Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch.  They are required to:

As I’ve documented many times now, “verification” is going to be a sticking point under the DSCSA and it’s going to be really hard to do right (see “What’s So Hard About Unique Identifier Verification?” and “Most Companies Will Do DSCSA Verification Wrong”).  The wholesale distributors have known this for a long time and they have made a solid effort to raise the understanding of the drug manufacturers and the FDA.  They proposed and kickstarted the development of the Verification Router Service (VRS) to help solve the expected problems (see “First Meeting of the HDA Verification Router Service Task Force”, “DSCSA: Saleable Returns Verification”, “DSCSA Serialization: What Wholesalers Expect” and “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers”).

But now, the VRS appears to be in trouble.  I keep hearing rumors that there are interoperability issues…and that important interoperability testing has not been done and no one has scheduled it.  And a growing list of manufacturers claim that they will not respond to verification requests at all, or will never respond with a “Yes”, regardless of what the DSCSA says.  There appear to be disagreements between the solution providers who are planning to offer VRS services, and between the companies who would be expected to buy and use those services. 

GS1 has already had to begin work on an update to their brand new verification messaging standard, which the VRS will use, and even when the update is complete, it won’t meet the needs of the industry, as I and others have spelled out (see “DSCSA Red Light Green Light: Verification Responses” and “GS1’s Messaging Standard For Verification Of Product Identifiers”).  I’ve heard “VRS is a mess” from multiple people in the industry.

It’s no longer a secret that several organizations have formally asked the FDA to provide “enforcement discretion”—a delay in the enforcement of the wholesaler’s 2019 requirements.  I can’t reveal which organizations, but it’s generally known in the industry by now.  Will the FDA agree?  I haven’t seen the formal requests so I don’t know how well they’ve developed their arguments, but I wouldn’t be surprised if they do.  In fact, I’d be surprised if they don’t agree, considering that they provided enforcement discretion to drug manufacturers back in 2017 when it became fairly obvious that so many companies were not going to be ready to apply the necessary 2D barcode by that November (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”). 

The wholesalers are unlikely to be able to verify a significant percentage of their saleable returns by November because of the problems with the VRS and because too few drug manufacturers are likely going to provide them with the list of SNI’s in each shipment.  Personally I don’t believe the list of SNI’s in shipments to drug wholesale distributors will comply, but the wholesalers do and the FDA hasn’t said it won’t.  The investment in GS1 EPCIS capability and the onboarding with the wholesalers needed for that VRS-alternative to work is not likely to occur by a sufficient number of drug manufacturers to fill in the gap. 

So in my view, the FDA will be forced to delay the wholesaler’s saleable returns verification requirement through enforcement discretion for up to a year, or risk losses in efficiency, profitability and potential spot shortages of drugs that could result from the inability of wholesalers to resell returned drugs that would otherwise be saleable.  And that would fulfill my prophecy of cascading delays of each deadline of the DSCSA from here on out (see “DSCSA Cascading Delays”). 

Given FDA’s recent history of super-critical DSCSA guidance being dropped on the industry at the last minute (see “FDA’s Late Recommendation On Human Readable”), I also wouldn’t be surprised if they give notice in the next few months that a list of SNI’s provided with an incoming shipment to wholesalers cannot be used later for the “verification” of saleable returns—something that, if they do intend to eventually say, should have been communicated years ago rather than now. 

The remaining question is, will they grant enforcement discretion for all of the wholesaler’s 2019 requirements, or only the SNI-based verification of saleable returns?  My bet is, only the latter.  What’s your bet?

Dirk.

2 thoughts on “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”

  1. These are great points regarding VRS enforcement and I have been asked this same question by customers. My response is similar to one of the other Big-3, “I can speculate but I don’t have secret insight into what the FDA will do. Until a decision is clear, we will continue to work as if the deadlines will be enforced.” There are definitely concerns by industry participants but the risk of noncompliance can be significant.
    I think it is important to act as if the law will be enforced or, at a minimum, define a contingency plan (with trigger points/dates) on your company’s action plan if the FDA does (or does not) choose to enforce the law.

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