Title: Planning for the Next Public Health Emergency and Medical
Countermeasure Development

Description: COVID-19 has underscored the importance of being able to
rapidly develop, manufacture, and distribute medical
countermeasures--such as drugs, vaccines and testing supplies. But in the
early days of the pandemic, the Department of Health and Human Services
(HHS) found itself unprepared to produce these critical supplies. We
talk with GAO's Mary Denigan-Macauley to find out more. 

Related GAO Work: GAO-23-105713, Public Health Preparedness: HHS Should
Plan for Medical Countermeasure Development and Manufacturing Risks 

Released: February 2023

[Music]

[Mary Denigan-Macauley:] Developing medical countermeasures for
biological, radiological, nuclear, and all of the emerging threats is no
easy task at all.

[Holly Hobbs:] Hi, and welcome to GAO's Watchdog Report. Your source for
news and information from the U.S. Government Accountability Office. I'm
your host, Holly Hobbs. The scariest days of COVID-19 may be behind us,
but there are important lessons learned that could help us prepare for
the next public health emergency. COVID has underscored the importance
of being able to rapidly develop, manufacture and distribute medical
countermeasures such as drugs, vaccines and testing supplies. But in the
early days of the pandemic, the Department of Health and Human Services,
HHS, found itself unprepared to produce these critical supplies. Today,
we'll talk with Mary Denigan-Macauley, a health policy expert, about
steps HHS is taking to improve its efforts and what more needs to be
done. Thank you for joining us.

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

[Holly Hobbs:] So, Mary, is the federal government prepared for the next
pandemic?

[Mary Denigan-Macauley:] Well, the short answer is no. Based on the
collective body of work that we have done, looking at HHS' efforts to
respond not only to this pandemic, but past infectious disease outbreaks
and other public health emergencies, there are some concerns that we
have. And they are not prepared. If we zero in specifically on HHS's
ability to manufacture countermeasures for a public health emergencies.
We found in this report that there are some glaring gaps and obstacles
that need to be overcome.

[Holly Hobbs:] So, what was HHS doing prior to the pandemic?

[Mary Denigan-Macauley:] So in about 2012, HHS developed a medical
countermeasure model at three different locations to be prepared for a
public health emergency. And it was really after the H1N1 pandemic,
which a lot of us forget. But we did have a pandemic. It just wasn't on
the scale that we see now with COVID. However, this effort was really
focused more on building up the facilities and the equipment needed to
produce the medical countermeasures. And they never had the opportunity
to really test what they put in place. It's one thing to manufacture a
small amount of product, but it's very different, as we saw during
COVID-19, to manufacture something for a pandemic of the size that we
saw.

[Holly Hobbs:] The U.S. was able to rapidly develop vaccines quickly
and. tThat's a major accomplishment.  But there were some challenges
that delayed these efforts, right? 

[Mary Denigan-Macauley:] Yes. So there is no question that was a major
success coming from the pandemic. But the manufacturing of those
vaccines itself was still a challenge. So in the case of this particular
program, because they hadn't tested some of the measures and some of the
equipment and facilities that they put in place to rapidly develop
medical countermeasures on a mass scale, we saw serious problems. So, to
give you an example, you may have heard in the news that there was
cross-contamination of the J&J vaccine with the AstraZeneca COVID
vaccine at one facility. And that actually prevented us from using that
important critical countermeasure at a time when we didn't have others
available to us to slow down the rapid spread.

[Holly Hobbs:] So has HHS taken steps to address these challenges?

[Mary Denigan-Macauley:] Yes. So HHS has learned from the pandemic about
the importance of mass producing countermeasures for a public health
emergency. They are definitely trying to learn from their past mistakes.
So most importantly, what we found in this report is that they ended the
medical countermeasure program that we examined because they realized
that it really didn't work well. Importantly, they have a new initiative
that they put in place going forward that they are hoping will help to
overcome some of the pitfalls that they encountered for the next crisis
that we have. It's important to note, however, that this new initiative
is still in the very early stages.

{MUSIC}

[Holly Hobbs:] So Mary just told us that while HHS's initial efforts to
create medical countermeasures like vaccines during COVID-19 were
delayed, it is taking steps to learn from mistakes so that it is ready
for the next public health emergency. So, Mary, what more do we think
HHS should be doing?

[Mary Denigan-Macauley:] While it's very positive that HHS has developed
this new program to account for the deficiencies that they saw
developing the medical countermeasures, we still have so many unanswered
questions because it is just so new. We actually don't know if this new
program is going to help them avoid the pitfalls that they saw. So, for
example, we found that HHS is really challenged to incentivize that
private sector to participate. And as we saw with the development of the
vaccines, that private sector is absolutely critical. And that's just
one of many challenges that we identified.

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

[Mary Denigan-Macauley:] Honestly, the true bottom line--that I want to
make sure that our listeners understand--is that developing medical
countermeasures for the vast range chemical, biological, radiological,
nuclear and all of the emerging threats, whether they occur naturally or
a bad guy tries to introduce something intentionally to harm us either
through a terrorist group, is no easy task at all. These threats also
can have very serious, life threatening consequences. The pandemic could
have been much worse. There could be biological attack coming from all
different directions with absolutely no countermeasures. And so it
really takes diligent planning, testing, situational awareness and
flexibility. And we also know that this is not something that the
private sector is willing to take on because there's no economic
incentive to do so for an event that has a high consequence but has a
low probability of occurring. So it's absolutely critical that the
federal government step in. Being able to get these countermeasures up
and running is absolutely critical. And the last thing I'd like to note
is that we placed HHS's leadership in coordination of public health
emergency on GAO's High Risk List. This High Risk List identifies
programs and policies in need of major transformation. Medical
countermeasure, manufacturing during a public health emergency is part
of that transformation that really needs to occur.

[Holly Hobbs:] That was Mary Denigan-Macauley discussing GAO's recent
review of HHS's efforts to develop and manufacture medical
countermeasures. 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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