Title: How is FDA working to Prevent Drug Shortages?

Description: Drug shortages are a serious public health concern. They
can delay or limit a patient's access to effective care, with
potentially dire consequences for their health. Over the summer, the
Food and Drug Administration was tracking more than 100 shortages. We'll
learn more from GAO's Mary Denigan-Macauley.

Related work: GAO-25-107110, Drug Shortages: HHS Should Implement a
Mechanism to Coordinate Its Activities

Released: April 2025

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[ Mary Denigan-Macauley: ] Drug shortages are not going away. FDA has a
critical role to play, but it cannot do it alone.

[Holly Hobbs:] Hi and welcome to GAO's Watchdog Report. Your source for
fact-based, nonpartisan news and information from the U.S. Government
Accountability Office. I'm your host, Holly Hobbs. Drug shortages are a
serious public health concern. They can delay or limit a patient's
access to effective care, with potentially dire consequences for their
health. Over the summer, the Food and Drug Administration was tracking a
number of drug shortages. We'll learn more about this issue and what's
being done about it from GAO's Mary Denigan-Macauley. Thanks for joining
us.

[ Mary Denigan-Macauley: ] Happy to be here. 

[ Holly Hobbs: ] Mary, maybe we can start with what are some examples of
drugs that have recently had shortages? 

[ Mary Denigan-Macauley: ] Every year we have over 100 drugs that are in
shortage. And these are really, very important drugs that are
lifesaving. For example, oncology drugs that treat cancer. Drugs that
are necessary for surgeries. And so, when they're in shortage, patients
can't get surgeries. They're not getting the treatment they need to be
able to survive the cancer that they're experiencing. So, it's a pretty
serious issue. 

[ Holly Hobbs: ] What causes a drug shortage? 

[ Mary Denigan-Macauley: ] In its simplest form--think of your economics
101 supply and demand, right--when demand outpaces supply, you're going
to have a shortage. And think about during the pandemic when we had the
toilet paper crisis. Everyone was hoarding toilet paper. And so we had,
high, high demand and prices just soared--some people were saying like
700%. And so, in that case, someone will step in and they'll produce
more of the product to be able to alleviate the shortage so it doesn't
go on for years and years. Drugs are a little different. It doesn't play
the same way because it's very expensive and time consuming to produce a
drug. And so having that supply on hand is difficult. So, economics and
supply is one of the reasons. Mother Nature comes into play too. Heparin
is a great example. Down in Puerto Rico, in 2017, we had Hurricane Irma
and Maria hit a plant that caused a shortage of heparin. And then just
as the supply was getting back in action, heparin was in high demand
during COVID-19, and that exasperated the supply once again. Then a
tornado hit a plant, in 2023, in North Carolina. And that further
exasperated the supply. So, Mother Nature plays a hand. When you
manufacture the drug. It also has to be of a very good quality. So the
Food and Drug Administration that does inspections that needs to approve
that drug to be sold on the market to make sure that it's safe and
effective. If they find a problem, for example, manufacturing has to
stop. So there are a variety of different things that can cause supply
shortages.

[ Holly Hobbs: ] So FDA is tracking this. Do they know or do we know if
it's getting better or worse? 

[ Mary Denigan-Macauley: ] You know, that's, it's a tough question
because
it's been happening for such a long period of time. We've had drug
supply problems over the years. The recent data that we analyzed has
shown that the number of drugs in shortage is actually going down.
However, the shortages are lasting longer. And so, this is not something
that's going to be solved in the near future. 

[ Holly Hobbs: ] You said that we're tracking it. How are we or FDA
tracking shortages? 

[ Mary Denigan-Macauley: ] So the Food and Drug Administration, or FDA, 
is required by law to be able to track these. And they do. And they get
their information from a variety of different sources. So, for example,
manufacturers are required to report if they think there's going to be a
potential shortage. They also get information from hospitals and
doctors. And so, there are dedicated staff at FDA that look at this
information. They analyze it. And when something's going to be in
shortage, they go ahead, and they post it on their website.

[ Holly Hobbs: ] So what's being done to solve this problem of
shortages?

[ Mary Denigan-Macauley: ] FDA has an important role here. There are a
variety of things that FDA can do. They can extend the shelf life of a
drug to be able to keep the supply. They can also look if other
countries are manufacturing that drug and see if it's safe and
effective, that it can be imported into the United States. They also
have early efforts at developing what we call a quality maturity
program, to ensure that the drugs can be manufactured without defects,
so that would slow down the production of certain drugs, or they need to
be taken off the market because of a defect. But, FDA's only one of the
players. There are other agencies within the Department of Health and
Human Services where FDA is. So, for example, another agency is looking
at ways of bringing certain key ingredients to manufacture them here in
the United States so that we're not reliant on those overseas. You also
have other agencies, for example, the Drug Enforcement Agency, control
certain drugs so that they're not misused. You have the military, which
is a large purchaser of drugs from the federal government to be able to
ensure their supply for their military members. And you have programs
like Medicare that have insurance to help the public pay for the drugs
that they need as they age. So a lot of different players, FDA cannot do
this alone. 

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[ Holly Hobbs: ] Mary just told us that the Food and Drug Administration
plays a key role in helping to prevent drug shortages. But that FDA is
just one agency working on this issue. Mary, what more do we think
should be done to address drug shortages? 

[ Mary Denigan-Macauley: ] We really need to have a coordinated effort,
not only within HHS, but also across the federal government to shore up
the supplies so that we can catch a supply issue before it becomes
critical and before we get into a shortage situation. We made a
recommendation that Health and Human Services should do this because
they had initial efforts to coordinate.  And we feel it's important that
they continue, moving forward. 

[ Holly Hobbs: ] And last question, what's the bottom line of this
report? 

[ Mary Denigan-Macauley: ] The bottom line is that FDA has a critical
role
to play, but it cannot do it alone. It must coordinate with the other
key players. And we need to do this to ensure that we have that supply
of drugs that Americans need and rely on every day for important
lifesaving treatments. 

[ Holly Hobbs: ] That was Mary Denigan-Macauley talking about our new
report on drug shortages. Thanks for your time, Mary. 

[ Mary Denigan-Macauley: ] Thanks for having me, Holly. 

[ Holly Hobbs: ] And thank you for listening to the Watchdog Report. To
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