What happens with end of the COVID emergency declaration?

How to solve America’s drug shortage problem

Lisa Jarvis
Bloomberg Opinion (TNS)

Drug shortages in the U.S. are forcing physicians and the public to scramble for access to vital medicines. While the problem isn’t new, the number of products in scarce supply is nearing an all-time high — and could get worse as generic drug makers pare back on the breadth of products they manufacture or even shut down. The issue has gotten serious enough to be deemed a national security threat, and President Joe Biden’s administration has formed a team to try to address the issue.

To understand the root cause of these supply shortages and what’s needed to fix them, I spoke with Erin Fox, associate chief pharmacy officer at the University of Utah Health, who since 2001 has devoted her career to tracking shortages. Our conversation has been edited and condensed.

Drug shortages in the US are forcing physicians and the public to scramble for access to vital medicines. (Dreamstime/TNS)

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Lisa Jarvis: We’re hearing a lot about drug shortages now, whether that’s hospitals deciding who can have certain cancer medicines or parents struggling to fill their kids’ Adderall prescriptions. How does this compare to previous shortages?

Erin Fox: What's different now is that we have a large number of medications in shortage that are affecting both patients in hospitals [and] also at the pharmacy counter — even people just trying to buy simple over-the-counter pain relievers like children's Tylenol and children's Advil. All of these have been happening at about the same time, for a variety of reasons. But altogether, we're at the highest number of shortages that we've been monitoring in about 10 years. My team and I have been doing this work since 2001, and in the past few years, things had gotten a little bit better. But right now, it’s just about the worst it’s been.

LJ: In addition to tracking shortages, your team tries to understand their root cause. Why don’t companies share more information?

EF: It’s a frustrating problem. One of the reasons we began tracking these national shortage data is that our team of clinical pharmacists can provide recommendations to health care providers on alternative ways to mitigate problems. We try to provide information about what is available, what isn't available, and most importantly, why. It can be helpful to understand how long the shortage is going to last. With shipping [for example], the shortage will be fairly short. But if it's a manufacturing problem, a raw material problem, or some kind of a regulatory issue, we expect those shortages to last at least a year.

And yet that’s information companies don't have to provide. They also don't have to make the reasons public. Because it's not a requirement, many just choose not to. Not even the FDA has all of the information that they truly need.

LJ: What should be done to increase transparency?

EF: [One] thing is understanding which companies actually make which drugs and in which location. Often, when you look at the label of a drug, it will simply say “manufactured for,” and that drug company name. But it doesn't tell you the exact company that made the product. When you're trying to understand even what the overall supply chain looks like, you can look at the list for a specific drug and it might look like there are four or five suppliers. You might think, “Oh, this should be fine.” But sometimes, just one or two companies are making the drug and the other companies are relabeling it. That gives people a false sense of security in the overall supply chain.

LJ: How hard will it be to introduce that kind of transparency into the drug supply system?

EF: It would be a change to the labeling laws. Right now, you have to list the distributor or the manufacturer, and it would mean changing that or to an and.

LJ: Injectable drugs seem to be consistently in shortage. Why is that?

EF: Generic injectable drugs are hard to make. You have to make sure that they're sterile, there's no contamination, there's no bacteria growing. They’re much more difficult to manufacture than, say, a tablet or a capsule. We have fewer overall manufacturing facilities to make injectable products.

And in many cases, injectable products are very low margin. Hospitals really are incentivized to use the absolute lowest-cost products, so we kind of get a race to the bottom on pricing. Some companies are trying to compete, and they may cut their prices — and in doing so, they may cut corners on quality.

And they're made in batches that are not as large as tablets or capsules. In many cases, companies are making multiple products on the same manufacturing line and cleaning in between — that’s another reason it's not easy to switch or suddenly choose to ramp up supplies of a drug that’s in shortage. Because if they stop their current manufacturing process, it may result in shortages of many other drugs.

LJ: In March, you testified before Congress about the threat of drug shortages and told policymakers that resolving shortages of generic injectables might require raising prices. Will it be possible to convince people that some products might just need to cost more?

EF: Hospitals are already paying more [because of] the shortages. My argument is instead of paying to buy expensive alternative drugs, perhaps it makes more sense to just spend a little bit more on the products that we actually need every day.

That would mean knowing that the company is actually doing work on their end to have a business continuity plan, whether that's manufacturing buffer inventory to give themselves a longer lead time if there is a shortage, or perhaps having some redundancy in places in their supply chain.

We know that costs money. But these are very low-cost drugs — in some cases, like 50 cents a vial. If you raise the price to say 75 cents a vial, it is probably going to be worth it.

LJ: A lot of people have become acutely aware of drug shortages because they can’t get Adderall for themselves or their child. How similar is this to the other shortages?

EF: It's different, but it's a little bit the same. We have less information about why this happened. One company, Teva, had a staffing problem last fall because of an increase in COVID cases. That seems like something that that should resolve pretty quickly — for whatever reason, it did not. Then as people can't access one ADHD medication, they're moving on to another, increasing demand for the alternative.

There's been finger-pointing between the drug companies and DEA. The drug companies say that they need more of the raw material … and the DEA has said that they will not increase the quota for those medications because the drug companies haven’t [met] the quota.

We don't have good transparency into the system. What we cannot know is how much these companies [are] producing and how many prescriptions are not able to be filled. We have no transparency to even try to understand and calculate that delta.

With Adderall, because it's a controlled substance, it's much harder for patients to shop around and find a pharmacy that has product — and wholesalers limit the amount pharmacies can access.

All these things together are making for a very frustrating situation for patients and families.

LJ: Do you think the recent attention to the issue will result in meaningful change for patients?

EF: I hope so. The one bright spot of COVID is the attention that it’s focused on our supply chain. It used to be very hard to get any reporter to be interested in drug shortages unless I could find a patient who was harmed — which I understand! But now, it's very common to talk about why these shortages are happening and what we can do to fix them.

Everyone is angry at the FDA, yet at the same time, the FDA can't force any company to make a product, no matter how life-saving. This is an industry problem to fix. It's costly, but the benefits to society are so great.

— Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.