Title: FDA's Foreign Inspections of Drug Manufacturers Have Not
Rebounded to Pre-pandemic Levels

Related work: GAO-25-106775, Drug Safety: FDA Should Implement
Strategies to Retain Its Inspection Workforce 

Released: November 2024

Description: The Food and Drug Administration (FDA) inspects drug
manufacturers here and overseas to ensure the safety and quality of drug
sold in the United States. But FDA paused many of its in-person
inspection efforts during COVID-19 because of travel disruptions and
safety concerns. So now that COVID is over, are inspections back to
normal? GAO's Mary Denigan-Macauley tells us more.

{Music}

[Mary Denigan-Macauley:] Some of the contaminations can be critical. In
this case with the eye drops, people lost vision and some people died.

[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. The Food and Drug
Administration inspects drug manufacturers, both here and overseas to
ensure the safety and quality of drugs sold in the United States. But
FDA paused many of its in-person inspection efforts during COVID-19
because of travel disruptions and safety concerns. So now that COVID is
over, has FDA recovered? Are inspections back to normal? We'll find out
more from GAO's Mary Denigan-Macauley, an expert on health care policy,
who has a new report out on this issue. Thanks for joining us.

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

[Holly Hobbs:] Maybe we can start with how did FDA conduct inspections
during COVID? What was different?

[Mary Denigan-Macauley:] Yeah. So prior to COVID, FDA sent people on
site to the manufacturing company—whether that be here in the United
States or overseas—to look to make sure that the drug that is being
manufactured is being manufactured properly so that it's safe and that
it's working the way it's supposed to work. But during COVID, like
everything else, they shut down a lot of the operations and they had to
actually shut down the people going over and doing the inspections for
their own safety and for the safety of the employees producing the
drugs. So, they used what we call alternative tools. Some of those tools
are things that they already had in their toolbox. For example, they
looked at inspection reports from trusted foreign regulators like
Germany. If they had recently done an inspection, then they could say,
okay, if Germany was recently there and didn't finding manufacturing
problems, we can probably assume that that manufacturer is okay. They
used something more frequently than they had used in the past—and that
is reviewing documentation for manufacturers actually looking at the
manufacturing, the printed materials. As you can see, it's not quite the
same as being on site and visually looking at the manufacture to ensure
it's being done properly and cleanly. Sanitation is important. They also
use something that's new called live stream video. And it doesn't seem
that new to us in this generation, but to be able to have a live stream
video in a manufacturing plant is pretty novel. So that was a new
technique as well.

[Holly Hobbs:] Are they still using any of these alternative methods
now?

[Mary Denigan-Macauley:] They are. So, while the inspection is still the
primary tool, they will continue to rely on other regulators that they
trust to be able to use their manufacturing reports. They're looking at
a hybrid pilot where they have one person inspecting the plant in
person, and then they have a live stream video, someone hooking in that
way or reviewing documentations from afar. So they're trying to look at
different ways to use the tools to augment the inspection. And that's
the key. It's augment. It's not replacing.

[Holly Hobbs:] So now that COVID is over, are inspections mostly back to
normal, back to the normal volume we would have seen before COVID?

[Mary Denigan-Macauley:] So FDA is back up and running. They are doing
inspections overseas and they're doing them domestically as well. And
we're back to the trend that we had hoped that they would be where
they're doing more inspections overseas than they're doing here in the
U.S., because more of the drugs are being manufactured overseas for the
U.S. market. But we're not at the levels that we saw before. 

[Holly Hobbs:] If the number of inspections are down, what does that
mean for drug safety?

[Mary Denigan-Macauley:] So for drug safety, those inspections are
absolutely critical because it provides that extra eye. If you know that
someone's has the potential to come in and look over your shoulder, then
you're going to be on your best behavior. And unfortunately, there are
some rogue actors out there. But the majority of the drug manufacturing
is generally considered to be safe. And it's important to remember that
the responsibility falls to the manufacturer. So that's of utmost
importance. But having those inspections is still critical. It's
important for FDA to go in and to spot check on those facilities that
they think are the highest risk of having some issues.

[Holly Hobbs:] Why are inspections still down? What's going on at FDA?

[Mary Denigan-Macauley:] Well, there's a variety of things that are
going on. Most importantly is the inspection workforce. They're having a
hard time maintaining the workforce that they need to do, the number of
inspections that they need to do. And there are some other factors. For
example, there's still a State Department travel warning for China. And
so that is going to cause some complications. You still have to consider
the safety of the employees. But by far it's the attrition of the
workforce. And we do have concerns there.

[Holly Hobbs:] So FDA needs more inspectors and it needs to retain the
inspectors it has. Is the agency taking any action to do that?

[Mary Denigan-Macauley:] They are. And it's not the first time that we
flag this issue. We've had longstanding concerns about their ability to
retain the workforce. And it's for that reason that we have put them on
the High Risk List, saying that their oversight of medical products is
in jeopardy because of their inability to retain that workforce. So the
High Risk List is our way of putting issues that we have concerns about
duplication, overlap and fragmentation for issues that are of high
criticality. In our case, it's actually about transformation. We would
like to see a transformation of how FDA oversees the medical products. 

[Holly Hobbs:] Why are inspectors leaving FDA, and why is it so hard to
attract new inspectors?

[Mary Denigan-Macauley:] Some of the contributing factors are it's a
very tough job. You have a single inspector going over to a foreign
country, long hours on an airplane—in the back of an airplane. We have
to be careful with taxpayer dollars, multiple inspections that can be
back-to-back. You can be away from the family for a long period of time.
And then you have rigorous reports that have to be written up when you
get home, plus you're working in different languages and different
cultures. So, there are a lot of different things that we've reported
out on are the reason, but primarily it is the pay and the conditions of
the work that is causing the attrition and or attrition is much higher
than they want. 

{MUSIC}

[Holly Hobbs:] Mary just told us that FDA's in-person inspections of
overseas drug manufactures have rebounded. But they still aren't at
pre-pandemic levels because of a shortage of needed inspectors. So,
Mary, what more do we think the FDA should be doing to attract new
inspectors and retain the ones it has?

[Mary Denigan-Macauley:] So, they're looking at the causes of why the
inspectors are leaving. What we'd like for them to do is to come up with
a plan to address all of the causes, and to come up with a game plan and
to strategize about how they're going to keep them. And they are a
little bit in a bind, because the more people that leave, the more
investigators that leave, the more inspections the staff that stay have
to do. And they also have to get staff on board, and then train them,
and then get them up to speed to be able to even do the inspection
overseas. And so that training also taxes the current employees that are
there. So they have to come up with some strategies working across FDA.
This is not just one small component. These inspectors are coming from
different areas. And so we have raised this to the level of senior
management to be able to get an action plan going.

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

[Mary Denigan-Macauley:] The bottom line is that these inspections are
absolutely critical. If you think back to when we had the eye drop
contaminations, FDA found that in an over-the-counter eye drop, some of
the contaminations can be critical. In this case with the eye drops.
People lost vision and some people died. So getting these inspections
back up and running is absolutely critical in maintaining this
workforce. And so we'll keep our eyes on it.

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

[Mary Denigan-Macauley:] Thanks for your time, Holly.

[Holly Hobbs:] And thank you for listening to the Watchdog Report. To
hear more podcasts, subscribe to us on Apple Podcasts, Spotify, or
wherever you listen. And make sure to leave a rating and review to let
others know about the work we're doing. For more from the congressional
watchdog, the U.S. Government Accountability Office, visit us at
GAO.gov.