Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”). Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023. Forward motion has been made over the last month on two fronts: The DSCSA governance organization and the Verification Router Service (VRS).
I understand that the DSCSA governance organization has been formally formed and a name has been chosen. I just don’t know what it is yet. My normal source for information about this group is a staff member of the Pharmaceutical Distribution Security Alliance (PDSA), the group that kickstarted the governance effort. But now that the new group has begun, it is fully independent of PDSA and wishes to control the information flow about the group itself. That is appropriate, but the result is that no official information is getting out, as far as I can tell. The new organization relies on volunteers within the member companies to do the groundwork—including marketing and press communications—and they clearly have a lot on their plate right now, so I’ll have to follow-up this essay with another one once I get the details. Of course, readers who are members of the new governance organization (whatever it’s called) will know a lot more than those who—like me—are not.
As I said, the one thing I was able to learn is that the group has started, they have elected their board of directors, they chose a name and they have bought an internet domain name that matches the organization (for my ideas for the name, see “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders”). So far that makes them right on schedule, as they defined it back in the summer (see “PDSA Releases Prospectus To Prospective Governance Group Members”). According to that schedule, they have until the end of January to acquire tax exempt status as a 501(c) legal entity, and the middle of February to draft the organizations official articles and bylaws. All that time, someone will be working on their FDA DSCSA pilot that covers the formation of a governance organization. Basically, they have to write a report about the issues they encountered during their formation. I can’t wait to read it.
The other front moving forward is the VRS and its prime mover is the VRS Task Force. That group was originally kicked off by the Healthcare Distribution Alliance (HDA) almost 3 years ago (see “First Meeting of the HDA Verification Router Service Task Force”). While the HDA doesn’t seem to want to facilitate or lead the organization, it also doesn’t seem to want to let go of it. It seem to me that as soon as the new DSCSA governance organization gets fully operational, the VRS task force should become a permanent subcommittee under it, but I’m not sure HDA would agree. I think it would not be a good thing to have multiple organizations with overlapping governance purposes, and the VRS should not be a temporary task force but should have a permanent existence. That new organization is the right place for it.
The VRS Task Force met about two weeks ago to discuss a plan to capitalize on the year given to the wholesalers and manufacturers by the FDA to get their returns verification technology working smoothly (see “No Surprise: DSCSA Verification Delay”). Fortunately the HDA posted a read-out of that meeting, less than one day after it occurred (ahem, attention new DSCSA governance organization…see how it’s done?). You can read Justine Freisleben’s post about it on the HDA blog here. The Task Force agreed on a plan for the next twelve months to wrestle the VRS from the “mess” it is has been described as today, into the reliable, interoperable, easy to use, responsive and error-free solution it was always intended to be by the time the FDA’s enforcement discretion ends next November 27. Make sure you read Ms. Freisleben’s post for the full plan.
The industry has stepped up on two fronts. Now it’s the FDA’s turn to step up.