FDA Inaction On Fixing The NDC Indicates Why They Should Get Out Of The Numbering Business

It’s been eleven months since the FDA held their public hearing to collect ideas for fixing the National Drug Code (NDC) system (see “FDA Seeks Input On The Future Format of the National Drug Code” and “FDA New NDC Format Public Meeting”).  The FDA, themselves, estimated that they may have as little as 10 years before they run out of Labeler Codes, and that was over a year ago.  So now we have less than nine years?  My friends, it’s almost time to panic because the FDA seems to have dropped the ball after hearing from the industry that they would need at least ten years to prepare for any changes that the FDA may make (see “FDA New NDC Format Public Meeting”).

Briefly, the NDC system was defined back in the 1970s as a 9-digit number to identify drugs using a 4-digit “Labeler code” prefix to identify the company owning the marketing authorization of the drug.  Very quickly they realized they were going to run out of the 4-digit labeler codes so they made the full NDC a 10-digit code with a 4 or 5-digit Labeler code prefix.  The length of the other two fields were adjusted to keep the length of the NDC just 10 digits no matter the length of the Labeler code prefix (see “Anatomy Of The National Drug Code” for the full history and details).  Over the years, that difference in field lengths has cause problems, but the industry has learned how to work around it (kind of, see “An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon”).

It was inevitable that they would someday run out of the 5-digit Labeler Code prefix.  In 2016 the FDA buried a bombshell inside a lengthy Final Rule with the boring title of “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs”.  They said that it was a longstanding plan that the NDC was actually a variable length identifier, either 10- or 11-digits long, depending on the length of the Labeler Code prefix.  And once the 5-digit Labeler Codes were expended, they would begin issuing 6-digit Labeler Codes. 

Oops.  Sorry, that’s not going to work.  You can’t just flip that switch at some random time in the future.  It would blow up every existing system in the industry that has an NDC field.  And that includes the pharmacy and reimbursement company system that convert all 10-digit NDCs today into 11-digit “NDC-based reimbursement codes” (as I call them).  I documented the problems with this quiet “announcement” in my essay “NDC Nearing Its End, Afflicted by ‘Identifier Failure’”.

Apparently the FDA figured that out (I’d like to think someone read RxTrace but who really knows?), so they initiated the public meeting to discuss ideas with the industry for how that change would be implemented.  They got an earful, including my own snarky (but hopefully not disrespectful…it’s a line I walk pretty often, as you may know) presentation at the meeting (see “An Open Letter To The FDA: New NDC Format Public Meeting” and “My Comments Regarding The New NDC Format”).

Of course I have my own ideas about how the FDA should address the changes that will be necessary.  You can read them in the links about.  But that’s not really the subject of this essay.  The point I want to make this time, is that the lack of apparent action by the FDA since they held that public meeting last year is all we need to see why they should get out of the drug numbering business.  The resounding message of that meeting was that companies will need as much as 10 years to make and test the changes that will be necessary, no matter how the FDA decides to change the NDC system.  That means we need a final decision ASAP about exactly what that change is going to be.  No, we don’t have 10 years (now 9 years) to decide how to do it.  We need 10 years after they freeze the plan for how it will be done, to implement/test the changes that follow from that plan.

Based on that urgency, the FDA should have created a task force at the beginning of 2019 with the assigned task to drive to a final decision by the end of 2019.  Yes, it would have been hard to do.  Yes, it would have been time consuming and would divert the attention of a number of FDA workers—some of them high-up in the structure.  Yes it would have been contentious with lots of complaining from the industry (and snark from RxTrace), but it would have been done to avoid future disruptions to the operation of the supply chain.  Which means it would ultimately be aimed at protecting patients from shortages and errors.

If you allow yourself to think about what it really means, it begins to look like a freight train coming straight at us all.  Right now, it’s in the distance, but it’s barreling straight toward us.  We have time to do something about it, but we are frozen.  We can’t move.  We can’t do anything to get out of its way until the FDA decides how it’s going to work.  When that happens, will we have time to get out of its way?  Some of us will, but others won’t.  Then what happens?

Contrast this with the way GS1 and HIBCC deal with changes they have realized were necessary to their product identifier numbering systems.  They convene a group of volunteer end-users of their numbers and technical experts who work together with a sense of urgency and openness to evaluate the options, decide on the best one, and document the changes clearly.  I’ve been a part of many of those groups over the years and as imperfect as they appear while you are inside of them, when you look back at what was accomplished, you realize that the process works well.

What is necessary here is to change a product identification system.  One that is relied upon by patients, healthcare professionals, payers, and supply chain operators all at the same time.  That’s a hugely diverse group and they have diverse needs, but I’m confident those needs do not conflict.  It just means a lot of thought and planning will need to be applied to minimize the pain of conversion for everyone.  The FDA is clearly incapable of doing that.  They are regulators, not product identification experts.  They should definitely participate, but they should relinquish the lead to the professionals.  And they should do it NOW!

Dirk.

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