The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing...” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders“). The Pharmaceutical Distribution Security Alliance (PDSA) initiated the development of that new organization last year and we now have its name: The Partnership for DSCSA Governance, Inc., or PDG. I am told their website will be set up in the next few weeks, so until then, I have posted several of their public documents for RxTrace readers. Let’s take a look at them.
The Press Release
On December 16, 2019 Leavitt Partners, the law firm that facilitates the PDSA work, published a press release to announce the formal launch of the PDG (See “Nonprofit Governance Body Launched to Achieve Interoperable Drug Tracing“). The press release is pretty light on details but from it, we can see who the initial board elected in some of the leadership positions. Uptown Pharmacy owner and pharmacist, Max Peoples R.Ph is Chairman of the PDG Board, Senior Director of Government & Regulatory Affairs at Medline Industries, Inc., Matt Price is Vice Chairman of the PDG Board and Leavitt Partners Consultant, Eric Marshall is Executive Director of PDG. All are quoted in the press release. Also quoted is Vice President of Manufacturer Operations at AmerisourceBergen and PDG Board member, Matt Sample. Otherwise the press release is mostly fluff, as so many are.
The PDG Prospectus
The document with all the details is the prospectus, which was most recently been updated by the elected board members on January 7, 2020. Ultimately the Board will have 14 members with a balanced seat reservation for the three primary segments of the supply chain–dispensers, wholesale distributors/3PLs and manufacturers/repackagers–and two at-large seats (For coverage of an earlier version of the prospectus, see “PDSA Releases Prospectus To Prospective Governance Group Members“). However, in this special initial six-month formation period through April 1, 2020, the elected board has only 10 members, with balanced representation across the primary segments. Membership has been increasing steadily since it was opened earlier in the fall.
Most of the work of the PDG will occur in committees. Three main committees are planned: a Membership Committee, a Finance Committee, and an Interoperability Committee. Only the Finance Committee is limited to elected Board members. Most people interested in furthering the stated goals of the organization will want to participate in the Interoperability Committee and any of its likely sub-committees and work groups.
Under the Interoperability Committee there is currently one work group planned, called the Technical Work Group, which will be open to “…both general members and non-member thought leaders, such as service providers and other experts.”
The annual membership fees are provided in the prospectus. The only change to the dues since the original document was published last August is the addition of lower cost tiers for “Technical Experts”, including one new tier for technical experts with 25 or fewer full-time employees. That fits my business and the price is right so I am planning to join. I imagine a lot of other technical experts will join as well (see “PDG Technical Expert Application“). That should make the PDG the focal point of debate about exactly how to achieve interoperability for DSCSA data exchange. But the large number of voices from inside and outside the supply chain–many with vested or conflicting interests–will certainly require well-defined and strong controls to force decisiveness after debates have reached their point of diminishing returns. Without that, debates will go on forever. Of course, technical experts won’t get to vote, so that will help…as long as the leaders call for votes at the right times. That can be a tough call in some situations.
The initial formation committee and the initial 10-member board have accomplished a lot since it was seated on November 13, 2019. The prospectus lists the following key formation milestones:
- Entity Officially Incorporated, October 4, 2019
- Governance Body Kick-Off Meeting, October 14, 2019
- Board Elections, October 15 – October 30, 2019
- Board Officially Seated; Entity Officially Named the Partnership for DSCSA Governance (PDG), November 13, 2019
- Board Meeting; Committee Chairs Appointed, November 21, 2019
- Board Meeting, December 12, 2019
- PDG Membership & Prospects Meeting, December 13, 2019
- Public Rollout of PDG, December 16, 2019
- Committee Activity Commences, January 2020
Within the first year of business, the organization must accomplish the following additional milestones:
- Complete FDA pilot – Target date: April 2020
- Approve a business plan – Target date: July 2020
- Establish a high-level blueprint for interoperability – Target date: September 2020
Regular readers of RxTrace know that this organization is exactly the kind of thing I think is necessary to have any hope of reaching the Enhanced Drug Distribution (EDDS) phase defined for November 2023 in the DSCSA. The industry has taken a huge step by forming this organization with the expectation that the FDA will acknowledge it as the primary representative of the industry and will work with it to help define the requirements and the acceptable parameters of the EDDS. The industry has done their part and the ball will soon be in the FDA’s court. Do they even have a plan?