Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”). Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes. Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading. Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law.
For previous examples of HDA’s commentary on earlier FDA draft guidances and public meetings related to the DSCSA, see “FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers”, “HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance”, “HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’”, “HDA Urges FDA…Please Re-Read The DSCSA”, “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”, and “HDA Schools FDA On DSCSA”.
HDA’s comments on the latest draft guidance can be viewed here. A few other organizations also submitted comments (here is the full set of responses) but none rise to the level of importance of HDA’s. I do not normally submit comments to the FDA for their draft guidance documents, but I sometimes publish my review of them here in RxTrace (for some of my thoughts on the Verification Systems draft guidance, see “Most Companies Will Do DSCSA Verification Wrong” and “DSCSA: Verification Systems Draft Guidance”).
In my recent essay about verification, “Most Companies Will Do DSCSA Verification Wrong”, I extracted language from the FDA’s verification systems draft guidance to show why companies are likely to do it wrong. HDA’s comments around the FDA section I extracted from are very interesting. They don’t believe the DSCSA obligates drug manufactures and repackagers to respond to verification requests in any way other than to the statutory definition of “verification”.
“The DSCSA only requires that the manufacturer or repackager confirm whether or not the product identifier it received from a trading partner corresponds to one it affixed to a product. The DSCSA imposes no other duty upon the manufacturer or repackager.”
On the other hand…
“…[W]e believe that trading partners should have flexibility to try to resolve verification issues through business processes and SOPs without automatically elevating the issue to a full suspect product investigation […].”
Well, isn’t “trying to resolve verification issues through business processes and SOPs” what a “suspect product investigation” is? I don’t have a problem calling it that, even if the “verification issue” being resolved is just a communication issue. Once a verification request is issued, until you can fully “verify” a product, using the statutory definition, that product should be considered “suspect”. I think the main reason HDA doesn’t want these products to be considered “suspect” just yet is because they don’t want to have to quarantine them.
In my view, the entire “returned drug” area of a wholesaler’s warehouse should be composed of a quarantine area, and a non-quarantine area. All DSCSA products received on return should go into the quarantined area and not leave until they are found to be non-saleable or are verified as saleable. That way, if “verification issues” occur, those drugs don’t need to be moved because they are already in a quarantine area. But that’s just me, and maybe that’s one of those “over and above” the statutory requirements (see “DSCSA Verification and Suspect Product”).
I think the HDA seems to agree that it is a good idea for companies to go beyond that minimal statutory obligation by incorporating some of the additional capabilities that the draft guidance seems to say is obligatory. (This is one of the things I was trying to say in last week’s essay.)
“Wholesale distributors deem verification to be part of a broader collection of business processes and SOPs around suspect and illegitimate product and saleable returns. A successfully verified product may still be suspect or illegitimate and an unsuccessfully verified product may not be suspect or illegitimate. Verification is only one, narrow part of broader security measures trading partners must implement.”
“…[V]erification has proven to be a very difficult and complex matter. At this time, HDA does not believe there is consensus within industry as to whether or how to build additional intelligence and processes around verification generally and the VRS specifically because of recognition that a ‘yes’ or ‘no’ verification response may not ‘tell the whole story’.” (See “DSCSA Red Light Green Light: Verification Responses”.)
“A product can be verified and yet still be suspect (for instance, if the identifier that is the subject of the request is one the manufacturer assigned and has since decommissioned). A verification on a “good” product could fail (due to a scanning, formatting or user error). A product identifier could be verified as a “good match” and the product associated with the verified identifier could be legitimate, but nevertheless the product should not be dispensed or sold for other reasons.”
“In short, other processes, functionalities and messaging will need to augment verification to help assure that only safe, pure, potent products continue to move in the supply chain to patients. Industry is working diligently to resolve these many issues. We ask, in the meantime, that the Draft Guidance provide greater flexibility as trading partners work to implement this part of the DSCSA and build meaningful processes around verification functions.”
And then they propose some significant, rational changes to this section of the draft guidance.
I do not totally agree with everything the HDA says, but the vast majority of the proposed changes in this commentary is right on and the FDA will likely agree with most of their reasoning. In this submission, HDA proposes changes to a lot more sections of the draft guidance than I have covered here and it is all worth reading. It will be interesting to see which proposed changes the FDA picks up in their final guidance, and which they do not.