FDA’s DSCSA Pilot Project Program

The FDA’s DSCSA Pilot Project Program was intended to assist drug supply chain stakeholders, including FDA, in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.

Under this program, FDA worked with selected participants to explore and evaluate methods to enhance the safety and security of the drug supply chain. More information on the Pilot Project Program and Program participants is available here.

Of note, the Partnership for DSCSA Governance (PDG) Pilot proposal was submitted to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA), but responsibility for the Pilot transitioned to the PDG upon successful formation in November 2019.

Test, Learn and Refine

The PDG Governance Pilot Project was designed to test, learn from, and refine the organizational structure and processes of a DSCSA interoperability governance body (now formally PDG).

A precondition of the pilot work was successful formation of an independent, balanced, sector-neutral nonprofit industry governance body to support the secure, electronic, interoperable tracing, and verification of prescription drugs in the U.S. supply chain, as required by the DSCSA and according to pre-established industry principles of governance, such as engagement of all trading partner sectors of the supply chain is critical to achieving supply chain security and improving patient safety and that the governance body should promote balanced participation/representation among all trading partners—all sectors, company sizes, and business models—in carrying out its objectives.

Through formation of an independent, balanced, sector-neutral nonprofit industry governance body, PDG successfully demonstrated industry’s ability to collectively and collaboratively govern the DSCSA interoperability environment as needed to support successful implementation.

Testing the structural elements and processes to evaluate the ability of PDG to successfully govern the DSCSA interoperability environment required PDG to formally exercise each process within the context of a substantive use case. Therefore, in addition to testing and evaluating governance processes, the Pilot Work Group (a subgroup of the Interoperability Committee) was able to examine, solve for, and provide clear recommendations to the Interoperability Committee on the business requirements for confirming if an entity engaged in interoperable verification and tracing is an “authorized” (as defined in DSCSA) trading partner (i.e., manufacturer, repackager, wholesaler, third party logistics provider, dispenser).

Pilot Project Completion

Completion of the Pilot Project, including evaluation of the established PDG structure and governance systems, showed that the PDG governance structure is sound, that PDG members are effectively engaged, that meaningful progress toward 2023 interoperability can be made within PDG, and that PDG has been successful in abiding by the key principles of governance.

In addition, the PDG Pilot Project helped PDG understand where governance processes can be marginally modified to improve PDG operation and effectiveness. 

Full results and key learnings of the Pilot Project are included in the PDG Final Pilot Report.