HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA

The final day of HDA’s Traceability Seminar built off the established momentum of day one, with a panel that was centered around “Legal Perspectives for DSCSA Compliance Legal Teams,” with Ilisa B.G. Bernstein, president of Bernstein Rx Solutions, LLC as moderator.

She was joined by Jennell Bilek, equity partner, Carlson Caspers; Chris Smith, senior counsel, Epstein Becker & Green, P.C.; and Theodore Sullivan, partner, Quarles & Brady LLP, to discuss their insight surrounding some of the more common questions that they encounter in their practice, pertaining to the management of standard operating procedures (SOPs), stabilization efforts, and plenty more.

Please note that the conversation below has been edited for length and clarity.

Bernstein: In regard to SOPs, how have you been working with your clients to implement or draft procedures, specifically when it comes to suspect and illegitimate products?

Bilek: I’m probably speaking to the choir in stating that SOPs are very valuable—not only valuable not only in terms of your employees knowing what to do, but also understanding that there's always going to be mistakes, whether it's a machine or it's a person, and it's a lot easier to negotiate and work with an agency or another private party to acknowledge that there may have been a mistake, here’s our SOP. Everyone should know this because if you're licensed—whether it be a state board of pharmacy, Department of Health, the FDA, or you have to comply with cGMP, you have SOPs in place already.

I think what DSCSA has done is just make sure to look at your SOPs and make sure that you've added the extra detail and the little nuances that have come from the Act, and when I say little nuances, just from maybe more of a legal perspective, not talking about interoperability at all, and the conflict of complexity with the data exchange that is needing to happen. If you already have SOPs in place, it involves—in my experience—tweaking them that to be a little bit more precise and detailed on things like product identifiers and non-saleable returns.

Smith: I am still amazed at the number of clients that come to me who are just getting around to wanting SOPs. I still see that. I always remain shocked by the level that exists of lack of awareness of the DSCSA even 11 years out.

Just to give it some other context for the SOP issue, if you're going through a sale of acquisition, it's to come up in diligence, increasingly these days, and if you don't even have them, there's going to be questions about whether you're really complying with the DSCSA. Is that some potential lagging liability for buying or even it isn’t, have you had any issues? Are you really practicing what you have in place? Additionally, I've seen it come up in adverse actions against entities—recruitment actions—where the lack of SOPs came up as part of the basis for payer recruitment. There are a number of contexts in which this could become important as we move forward.

Sullivan: One of the top questions in my acquisition checklist is show me your compliance SOPs. But beyond SOPs, one thing has come up with inspections is that companies will have SOPs, but they're not following them, and there's no documentation of training. It’s important to have the SOPs, train your people, and document the training.

When you develop SOPs, it does not just put you in attempt to compliance—it really does increase your understanding of the requirements. We work through SOPs, where the client. in drafting them, will come to me with questions such as, “we thought we understood this, but what does this mean once you start really digging into it?” So it'll raise attention to areas where you may not have full understanding of requirements, and actually increase your compliance beyond just the SOPs.

Bernstein: The last year has been a time where the supply chain and trade partners are supposed to be working with each other and stabilizing those connections. What have you been talking with your clients about, in terms of pilots?

Smith: I think it's beyond frustration here. The issue was highlighted by Kevin [Nicholson] and NACDS [National Association of Chain Drug Stores] in their outreach to the FDA.

Bilek: As trading partners, people are used to making sure that they comply and not have to worry as much about what everyone else is doing. And I think one of the challenges is that everyone is supposed to work together, and that means they're supposed to work together with their competitors as well.

More of the specifics that I get are, why do I need a GLN [global location number]? Do I really need a GLN? For probably most of you, I’d advise to get a GLN. It's so much easier, as you can track the location, so much easier than an address. From other perspectives, maybe your facility is actually not in the United States, why do I need to do this? It's not actually in the statute. Now these things are certainly a good guidance and recommended, but if you look at the statute, and from my perspective as an attorney, it is not actually specifically or explicitly in there.

That can sometimes be frustrating for people, but I feel like, particularly in the last six to eight months, more companies are kind of just getting on board with that. The excess data standard is much more complicated, and I think that's where there's a lot of vendors out there as well, whether you do your own setup of that or not—or use a utilize a vendor—I think it all just sort of stems from this mindset that we're all competitors, and all these entities are competitors, and yet, everyone's supposed to be exchanging information in a little bit more detail than we have, or that people have in the past.

Sullivan: Regarding guidance versus law, you may win the battle, but if you have an inspector telling you have to do it this way because guidance says so, you still need a Form 483 observation if you're not in compliance with the guidance.

Reference

Bernstein IBG, Bilek J, Smith C, Sullivan T. Legal Perspectives for DSCSA Compliance Legal Teams. August 28, 2024. HDA 2024 Traceability Seminar. Washington, DC.