The FDA held the first of three scheduled DSCSA public meetings last week. This one focused on:
- The vision for 2023; and,
- The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.
The meeting started off with short presentations by representatives from:
- Biotechnology Innovation Organization (BIO)
- Association for Accessible Medicines (AAM)
- Healthcare Distribution Alliance (HDA)
- National Association of Chain Drug Stores (NACDS)
- American Pharmacists Association (APhA)
In the short time they were each given, these speakers represented the positions of their organizations well. Those representing supply chain members were rigid in their preferences to stick to requirements contained in the law for 2023, but they did not all agree on everything.
In several brief presentations throughout the day, and in handout material and their slides, the FDA made it clear that they see benefits in going well beyond the requirements that are contained in the law for 2023. That exposed a gulf in goals that was the undercurrent of the rest of the meeting.
Most of the meeting time was spent in small group discussions, as those who have attended FDA supply chain security meetings in the past are familiar. FDA assigned seats at each table, attempting to balance each table with representatives from manufacturers, wholesale distributors, dispensers and solution providers or consultants. Each table also was assigned an FDA scribe and a facilitator. I was assigned a table that had a great balance and perhaps one of the better facilitators. Two of the industry association speakers were at my table too, which made things particularly interesting.
Right off the top, our table started talking about things that went beyond the requirements of the law. In my view, the industry has enough to do just to meet the requirements of the law by 2023 (in fact, well more than can be accomplished by then), let alone going beyond those requirements, and I don’t like “wasting” time brainstorming things beyond that when time is so precious. So I pointed out that the topic was outside the 2023 requirements. The FDA facilitator challenged my attempt to realign, saying that we need to consider things that go beyond the requirements. That set the stage for the rest of the day.
Many of the attendees seemed to be fine with discussing things that I would consider “off-topic” for what the industry is facing, but there were definitely those who had a similar belief. You could tell by the questions they asked and the comments they made—and sometimes their facial expressions.
One person told the FDA panel during a Q&A segment that the industry will need the FDA’s “vision” for 2023 by the middle of 2018 so there would be sufficient time to design and implement solutions. Sounds like me talking, but it wasn’t. In response, an FDA official simply pointed to their slide titled “Vision of the 2023 for the Drug Distribution System”, as if to say, “you don’t have to wait another year, here is our vision for you right now”. The slide had five bullets on it.
But the most concerning part of the whole day was near the end when an FDA speaker responded to a question about governance with the implication that they were waiting for the industry to start organizing their own governance and solutions to meet the 2023 requirements (and beyond). At least that was my interpretation of what was said. In that comment it seemed like there was a major disconnect about what the industry is waiting for and expecting from the FDA, and what the FDA is waiting for and expecting from the industry. If my interpretation is right, it would be a shocking thing coming from the FDA, who, in some ways appears to be actually withholding mandated guidance, and consequently leaves many in the dark about what to do right now, let alone 2023 (see “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”).
What I think is needed is for the FDA to provide their detailed interpretation of the DSCSA 2023 requirements and then debate with the industry over that interpretation. Let companies and industry organizations propose solution architectures, along with pros and cons, until we have a well-defined set that we can vigorously debate. And then, to ensure interoperability throughout the supply chain, this diverse group has to pick one. And you can’t do that in only three rigidly controlled public meetings over six months.
The FDA wanted to start out with requirements and did not want to leap directly to solution models. I get that. They’re right, but the few requirements for 2023 are already spelled out in the DSCSA. We should focus on those, and just make sure the solution architecture selected does not specifically block the eventual implementation of all those extras the FDA wants to talk about today. That part should be easy.