 10-15 years (see “FDA Seeks Input On The Future Format of the National Drug Code“);
GS1 US announced the publication of their “2018 Update: Implementation of DSCSA Serialization Requirements“. This is the follow-up to their 2017 wholesale distributor barcode scanning assessment. I’ll have more to say about this assessment in a future essay.
HDA’s Executive Vice President of Industry Relations, Membership & Education and Chief Operating Officer of the HDA Research Foundation, Perry Fri offered an overview of the results of the Foundation’s 2018 Manufacturer’s Serialization Readiness Survey. I will write a lot more about those results in a future essay. For my thoughts on last year’s results, see “HDA’s 2017 Manufacturer Serialization Readiness Survey Results“.
HDA provided an update on the development of their Verification Router Service (VRS) (see “Newly Published Material From HDA and C4SCS“). More on that in a future essay.
After the FDA update, my favorite session is always the one when the lawyers representing HDA discuss the recent FDA actions and guidance. They had a lot to discuss this year. For the most part, this was a review of the comments they have submitted to the FDA for each of the guidance documents that have been released this year (see “HDA Urges FDA…Please Re-Read The DSCSA“, “HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’” and “HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance“). Despite the negative titles of those essays, the HDA actually liked more about the 2018 FDA guidance documents than they disagreed with. But some of the parts they disagreed with, they really, really disagreed with them!
Sadly, I missed the session on “A Vision for 2023”, led by Perry Fri and a star-studded panel. I was busy in the hall having a great conversation with a dispenser. But I did make it to the dispenser panel session. For the first time, I found that the three dispensers on the panel seemed to understand their DSCSA responsibilities and have an appropriate level of appreciation for the difficulties they face in working with the other members of the supply chain in meeting them (see “Does the DSCSA Have A ‘Spirit’“). That was refreshing.
Something else that was refreshing this year was the number of young people who are being offered thought-leadership roles in the industry. As some of the original leaders retire or move on, it is heartening to see young people being given a more active role. These include speakers and panelists at this event, last year’s event, and other events, including:
- David Aguero, Manager, Medication Systems and Informatics with St. Jude Children’s Research Hospital
- Justine Freisleben, Senior Director, Industry Relations with HDA;
- Scott Hatakeyama, Director, Buy to Pay with Kaiser Permanente;
- Andrew Meyer, Traceability Lead / Senior Systems Analyst with Mutual Wholesale Drug Company;
- Arthi Nagaraj, Specialist, Supply Chain Processes with Sanofi US;
- Senthil Rajaratnam, Manager, Affiliate Relations, Global Serialization with Lilly USA;
- Michael Rowe, Manager, Operations Technology, Track & Trace, with Cardinal Health;
- Matt Sample, VP, Manufacturer Operations with AmerisourceBergen;
- Allison Sheldon, Senior Manager, Business Technology with Pfizer;
- Gary Tiamsic, Manager, Regulatory Affairs with Henry Schein.
It is very encouraging to see the level of understanding of the DSCSA, and the excellent thinking and presentation skills these people have displayed so early in their careers. Watch them. They’re going to go far, whether their futures have anything to do with the DSCSA or not. Doors are going to open for them, and they should. Congratulations to the HDA organization for recognizing their potential and giving them a chance to demonstrate it. This, plus HDA’s excellent career mentoring program shows us where their hearts are.
Every HDA Traceability Seminar is great. This one did not disappoint.