PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders

Last week the Pharmaceutical Distribution Security Alliance (PDSA) held a workshop for interested stakeholders to brainstorm just how their proposed independent, balanced and sector-neutral organization might meet their vision.  This was the follow-on meeting tied to the publication of two documents last month that provided their “vision” and the actual proposal for the organization (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability”). 

The meeting was attended by about 80 people from U.S. pharma supply chain stakeholder companies, solution providers and at least one person from the FDA.  During the last session of the day, the organizers presented a suggested timetable that would have the organization fully operational in about one year.  They also provided a range of estimates for the total cost to create such an organization.  I can’t provide you with their cost figures but I am sure the organizers would be willing to share it with you (see contact info below).

As a workshop, the organizers wanted to make sure people felt free to be creative in their discussions so everything was treated as “off-the-record”.  I’m happy to honor that, but it means I can’t explain in RxTrace what was said.  I’ll only say that the discussion did not deviate very far from what PDSA wrote in those two documents, but many good questions were raised by the attendees.  I can say that I asked one question related to the two “at-large” board members.  It’s a pretty arcane question but I will share it with you as I recall it now.  I asked, “Don’t the two ‘at-large’ board seats threaten the ‘balance’ and ‘sector-neutrality’ of the organization, especially considering the likely differences in the number of members between the three sectors?”

Let me explain.  As currently defined in “White Paper #1” from the PDSA, the board of directors would be composed of 4 representatives from the manufacturer sector, 4 representatives from the wholesale distributor sector, and 4 representatives from the dispenser sector.  So far so good.  Sounds balanced and sector-neutral.  But then, they propose two “at-large” board members which would be elected by the general membership without regard to their sector, except that both must be from different sectors.  The effect of this is, two sectors will have 5 representatives on the board, but the third sector will have only 4 members.  Oops.  That’s not balanced, and so it could end up not being sector-neutral.  That’s the point of my question.

The answer was to explain why they decided to include those two “at-large” seats but that, once formed, the board could make adjustments to its own constitution.  Sure, but once you include those two at-large seats, they will be impossible to get rid of, even if they end up tipping the balance and causing a loss in confidence in the overall organization by members of that one sector that is represented by only 4 members.  I think that’s true no matter which sector would end up getting the short end of the stick.  So in my view, the answer to my question is, “yes, those at-large seats do threaten the balance and sector-neutral goals of the organization and therefore they threaten the long-term viability of the whole thing.”  We’ll see.


As far as I can tell, the PDSA has not assigned a name to the organization they are proposing.  That’s unfortunate because it makes it hard to explain when people are talking about the proposed future (unnamed) organization, and when they are talking about the PDSA.  If we had a spiffy name for the proposed organization, it would be easy to make that distinction clear. 

PDSA insists they do not intend to be that future organization and that they are only facilitating its creation.  That’s fine, so the future organization will not be called “PDSA”.  And it won’t be called “GS1”, “HDA” or any other existing organization.  I assume the organizers expect the initial board of the future organization to decide what they want to call themselves, rather than PDSA choosing the name, but I’m not sure that’s so important.

So what should we call it? 

  • “DSCSA Stakeholder Governance Organization”, (DSGO)?  No, www.dsgo.org is already taken.
  • “Interoperability Governance for DSCSA”, (IGD)?  Maybe, www.igd.org appears to be “for sale”.
  • “Drug Supply Chain Governance Organization”, (DSCGO, pronounced “desk-go”)?  Maybe, www.dscgo.org is available.
  • “Drug Supply Chain Interoperability Governance Organization”, (DSCIGO, pronounced “D-sig-O”)?  Maybe, www.dscigo.org is available.

Or should we go for some name that isn’t descriptive at all.  You know, like “Origin” (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”).  That’s taken, but you see what I mean.  How about “Interop”?  www.interop.org is available, for a hefty price.  Of course, just because a domain name is available doesn’t mean you won’t run into trademark issues (see “How RxTrace Became The Target Of A Counterfeiter”).

What’s your idea for a name?

I look forward to this organization getting formed.  If you want more information about it, contact Eric dot Marshall at Leavitt Partners dot com, or send me a message and I’ll put you in touch with him.