The Drug Supply Chain Security Act (DSCSA) makes it clear that the FDA must work with industry stakeholders to figure out exactly how the US pharma supply chain should meet its requirements after November 27, 2023–see DSCSA Section 582(g). That section specifies “The transaction information and the transaction statements shall be exchanged in a secure, interoperable, electronic manner…”. There is no mention of the creation of an independent third-party to design or coordinate that exchange, and, as I pointed out a few weeks ago (see “HDA Schools FDA On DSCSA“), the Healthcare Distribution Alliance (HDA) strongly opposes the establishment of a centralized system to ensure interoperability–something like the European Medicines Verification System (EMVS).
That much is clear, but I don’t know their position on the establishment of a non-profit, stakeholder member organization like the European Medicines Verification Organization (EMVO) to help the FDA define their requirements. Immediately after being formed, that organization would need to quickly and professionally make the hard decisions that will need to be made to design the industry data exchange technical architecture and processes for everyone in the supply chain to adopt and follow. Let’s temporarily refer to it as the “USMVO”.
To better understand what would be needed if a USMVO were to be set up here, let’s first take a look at what the EMVO is.
The EU FMD Delegated Regulation clearly specifies the creation of an organization like the EMVO. Under Article 31, “Establishment of the repositories system”, it refers to a
“…non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features.”
And, in setting up the system of repositories, those entities
“…shall consult at least wholesalers, persons authorised or entitled to supply medicinal products to the public and relevant national competent authorities.”
And about the funding of such an organization, they said,
“Wholesalers and persons authorised or entitled to supply medicinal products to the public are entitled to participate in the legal entity or entities referred to in paragraph 1, on a voluntary basis, at no cost.”
And just to be clear, they then said:
“The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features…”
Six months before the Delegated Regulation was officially published–but after it was clear what that regulation would ultimately say–the EMVO was formed with support from the major pharma supply chain industry associations in Europe.
Since its formation in 2015 the EMVO has pumped out the design of the system of repositories, the actual EU Hub central repository, and the high-quality documentation necessary for solution vendors and the industry to communicate with it. They are the central coordinators of the developments that were needed to meet the 2019 deadline. They made the hard decisions that were necessary, and if the industry is able to meet that deadline, the credit goes largely to the diligent work of the EMVO.
Could this approach work in the US? One reason it works as well as it seems to in the EU is that the approach is spelled out so clearly in the regulation itself. We don’t have that here, and that is probably why it hasn’t happened here yet.
The only way it could get started here now is if the major industry associations–representing drug manufacturers, wholesale distributors and dispensers–were to voluntarily decide that such an organization is necessary and is in their best interest.
The USMVO organization would have to be independent of each of the industry organizations but it would need to be funded by those organizations, at least at first. Without the need for a permanent centralized infrastructure the USMVO might not need to exist forever (unlike the EMVO which will need to exist into perpetuity).
The main job functions of the USMVO would be to make those hard decisions about how the DSCSA data exchange will need to occur after 2023 and publish the technical specifications suitable to ensure solution providers and stakeholders can implement solutions that are interoperable under that approach.
In my view, the establishment of something like a USMVO–and soon–is the only way the industry–and the FDA–has any hope of arriving at the 2023 deadline without total chaos, technically. The FDA is incapable of filling this role and there is no existing organization today with the mission, the credibility and the will necessary to accomplish what needs to be done. The Pharmaceutical Distribution Security Alliance (PDSA) comes closest because it is composed in the way I describe above, but, as far as I can tell, their mission does not align well with what is necessary here. Maybe they could spin something off that does have that mission.
Whether it is the PDSA or some new organization, time is running out.