How a Government Shutdown Could Delay FDA Actions, Disrupt Pharmacy Operations

In an interview with Pharmacy Times®, Ron Lanton, Esq, partner at Lanton Law, detailed the potential consequences of a federal government shutdown on the pharmacy sector. Lanton explained that the shutdown could delay FDA reviews, inspections, and policy decisions, forcing pharmacies to navigate compliance issues with limited regulatory support. Lanton urged pharmacies to review their standard operating procedures (SOPs), consult legal counsel when needed, and maintain strong compliance practices. He also suggested that pharmacies consider temporary contingency plans, such as exploring cash-based models, and remain proactive by communicating with congressional representatives to stay informed and advocate for timely resolution.

This transcript was lightly edited for grammar and clarity using artificial intelligence.

Pharmacy Times: If a federal shutdown persists, how might it hamper FDA review timelines, inspections, or enforcement actions relevant to pharmacies?

Ron Lanton, Esq: Well, it will impact it, and the impact will be further delay. So there’s going to be a lot of delay around policy decisions and questions that a pharmacy may have. But once that shutdown is over, the FDA will pick right up where it left off. I think the most recent example, as nightmarish as it was, was COVID, where the FDA did shut down—but once everything started to open back up slowly, we just kind of picked up where we left off.

Pharmacy Times: What are the legal or compliance risks to pharmacies—including retail, specialty, and compounding pharmacies—during the period when regulatory support or oversight is constrained?

Lanton: Well, it’s not an ideal time, especially if you have questions that need timely answers. But I think you really need to keep up your best practices. I would advise reviewing your SOPs and possibly getting some advice from legal counsel when government officials are not able to readily answer questions that you need. But yeah, it’s definitely not an ideal time, and I hope they get this resolved quickly.

Pharmacy Times: How might delayed federal appropriations affect programs such as 340B, Medicare and Medicaid reimbursements, and FDA approvals that pharmacies rely on, and what contingency strategies, if any, should they consider?

Lanton: I think the delays affect funding and the continuity of a lot of these programs. We saw that when it came to telehealth and some Affordable Care Act (ACA) issues. I mean, that’s why they’re shut down right now—the ACA issues. I think some contingency strategies could be that pharmacies move more toward cash-based models. I know that we’ve talked to a lot of pharmacies about the Mark Cuban Cost Plus model and contracts for that.

For those that want to feel empowered and understand a little bit more about what’s going on, I would personally call some of your congressional representatives. It may not do much, but it might give you peace of mind to see exactly where everything is and maybe a little insight into when this might be over, rather than just hearing it secondhand from the news. I think it’s good to just be in the know anyway. Otherwise, it’s one of those “hurry up and wait” policies—you can’t really do much; you just have to wait it out. It’s stressful and uncomfortable, but like I said, to feel like you have some power, it might be good to call. And I think that actually hearing from a pharmacy—if I’m a senator or representative and I hear from a constituent—makes me want to hurry up and get it resolved, because I don’t look good. So that’s where I see things.