Speed-date with the DSCSA pilot project sponsors

Bells didn’t exactly ring out when the organizations conducting pilot projects addressing the Drug Supply Chain Security Act (DSCSA) filed their reports with FDA. That agency had picked 20 companies or groups to evaluate a range of technical and business issues for DSCSA compliance, which has a 2023 deadline for completion. Some of the 20 made their reports public as early as February; others announced theirs in June, and some have not published anything.

Now, the Partnership for DSCSA Governance (PDG)—the creation of which, strangely, was one of the pilot projects—is holding a webinar on July 23 and 31 for the sponsors to present their findings. The webinar will be somewhat like speed dating: each presentation (18 of the 20 have signed on) will have an 18-minute slot. Some of the already-public FDA filings are 40+-page reports, so there will be some fast talking to make the presentations.

When FDA announced the program, it said that it “will end after the pilot projects are completed and FDA issues a final program report,” but that report is still in the works.

Industry slogs ahead

The pilot program was something written into the original 2013 DSCSA law, and there have been regulatory deadlines to be met since 2015. Currently, much of the US focus is on the requirement that wholesalers who receive product returns (usually, overstock from pharmacies) need to validate those returns with the original manufacturer before sending the product back into commercial distribution. The Healthcare Distribution Alliance had estimated that these “saleable returns” constitute 2-3% of total pharmaceutical inventory—a not-insignificant quantity, worth billions of dollars.

Wholesalers, and their solution providers, have been busy setting up “Verification Router Services” (VRSs) to accommodate the data-storage and messaging requirements for saleable returns validation. The original deadline for meeting the DSCSA requirement was November 2019, but that was pushed a year out. Now, because of the pandemic, industry insiders are concerned that the distribution network will be unable to meet a November 2020 deadline.

Registration for the webinar is accessible at: https://info.leavittpartners.com/dscsa-pilot-program-round-robin