HHS Should Plan for Medical Countermeasure Development and Manufacturing Risks (GAO-23-105713)
Summary
A GAO report to congressional committees, GAO-23-105713, dated February 2023, on public health preparedness. It states that the COVID-19 pandemic and other recent public health emergencies highlight the threat posed by new and emerging infectious diseases. GAO reports that in 2012 the Department of Health and Human Services (HHS) established the Centers for Innovation in Advanced Development and Manufacturing (CIADM), a program to improve domestic infrastructure and expertise to produce medical countermeasures such as drugs and vaccines in response to public health emergencies. Its title states that HHS should plan for medical countermeasure development and manufacturing risks.
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United States Government Accountability Office
Report to Congressional Committees
February 2023
PUBLIC HEALTH
PREPAREDNESS
HHS Should Plan
for Medical
Countermeasure
Development and
Manufacturing Risks
Accessible Version
GAO-23-105713
February 2023
GAO Highlights PUBLIC HEALTH PREPAREDNESS
Highlights of GAO-23-105713, a report to HHS Should Plan for Medical Countermeasure
congressional committees
Development and Manufacturing Risks
Why GAO Did This Study What GAO Found
The COVID-19 pandemic and other In 2012, the Department of Health and Human Services (HHS) established a
recent public health emergencies program to improve domestic infrastructure and expertise to produce medical
highlight the threat of widespread countermeasures—such as drugs and vaccines—in response to public health
illness and death posed by new and emergencies. This program, known as the Centers for Innovation in Advanced
emerging infectious diseases. GAO Development and Manufacturing (CIADM), was originally composed of three
has designated HHS’s leadership and sites responsible for, among other things, rapidly producing countermeasures for
coordination of public health
a pandemic. During the period prior to the COVID-19 pandemic, HHS funded the
emergencies as a high-risk area due to
sites to produce small batches of drug substances for other manufacturers.
the need to be prepared for, and
effectively respond to, future public
During the COVID-19 pandemic, HHS provided increased funding to reserve
health threats. capacity to produce products at a larger scale to aid the pandemic response.
However, HHS said that the sites faced challenges reliably producing products at
The CARES Act includes a provision a larger scale, such as poor quality control, that led to the eventual shutdown of
for GAO to report on its ongoing one site due to cross-contamination.
monitoring and oversight efforts related
to the COVID-19 pandemic. This report An internal HHS review found that a lack of regular manufacturing work from
examines (1) how HHS used CIADM either HHS or other manufacturers prevented the sites from developing the
program funds prior to and during the capability to rapidly produce countermeasures at a large scale as the program
COVID-19 pandemic, (2) what intended. HHS and site officials identified several reasons for this underuse,
challenges affected the CIADM including a lack of dedicated funding from HHS and challenges attracting
program’s effectiveness in developing external manufacturers to use the sites for countermeasure production.
and manufacturing countermeasures,
and (3) how HHS plans to use its new HHS is ending the CIADM program and plans to transition to a new program
program model to address the model—the National Biopharmaceutical Manufacturing Partnership (BioMaP).
challenges of the CIADM program. BioMaP is early in its development, and it is unclear how BioMaP will address
some of the challenges faced by the CIADM program, as in the following
To address these objectives, GAO examples.
examined HHS documents and leading
practices for managing program risks · BioMaP is expected to use a different contracting structure intended to
and interviewed and reviewed written provide more incentives for industry partners to participate. However, this
correspondence with representatives different structure requires additional expertise to manage effectively.
from HHS and the three CIADM sites. Moreover, HHS told GAO that its contracting staff had previously faced
resource challenges using this different contracting structure for other
What GAO Recommends programs during the COVID-19 pandemic. HHS officials said in April
GAO is recommending that HHS 2022 that the agency has half the contracting staff needed to manage its
incorporate into the development of its contracting portfolio. This creates the risk that the agency may not have
new program model an approach to enough resources and expertise to manage this different structure
systematically assess, and respond to, effectively.
known challenges and risks associated
with advanced development and · HHS does not have a sustainable source of funding for the new program
manufacturing of medical model, and it has not yet developed detailed plans or budgets. HHS
countermeasures. We provided a draft officials said that, without sustained funding for BioMaP or a similar
of this report to HHS for review and program, the agency would be unprepared to respond to the next
comment. HHS concurred with our pandemic.
recommendation.
As HHS is developing its plans for a new program model for countermeasure
production, incorporating an approach to address these challenges and risks
View GAO-23-105713. For more information,
would provide HHS with greater assurance that it can avoid repeating the
contact Mary Denigan-Macauley at (202) 512- challenges of the CIADM program.
7114 or deniganmacauleym@gao.gov.
United States Government Accountability Office
Contents
GAO Highlights ii
Why GAO Did This Study ii
What GAO Recommends ii
What GAO Found ii
Letter 1
Background 4
HHS Used CIADM Program Funds to Increase Manufacturing
Capacity and Provided Relatively Few Funds for
Countermeasures Prior to the COVID-19 Pandemic 8
Underuse of the Sites Prevented Full Development of
Manufacturing Capabilities, Affecting COVID-19 Vaccine
Production 12
It Is Unclear How HHS Plans to Address Known Challenges and
Future Risks in Its Proposed Program Model 17
Conclusions 25
Recommendation for Executive Action 25
Agency Comments 25
Appendix I: Comments from the Department of Health and Human Services 30
Text of Appendix I: Comments from the Department of Health and
Human Services 32
Appendix II: GAO Contact and Staff Acknowledgments 34
Tables
Table 1: Spending on, and Examples of, Base Contract Activities
Conducted by Centers for Innovation in Advanced
Development and Manufacturing (CIADM) Sites, 2012
through 2021 9
Table 2: Task Orders Issued to Centers for Innovation in
Advanced Development and Manufacturing (CIADM)
Sites, Prior to and During the COVID-19 Pandemic, 2012
through 2021 10
Page i GAO-23-105713 Medical Countermeasure Development
Abbreviations
BARDA Biomedical Advanced Research and
Development Authority
BioMaP National Biopharmaceutical Manufacturing
Partnership
CIADM Centers for Innovation in Advanced Development
and Manufacturing
COVID-19 Coronavirus Disease 2019
DOD Department of Defense
FDA Food and Drug Administration
HHS Department of Health and Human Services
OTA Other Transaction Agreement
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Page ii GAO-23-105713 Medical Countermeasure Development
441 G St. N.W.
Washington, DC 20548
Letter
February 2, 2023
Congressional Committees
The COVID-19 pandemic and other public health emergencies—such as
the 2009 H1N1 influenza pandemic and the 2022 mpox outbreak—
highlight the threat of widespread illness and death posed by new and
emerging infectious diseases.1 These threats underscore the importance
of being able to rapidly develop, manufacture, and distribute medical
countermeasures to respond to public health emergencies. Medical
countermeasures are drugs, vaccines, and devices to diagnose, treat,
prevent, or mitigate the health effects of exposure to a chemical,
biological, radiological, or nuclear agent. The Department of Health and
Human Services (HHS) is the primary federal department responsible for
medical countermeasure development and procurement, and other public
health preparedness.
Many factors make it difficult to rapidly develop and manufacture medical
countermeasures—referred to in this report as countermeasures—in
response to public health emergencies. We have previously reported that,
like pharmaceutical products in general, producing countermeasures is
time-consuming, complex, and expensive. Unlike most pharmaceutical
products, there is no general commercial market for countermeasures
used in response to low-probability, high-consequence events. This may
reduce incentives for large pharmaceutical companies to invest
consistently in these products instead of others that may be more
profitable.2
The 2009 H1N1 pandemic raised concerns about the United States’
ability to rapidly manufacture needed countermeasures in an emergency,
with the federal government acknowledging that it was not able to provide
enough vaccines before the pandemic spread through the population.3
Following this pandemic, HHS conducted a review in 2010 of its existing
1Mpox was formerly known as monkeypox. The World Health Organization recommended
the name change in November 2022.
2GAO, National Preparedness: HHS Has Funded Flexible Manufacturing Activities for
Medical Countermeasures, but It Is Too Soon to Assess Their Effect, GAO-14-329
(Washington, D.C.: Mar. 31, 2014).
3Department of Health and Human Services, The Public Health Emergency
Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range
National Needs, (Washington, D.C.: Aug. 2010).
Page 1 GAO-23-105713 Medical Countermeasure Development
Letter
countermeasure efforts. In response to a recommendation in that review,
HHS created the Centers for Innovation in Advanced Development and
Manufacturing (CIADM) program in 2012. HHS intended that the program
would provide both initial and ongoing support to enhance domestic
infrastructure and expertise for countermeasure development and
manufacturing.
In 2012, HHS awarded funding to three contractors (two biomanufacturing
companies and one university) to establish CIADM facilities—hereafter
referred to as sites. HHS used the program to support the manufacture of
COVID-19 vaccines developed under Operation Warp Speed, but HHS
reported that the program had limitations that hindered its effectiveness
and that the program did not work as intended.4 In 2022, HHS formally
announced that it was ending the CIADM program and developing a new
program model for rapid countermeasure production that is intended to
replace it.5
The CARES Act includes a provision for us to report on ongoing
monitoring and oversight efforts related to the COVID-19 pandemic.6 This
report is part of our body of work in response to the CARES Act and
related to HHS’ leadership and coordination of public health emergencies,
which we identified as an area of high risk due to the need to be prepared
for, and effectively respond to, future public health threats.7 This report
focuses on the federal government’s efforts related to the CIADM
program. Specifically, we:
4Operation Warp Speed was a partnership, launched in May 2020, between HHS and the
Department of Defense (DOD) to accelerate the development of a COVID-19 vaccine. The
program led to the development of three vaccines, two of which began distribution in
December 2020. For more information, see GAO, Operation Warp Speed: Accelerated
COVID-19 Vaccine Development Status and Efforts to Address Manufacturing
Challenges, GAO-21-319 (Washington D.C.: Feb. 11, 2021); and GAO, COVID-19: HHS
and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address Outstanding
Issues, GAO-22-104453 (Washington, D.C.: Jan. 19, 2022).
5Department of Health and Human Services, Fiscal Year 2023: Public Health and Social
Services Emergency Fund: Justification of Estimates for Appropriations Committee
(Washington, D.C.: Mar. 28, 2022).
6Pub. L. No. 116-136, § 19010(b), 134 Stat. 281, 580 (2020). The American Rescue Plan
Act of 2021 also includes a provision for us to conduct oversight of the COVID-19
response. Pub. L. No. 117-2, § 4002, 135 Stat. 4, 78. All of GAO’s reports related to the
COVID-19 pandemic are available on GAO’s website at https://www.gao.gov/coronavirus.
7GAO, High Risk Series: Dedicated Leadership Needed to Address Limited Progress in
Most High-Risk Areas, GAO-21-119SP (Washington, D.C.: Mar. 2, 2021).
Page 2 GAO-23-105713 Medical Countermeasure Development
Letter
1. describe how HHS used CIADM program funds prior to and during the
COVID-19 pandemic;
2. describe what challenges affected the CIADM program’s effectiveness
in developing and manufacturing countermeasures; and
3. examine how HHS plans to use its new program model to address the
challenges of countermeasure development faced by the CIADM
program.
To describe both (1) how HHS used CIADM program funds prior to and
during the COVID-19 pandemic, as well as (2) what challenges affected
the CIADM program’s effectiveness in developing and manufacturing
countermeasures, we reviewed contracts for all three sites and
performance documents for two sites active during the COVID-19
response to identify program funding and activities. This documentation
included the CIADM contracts between each site and the Biomedical
Advanced Research and Development Authority (BARDA), the office
within HHS’ Administration for Strategic Preparedness and Response that
was responsible for oversight of the CIADM program.8 We also reviewed
orders for services under the CIADM contracts, progress reports
submitted by sites to BARDA during the COVID-19 response, and audit
reports and documentation from BARDA site visits and inspections
related to the CIADM program.
To examine how HHS plans to use its new program model to address the
challenges of countermeasure development faced by the CIADM
program, we reviewed documentation and presentations evaluating the
CIADM program and outlining BARDA’s initial plans for the proposed
program model.9 We assessed BARDA’s initial plans against leading
practices for risk management, a forward-looking management approach
8The Administration for Strategic Preparedness and Response was previously known as
the Office of the Assistant Secretary for Preparedness and Response. In July 2022, HHS
announced that it would elevate the office from a staff division to a standalone operating
division. As part of this change, its name was changed to the Administration for Strategic
Preparedness and Response.
9Specifically, we reviewed a Request for Information that BARDA released in October
2021 to solicit feedback from biopharmaceutical industry representatives on a new
program model (accessed October 28, 2022 from
https://www.medicalcountermeasures.gov/media/38403/barda-rfi-biomap-consortium.pdf.)
We also reviewed a presentation that the Administration for Strategic Preparedness and
Response and BARDA made to the Biotechnology Innovation Organization International
Convention in June 2022.
Page 3 GAO-23-105713 Medical Countermeasure Development
Letter
that allows agencies to assess threats and opportunities that could affect
the achievement of their goals.10 Risk management involves managing
both “risks” (where there is the potential for either a negative or positive
outcome in the future), which agencies may or may not be aware of in the
present, and “challenges” (actual, known issues or threats agencies have
faced in the past or are currently facing). These leading practices include
the Office of Management and Budget’s Circular No. A-123, which
defines management responsibilities for risk management within federal
agencies.11
For all three objectives, we interviewed and reviewed written
correspondence with officials at BARDA and each of the three original
sites. These discussions provided information about BARDA’s and sites’
experiences in the CIADM program, such as activities the sites undertook
during the program and communications between BARDA and the sites
about progress and challenges. These discussions also provided insight
into what lessons BARDA and the sites learned from these experiences
with the CIADM program and how they could be applied to BARDA’s new
proposed program model for countermeasure production.
We conducted this performance audit from January 2022 to February
2023 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit to
obtain sufficient, appropriate evidence to provide a reasonable basis for
our findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our findings
and conclusions based on our audit objectives.
Background
HHS is the primary federal department responsible for public health
preparedness. Within HHS, the Administration for Strategic Preparedness
and Response leads the federal medical and public health response to
public health emergencies, including strategic planning and support for
developing and securing countermeasures. Within that, BARDA
coordinates and supports advanced research and development,
10GAO, Enterprise Risk Management: Selected Agencies’ Experiences Illustrate Good
Practices in Managing Risk, GAO-17-63 (Washington, D.C.: Dec. 1, 2016).
11Office of Management and Budget, OMB Circular No. A-123: Management’s
Responsibility for Enterprise Risk Management and Internal Control, OMB Circular A-123
(Washington, D.C.: Jul. 15, 2016).
Page 4 GAO-23-105713 Medical Countermeasure Development
Letter
manufacturing, and initial procurement of countermeasures and was
responsible for overseeing the CIADM program.
HHS created the CIADM program in response to prior challenges in
developing countermeasures. Specifically, in its 2010 review of
countermeasure efforts, HHS stated that, while the nation did effectively
make and test vaccines in response to the 2009 H1N1 pandemic, the
vaccines were not broadly available before the virus had spread through
the population. This led the agency to conclude that the nation needed
faster methods to develop and manufacture vaccines or other
countermeasures. HHS reported that its goal for the CIADM program was
to support the country’s ability to develop and manufacture new
countermeasures in a timely manner by constructing facilities that would
aid in both short-term emergency and long-term ongoing activities. In the
short term, the sites would be able to rapidly produce vaccines for the
nation for an emerging disease when a vaccine is available, known as
“surge production capacity.” In the long term, the sites would provide
assistance to larger pharmaceutical manufacturers for developing and
producing new countermeasures, which could be accomplished during
pandemic or non-pandemic periods.
The CIADM program began in 2012, when BARDA awarded contracts to
establish three sites: Emergent Manufacturing Operations of Baltimore
LLC (Emergent); CSL Seqirus of Holly Springs, NC (CSL Seqirus); and
Texas A&M University System of College Station, TX (Texas A&M).12 To
accomplish the short-term and long-term goals mentioned above, the
sites were contracted to provide three types of services as follows.
1. Surge production capacity for influenza pandemic response (at least
50 million finished doses within 4 months of an influenza pandemic).
2. Services to assist in countermeasure development and production,
such as production of drug substances for clinical trials. These
services, known as “core services,” were intended to allow the sites to
support those who have existing contracts with BARDA or other
government partners.
12CSL Seqirus (known as Seqirus until August 2022) was created in 2015 when its parent
company, CSL Limited, acquired the influenza vaccine business of Novartis Vaccines and
Diagnostics, Inc. of Cambridge, MA, which received the original CIADM award. In
December 2016, the government novated the CIADM contract originally awarded to
Novartis to CSL Seqirus.
Page 5 GAO-23-105713 Medical Countermeasure Development
Letter
3. Workforce training to enhance and maintain overall U.S. capabilities
and expertise to develop and produce countermeasures.
BARDA intended for these activities to improve both the capacity and
capability of domestic countermeasure manufacturing. “Capacity” refers
to the facilities and infrastructure needed to sustainably develop and
produce countermeasures. “Capability” refers to the workforce skills,
materials, and quality control systems needed to reliably produce
countermeasures at a sufficient scale and level of quality. According to
BARDA officials, while the sites were expected to be able to pivot to
surge production capacity if needed, the primary capability needed from
the sites was core service assistance to countermeasure developers.
Specifically, according to BARDA officials, the sites were allowed to use
their CIADM program capacity in nonpandemic periods for other activities,
including commercial manufacturing, provided that the sites made their
influenza vaccine surge capacity available upon request from HHS to
respond to a pandemic.13 BARDA would monitor the sites through audits
and site visits to ensure that the sites were able to meet the terms of their
contracts.
Under the CIADM program, each site had a contract, which covered
setup activities—such as facility design, construction, and testing—that
would allow the sites to build the capacity needed to provide further
services. The contracts also included option periods for the three services
mentioned above—vaccine surge production capacity, core services, and
workforce development.14 BARDA would assess the sites to determine if
they were ready to provide both surge production capacity and core
services. Once the sites were deemed ready, they could be awarded task
orders to provide those services. BARDA anticipated providing task
orders for each of the three types of services throughout the program.
The CIADM program used indefinite delivery/indefinite quantity contracts,
a contract type in which the government must order, and the contractor
must provide, a minimum agreed-upon quantity of products or services,
and the contractor must provide any other quantities ordered by the
13While surge capacity at the CIADMs was intended for pandemic influenza vaccine
production, BARDA officials also told us this capacity could have been used to
manufacture other medical countermeasures, such as an anthrax vaccine, in a public
health emergency.
14Work during the option periods, including for task orders, may have been completed
under an indefinite-delivery/indefinite quantity or a cost-plus-fixed-fee contract type.
Page 6 GAO-23-105713 Medical Countermeasure Development
Letter
government up to a stated maximum.15 Every CIADM site contract was
subject to the Federal Acquisition Regulation, which is the principal set of
rules for acquiring supplies or services in the federal government.
Indefinite delivery/indefinite quantity contracts awarded under the Federal
Acquisition Regulation are generally subject to certain requirements
intended to provide products or services that have the best value to the
government while fulfilling policy objectives. These include standard
requirements for competition among vendors and for reporting certain
information into a federal procurement database. Requirements can also
include further terms and conditions regarding government-unique cost
accounting systems and cost data reporting, and rights to intellectual
property developed under contracts, among others.
While the CIADM program started with three sites, over the course of the
program, the number of participating sites was reduced to one. According
to officials from BARDA and the site, one site (CSL Seqirus) reached a
mutual agreement with BARDA to end its participation in the CIADM
program in 2018, and it did not participate in the response to the COVID-
19 pandemic. Another site (Emergent) agreed to stop production from
April to July 2021, after the site informed HHS of cross-contamination. A
subsequent Food and Drug Administration (FDA) inspection of the site’s
COVID-19 vaccine production reported observations of non-compliance
with current good manufacturing practices that could have led to cross-
contamination of one vaccine product with another. BARDA officials said
they worked with Emergent to attempt to remedy the issues, but the two
sides eventually reached a mutual agreement to terminate Emergent’s
CIADM contract.16
In addition, the Department of Defense (DOD) established an advanced
development and manufacturing facility focused on developing and
manufacturing biological countermeasures to mitigate the health effects of
biological agents and naturally occurring diseases on armed forces
15For additional details on indefinite delivery/indefinite quantity contracts, see GAO,
Federal Contracts: Agencies Widely Used Indefinite Contracts to Provide Flexibility to
Meet Mission Needs, GAO-17-329 (Washington, D.C.: Apr. 13, 2017).
16United States House of Representatives Select Committee on the Coronavirus Crisis,
Committee on Oversight and Reform, The Coronavirus Vaccine Manufacturing Failures of
Emergent Biosolutions (May 2022).
Page 7 GAO-23-105713 Medical Countermeasure Development
Letter
personnel specifically.17 While this program is separate from the CIADM
program, DOD and HHS officials coordinated to develop their respective
facilities, including agency officials serving on each other’s contract
evaluation panels and governance boards.
HHS Used CIADM Program Funds to Increase
Manufacturing Capacity and Provided
Relatively Few Funds for Countermeasures
Prior to the COVID19 Pandemic
From 2012 through 2021, BARDA used CIADM program funds to
construct or retrofit manufacturing facilities and develop workforce training
programs at the sites. BARDA increased the amount of funding to
facilities to aid in the response to the COVID-19 pandemic, spending
more than it did on countermeasure production prior to the pandemic.
HHS Used CIADM Program Funding to Expand
Manufacturing Facilities and Develop Workforce Training
Programs
From the CIADM program’s start in 2012 through 2021, BARDA used
program funds to increase manufacturing capacity at the sites, according
to our review of contract documentation and written correspondence with
BARDA officials. For example, under their base contracts, the sites
constructed new facilities for producing countermeasures, retrofitted
existing facilities with newer manufacturing equipment, and developed
programs to train a biopharmaceutical workforce in countermeasure
manufacturing at the sites, as shown below in table 1. The CIADM
program used a public-private partnership model, so both the government
and the sites contributed funds, but for all three sites a majority of funds
were provided by the government. In total, BARDA provided
17The DOD facility was operated by Ology Bioservices, Inc. in Alachua, Florida (formerly
Nanotherapeutics, Inc.) and became fully operational in 2017. National Resilience, Inc.
acquired Ology in April 2021. For more information about the DOD site, see GAO,
Biological Defense: Additional Information That Congress May Find Useful as it Considers
DOD’s Advanced Development and Manufacturing Capability, GAO-17-701 (Washington,
D.C.: July 17, 2017).
Page 8 GAO-23-105713 Medical Countermeasure Development
Letter
approximately $400 million in funding to the sites for these base contract
activities.
Table 1: Spending on, and Examples of, Base Contract Activities Conducted by Centers for Innovation in Advanced
Development and Manufacturing (CIADM) Sites, 2012 through 2021
Dollars
Government spending
on base contract Site’s cost share on
Site activitiesa base contract activities Examples of base contract activities
Emergent Manufacturing 136,664,874 61,955,061 · Renovated and updated its existing production
Operations of Baltimore facilities, which site officials said allowed them to
LLC approximately double their production capacity.
CSL Seqirusb 89,621,848c 30,929,625 · Modification of manufacturing process to
increase capacity for pandemic influenza vaccine
production, as well as establishing clinical trial
material fill/finish capacity.
Texas A&M University 176,664,509 112,024,543 · Constructed a new facility for flexible
System manufacturing of vaccines against viruses using
insect and mammalian cells.
· Developed program to train biopharmaceutical
staff on manufacturing processes.
Source: GAO analysis of Biomedical Advanced Research and Development Authority (BARDA) contracts and written correspondence, and interviews and written correspondence with CIADM site officials.
| GAO-23-105713
a
As of October 2022, BARDA officials told us that the amounts included for Emergent and CSL
Seqirus reflect disbursements to the CIADM sites. Because the CIADM program had not formally
ended at this time, the funding amount for Texas A&M reflects obligated amounts.
b
CSL Seqirus (known as Seqirus until August 2022) was created in 2015 when its parent company,
CSL Limited, acquired the influenza vaccine business of Novartis Vaccines and Diagnostics, Inc. of
Cambridge, MA, which received the original CIADM award. In December 2016, the government
novated the CIADM contract originally awarded to Novartis to CSL Seqirus.
c
In fiscal year 2009, prior to the CIADM program, BARDA awarded approximately $487 million to
Novartis for the construction of an influenza vaccine manufacturing facility in Holly Springs, NC, which
has been incorporated into the Novartis CIADM. The contract called for BARDA and Novartis to share
the cost of the facility, with BARDA providing about 40 percent and the company paying about 60
percent.
HHS Increased Funding to the Sites to Aid COVID19
Pandemic Response, Compared to PrePandemic
Funding to Produce Countermeasures
HHS provided the CIADM sites with funds to reserve commercial-scale
capacity to aid in the response to the COVID-19 pandemic.18 Specifically,
18The base contract permitted HHS to unilaterally modify task orders to assign them a
priority that allows the government to require preferential acceptance and performance of
contracts or orders supporting certain approved national defense programs, such as the
COVID-19 response.
Page 9 GAO-23-105713 Medical Countermeasure Development
Letter
as shown in table 2 below, BARDA provided over $750 million in funding
from 2020 through 2021 through two task orders to reserve capacity (i.e.,
prevent other manufacturing work from occurring) that could be used to
produce vaccine candidates and therapeutics as part of the government’s
COVID-19 response. The reserved capacity at the two sites that were still
participating at the time of the pandemic (Emergent and Texas A&M) was
primarily of the equipment purchased and facilities constructed or
retrofitted through the CIADM program. BARDA officials said that they
paired both sites with vaccine manufacturers to assist the federal
government’s response, with officials saying that they did so based on
each site’s characteristics and the vaccine developer’s needs.19 While the
sites did produce some vaccine ingredients for the manufacturers, site
officials said that they could not determine if ingredients they were
contracted to produce were used in vaccines that manufacturers
distributed to the public.
Table 2: Task Orders Issued to Centers for Innovation in Advanced Development and Manufacturing (CIADM) Sites, Prior to
and During the COVID-19 Pandemic, 2012 through 2021
Prior to COVID-19 Pandemic (2012-2020) During COVID-19 Pandemic (2020-2021)
Government Government
spending on spending on
task ordersa task ordersa
CIADM site (dollars) Task order activities (dollars) Task order activities
Emergent 32,103,568 Five task orders for sites to assist other 506,369,568 One task order to reserve capacity for
Manufacturing manufacturers in production of small commercial-scale production, which
Operations of batches of drug substances for: was used by another manufacturer to
Baltimore LLC · Ebola virus vaccine (2015-2017) produce one COVID-19 vaccine drug
substance.
· Purification of monoclonal antibodies
for non-clinical use (2015-2016)b
· Zika virus vaccine candidate
(2016-2017)
· Viral Hemorrhagic Fever therapeutic
(2017)c
· Testing and shelf-life extension of
adjuvant for pandemic preparedness
(2018-2021)d
CSL Seqiruse 0 N/A – no task orders issued - -
19According to BARDA officials, the task order funding was used to reserve capacity for
vaccine production once viable candidates had emerged. This funding was not directly for
vaccine production, since each site contracted separately with the manufacturers to
produce vaccines based on manufacturer specifications. In other words, BARDA issued
the task orders to hold manufacturing capacity so that it could not be used for alternate
purposes.
Page 10 GAO-23-105713 Medical Countermeasure Development
Letter
Prior to COVID-19 Pandemic (2012-2020) During COVID-19 Pandemic (2020-2021)
Government Government
spending on spending on
task ordersa task ordersa
CIADM site (dollars) Task order activities (dollars) Task order activities
Texas A&M 1,054,086 One task order for the technology 272,440,877 One task order to reserve capacity for
University transfer of anthrax vaccine drug commercial-scale production, which
System substance (2016-2017).f was used by other manufacturers to
produce two COVID-19 vaccine
candidates.
Source: GAO analysis of Biomedical Advanced Research and Development Authority (BARDA) task orders and written correspondence and CIADM site documentation and written correspondence. |
GAO-23-105713
a
According to BARDA officials, the spending amounts included for Emergent and Texas A&M reflect
disbursements to the CIADM sites.
b
Monoclonal antibodies are laboratory-produced antibodies that act to mimic the immune system’s
ability to fight off pathogens. They are not vaccines and have traditionally been used as treatments for
individuals that are already infected. “Non-clinical use” refers to experiments in which test articles are
studied prospectively in test systems under laboratory conditions to determine their safety. The term
does not include studies utilizing human subjects or clinical studies or field trials in animals.
c
Viral Hemorrhagic Fevers are a group of diseases that affect many organ systems of the body,
damages the overall cardiovascular system, and reduces the body’s ability to function on its own.
These include yellow fever and dengue fever, among others.
d
Adjuvants are compounds such as aluminum salts that help to enhance the immune response, which
are often added to vaccines.
e
CSL Seqirus (known as Seqirus until August 2022) was created in 2015 when its parent company,
CSL Limited, acquired the influenza vaccine business of Novartis Vaccines and Diagnostics, Inc. of
Cambridge, MA, which received the original CIADM award. In December 2016, the government
novated the CIADM contract originally awarded to Novartis to CSL Seqirus.
f
Technology transfer” refers to the process of transmitting key product information such as product
knowledge and experience, manufacturing process, and analytical methods from one entity to
another for the purposes of product development and manufacturing.
As shown in table 2, HHS provided funds to the sites through multiple
task orders prior to the COVID-19 pandemic, but these task orders were
for smaller-scale production. Specifically, BARDA awarded six task orders
worth a total of $33 million. These activities were primarily for
manufacturing small batches of drug substances for manufacturing
clients, such as for use in clinical trials, and were not intended to be used
by the general population. Only two of the three sites received task
orders, with one site (CSL Seqirus) receiving no task orders. The 18
months from April 2016 through September 2017 was the only period in
which the two sites had ongoing task orders in place at the same time.
Page 11 GAO-23-105713 Medical Countermeasure Development
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Underuse of the Sites Prevented Full
Development of Manufacturing Capabilities,
Affecting COVID19 Vaccine Production
BARDA and site officials identified key challenges that prevented the sites
from being used to develop their full capability. Specifically, the CIADM
sites did not receive consistent funding and production work from HHS or
external manufacturing partners. These challenges led to underuse of the
facilities and did not allow them to develop capabilities to produce
countermeasures in line with the intended goals of the program. While the
COVID-19 pandemic drove increased use of the sites and helped them
develop additional capabilities, the sites faced difficulties resulting from
underuse prior to the pandemic.
According to BARDA and DOD, Inconsistent Funding and
Production Work Prior to the COVID19 Pandemic
Prevented Sites from Fully Developing Production
Capabilities
BARDA officials told us they intended for the CIADM sites to have regular
work in order to ensure that they would maintain an operational state that
would allow them to produce countermeasures as needed. However, in
2018, a joint team from BARDA and DOD—known internally as the “Tiger
Team”—conducted an internal review of the CIADM program sites and
the DOD advanced manufacturing site. The team found significant
underuse of all of the sites. Specifically, it found that two of the CIADM
sites had none of their available capacity used, and the remaining site
had 7 percent used. In comparison, the DOD site was using an estimated
38 percent of its capacity at that time, although BARDA and DOD also
considered that site to be significantly underused.
BARDA officials said regular use of site capacity is necessary to ensure
that the sites have opportunities to practice and refine manufacturing
processes, establish expertise in production, and maintain expertise at a
level where they could rapidly produce countermeasures at commercial
scale. According to FDA, in order to produce at commercial scale,
manufacturing facilities must be able to maintain high quality levels when
producing high volumes and conduct numerous rounds of process
validation, in line with FDA requirements for current good manufacturing
practices (see sidebar). BARDA officials said that without regular use the
Page 12 GAO-23-105713 Medical Countermeasure Development
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sites were not able to build the capabilities needed to be prepared, such
as hiring a sufficient number of experienced workers and having enough
time to ensure that the equipment could be properly tested and validated
for quality control purposes. BARDA officials told us that the sites’
experience with clinical trial production in the pre-pandemic task orders
they received did not necessarily translate to commercial scale
production, such as was needed for the COVID-19 pandemic response.
Being able to reliably produce countermeasures at a commercial scale for
the national population was the goal of the surge production capacity
service envisioned by BARDA.
Page 13 GAO-23-105713 Medical Countermeasure Development
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FDA Inspections and Current Good BARDA and site officials identified key challenges that prevented the sites
Manufacturing Practices for Vaccines from being used to develop their full capability.
· Difficulties attracting manufacturing partners. The Tiger Team
review and BARDA officials found that industry partners were hesitant
to use the sites for production. BARDA intended for the sites to
maintain work by contracting with countermeasure developers to
produce their products. However, two primary factors hindered this
work. First, officials from the sites told us that countermeasure
manufacturers were hesitant to use site manufacturing space.
Specifically, officials from two sites said that industry partners were
The Food and Drug Administration (FDA) concerned about the risk of being forced out of the sites when the
ensures the quality of vaccines marketed in
the U.S. by monitoring manufacturing government later needed the capacity for other reasons.20 Second,
facilities’ compliance with current good the sites did not have an established history of manufacturing FDA-
manufacturing practices. Current good
manufacturing practices are FDA regulations approved countermeasures, and the Tiger Team review found that
that contain minimum requirements for the this inexperience could result in manufacturing delays that could pose
methods, facilities, and controls used in a risk to developers’ profit incentive for a potential product.21 Without
manufacturing, processing, and packing of a
product. See 21 C.F.R. Parts 210 and 211 external manufacturing partners to provide the sites with regular work,
(2021). FDA considers compliance with the sites would need to rely on BARDA task orders for work to
current good manufacturing practices as part
of its review of new product applications, as develop capabilities.
well as during post-marketing inspections.
Sources: FDA and GAO-22-105051 (information);
· Lack of sustainment funding from HHS. BARDA officials said HHS
warut/stock.adobe.com (photo). | GAO-23-105713 lacked funding to sustain production at the sites, and this limited the
CIADM program’s effectiveness. As mentioned above, BARDA spent
approximately $4 million per year, on average, on task orders prior to
the pandemic; however, maintaining a facility in a ready state requires
consistent funding of $30 to $60 million per year, according to officials
from BARDA and one site we interviewed.
BARDA officials told us that the lack of sustainment funding meant
that the agency was limited in its ability to issue regular task orders,
monitor sites to provide technical assistance carrying out their
contractual obligations, and pay reservation fees to keep facilities in a
ready state and reserve unused capacity. Officials from one site told
20BARDA officials noted that this risk is not limited to manufacturers working with BARDA.
Under the Defense Production Act, the U.S. government can require any company to
prioritize government contracts for medical supplies to address a national emergency.
Pub. L. No. 81-774 (1950), codified at 50 U.S.C. §§ 4501 et seq., as amended.
21For example, a 2016 study conducted for DOD found that medical countermeasures had
little to no commercial market, and the department would not buy sufficient quantities at
high enough prices to justify the opportunity cost to large pharmaceutical manufacturers.
Thus, delays in manufacturing would result in even fewer quantities being sold, which
would have a further negative impact on opportunity cost. See Institute for Defense
Analyses, Cost Benefit Analysis of the DOD Advanced Development and Manufacturing
Facility for Medical Countermeasures (July 2016).
Page 14 GAO-23-105713 Medical Countermeasure Development
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us that this prevented the site from fully staffing its facility. BARDA
officials told us that, even though it was bad for the relationships with
sites, BARDA avoided officially designating sites as ready to provide
core services, as that would have required the agency to pay
sustainment fees, for which it did not have funds available.
According to BARDA officials, BARDA sought to request sustainment
funding from Congress for the CIADM program, but these were
ultimately not included in HHS’s budgets for fiscal years 2018 through
2020. BARDA officials also said that funding intended for advanced
research and development work was used to support other high
priority programs outside of the CIADM program.
BARDA’s underuse of the sites also resulted in limited agency oversight
of, and unclear communication with, the CIADM sites.
· Limited BARDA oversight. Underuse of the sites resulted in BARDA
conducting more limited oversight activities. According to BARDA
officials, assessing a site’s capabilities is difficult without a product in
production. Thus, the extent of BARDA’s annual audits, site visits, and
collection of progress reports and documents from sites depended
heavily on whether a task order had been issued to a site to produce
a product. According to BARDA officials, sites sent regular reports as
outlined in their contracts, and BARDA conducted contractual
oversight activities, but, without task orders, the oversight activities
were more limited in scope and frequency. For example, officials from
one site told us that BARDA had more substantive discussions with
them once the site received a task order to produce a product,
whereas without a product BARDA was more focused on standard
meetings and audits to monitor compliance.
· Inconsistent BARDA guidance. The sites did not always receive
clear guidance from BARDA on what they were expected to do,
according to site officials. Officials from two sites told us that they
would make proposals to BARDA, such as identifying potential
manufacturing partners for countermeasure development, but could
not reach agreement with BARDA officials about how to proceed and
would not always receive clear guidance about how to improve the
proposals. Officials from one site told us they were unable to start
several projects because the site and BARDA could not reach an
agreement on project requirements despite multiple proposal
revisions. These officials also said the subject matter experts BARDA
provided to the site gave inconsistent or conflicting guidance with
each other. BARDA officials told us that the program’s lack of
Page 15 GAO-23-105713 Medical Countermeasure Development
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sustainment funding limited their ability to provide consistent support
and guidance on these proposals.
BARDA officials and officials from one site also said the CIADM
program experienced high levels of turnover among the contracting
officers at BARDA over the program’s duration. These officials said
this made the program less efficient due to the new officers’ low level
of familiarity with their sites’ contracts. In the past, we have found that
turnover among the contracting workforce leads to lost institutional
knowledge and can lead to inefficiencies in the contracting process.22
Although the COVID19 Pandemic Response Led to
Increased Use of the Sites, Difficulties Resulted from the
Prior Underuse
Resources from the federal government’s response to the COVID-19
pandemic allowed BARDA to reserve sites’ capacity for commercial
production of COVID-19 vaccines and therapeutics. This helped address
some of the previously mentioned challenges associated with underuse.
· Task order spending allowed sites to expand operations. As
previously mentioned, BARDA-provided COVID-19 task orders for
capacity reservation at the two remaining active sites were worth
approximately $750 million, which was a significant increase from pre-
pandemic spending. The funding allowed the sites to reserve capacity
and to quickly set up facilities and infrastructure and hire staff to
produce vaccine ingredients.
· Vaccine production increased BARDA oversight of sites.
According to officials from BARDA and the two active sites, BARDA
provided more frequent and consistent oversight to the sites as they
set up their operations to produce COVID-19 vaccine candidates.
BARDA officials told us they provided staff to the two sites remaining
in the program to coordinate and provide technical support and held
daily calls with both sites to monitor construction efforts, staffing
progress, and supply chain logistics. This aimed to ensure that sites
could quickly acquire the experience and capability needed to
produce vaccines at commercial scale. BARDA officials told us
BARDA also conducted extensive review of both sites to assess
readiness for vaccine manufacturing activities and to ensure that the
sites were compliant with FDA manufacturing requirements. BARDA
22GAO, Acquisition Planning: Opportunities to Build Strong Foundations for Better
Services Contracts, GAO-11-672 (Washington D.C.: Aug. 9, 2011).
Page 16 GAO-23-105713 Medical Countermeasure Development
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officials said that they helped both sites with recruitment efforts and
provided them with additional staff with laboratory or biomanufacturing
expertise to aid with staffing shortages, as well as providing on-site
manufacturing experts to work with the sites to improve quality
systems. CIADM site officials said that BARDA was much more
involved in day-to-day operations during the pandemic and was more
helpful.
However, the CIADM program’s lack of readiness affected its ability to
respond to the COVID-19 pandemic. BARDA officials told us that the sites
were not ready to produce high-quality countermeasures reliably at a
commercial scale during the pandemic, and were learning in real time.
They said that before production could begin during the pandemic, the
sites had to create quality systems, which would have already been
created and sufficiently tested in a facility that had been regularly
producing commercial-scale products. However, BARDA officials said
that, because the sites had lacked regular work to develop capability and
the associated workforce experience, the sites ran into issues maintaining
quality standards when manufacturing COVID-19 vaccines at commercial
scale, as illustrated in the following examples.
· Emergent experienced issues related to cross-contamination that led
the facility to temporarily shut down and, subsequently, to a mutual
agreement with BARDA to terminate the site’s contract in November
2021.
· BARDA audits found issues with aspects of the quality systems of
Texas A&M’s primary subcontractor during the pandemic, such as
inconsistent record keeping and deviations from procedure for
assessing risks from drug substance manufacturing.
Partially as a result of these problems, none of the CIADM sites were able
to manufacture vaccines reliably for the national population in order to
meet the program’s surge production capacity goal.
It Is Unclear How HHS Plans to Address Known
Challenges and Future Risks in Its Proposed
Program Model
BARDA has provided some information about how its proposed program
model plans to address some challenges experienced by the CIADM
program. However, because these plans are not fully developed, it is
Page 17 GAO-23-105713 Medical Countermeasure Development
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unclear how the program model will address or mitigate all known
challenges and future risks.
HHS Has Provided Some Information on How Its
Proposed Program Model Plans to Address Some CIADM
Program Challenges
BARDA officials provided some information on how the agency plans to
address challenges experienced by the CIADM program in its proposed
new program model, known as the National Biopharmaceutical
Manufacturing Partnership (BioMaP). In a June 2022 presentation to
industry representatives, BARDA officials said the agency’s vision is to
establish infrastructure, manufacturing platforms, and a supply chain
capable of producing enough vaccines for the entire U.S. population
within 130 days—and the global population within 200 days—after
identification of a potential pandemic threat.23 According to BARDA
officials, BioMaP will focus on supply chain, industrial base expansion
and innovation, and large-scale vaccine drug substance manufacturing.
This program model is expected to use a consortium—a group of
members interested in a specific technology area —that will provide the
government with a ready pool of stakeholders to innovate in that
technology area, according to BARDA officials. Consortium members can
include traditional contractors, nontraditional contractors, academic
institutions, and non-profit organizations, among others. Under this type
of arrangement, members would typically sign a consortium membership
agreement (also referred to as articles of collaboration). That agreement
could outline information about the consortium’s governance structure,
membership dues, rules for handling proprietary information within the
consortium, principles for handling intellectual property, and other
principles that the members agree to when joining the consortium. The
consortium may also have a separate entity that manages the
consortium.
The President’s budget request to Congress for fiscal year 2023 said that
consortium members were expected to be established by the end of fiscal
year 2022. In October 2022, BARDA officials told us that they planned to
23This aligns with the goal for vaccine production called for in the 2022 National
Biodefense Strategy. See White House, National Biodefense Strategy and Implementation
Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and
Achieving Global Health Security (Washington, D.C.: October 2022).
Page 18 GAO-23-105713 Medical Countermeasure Development
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have the consortium members in place in early fiscal year 2023, but did
not provide a timeline for starting manufacturing efforts, as funding was
not yet available.
BARDA officials indicated that under current plans for BioMaP, BARDA
will use a different contracting structure than it did for the CIADM
program, which agency officials said will allow for more flexibility.
Specifically, BARDA plans to use a contracting mechanism known as
Other Transaction Agreements (OTA).24 The flexibility of OTAs can help
agencies address the concerns of nontraditional contractors—entities that
do not typically do business with the federal government, such as start-up
companies—about the requirements that typically apply to federal
procurement contracts.25 BARDA officials told us that they have faced
challenges engaging with companies in the past due to the industry’s
desire to avoid certain provisions—such as cost accounting standards
and audits—that are part of contracts regulated by the Federal Acquisition
Regulation, which included the CIADM program contracts. We previously
reported that the OTA structure has been used for research, prototyping,
and production of new technologies or products with nontraditional
companies. However, we have also found risks with the use of this model.
For example, OTAs are exempt from the Federal Acquisition Regulation,
so they do not require certain procurement contract oversight
mechanisms.26
While BARDA has established its plan to use an OTA contract structure
for BioMaP, many aspects of the program model remain under
24When an OTA is awarded to a consortium, the task orders resulting from that OTA may
be awarded to the members of that consortium. OTAs are not required to include terms
and conditions that are typically required when using traditional procurement contracts
subject to the Federal Acquisition Regulation, as the CIADM program contracts were.
OTAs enable agencies and contract awardees to negotiate terms and conditions specific
to each awarded contract or task order. For more information on consortium-based OTAs,
see GAO, Other Transaction Agreements: DOD Can Improve Planning for Consortia
Awards, GAO-22-105357 (Washington, D.C.: Sept. 20, 2022) and GAO-21-501.
25These concerns can be related to requirements establishing a government-unique cost
accounting system or losing intellectual property rights, among others. GAO, COVID-19
Contracting: Actions Needed to Enhance Transparency and Oversight of Selected
Awards, GAO-21-501 (Washington, D.C.: July 26, 2021).
26See, for example, GAO, Army Modernization: Army Should Improve Use of Alternative
Agreements and Approaches by Enhancing Oversight and Communication of Lessons
Learned, GAO-21-8 (Washington, D.C.: Oct. 1, 2020) and COVID-19: Critical Vaccine
Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused
Federal Attention, GAO-21-265 (Washington, D.C.: Jan. 28, 2021).
Page 19 GAO-23-105713 Medical Countermeasure Development
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consideration, and the agency is collecting industry feedback. BARDA
officials said that the program model will encourage industry participation,
and BARDA has proposed a plan for sustainable funding, which were key
challenges of the CIADM program. However, industry stakeholders and
site officials noted some unaddressed risks. Additionally, the OTA
contract structure would introduce its own risks related to the resources
and expertise needed to manage the structure. BARDA’s proposal has
not yet clarified how the program model will work in practice, and industry
representatives have expressed concerns about BARDA’s plan for the
program.
· Encouraging industry participation. BARDA officials said that the
use of OTA contracting under BioMaP will provide more incentives for
industry stakeholders to participate, but industry stakeholders are not
as certain. According to BARDA officials and industry stakeholders,
the OTA structure allows for flexibilities that could better incentivize
manufacturing partner participation.27 BARDA officials said an OTA
structure could enable BARDA to identify and attract manufacturing
partners that may not ordinarily do business with the government—
which they said has been historically challenging in the
pharmaceutical field.
BARDA officials said that the new contracting approach could also
encourage larger, more established industry partners to participate.
According to the officials, these larger manufacturers would be able to
maintain a prepared workforce and capability based on their regular
commercial work, resulting in BARDA needing to provide less regular
funding for the sites.
In response to a BARDA survey, industry stakeholders agreed that
the OTA contract structure offers some benefits to encourage industry
participation, such as more flexible terms and stronger intellectual
property protections. However, industry stakeholders still expressed
concerns about industry participation. For example, officials from one
CIADM site told us that manufacturers would continue to be hesitant
to invest into staff and facilities when they know that the U.S.
government can take over their existing capacity during a public
health response.
27For instance, the OTA structure allows for more flexible arrangements than can be done
under traditional contracting subject to the Federal Acquisition Regulation. These more
flexible terms can incorporate commercially acceptable terms, ease infrastructure
requirements for proposing and tracking costs, and protect contractors’ intellectual
property.
Page 20 GAO-23-105713 Medical Countermeasure Development
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· Providing a sustainable funding source. BARDA has not identified
dedicated funding for BioMaP, raising questions about the viability of
the program. The President’s budget request to Congress for fiscal
year 2023 identified the program, but did not request funding
specifically for BioMaP. However, BARDA officials have said that
BioMaP’s proposed funding is accounted for within the White House’s
American Pandemic Preparedness Plan, a September 2021 plan from
the White House to improve the country’s ability to respond to
pandemics.28 According to officials, the plan proposed spending $81.7
billion for efforts to Prepare for Future Pandemics and Advance
Health Security for Other Biological Threats, with $40 billion of that
going to BARDA. BARDA officials indicated that they did not request
dedicated funding for BioMaP, but $10 billion to $13 billion of the
funds for BARDA would be for its manufacturing-related efforts, which
would include BioMaP and other programs. BARDA officials told us
that they have not developed formal budgets or created acquisition
plans for BioMaP, because they are waiting for funding to be secured
before doing so.
Industry stakeholders and site officials said that the program needs a
source of sustained funding to ensure industry participation and
maintain capacity and capability. Industry representatives and site
officials said that manufacturers cannot afford to keep manufacturing
lines unused for the government’s future use without sustainment
funding.
28The American Pandemic Preparedness Plan was announced in September 2021 and
aims to transform capabilities to respond rapidly and effectively to any future pandemic or
high consequence biological threat by (1) transforming our medical defenses, (2) ensuring
situational awareness, (3) strengthening public health systems, (4) building core
capabilities, and (5) managing the mission. See White House, American Pandemic
Preparedness: Transforming Our Capabilities (Washington, D.C.: September 2021).
Page 21 GAO-23-105713 Medical Countermeasure Development
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· OTA Structure. BARDA’s contracting workforce may not have the
Other Transaction Agreements (OTA) Use
During COVID-19 resources and expertise to effectively administer an OTA contract
Most of the COVID-19 OTA dollars were structure as a part of BioMaP. HHS officials have reported that, as of
obligated in July 2020 and driven by vaccine April 2022, BARDA only had half of the contracting staff needed to
awards. Of the $12.5 billion the Departments execute its contract portfolio. We previously reported that, while OTA
of Defense, Health and Human Services
(HHS), and Homeland Security obligated for structures provide more flexibility than traditional contracts subject to
COVID-19 OTAs, $8.9 billion or 71 percent the Federal Acquisition Regulation, they are not required to include
was for vaccine development—including
clinical trials—and manufacturing efforts. The
the same oversight mechanisms used with traditional contracts.29
remaining $3.6 billion was for medical Because of the lack of the formal structure in traditional contracts, the
research and development and other OTA structure can be more complex to oversee and can require more
nonvaccine products and services. HHS
obligated at least $1.6 billion on COVID-19- expertise from contracting officers. We found that HHS has
related OTAs from March 2020 through March established guidance and training related to the administration of OTA
2021—primarily to help accelerate vaccine
development and manufacturing. However,
structures, but the agency has not updated its OTA guidance for
this is an underreported figure because HHS contracting staff since 2012 to account for any new risks associated
misreported its OTAs as procurement with the OTA model.30
contracts. From November 2020 through
March 2021, OTA obligations were While BARDA officials told us the agency has managed OTA
comparatively not as significant as earlier in
the pandemic. This was, in part, because structures in the past and their contracting officers gained experience
additional vaccine doses were acquired using working with OTAs during the pandemic (see sidebar), we found HHS
procurement contracts instead of OTAs.
and BARDA also experienced challenges. Specifically, during the
Source: GAO-21-501. | GAO-23-105713
COVID-19 pandemic HHS’s acquisition workforce did not have the
capacity or expertise to manage OTA contracting needs and had to
partner with DOD to administer those contracts.
BARDA officials told us that the agency is planning to use a separate
consortium management firm to manage the BioMaP consortium.
While this could alleviate some risks related to resources and
expertise, BARDA’s contracting staff would still need to oversee the
contract with the consortium management firm. In prior work, we
found that HHS’s OTA guidance did not include what certain
information that contract officers should consider when using
consortium management firms, including what enhanced oversight
activities may be appropriate, and we recommended that HHS update
its OTA guidance.31 Therefore, although BARDA has gained more
experience managing OTAs, an additional OTA in its portfolio could
29GAO-22-105357.
30According to HHS guidance, contracting officers overseeing an OTA must possess the
necessary experience, responsibility, business acumen, and judgment to operate in the
relatively unstructured business environment of the OTA without the Federal Acquisition
Regulation framework to guide them. These individuals must also receive appropriate
OTA training before being delegated authority to administer OTAs. BARDA officials told us
that 13 out of approximately 80 BARDA contracting officers were sanctioned to administer
OTAs as of August 2022. For more information, see GAO-21-501.
31GAO-21-501. As of January 2023, this recommendation remains open.
Page 22 GAO-23-105713 Medical Countermeasure Development
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pose a risk if the agency does not have enough contracting staff or
out-of-date guidance in managing a complex structure.
· Potential challenges with BioMaP’s vision. BioMaP is still under
development, and industry stakeholders and officials from one site
expressed confusion about how the program model will work and
whether it could face additional challenges. Officials from one site
expressed concern about using a model that relies on responding to
ad-hoc task orders instead of regular, sustained task orders. The
officials told us that, without regular task orders, BioMaP’s consortium
would be more of an “on-paper” exercise with partners that would not
be regularly producing useful countermeasures. Industry
representatives expressed the need for clear communication from
BARDA on priority access to facilities.
Industry stakeholders also noted additional barriers to participation,
such as technological change and concerns around raw materials and
supply chains. From a technological perspective, industry
representatives told BARDA that there would need to be limits or
constraints on technological changes. One site representative told us
that it is not easy to pivot manufacturing platforms quickly, suggesting
that BARDA should consider funding a subset of flexible technologies
that have redundant capacity that could be drawn upon during a
pandemic response.32 Industry representatives also told BARDA that
there are already risks to supply chains and uncertainty in lead times
that would affect future manufacturing efforts. Additionally, BARDA
officials told us that sustaining a biopharmaceutical response
infrastructure adequate for multiple different infection or pathogen
scenarios must consider supporting a range of manufacturing
methodologies, which may need changing over time as technologies
improve.
32For example, as part of the COVID-19 response, the government supported multiple
manufacturing technologies during vaccine development in order to mitigate the risk that
any one platform or specific vaccine candidate could fail because of problems with safety,
efficacy, industrial manufacturability, or scheduling factors. This strategy included two
vaccine platforms that had not previously been used in a licensed vaccine, but could
theoretically be quickly adapted to COVID-19 and scaled up rapidly (i.e., the mRNA
platform and replication-defective live-vector platform), and one platform that had been
proven (i.e., the recombinant-subunit-adjuvanted protein platform). For more information,
see GAO, Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status
and Efforts to Address Manufacturing Challenges, GAO-21-319 (Washington, D.C.: Feb.
11, 2021).
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HHS Has Not Fully Developed Its Plans for How BioMaP
Will Address or Mitigate Known Challenges and Future
Risks
While BARDA has outlined a framework for its intended BioMaP program
model, it is not prepared to address or mitigate known challenges and
future risks because BARDA has not yet fully developed its plans for the
program model. BARDA officials, site officials, and our previous work
have identified risks that could affect BARDA’s ability to achieve the goals
outlined in BioMaP’s vision—some carried over from the CIADM program,
and some introduced by the framework for its successor, the BioMaP
program model. The results of the CIADM program have shown that
building initial capacity is not enough. According to BARDA officials,
underuse of the sites posed a significant challenge to the CIADM
program’s success, as the sites were never able to develop the capability
they would have needed to meet the goals of the program.
According to leading practices for risk management, agencies should
regularly incorporate risk management activities into their program
operations in order to ensure that future risks can be addressed.
Specifically, the Office of Management and Budget’s Circular A-123
requires federal agencies to integrate risk management activities into their
program management to help ensure they are effectively managing risks
that could affect the achievement of agency objectives. Then, once initial
risks are identified, the circular notes that is important for agencies to
regularly re-examine risks to identify new risks or changes to existing
risks.
Fully developing a plan to systematically assess and respond to
challenges associated with advanced development and manufacturing of
medical countermeasure programs would help BARDA ensure it avoids
the challenges experienced by the CIADM program. Such a plan would
include clearly documenting risks, tracking progress made in addressing
risks, estimating resources needed to address risks, and communicating
this information to key decision makers, such as HHS leadership and
Congress. For example, this plan could include strategies to identify
resource needs sufficient to ensure needed domestic capacity is
sustained, as BARDA officials noted that a lack of sustained funding for
this or a similar program will impede their ability to respond to the next
pandemic.
Page 24 GAO-23-105713 Medical Countermeasure Development
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Conclusions
The CIADM program was envisioned as a way to build domestic capacity
to rapidly produce countermeasures to save lives during a public health
emergency, but the program did not meet its goals. As HHS develops a
new program model, appropriate risk planning will be critical to ensuring it
can systematically assess, analyze, and respond to known challenges
and manage future risks. If HHS does not develop an effective program
model, it may not secure the private sector partnerships necessary to
provide countermeasure surge manufacturing capacity and capability
during future public health emergencies. Without a program that has the
capability to build up, maintain, and regularly use domestic
countermeasure manufacturing capabilities, HHS risks being unable to
meet countermeasure manufacturing goals for future public health
emergencies, especially if these emergencies bring about risks that the
agency has not planned for, such as those experienced during the
COVID-19 response.
Recommendation for Executive Action
The Secretary of Health and Human Services should direct BARDA to, as
part of the development of a new program model, incorporate an
approach to systematically assess and respond to known challenges and
future risks associated with advanced development and manufacturing of
countermeasures—including challenges related to funding and risks
associated with effectively managing the contracting structure. Such an
approach should clearly document program risks, ensure that progress in
addressing risks is tracked, estimate needed program resources, and
communicate this information to key decision makers. (Recommendation
1)
Agency Comments
We provided a draft of this report to HHS for review and comment. In its
written comments, which are reproduced in appendix I, HHS concurred
with our recommendation. The agency stated that, while BioMaP is early
in development, it will work to ensure the effort aligns with the principles
outlined in our recommendation and that it communicates with key
decision makers as the effort moves forward. HHS also provided
technical comments, which we incorporated as appropriate.
Page 25 GAO-23-105713 Medical Countermeasure Development
Letter
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Health and Human Services, and other
interested parties. In addition, the report is available at no charge on the
GAO website at http://www.gao.gov.
Page 26 GAO-23-105713 Medical Countermeasure Development
Letter
If you or your staff have any questions about this report, please contact
Mary Denigan-Macauley at (202) 512-7114 or
deniganmacauleym@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last page
of this report. GAO staff who made major contributions to this report are
listed in appendix II.
Mary Denigan-Macauley
Director, Health Care
Page 27 GAO-23-105713 Medical Countermeasure Development
Letter
List of Committees
Chairman
Vice Chairman
Committee on Appropriations
United States Senate
Chair
Ranking Member
Committee on Finance
United States Senate
Chair
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate
Chairman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate
The Honorable Kay Granger
Chair
The Honorable Rosa L. DeLauro
Ranking Member
Committee on Appropriations
House of Representatives
The Honorable Cathy McMorris Rodgers
Chair
The Honorable Frank Pallone, Jr.
Ranking Member
Committee on Energy and Commerce
House of Representatives
Page 28 GAO-23-105713 Medical Countermeasure Development
Letter
The Honorable Mark E. Green, MD
Chairman
The Honorable Bennie G. Thompson
Ranking Member
Committee on Homeland Security
House of Representatives
The Honorable James Comer
Chairman
The Honorable Jamie Raskin
Ranking Member
Committee on Oversight and Accountability
House of Representatives
The Honorable Jason Smith
Chairman
The Honorable Richard Neal
Ranking Member
Committee on Ways and Means
House of Representatives
Page 29 GAO-23-105713 Medical Countermeasure Development
Appendix I: Comments from the Department of
Health and Human Services
Appendix I: Comments from the
Department of Health and Human
Services
Page 30 GAO-23-105713 Medical Countermeasure Development
Appendix I: Comments from the Department of
Health and Human Services
Page 31 GAO-23-105713 Medical Countermeasure Development
Appendix I: Comments from the Department of
Health and Human Services
Text of Appendix I: Comments from the Department of
Health and Human Services
January 9, 2023
Mary Denigan-Macauley Director, Health Care
U.S. Government Accountability Office 441 G Street NW
Washington, DC 20548
Dear Ms. Denigan-Macauley:
Attached are comments on the U.S. Government Accountability Office’s (GAO)
report entitled, “PUBLIC HEALTH PREPAREDNESS: HHS Should Plan for Medical
Countermeasure Development and Manufacturing Risks” (GAO-23-105713).
The Department appreciates the opportunity to review this report prior to publication.
Sincerely,
Melanie Anne Egorin, PhD Assistant Secretary for Legislation
Attachment
GENERAL COMMENTS FROM THE DEPARTMENT OF HEALTH
& HUMAN SERVICES ON THE GOVERNMENT
ACCOUNTABILITY OFFICE’S DRAFT REPORT PUBLIC
HEALTH PREPAREDNESS: HHS SHOULD PLAN FOR MEDICAL
COUNTERMEASURE DEVELOPMENT AND MANUFACTURING
RISK GAO23105713)
The U.S. Department of Health & Human Services (HHS) appreciates the
opportunity from the Government Accountability Office (GAO) to review and
comment on this draft report.
General Comments Recommendation 1
The Secretary of Health and Human Services should direct BARDA to, as part of the
development of a new program model, incorporate an approach to systematically
Page 32 GAO-23-105713 Medical Countermeasure Development
Appendix I: Comments from the Department of
Health and Human Services
assess and respond to known challenges and future risks associated with advanced
development and manufacturing of countermeasures—including challenges related
to funding and risks associated with effectively managing the contracting structure.
Such an approach should clearly document program risks, ensure that progress in
addressing risks is tracked, estimate needed program resources, and communicate
this information to key decision makers.
HHS Response
HHS Concurs with GAO's recommendation.
ASPR concurs with this recommendation. ASPR BARDA will work to ensure that the
successor to the Centers for Innovation in Advanced Development and
Manufacturing Program - the National Biopharmaceutical Manufacturing Partnership
(BioMaP) -will align with the GAO recommendation. As GAO notes in the report,
BioMaP is still extremely early in development, and ASPR BARDA will work to
ensure communication with key decision makers as this effort moves forward.
Page 33 GAO-23-105713 Medical Countermeasure Development
Appendix II: GAO Contact and Staff
Acknowledgments
Appendix II: GAO Contact and
Staff Acknowledgments
GAO Contact
Mary Denigan-Macauley, (202) 512-7114, deniganmacauleym@gao.gov
Staff Acknowledgments
In addition to the contact named above, William Hadley (Assistant
Director), Matthew Green (Analyst in Charge), Benjamin Feldman, Meg
McAloon, Laurie Pachter, Emily Wilson Schwark, Meghan Perez, Janet
McKelvey, Claire Li, Michael Dickens, and Roxanna Sun made key
contributions to this report.
(105713)
Page 34 GAO-23-105713 Medical Countermeasure Development
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