Complying with the DSCSA

PC: Back in June, the Partnership for DSCSA Governance (PDG) and the FDA held a joint public meeting on DSCSA implementation and stabilization efforts which you attended and spoke at. What exactly was the purpose of the meeting, and what was accomplished?

Rowe: Back in middle of June, there was a public meeting that was facilitated by FDA in partnership with the PDG which is the Partnership for DSCSA Governance, which is a group that's really working collaboratively to work on standards on how to comply with DSCSA. The FDA is actually a sitting member within that committee. The purpose and intent behind the meeting was really to act as a listening session, almost like a check in on how things had progressed from the stabilization period announcement back in August of last year—how well had industry moved to enhanced drug security—and so it gave an opportunity for different stakeholders to provide their perspectives, to share what's going well, share what's not going well. That was really the main intent. It was a listening session, primarily, and that was its intent, and was that accomplished? I think we'll have to see how the FDA responds after being at that meeting. It was also an opportunity for the FDA to share a little bit about their perspectives, and they made it very clear at that meeting that the stabilization period will not be extended in a broad manner.

Despite some of the challenges that a lot of industry players have, I think a lot of progress has been made, but there're still a lot of concerns about what I call these clerical exception-based errors causing product that really is good, but keeping that from further being distributed. At the same token, regarding balancing patient safety for medications that really shouldn't be in supply chain: how do we curb that?