3 [Potential] Solutions To A More Resilient Supply Chain

By Katie Anderson, Chief Editor, Pharmaceutical Online

At the 2025  RAPS Convergence in Pittsburgh, Carrie Harney (US Pharmacopeia), Demetra Macheras (AbbVie, on behalf of ISPE) and Athanasios Lapatinas (European Medicines Agency) hosted a panel discussion on “Building Resilient Drug Supply Chains.” In her opening presentation, Harney noted that there were 98 drug shortages in 2024, 40 medicines in shortage for over three years, and the average duration of a shortage has increased from three years to four years. She added that lower priced drugs have a higher shortage risk and presented three potential solutions to strengthening the supply chain—improving visibility, scaling new methods of manufacturing and incentivizing resilience. I had a chance to catch up with Harney after her presentation to get more of her thoughts on the issue.

Q: Can you shed some light on why it is taking longer to resolve drug shortages now versus a few years ago?

Carrie: Sure, and I think this is something that we've uncovered as we've started to do some of these longer term analyses of drug shortages. When we think about the nature of the products, I think that with the ones experiencing these persistent shortages, there are several characteristics that many of them share. And as I mentioned in my talk, one of those is this idea of it being an older product, most likely generic and lower priced.

We have found when we have these lower prices for products, that can disincentivize and really complicate the ability to reinvest in quality systems, to invest in redundancy. And so I think that's probably one of the characteristics that might be driving some of these persistent shortages is just the economic nature of the market.

Q: So, the big question is well what do we do about it? How do we prevent drug shortages? How do we make the supply chain more resilient? You had three potential solutions, the first of which is greater visibility into the supply chain. Can you talk a little bit about how we look at the end-to-end supply chain and have better visibility on it?

Carrie: Well, first of all, I think it is just acknowledging the fact that we need to do so. I think for a long time there hadn't been the recognition that the supply chain goes all the way up to key starting materials. And then as science is evolving, and our ability to do this mapping through public sources, through looking at lots of different sorts of data, I think that's how we're going to get that bigger and more full picture of the supply chain. And I think it's important to think about having the visibility, but then using that visibility to develop the insights that speak to what is driving the vulnerability and is this really a vulnerability here? And so it's putting that data together in a way that can be impactful.

Q: To your second point with the process technologies and applying some of the newer process technologies to speed up manufacturing and reduced shortages, you had mentioned that 69% of shortages are sterile injectable drugs. How do we apply some of those process technologies not only to the oral solid dose where it's easily applicable, but also to injectables?

Carrie: That is a very good question. But I think it can start first with looking at the ingredients of what is going in. Because even what we have found is maybe when we have concentration of key starting materials in certain areas and we want to try to make those in different areas, can we make those differently? And so that might not be the sterile injectable, but just starting with that ingredient. But I would probably say we should talk to some of my colleagues of a little bit more knowledge in getting into the science part of that.

Q: I'd love to talk about your last solution point that is incentivizing supply chain resiliency. Can you talk a little bit about how we can incentivize supply chain resiliency, how the government can help what the USP is doing and how manufacturers can get involved in some of that incentivizing?

Carrie: I think this is the one that can be most impactful in the long term, and I think it starts with first understanding and having a common definition of what is resilient. Right now, there just isn't that common definition. We may have purchasers who are making decisions, but they are using their own criteria.

We think that there is value in setting a standard benchmark that can comprise several factors, but really can assess that baseline of resilience. And then using that benchmark kind of consistently across different purchasers helps to, I think, drive some consistency in decision making and think about the factors that we can pull into that benchmark, which could include some of the use of new technologies, domestic manufacturing, some of these other things. So, it's just a matter of kind of building that one accepted standard that then can be used across different purchasers and manufacturers can be involved in thinking about what are the relevant factors that define resilience, because we want to make sure it's something that's practical and implementable from the beginning.