Last week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain. The scope of work is:
“Development and implementation of a program for the pilot projects will include, but is not limited to: development of the program structure, determination of the scope of the pilot projects and what issues should be covered, ensuring the pilot project design fulfills the requirement of the DSCSA, development of an enrollment process for potential participants, development of timing and schedule, development of monitoring and reporting schedule, development of pilot project metrics and evaluation plan; and development of a communication plan. The pilot project(s) developed under the DSCSA need to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain, through
utilization of the product identifier for tracing of a product throughout the supply chain and may include verification of product identifier, including the use of aggregation and inference;
improvement of the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product; and
identification of system attributes that are necessary to implement the requirements established under the DSCSA.”
The RFP was posted on July 31, 2015 and responses must be submitted by midnight on August 13, 2015. As part of developing the program, the contractor will also help the FDA run a public workshop and docket to collect ideas and comments that will help guide the design of the pilots. The “period of performance” is eight months from date of the award.
Based on the timing in the RFP, I would guess we could see the public workshop for the pilot program development sometime in the next 5 or 6 months. I will guess no earlier than January, and so the pilots would most likely occur in 2016.
This work is mandated by DSCSA Section 582(j) “Pilot Projects”. For more about the requirements of the DSCSA, see “The Drug Supply Chain Security Act Explained”.
This will not be the only RFP the FDA issues for assistance doing a study under the DSCSA. Section 582(g)(3) of the DSCSA, “Assessment”, requires the FDA to enter into a contract with a private, independent consulting firm with the expertise to conduct a technology and software assessment that looks specifically at the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level. That assessment must be completed no later than May 27, 2021. I see no evidence that this new RFP has anything to do with this requirement, so watch for another one in the future. Nor does it appear that this RFP is for conducting any of the 5 public meetings that the DSCSA requires of the FDA in Section 582(i), “Public Meetings”.
So the fun is only beginning!