The FDA Drug Shortage List Signals Deeper Concerns for the US Medicine Supply Chain

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MMS Founder and CEO, Uma Sharma, shares her thoughts on the ongoing issue of drug shortages in the US.

While we continue to push forward on innovative and first-in-class therapies at MMS, I also subscribe to the FDA’s drug shortage alerts. My review this week was alarming as before and a continued signal of what’s bubbling under the surface in healthcare today and that is what prompted this blog.

The FDA’s drug shortage database helps illustrate how fragile the US drug supply really is. I say ‘illustrate’ because there is no commentary or analysis. It is just a running log of where supply is failing to meet demand in real time.

From Episodic Shortages to Structural Failure

The FDA defines a shortage as a situation where supply cannot meet current or projected demand. While that may sound straightforward, it is not. Because when essential drugs consistently show up on that list, it is no longer episodic but signals an underlying structural failure. Think of it like your grocery store having empty shelves in different sections week after week. At some point, you stop blaming individual items and start questioning the supply behind the store itself.

We as CROs are routinely asked about disaster recovery and business continuity by our sponsors. There is an expectation that critical processes have backup plans, redundancy, and clear pathways if something fails. It’s worth asking how that same thinking applies to the supply chain for many of these generic drugs.

The FDA points to manufacturing and quality failures as the primary driver of shortages. When a facility goes down due to contamination, inspection findings, or equipment issues, supply doesn’t taper, it drops. And in many cases, there isn’t a second or third manufacturer ready to step in. That is a reflection of how tightly the system is built, with limited redundancy where it matters most.

Shortages At the Point of Care

When you look at the list of shortages through a clinical lens, the most critical shortages are not niche therapies. They are oncology injectables, common ICU meds, anesthetics, and even basic hospital inputs like IV fluids. Drugs like carboplatin and methotrexate are foundational to cancer care. When they are in shortage, treatment plans are adjusted, delayed, or rationed.

I saw this firsthand when my sister was diagnosed with Stage 4 cancer, she was prioritized for a chemotherapy drug in shortage. We were grateful, but it was hard not to think about what that meant for someone earlier in their diagnosis. In a constrained

system, prioritization is unavoidable and always translates into real decisions about sequencing care. It also means that access for one patient often comes at the expense of timing for another.

The same dynamic applies across other high-impact categories. ICU drugs like epinephrine and norepinephrine are used in moments where there is no margin for delay. Anesthetics like propofol and midazolam affect surgical schedules and ICU management. Even products like saline, dextrose, and sterile water, which rarely get attention, are part of every hospital workflow and when supply tightens, the impact extends well beyond any single drug.

Underneath this is concentration risk. Many of these products, particularly sterile injectables and generics, are made by a small number of manufacturers. At the same time, a significant share of active pharmaceutical ingredients is sourced globally, primarily from China and India. That creates a system where a disruption in one location can ripple quickly across the entire healthcare ecosystem.

Why The Market Keeps Failing Essential Medicines

The economics here reinforce the problem. A large portion of these drugs are low-margin generics. Over time, that has reduced the number of manufacturers and discouraged investment in redundancy. Fewer players and limited buffer capacity may be efficient, but they leave little room to absorb disruption.

The FDA plays an important role in monitoring shortages and working with manufacturers, but it cannot require companies to produce a drug or maintain excess capacity. That means it is often managing the consequences rather than shaping the underlying structure. External pressures are making these dynamics more visible. Global supply chains are under strain from geopolitical tension, export restrictions, and cost pressures. Tariffs add friction by increasing input costs and uncertainty, particularly for imported components. They are not the root cause, but in a system with limited flexibility, they contribute to the strain.

One Shortage Sparks the Next

Demand shifts add another layer. When clinical practice changes or substitutions occur because another drug is unavailable, demand can increase quickly. For example, when one chemotherapy agent or antibiotic goes into shortage, clinicians don’t stop treating patients, they pivot to the next best alternative. That shift is often immediate and happens across multiple health systems at the same time. The result is that the pressure doesn’t stay contained to one drug in short supply. It cascades. A shortage in one product can quickly create secondary shortages in others that were previously stable. In some cases, these alternatives are not perfect substitutes, which introduces additional clinical complexity while also increasing utilization.

In a more resilient system, supply would have the flexibility to absorb these shifts. Manufacturers would have the capacity to scale, and there would be enough redundancy in the network to respond to changing demand. Here, that flexibility is limited. Production is tightly optimized, lead times are long, and additional capacity is not readily available. So instead of adjusting smoothly, the system amplifies the disruption. One shortage turns into several, and what starts as a supply issue in one area becomes a broader constraint across multiple categories of care.

Over time, our system has been optimized for cost, scale, and efficiency. Redundancy, geographic diversity, and surge capacity have not been priorities. That approach worked when conditions were stable. It is much harder to sustain in the current environment, where disruptions are more frequent and less predictable, and the system has far less room to absorb them.

The FDA shortage list is the grim reality of our times. Not just a collection of isolated issues but an early and consistent signal of where the system is under strain. Increasingly, that strain is concentrated in the areas that matter most for delivering care, which should give all of us pause as we think about how this system is expected to function going forward.

Final Thoughts

Advancing new and innovative therapies remains critical. At the same time, it is worth asking how sustainable that progress is if the basic scaffolding that supports everyday care continues to show signs of strain.

If we treat shortages as a periodic inconvenience, we will keep responding too late and at too high a cost. Strengthening the foundation will require more than monitoring, it will require incentives for redundant manufacturing, greater transparency across the supply chain, and planning for surge capacity before the next disruption hits. The shortage list is already telling us where the weak points are; the question is whether we will use that signal to build a more resilient system.