AMNA NAWAZ: The U.S. is in the midst of an ongoing prescription drug shortage, with more medications in short supply for longer stretches of time.

Laura Barron-Lopez has more on what's behind it all.

LAURA BARRON-LOPEZ: Amna, drug shortages in the U.S. are the highest they have been in the last nine years.

Based on the most recent data, drug shortages increased by approximately 30 percent between 2021 and 2022.

Medications currently in short supply include chemotherapy drugs, antibiotics, ADHD medication like Adderall, and other critical drug drugs used to treat a variety of conditions.

It's a reality making treatment decisions difficult for doctors and patients.

Erin Fox is tracking the shortages.

She's a national expert on drug shortages at the University of Utah.

Erin, thank you so much for joining us.

Can you help us understand what is happening here, how severe the current drug shortages are, and how many drugs are actually in short supply?

ERIN FOX, University of Utah: So, I think, when people think of a shortage, you think of something that is completely, 100 percent out.

And that's not the case with the drug shortages that we have right now.

You can usually get some, but it's not enough.

And so that means that some patients are getting rationed care, some patients are able to access medicines and others aren't.

And so that's a really frustrating situation right now.

LAURA BARRON-LOPEZ: Out of the drugs that are in short supply, which ones are having the most detrimental impact on patients?

ERIN FOX: I think the most frustrating and the most detrimental to patient care are the chemotherapy shortages.

We just don't have alternatives for these agents.

And it's one thing to have cancer and be struggling with that.

But then to add on the fear that your treatment will not be available, or you may get a lower dose, or your treatment just may be delayed in some way, that's really frustrating.

So I think those are probably the most impactful we have right now.

LAURA BARRON-LOPEZ: And what is actually causing these shortages?

Is it manufacturing?

Is it competition with China, labor shortages?

What exactly is creating this situation?

ERIN FOX: That's a good question.

In a lot of cases, we don't know the true root cause of many of these shortages.

Drug companies are allowed to keep that a secret.

But we do know from FDA's data that, most of the time, it's a manufacturing problem, a quality issue at the factory.

And that's exactly what's happening with the chemotherapy shortages.

There was a factory in India that had some really severe quality problems last December.

They had to close to fix those.

Unfortunately, the other companies can't make up the difference and really have an uninterrupted supply.

LAURA BARRON-LOPEZ: Transparency is something that some lawmakers in Congress are hoping to address.

They want to pass legislation specifically to fix that chemotherapy drug shortage that you're talking about, though it's unclear if there are actually enough votes currently to get that done.

One of the measures, in particular, would grant the FDA new authority to require drugmakers to alert them if there's demands in certain drugs amongst the population.

Would a measure like that actually fix this problem?

ERIN FOX: It probably wouldn't fix the chemotherapy shortage problem, because FDA knew that there was a manufacturing problem already.

But the demand shortages that we saw for things like children's pain relievers, the amoxicillin shortage, some common antibiotic shortages that we have seen over last winter, that really would help.

In those cases, we did have big spikes in demand.

FDA was not aware.

And so FDA couldn't use their usual toolkit that they have to try to prevent those shortages from happening without that extra awareness.

So I do think that would be helpful.

LAURA BARRON-LOPEZ: Beyond that, if you could wave a wand and transform this drug supply system that we have, what specifically needs to change to make sure that shortages like this don't happen again?

ERIN FOX: You know, right now, with many of these products, the only competition point between these generic products that are pretty low-cost and low-margin is price.

And so we have had a race to the bottom.

And, sometimes, that creates an incentive to cut corners on quality.

And so what we need are measures that would allow these companies to compete more on quality, their ability to supply, their ability to have redundancy in their supply chains.

Those things could allow them to perhaps charge a little bit of a higher price.

And then it's worth it for hospitals to pay a little bit extra if they know they're going to have an assured supply of a higher-quality product.

And so we just really need to get away from this pass/fail system that FDA has set up, where the only competition point is price.

And let's look a little bit further onto quality measures.

LAURA BARRON-LOPEZ: Erin, is there anything that the Biden administration could do through executive action, as we were just talking about, because of the fact that Congress appears not settled at all on legislation?

ERIN FOX: You know, I think back to the Obama administration and some of the executive actions they took.

They did require a notification rule.

At that time, there was no notification required for companies to tell the FDA when they were having a shortfall.

So, certainly, that increase-in-demand notification might work for an executive order.

But, really, the changes that we need to happen are coming from Congress, coming from perhaps CMS, and also some public-private partnerships as well.

LAURA BARRON-LOPEZ: That's Erin Fox of the University of Utah.

Thank you so much for your time.

ERIN FOX: Thank you so much.

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