FDA New NDC Format Public Meeting

I attended the FDA’s New NDC Format Public Meeting last Monday where I presented my open letter that was last Monday’s RxTrace essay (see “An Open Letter To The FDA: New NDC Format Public Meeting”).  After a welcome from Dr. Janet Woodcock, Director, FDA, Center For Drug Evaluation and Research (CDER) and a brief overview of the purpose of the meeting by Paul Loebach of FDA CDER, there were nine presentations from stakeholders and the public.  After each presentation, the FDA panel asked questions of the speaker.  Questions from the audience were not allowed, apparently due to the way the meeting was classified.

Presentations were made by:

  1. Patricia Milazzo, Wolters Kluwer Health
  2. Kevin Nicholson, National Association of Chain Drug Stores (NACDS)
  3. Michele Davidson, Walgreen Co.
  4. Michael Stecher, Apotex
  5. John Klimek, National Council for Prescription Drug Programs (NCPDP)
  6. Tom Bizzaro, First Databank, Inc.
  7. Dwight DeVera, RXTransparent
  8. Dirk Rodgers, Systech International and RxTrace
  9. Peter Sturtevant, GS1 US

Leyla Rahjou-Esfandiary, FDA CDER made some brief closing remarks.

The purpose of this essay is not to recap the entire event.  If you want that, I suggest you check out the FDA’s webcast recording of the event.  I’m just going to discuss some of the ideas that stuck out for me, one way or another.

It was a good meeting and the FDA panel asked some good questions.  It sounds like Paul Loebach has a technical background and because he works with the FDA drug registration and listing service, he should be able to fully understand any of the technical issues surrounding this change.  If I heard him right, he wrote the software for that drug registration and listing service back in the early 1990s.  I didn’t get the feeling that any of the other panelists had a technical background, but one person should be enough to help the others understand the technical significance of the various options.

The FDA wanted each of the speakers to weigh the pros and cons of their Options A, B, C and D posted on the meeting website, and include their preference in their presentations.  I don’t remember anyone expressing a preference for A, B or C.  As I recall, everyone who expressed an opinion of their favorite chose Option D.  I was opposed to all of the options, including D, because they will all result in multiple identifiers for every drug package, which I think will increase risks to patients.

Most speakers expressed strong support for identifying a single date when the switch to the new format would take place.  A single date, way out in the future, will allow companies to make the necessary changes and investments necessary to be ready for the change.  Several pointed out how this change will have ripple effects in their systems similar to what happened for Y2K.  Everyone—including the FDA—acknowledged that this will be a very costly change and will require changes to many systems—including theirs.

I was particularly impressed by the presentations made by Michael Stecher, Tom Bizzaro and Peter Sturtevant.  Together, our four presentations complemented each other nicely.  Michael called upon the FDA to eliminate the “smart-code” feature of the current NDC system when they move to a future format.  What he meant is to eliminate the three data elements that cause the current NDC to be split into three segments.  That is, the Labeler Code, the Product Code and the Pack Size (see “Anatomy Of The National Drug Code”).  Eliminating all of those segments and treating the NDC as a single unique identifier for a single drug and its package configuration would open up more numbers without needing to expand the Labeler Code segment.  The Product Code and Pack Size would just become attributes stored in the product master data instead of inside the NDC.

Michael proposed the possibility of getting GS1 to add another two-digit “country code” (currently only “03” is usable for US drugs) to their GS1 US Global Company Prefixes (GCPs), which, if coordinated with the FDA, could open up additional Labeler Code numeric ranges.  That way when the FDA expands the Labeler Code to 6-digits, GS1 would begin assigning GCPs with that new country code range.

What I liked about Michael’s presentation is that his ideas were aimed at keeping the expanded NDC inside of a GTIN-14.  That doesn’t make it a single identifier for every drug, but at least is isn’t as bad as having two completely different identifiers for every one.  I’ve known Michael for quite a few years and I like the way he thinks.

I did not know Tom, but I also like the way he thinks.  He agreed with much of what Michael had said, including the elimination of the “smart-code” character of the NDC.  He explained that was only done years ago to assist with manual processes and it has no place in the computer-age.  Amen.  Tom advocated for just using GTIN-14s as NDCs, which is right in alignment with my thinking (see “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”, “UDI And The Approaching End Of The NDC” and “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”).

I decided not to propose the full idea of changing the NDC system into something like the UDI system of identifier definition and assignment because I felt that topic would be too deep and I thought I would lose the panelists in the technical details.  I just focused on exposing the risks to patients of having two different identifiers for every drug package, and how it could get much worse when they expand the Labeler Code to 6 digits.  Their goal should be to lower risks to patients by getting to a single identifier for every package and then get everyone to use it.  Exactly how that is accomplished is secondary.

Peter’s presentation connected many of the topics that Michael, Tom and I had opened with the panel and he was able to answer their questions about what GS1 would be able to do, and, more importantly, what GS1 is not likely to do to make this transition a smooth one.

Some on the panel proposed that GS1 expand their GTIN structure from a 14-digit to a 16-digit identifier to accommodate the enlarged NDC.  I had been asked the same thing during my Q&A section, and I expressed doubt that GS1 would be willing to do that for a single vertical market in a single country.  These panelists seemed to believe that GS1 should adapt the GTIN to the FDA’s identifier decisions, much like they did back in 1973 when the UPC was defined to be compatible with the brand new NDC system.  Peter stated firmly that GS1 would not do that because the GTIN is a global standard used in many industries.  His firmness on that question seemed to rattle more than one panelist.

Peter also explained more about how Unique Device Identification (UDI) works using GS1 issued identifiers as a potential model for the NDC (see “FDA Proposed UDI: A Revolution In Number Assignment”).  It seemed to me that some of the panelists might be receptive to that approach, but I don’t think they understood the full extent of the idea and its implications.

The next steps are for everyone to submit their comments to the FDA’s open docket on this topic before January 5, and then FDA will read them, and determine their next steps at that time.  I just hope they realize we don’t have a lot of time to waste before we have a solid specification for how the new NDC system will work.