GAO-23-106529, CARES ACT: Experts Identified Safeguards to Help Selected HHS Agencies Protect Against Potential Political Interference
- Issuer
- Government Accountability Office
- Document type
- Memorandum
- Date
- 2023-09-14
Summary
A U.S. Government Accountability Office report to congressional requesters, GAO-23-106529, dated September 14, 2023 and issued as part of GAO's CARES Act oversight work. It describes actions experts believe four Department of Health and Human Services agencies, CDC, FDA, NIH and ASPR, could take to protect against political interference. GAO convened a roundtable of 11 experts in May 2023, with help from the National Academies of Sciences, Engineering, and Medicine, and gave them six case studies of potential political interference during the COVID-19 response. The experts identified safeguards in three areas, and the report states that HHS is updating its scientific integrity policy in response to recommendations GAO made in April 2022. Appendices cover objective, scope and methodology, comments from HHS, and GAO contacts.
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United States Government Accountability Office
Report to Congressional Requesters
CARES ACT
September 2023
Experts Identified
Safeguards to Help
Selected HHS
Agencies Protect
Against Potential
Political Interference
GAO-23-106529
September 2023
CARES ACT
Experts Identified Safeguards to Help Selected HHS
Agencies Protect Against Potential Political
Highlights of GAO-23-106529, a report to
Interference
congressional requesters
Why GAO Did This Study What GAO Found
Recent reports have identified Department of Health and Human Services (HHS) agencies—including the
shortcomings in HHS’s response to the Centers for Disease Control and Prevention (CDC), the Food and Drug
COVID-19 pandemic, including Administration (FDA), the National Institutes of Health (NIH), and the
allegations of political interference. In Administration for Strategic Preparedness and Response (ASPR)—have been at
April 2022, GAO made the forefront of the federal government’s response to the COVID-19 pandemic.
recommendations to HHS and agency Like most federal agencies, HHS leadership consists of both political appointees
heads, including that they develop and career officials who work together to oversee agency operations and
procedures for reporting and implement the administration’s policy priorities. Political involvement or undue
addressing allegations of political
external influence becomes interference when it seeks to undermine an agency’s
interference and train staff on how to
impartiality, nonpartisanship, and professional judgment, according to the
report such allegations. This report
examines further actions selected
National Academies of Sciences, Engineering, and Medicine.
agencies—CDC, FDA, NIH, and Experts participating in a roundtable convened by GAO identified safeguards in
ASPR—could take to protect against three areas that could help selected HHS agencies protect against potential
such interference. GAO selected these political interference.
agencies because of the key roles they
played in the COVID-19 response. Safeguards Identified by Experts to Help Selected Department of Health and Human Services
Agencies Protect Against Potential Political Interference
GAO convened a roundtable of 11
experts to discuss actions selected
HHS agencies could take to protect
against potential political interference.
GAO contracted with the National
Academies of Sciences, Engineering,
and Medicine to help identify
individuals with expertise in this topic
area. The selected experts
represented a range of perspectives
and experiences, including working in
the federal government; various
academic areas, including political
science; and the non-profit sector.
GAO also reviewed federal guidance Selected HHS agencies have taken, or are in the process of taking, steps related
related to scientific integrity and to some of these safeguards. For example, HHS officials told GAO that the
interviewed HHS officials. department is updating its existing scientific integrity policy, as required by a
What GAO Recommends presidential memorandum issued in January 2021. According to officials, the
updated HHS policy will include specific provisions prohibiting political
HHS is taking steps to address the interference and clear procedures for reporting and handling allegations of
recommendations GAO made in April political interference, among other things. In another example, HHS has
2022. For example, HHS is updating its designated an interim scientific integrity official dedicated to ensuring scientific
scientific integrity policy to include integrity at HHS.
specific provisions prohibiting political
interference, among other things, and While establishing safeguards against potential political interference is important,
developing training for staff. GAO will experts noted no agency is fully insulated from political influence and there is an
continue to monitor implementation. appropriate role for political appointees and elected officials in agency processes.
For example, experts told GAO it is appropriate for a political appointee or
elected official to encourage an agency to expedite or prioritize a project.
View GAO-23-106529. For more information,
contact Jessica Farb at (202) 512-7114 or However, experts said it would be inappropriate to exert influence in a manner
farbj@gao.gov. that interferes with the scientific integrity of the process or seeks to distort or
misuse the science behind a decision.
United States Government Accountability Office
Contents
Letter 1
Background 5
Experts Identified Safeguards in Three Areas That Could Help
Protect Against Political Interference at Selected HHS Agencies 12
Agency Comments 20
Appendix I Objective, Scope, and Methodology 23
Appendix II Comments from the Department of Health and Human Services 28
Appendix III GAO Contact and Staff Acknowledgments 30
Tables
Table 1: Alphabetical List of Expert Participants in GAO Expert
Panel to Identify Actions Selected HHS Agencies Could
Take to Protect Against Potential Political Interference,
Held May 1-2, 2023, and Institutional Affiliation at the
Time of Roundtable 25
Table 2: Six Instances of Potential Political Interference at
Selected Department of Health and Human Services
Agencies Provided to Participants in GAO Expert Panel,
Held May 1-2, 2023 27
Figure
Figure 1: Missions and Organizational Structures of Selected
Department of Health and Human Services (HHS)
Agencies 6
Page i GAO-23-106529 Potential Political Interference
Abbreviations
ASPR Administration for Strategic Preparedness and Response
BARDA Biomedical Advanced Research and Development
Authority
CDC Centers for Disease Control and Prevention
EUA emergency use authorization
FDA Food and Drug Administration
HHS Department of Health and Human Services
MMWR Morbidity and Mortality Weekly Report
NIH National Institutes of Health
OSTP Office of Science and Technology Policy
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Page ii GAO-23-106529 Potential Political Interference
Letter
441 G St. N.W.
Washington, DC 20548
September 14, 2023
Congressional Requesters
Department of Health and Human Services (HHS) agencies—including
the Centers for Disease Control and Prevention (CDC), the Food and
Drug Administration (FDA), the National Institutes of Health (NIH), and
the Administration for Strategic Preparedness and Response (ASPR)—
have been at the forefront of the federal government’s efforts to combat
the COVID-19 pandemic. Like most federal agencies, HHS leadership
consists of both political appointees, selected by the President, and
career officials who work together to oversee agency operations and
implement the administration’s policy priorities. Political involvement or
other undue external influence becomes interference when it seeks to
undermine an agency’s impartiality, nonpartisanship, and professional
judgment, according to the National Academies of Sciences, Engineering,
and Medicine (National Academies). 1
Recent reports have identified shortcomings in HHS’s response to the
COVID-19 pandemic, including allegations of political interference. For
example, in March 2020, FDA issued an emergency use authorization
(EUA) for hydroxychloroquine and chloroquine for the treatment of
COVID-19, a decision that was criticized by government scientists and
others as lacking in scientific integrity; the EUA was revoked about 3
months after issuance. 2 Additionally, members of Congress and experts
1According to the National Academies, it provides independent, objective analysis and
advice to the nation, including the federal government, and conducts other activities to
solve complex problems and inform public policy decisions.
For the purposes of this report, we adapted a definition of “political interference” from a
2017 report by the National Academies, which states that undue external influences are
those from outside an agency that seek to undermine its impartiality, nonpartisanship, and
professional judgment. See National Academies of Sciences, Engineering, and Medicine,
Principles and Practices for a Federal Statistical Agency: Sixth Edition. (Washington, D.C.:
2017).
2The Secretary of Health and Human Services may declare that circumstances,
prescribed by statute, exist justifying the emergency use of certain medical products.
Once a declaration has been made, FDA may temporarily allow the use of unapproved
medical products or unapproved use of approved medical products by issuing an EUA,
provided certain statutory criteria are met. See 21 U.S.C. § 360bbb-3.
Page 1 GAO-23-106529 Potential Political Interference
alleged that political pressure influenced CDC’s decision to change its
mask guidance in May 2021, which the agency subsequently reversed in
July 2021. In April 2022, we reported that agency respondents from CDC,
FDA, and NIH told us that they observed instances of potential political
interference that may have compromised the scientific integrity of certain
aspects of the COVID-19 pandemic response. 3
Allegations of political interference affecting scientific decision-making
within federal agencies are not unique to the COVID-19 pandemic
response, though they appear to be increasing in frequency, according to
a recent analysis examining reports of scientific integrity violations in
federal policymaking from the 1950s to 2018. 4 Additionally, research
indicates that the potential political interference reported in the media and
in congressional inquiries during the COVID-19 pandemic may have
reduced trust in public health institutions. 5
You asked us to examine actions selected agencies could take to protect
against such interference. We selected four agencies within HHS that
For the purposes of this report, the term “scientific integrity” refers to the use of scientific
evidence and data to make policy decisions that are based on established scientific
methods and processes and are not inappropriately influenced by political considerations.
When appropriate, these decisions are then shared openly with the public. This definition
is consistent with our prior reports and was developed based on our review of existing
scientific integrity guidance for agencies. In NIH policy, the agency defines scientific
integrity as “maintaining the quality and objectivity of the research activities that [NIH]
funds and conducts, such that they are sound and worthy of the public’s confidence.” NIH,
NIH Policies and Procedures for Promoting Scientific Integrity, (November 2012).
For example, see Charles Piller, “Former FDA Leaders Decry Emergency Authorization of
Malaria Drugs for Coronavirus,” Science (Apr. 7, 2020).
3See GAO, Scientific Integrity, HHS Agencies Need to Develop Procedures and Train
Staff on Reporting and Addressing Political Interference, GAO-22-104613. (Washington,
D.C.: Apr. 20, 2022).
4See Emily Berman and Jacob Carter. “Policy Analysis: Scientific Integrity in Federal
Policymaking Under Past and Present Administrations,” Journal of Science Policy and
Governance, vol. 13, no. 1 (Sept. 2018).
5For example, a September 2020 KFF Health Tracking Poll found that about four in 10
adults said that both FDA and CDC are paying “too much attention” to politics when it
comes to reviewing and approving treatments for COVID-19 or issuing guidelines and
recommendations. See KFF, “KFF Health Tracking Poll – September 2020: Top Issues in
2020 Election, The Role of Misinformation, and Views on A Potential Coronavirus
Vaccine.”
https://www.kff.org/coronavirus-covid-19/report/kff-health-tracking-poll-september-2020/
(accessed June 12, 2023).
Page 2 GAO-23-106529 Potential Political Interference
have played key roles in the public health response to the COVID-19
pandemic: CDC, FDA, NIH, and ASPR. This report describes actions
experts believe these selected HHS agencies can take to protect against
political interference. This report is also part of our body of work
conducted in response to the CARES Act. 6
To address this objective, in May 2023, we convened a roundtable of 11
experts to discuss actions selected HHS agencies could take to protect
against potential political interference. Specifically, we contracted with the
National Academies to help us identify individuals with expertise in this
topic area. 7 The experts we selected represented a range of perspectives
and experiences, including those with experience working in the federal
government; various academic areas, including political science and
oversight and regulatory functions of government; and the non-profit
sector. The experts who participated in the roundtable and their
institutional affiliations at the time of our roundtable are listed in appendix
I.
The selected experts discussed how to define and recognize political
interference, and identified actions the selected HHS agencies could take
to protect against political interference. To help facilitate this discussion,
we selected six instances of potential political interference identified as
part of prior GAO work that we used as case studies for the experts to
review. 8 All six case studies occurred during the COVID-19 pandemic
6The CARES Act included a provision for us to monitor and oversee the federal
government’s efforts to prepare for, respond to, and recover from the COVID-19
pandemic. Pub. L. No. 116-136, § 19010(b), 134 Stat. 281, 580 (2020). The American
Rescue Plan Act of 2021 also included 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.
7This roundtable was planned and convened with the assistance of the National
Academies to better ensure that a breadth of expertise was brought to bear in its
composition; however, all final decisions regarding meeting substance and expert
participation were made by GAO.
8The six case studies are related to allegations that: (1) FDA was pressured to issue an
EUA for hydroxychloroquine and chloroquine for treatment of COVID-19, (2) the
development of CDC’s school reopening guidance inappropriately involved teachers
unions, (3) the White House directed NIH to cancel certain grant funding, (4) the CDC
Director was pressured to overrule the agency’s advisory committee when recommending
booster shots, (5) political appointees within HHS sought to edit CDC’s Morbidity and
Mortality Weekly Report (MMWR), and (6) political pressure influenced CDC in its decision
to lift the mask mandate for fully vaccinated individuals.
Page 3 GAO-23-106529 Potential Political Interference
response; involved events at CDC, FDA, NIH, or ASPR; and had
bipartisan identification as a significant instance of potential political
interference. To gather information about these case studies, we spoke
with former agency officials and other stakeholders and reviewed
applicable policies, procedures, and internal documents. (See appendix I
for more information on our selection of these case studies.)
We analyzed the roundtable transcripts to identify common themes
discussed by and key statements of experts regarding potential actions
HHS agencies could take to protect against political interference. The
actions identified by experts are not listed in any specific rank or order in
this report, and their inclusion should not be interpreted as GAO
endorsing any of them. 9 Implementing any one action or a combination of
actions might require additional efforts to address program design or legal
issues. We did not assess how effective the actions listed in this report
might be, or the extent to which legislative or policy changes and federal
financial support would be needed to implement them. However, we
report considerations experts noted concerning the potential effectiveness
of specific actions.
In addition to convening the roundtable, we reviewed relevant federal
guidance related to political interference and scientific integrity. For
example, we reviewed a federal framework for scientific integrity policy
and practice issued by the Office of Science and Technology Policy
(OSTP) in January 2023. 10 We also interviewed officials and reviewed
written responses from selected HHS agencies about actions they have
taken or are planning to take to address potential political interference.
9The comments of the experts represented the views of the experts themselves and not
the organizations with which they are affiliated, and are not generalizable to the views of
others in the field.
10Scientific Integrity Framework Interagency Working Group of the National Science and
Technology Council, A Framework for Federal Scientific Integrity Policy and Practice,
January 12, 2023. The Office of Science and Technology Policy (OSTP) was established
by the National Science and Technology Policy, Organization, and Priorities Act of 1976 to
provide the President and others within the Executive Office of the President with advice
on the scientific, engineering, and technological aspects of the economy, among other
topics. OSTP leads interagency science and technology policy coordination efforts and
serves as a source of scientific and technological analysis and judgment for the President
with respect to major policies, plans, and programs of the federal government, among
other things. The Director of OSTP serves as a member of the National Science and
Technology Council, which was established by executive order in 1993 to coordinate the
science and technology policy-making process across the federal government.
Page 4 GAO-23-106529 Potential Political Interference
We conducted this performance audit from January 2023 to September
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 and Selected HHS’s mission is to enhance the health and well-being of all Americans
Agencies by supporting sound, sustained advances in the sciences underlying
medicine, public health, and social services. Within HHS, the four
selected agencies—CDC, FDA, NIH, and ASPR—have distinct missions,
histories, and organizational structures (see fig. 1).
Page 5 GAO-23-106529 Potential Political Interference
Figure 1: Missions and Organizational Structures of Selected Department of Health and Human Services (HHS) Agencies
a
See Pub. L. No. 102-531, § 312, 106 Stat. 3469, 3504-06. Ten HHS offices and agencies, including
ASPR, CDC, FDA, and NIH, are designated components of the U.S. Public Health Service.
b
In August 2022, CDC announced a plan to reorganize the agency’s structure to prioritize public
health needs and efforts to curb continuing outbreaks. Among others things, preliminary actions
Page 6 GAO-23-106529 Potential Political Interference
include restructuring the agency’s communications office, creating a new executive council, and
establishing an office of intergovernmental affairs.
c
See Pub. L. No. 59-384, 34 Stat. 768.
d
See Health Research Extension Act of 1985, Pub. L. No. 99-158, 99 Stat. 820.
e
See Pub. L. No. 109-417, § 102, 120 Stat. 2831, 2832-34 (2006).
HHS officials told us that ASPR had 1,879 full-time employees and 4,231 intermittent employees
f
serving as ASPR responders, as of June 2023.
Political Interference As we previously noted, the term “political interference” refers to political
influence that seeks to undermine impartiality, nonpartisanship, and
professional judgment. 11 While the term political interference is broad in
nature, this report focuses on potential political interference in scientific
decision-making at the selected HHS agencies. The term “scientific
integrity” refers to the use of scientific evidence and data to make policy
decisions that are based on established scientific methods and
processes, are not inappropriately influenced by political considerations,
and are shared openly and transparently with the public, when
appropriate.
A January 2022 report by the National Science and Technology Council
concluded that, “while Federal science is fundamentally sound, it remains
subject to political and other forms of interference that can undermine
Federal decision-making and erode public trust in science.” 12 Since 2007,
Congress and multiple administrations have taken actions to protect the
integrity of federal science agencies by ensuring that they have policies
and procedures in place to protect against the suppression or alteration of
scientific findings for political purposes.
Additionally, structural characteristics of agencies related to their
organization and design can affect the degree of agency autonomy from
political influence, including both the appropriate exercise of the
President’s and Congress’s constitutional duties and inappropriate
political interference, according to the Sourcebook of United States
11In June 2023, HHS officials told us that they use the following definition of political
interference—inappropriately shaping or interfering in the conduct, management,
communication, or use of science for political advantage or such that it undermines
impartiality, nonpartisanship, or professional judgment. The definition we used for
purposes of reporting differs because we adopted National Academy’s definition in the
absence of a standardized definition at HHS when we began our review.
12See Scientific Integrity Fast-Track Action Committee of the National Science and
Technology Council, Protecting the Integrity of Government Science (January 2022).
Page 7 GAO-23-106529 Potential Political Interference
Executive Agencies (Sourcebook). 13 Agency features that allow for
presidential and congressional influence, such as appointments,
removals, and appropriations, can help provide for agency accountability
to elected officials. Conversely, structural features that enhance agency
autonomy from the President and Congress may help insulate it from
potential political interference.
Various U.S. government reports and political science articles have
explored topics related to agency independence and accountability; for
example, the Sourcebook provides a comprehensive list of over 60
structural characteristics that describe the features and organization of
federal agencies. 14 A 2021 presidential memorandum included
requirements for federal agencies to take certain actions to strengthen
scientific integrity, including developing and publishing procedures for
implementing scientific integrity policies. 15
In response to the presidential memorandum, OSTP issued a framework
in January 2023 to support regular assessment and iterative improvement
of agency scientific integrity policies and practices. The framework
identifies critical policy features that will guide OSTP’s assessment of
agency policies. Critical policy features outlined in the framework include
that agency policies should have the federal definition of scientific
integrity, describe the process for reporting allegations of potential
political interference, and be prominently and publicly available on the
13The Sourcebook is a report produced by the Administrative Conference of the United
States, an independent U.S. government agency. See J. Selin and D. Lewis, Sourcebook
of United States Executive Agencies (Second Edition) (Washington, D.C.: Administrative
Conference of the United States, October 2018).
14J. Selin and D. Lewis, Sourcebook of United States Executive Agencies (Second
Edition). We previously reported on these structural characteristics at selected HHS
agencies. See GAO, CARES Act: Structural Characteristics That Can Help Insulate HHS
Agencies against Potential Political Interference, GAO-23-105415. (Washington, D.C.:
Dec. 15, 2022).
15The White House, Memorandum on Restoring Trust in Government Through Scientific
Integrity and Evidence-Based Policymaking (January 27, 2021).
Page 8 GAO-23-106529 Potential Political Interference
agency’s website. 16 This framework includes a model scientific integrity
policy that agencies can use as they work to develop and improve their
own scientific integrity policies, practices, and culture. The model policy
also includes measures to prevent and address political interference in
the conduct, management, communication, or use of science, and notes
that such measures should be at the forefront of agency practices.
Potential Instances of Since the beginning of the COVID-19 pandemic response, there have
Political Interference at been allegations of political interference at the HHS agencies in our
review. We selected examples of these allegations that served as case
Selected HHS Agencies
studies for the expert panel. We did not ask the expert panelists to
determine whether political interference occurred in any of these case
studies. We provided these to the expert panelists for purposes of
facilitating discussion. The case studies were:
• FDA issuance of an EUA for hydroxychloroquine and
chloroquine. Allegations that FDA was pressured to issue an EUA for
hydroxychloroquine and chloroquine to treat COVID-19. 17 In March
2020, the President stated that trials of these drugs to treat COVID-19
were producing encouraging results and would be available to
Americans almost immediately. About a week later, the Biomedical
Advanced Research and Development Authority (BARDA) sponsored
an EUA request to use these drugs to treat COVID-19. 18 FDA issued
an EUA 2 days later. Some stakeholders—including several former
FDA officials—expressed concern regarding FDA’s EUA, stating that
data regarding the safety and effectiveness of these drugs for the
treatment of COVID-19 were largely anecdotal at the time the EUA
16According to the framework, scientific integrity is the adherence to professional
practices, ethical behavior, and the principles of honesty and objectivity when conducting,
managing, using the results of, and communicating about science and scientific activities.
Inclusivity, transparency, and protection from inappropriate influence are hallmarks of
scientific integrity. Scientific Integrity Framework Interagency Working Group of the
National Science and Technology Council, A Framework for Federal Scientific Integrity
Policy and Practice, January 12, 2023. The definition we developed for purposes of
reporting differs because we developed ours in the absence of a standardized federal
definition. Also in response to the 2021 presidential memorandum, OSTP published a
report in January 2022 that identified good agency practices on scientific integrity.
Scientific Integrity Fast-Track Action Committee, Protecting the Integrity of Government
Science.
17Hydroxychloroquine and chloroquine have been approved for other uses, such as the
treatment of malaria, but not for the treatment of COVID-19.
18BARDA, a component of ASPR, funds and helps oversee the advanced research and
development of certain medical countermeasures.
Page 9 GAO-23-106529 Potential Political Interference
was issued. The EUA was later revoked after data from a large
randomized controlled trial showed no evidence of benefit for mortality
or other outcomes. 19
• CDC school re-opening guidance. Allegations that the development
of CDC’s school reopening guidance inappropriately involved
teachers unions in February 2021. Officials from the White House and
CDC met with teachers unions to discuss school re-opening. One of
the unions provided suggested language for the guidance after the
meeting. CDC’s published guidance included the suggested
language. In February 2022, the incident manager of CDC’s COVID-
19 response later testified that receiving and incorporating language
written by stakeholders is “uncommon,” although receiving input on
potential guidance from stakeholders is normal. In March 2022, the
CDC Director testified that coordination with the teachers unions on
this guidance was appropriate and that CDC sought input on the
guidance from more than 50 stakeholders.
• NIH grant termination. Allegations that the White House directed
NIH to terminate a grant for a project studying how coronaviruses
spread from bats to people. NIH later reinstated but immediately
suspended the grant until the grantee could meet additional award
conditions related to biosafety, monitoring, and other concerns. 20 A
senior NIH official testified in June 2020 that NIH terminated the grant
because it was told to do so and later confirmed to the media that the
White House gave this direction to NIH. HHS’s Office of Inspector
General issued a report in January 2023 that found NIH did not follow
proper procedures in terminating the grant. 21
• CDC recommendations on COVID-19 booster shots. Allegations
that the White House pressured the CDC Director to adopt different
recommendations than CDC’s advisory committee when the
administration announced its plan to make COVID-19 vaccine booster
19FDA may revoke an EUA if the circumstances giving rise to the emergency declaration
no longer exist, the criteria for issuance of the EUA are no longer met, or other
circumstances make revocation appropriate to protect public health or safety. 21 U.S.C. §
360bbb-3(g)(2).
20In May 2023, NIH reinstated the grant, placing several stipulations on the scope of the
research and on the organization’s accounting practices.
21Department of Health and Human Services, Office of Inspector General, The National
Institutes of Health and EcoHealth Alliance Did Not Effectively Monitor Awards and
Subawards, Resulting in Missed Opportunities to Oversee Research and Other
Deficiencies, A-05-21-00025 (January 2023).
Page 10 GAO-23-106529 Potential Political Interference
shots available prior to FDA and CDC review. In September 2021,
news articles discussed concerns of health experts and scientists over
the role that politics may have played in the administration’s decisions
regarding booster shots. Members of CDC’s advisory committee
expressed concerns that the data did not necessarily support a
booster for the general population.
• CDC Morbidity and Mortality Weekly Report (MMWR). Allegations
that political appointees within HHS sought to edit draft MMWR article
summaries and titles. 22 In May 2020, CDC changed its longstanding
practice of not sharing certain information about upcoming MMWR
articles with individuals outside CDC, according to agency officials.
Specifically, CDC changed its practice of not sharing any information
about upcoming MMWR articles outside of CDC besides publication
titles because of the whole-of-government pandemic response,
according to these agency officials. As a result, MMWR summaries
(high-level article synopses) and proofs (full-text article drafts) were
shared with a number of individuals, including political appointees
outside of CDC, according to the agency. From May 2020 through the
end of the calendar year, a political appointee located outside CDC
requested that edits be made to upcoming MMWR articles.
In November 2020, three former MMWR editors-in-chief published an
op-ed in the Journal of the American Medical Association expressing
concerns about the editorial independence of the CDC publication. In
December 2020, the House Select Subcommittee on the Coronavirus
Crisis held a hearing to further investigate the matter and released
emails that it received from HHS that documented that a political
appointee had contacted the MMWR editor-in-chief on multiple
occasions to discuss specific articles prior to publication, based on the
appointee’s review of summaries. CDC resumed its former practice of
not sharing MMWR information prior to publication, other than
publication titles, outside the agency on January 20, 2021, according
to agency officials.
• CDC updates to mask guidance. Allegations that political pressure
influenced the agency in its decision to lift the mask mandate for fully
vaccinated individuals in May 2021; this decision was subsequently
reversed in July 2021. CDC faced criticism after updating its mask
guidance in May 2021 and July 2021, according to media reporting.
22According to CDC, the MMWR is the agency’s “primary vehicle for scientific publication
of timely, reliable, authoritative, accurate, objective, and useful public health information
and recommendations.”
Page 11 GAO-23-106529 Potential Political Interference
For example, multiple media reports cited criticism from experts and
political officials on CDC’s decision to update the agency’s mask
guidance in July 2021 without simultaneously providing the scientific
data to support the change. In addition, a member of Congress wrote
a letter to the Secretary of Health and Human Services expressing
concerns about political interference related to its constantly changing
mask guidance and asked for additional information on who was
involved in the decisions.
Experts in our roundtable identified safeguards to help protect against
Experts Identified potential political interference at selected HHS agencies. These
Safeguards in Three safeguards fell into three interrelated areas: agency processes, training
on agency scientific integrity processes, and institutional structures.
Areas That Could Selected HHS agencies have taken, or are in the process of taking, steps
Help Protect Against related to some of the safeguards identified by experts, such as
developing training on scientific integrity policies.
Political Interference
at Selected HHS
Agencies
Agency Processes Experts told us that specific agency processes should include certain
safeguards, including clear scientific integrity policies; transparency; and
clear documentation of the decision-making process.
Expert Perspective on Scientific Integrity • Scientific integrity policies. Experts told us that establishing
Policies scientific integrity policies is an important safeguard to protect against
Establishing scientific integrity policies “can potential political interference as it supports a culture of scientific
fortify decision makers and give them integrity. 23 According to experts, selected HHS agencies should
something to point to against political
influence.” consider several things when establishing or updating such policies,
Source: Statement from GAO’s roundtable of 11 experts. | including ensuring that the policy includes (1) a well-documented
GAO-23-106529
decision-making process for non-emergency and emergency
situations, (2) clear delineation of roles and responsibilities for both
internal and external stakeholders when making scientific decisions,
and (3) a transparent process by which officials can report and
address allegations of political interference.
23According to A Framework for Federal Scientific Integrity Policy and Practice, a culture
of scientific integrity means “both creating an empowering environment that is conducive
to innovation and progress and also protecting scientists and the process of science”
wherein “scientific findings and products must not be suppressed, delayed, or altered for
political purposes and must not be subjected to inappropriate influence,” among other
tenets.
Page 12 GAO-23-106529 Potential Political Interference
HHS issued a scientific integrity policy in 2012 that included principles
designed to ensure the integrity of scientific and scholarly activities
that the department conducts and supports, and the science it uses to
inform management and public policy decisions. In April 2023, HHS
officials told us HHS’s Office of the Assistant Secretary for Planning
and Evaluation is drafting updates to this scientific integrity policy, as
required by the January 2021 presidential memorandum. In July 2023,
HHS made a draft of the updated HHS scientific integrity policy
available for public comment. 24 According to HHS officials, the
updated policy will include specific provisions prohibiting political
interference, ensuring independent review of scientific activities,
prohibiting the suppression or delay of scientific findings for non-
scientific reasons, and protecting against retaliation, among other
things. We were also told that the updated policy will establish clear
procedures for reporting and handling allegations of political
interference.
This is consistent with our recommendations in April 2022 that HHS
and agency heads should ensure that procedures for reporting and
addressing potential political interference in scientific decision-making
are developed and documented, including adding a definition of
political interference to these policy documents. HHS concurred with
these recommendations. As of April 2023, these recommendations
had not been implemented. 25 Final publication of HHS’s scientific
integrity policy is expected in February 2024, according to HHS
officials. HHS agencies may develop their own complementary
policies but are not required to do so. CDC, FDA, and NIH developed
their own individual scientific integrity policies and procedures and,
according to HHS officials, are in the process of updating them.
According to officials, ASPR relies on HHS’s scientific integrity policy.
• Transparency. Experts told us that transparency in the decision-
making process should include noting the policy or process that
guided the decision, the evidence underlying the decision, and the
role of internal and external stakeholders when making a science-
based decision. Experts noted transparency is particularly important
for instances in which an agency changes its normal processes, such
24The version of the updated policy made available for public comment can be found at
https://www.federalregister.gov/public-inspection/2023-15408/draft-scientific-integrity-
policy (accessed Aug. 28, 2023).
25See GAO-22-104613.
Page 13 GAO-23-106529 Potential Political Interference
as during an emergency, or a political appointee or elected official
intervenes in an established process. For example, experts said that
agencies should share publicly those instances in which a political
official intervenes to stop, delay, or alter a normal process. According
to experts, in some of these instances political interference may not
have occurred, but a lack of transparency may have created the
perception that it did. Therefore, greater transparency can also help
address perceived instances of political interference. (See text box for
case study examples of how transparency may be a safeguard
against potential political interference.)
Case Study Examples:
Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of Hydroxychloroquine and Chloroquine
Experts told us that the EUA process is a technical, science-based process. They noted that it would have been a usual part of this process
for the administration to ask FDA to review the science and come to a science-based decision. However, in this instance, it appeared that
the administration did not request a review but instead announced availability of the treatment before any review was conducted. To ensure
political accountability, experts said it would be important to have transparency in any political decision that preempted or overrode the
technical, scientific process. Experts noted that in the case of an emergency, there can be some appropriate deviations from the normal
process; however, one expert said that the executive branch should be transparent about any decisions to supersede a technical or scientific
process in future emergencies.
CDC School Reopening Guidance
Experts told us it is appropriate for CDC to engage with a variety of stakeholders, including teachers unions, when developing guidance.
They said getting such input can help ensure the guidance reflects the needs and concerns of those most affected. However, experts noted
some concerns with the process for developing this particular guidance. For example, one expert noted that while there is a desire for CDC
to get input from many stakeholders, the lack of transparency when developing this guidance was an issue. Another expert told us CDC
should have been more inclusive of other stakeholder groups and should have been open about the stakeholders from which it sought input.
By doing so, people would see more balance in the various stakeholders involved rather than only seeing involvement by teachers unions,
according to this expert.
Source: GAO roundtable discussion with 11 experts. | GAO-23-106529
Experts told us that increased transparency can come with costs. For
example, one expert noted that increased transparency is important but
there is an added administrative burden that can both slow down and
complicate the decision-making process. Therefore, according to this
expert, it would be important to be mindful that any steps added to ensure
transparency do not cause undue burden. Another expert noted that
transparency may make agency officials less willing to say what they
really think should their opinion be unpopular or controversial.
OSTP has also identified transparency as a hallmark of scientific
integrity. 26 In particular, OSTP’s framework encourages federal agencies
to ensure the quality, accuracy, and transparency of scientific information
used to support policy and decision-making. Similarly, we previously
26Office of Science and Technology Policy, A Framework for Federal Scientific Integrity
Policy and Practice.
Page 14 GAO-23-106529 Potential Political Interference
reported that transparency is a component of an organizational culture
supportive of scientific integrity, which is a necessary foundation to
protect agencies against inappropriate influence, according to the
January 2022 report by the National Science and Technology Council. 27
HHS officials told us that transparency is a key component of OSTP’s
definition of scientific integrity and will be part of the department’s
updated scientific integrity policy. According to officials, to the extent
possible, information on scientific decisions will be made publicly
available.
Expert Perspective on Documenting • Documenting decision-making processes. Experts told us that
Decisions agencies need to document the decision-making processes—
“All these difficult issues do not go away when including what procedures guide those decisions. One expert noted it
you impose any kind of general requirement is particularly important that the process and any key decisions be
on real people. But if you give people the
opportunity, or even the expectation, that they documented in cases where an agency deviates from normal process,
document how they are making their such as during an emergency. Documenting the process also
decisions, I think maybe that might help.”
promotes transparency, which, as noted above, can protect against
Source: Statement from GAO’s roundtable of 11 experts. |
GAO-23-106529 potential political interference. One expert added that, although
documenting decisions is burdensome, it strengthens the scientific
process and transparency, and improves the decision-making process
overall. (See text box for case study example of how documenting
decision-making processes may be a safeguard against potential
political interference.)
Case Study Example: Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report
(MMWR)
Former CDC officials told us that, prior to the COVID-19 pandemic, draft MMWR article summaries (high-level article
synopses) and proofs (full-text article drafts) had never been shared outside CDC, a longstanding, though undocumented,
tradition intended to preserve the publication’s editorial independence and scientific integrity. In May 2020, CDC changed its
practice of not sharing any information about upcoming MMWR articles outside of CDC besides publication titles because of
the whole-of-government pandemic response, according to agency officials. As a result, MMWR summaries and proofs
were shared with a number of individuals, including political appointees outside of CDC, according to the agency.
When CDC changed its practice in May 2020, it opened the process up to political influence, according to experts. They told
us that documenting those informal review practices could safeguard against potential political interference because CDC
officials would be able to point to agreed-upon practices if outside officials attempt to influence the publication in the future.
Experts also noted that documenting the MMWR review policies could also help promote greater transparency, another
safeguard against potential political interference.
Source: GAO roundtable discussion with 11 experts. | GAO-23-106529
27See GAO-23-105415.
Page 15 GAO-23-106529 Potential Political Interference
Expert Perspective on Processes for Experts told us that developing a mechanism for federal agencies
Differing Scientific Opinions to formally document differences in scientific opinion could help
One expert said that the use of processes for enhance transparency in decision-making within HHS agencies.
handling “differing scientific opinions” would
have been a powerful process safeguard in
According to OSTP’s framework, each agency should develop a
the case study on FDA’s emergency use mechanism for employees engaged in the science informing
authorization for hydroxychloroquine and agency policy decisions to express any disagreement with
chloroquine. This expert suggested that the
use of such a process could have included scientific data, interpretations, or conclusions in writing. Under the
summarizing the scientific evidence and framework, differing scientific opinions should be documented as
presenting a different conclusion for decision-
maker consideration. part of the peer review or as part of agency documents considered
Source: Statement from GAO’s roundtable of 11 experts. | as part of the decision-making process. According to the
GAO-23-106529
framework, the use of such a process can increase early scientific
integrity consultations, helping to ensure accountability in the
process.
HHS officials told us that its updated scientific integrity policy will
address the decision-making process and describe steps officials
may use to document differing scientific opinions when it is
finalized in February 2024. According to officials, some agencies,
including FDA and CDC, also have existing dispute resolution
policies and may continue to use them when the updated scientific
integrity policy is finalized.
Expert Perspective on the Human Element While experts noted establishing agency processes is an important
of Decision-Making safeguard, they also told us no agency is fully insulated from political
In discussing a case study, one expert noted influence and there is an appropriate role for political appointees and
the importance of the human element when
making decisions and responding to potential
elected officials in agency processes. For example, experts told us it is
pressure, even when there are policies and appropriate for a political appointee or elected official to encourage an
procedures in place to protect against such agency to expedite or prioritize a project. One expert noted it would also
pressure.
be appropriate for political appointees or elected officials to evaluate risks
“I think this is a really powerful reminder that
at the end of every one of these decisions is a or trade-offs in decision-making. However, experts said it would be
human being subject to human pressures of inappropriate for a political appointee or elected official to exert influence
one kind or another. And if you were
continually threatened…both privately and in a manner that interferes with the scientific integrity of the process or
then [in] public and the media, for most seeks to distort or misuse the science behind a decision.
people, it just becomes too much. And I don’t
think that we can discount the human
condition here…I think whatever kinds of
solutions we want to propose need to buffer
people against that to the extent possible
recognizing we’re never going to fully
succeed.”
Source: Statement from GAO’s roundtable of 11 experts. |
GAO-23-106529
Page 16 GAO-23-106529 Potential Political Interference
Training on Scientific Experts told us training agency staff, including political appointees and
Integrity Processes career officials, on scientific integrity processes could serve as a
safeguard against potential political interference. According to experts,
agency officials are unclear about what would constitute political
interference and how to report it. Experts said this uncertainty could be
greater during an emergency when certain actions that would normally be
unusual may be more appropriate, such as not waiting for all scientific
evidence before making a decision. Additional training when officials
onboard, or during their tenure, could increase agency officials’
comprehension of political appointees’ appropriate role in an agency,
including instances in which there may be different roles during
emergency situations, and reduce political interference.
In our prior work, we found that CDC, FDA, NIH, and ASPR train staff on
some scientific-integrity-related topics, but only NIH includes information
on political interference in scientific decision-making as part of this
training. We recommended in April 2022 that employees and contractors
performing scientific activities in HHS agencies receive training on how to
report allegations of political interference in scientific decision-making. 28
HHS concurred with this recommendation. As of April 2023, this
recommendation has not been implemented.
HHS officials told us the agency will develop scientific integrity training
after it finalizes its scientific integrity policy in February 2024. According to
HHS officials, this training will be for all HHS staff, including employees,
political appointees, contractors, and others covered by the policy. The
training will describe HHS’s policies and procedures related to scientific
integrity, including how to recognize, avoid, and report potential political
interference. In addition, officials said the training will differentiate
between scientifically trained political appointees engaging in the
legitimate conduct, management, communication, and use of science,
and political appointees inappropriately breaching scientific integrity
because of political motivations.
Institutional Structures Experts told us establishing safeguards to strengthen agencies’
institutional structures could help selected HHS agencies protect against
potential political interference. In particular, experts told us using advisory
committees, limiting the number of political appointees, and designating a
28See GAO-22-104613.
Page 17 GAO-23-106529 Potential Political Interference
scientific integrity liaison or ombudsman could serve as safeguards
supporting an agency’s structure.
• Advisory Committees. Experts told us advisory committees can
provide independent advice or recommendations on scientific matters,
including recommendations that may differ from an agency’s decision,
which can help minimize political influence on scientific decisions.
Experts’ comments on advisory committees are consistent with the
model policy in OSTP’s framework, which states advisory committees
are an important tool for ensuring the credibility, quality, and
transparency of agency science. 29 Similarly, advisory committees can
help insulate an agency from political interference by allowing external
actors, such as scientific experts and researchers, to advise on
agency decision-making based on our review of a political science
article. 30 As we previously reported, all four of the selected HHS
agencies have active advisory committees that advise on key areas of
agencies’ scientific decision-making. 31 According to HHS officials, its
revised scientific integrity policy will affirm HHS’s adherence to the
Federal Advisory Committee Act in the recruitment and selection of
committee members based on expertise and knowledge when it is
finalized in February 2024. 32 (See text box for case study example of
how advisory committees may be a safeguard against potential
political interference.)
29Office of Science and Technology Policy, A Framework for Federal Scientific Integrity
Policy and Practice.
30Jennifer L. Selin, “What Makes an Agency Independent?,” American Journal of Political
Science, vol. 59, no. 4 (October 2015).
31GAO-23-105415.
32The Federal Advisory Committee Act helps assure that federal advisory committees: (1)
provide advice that is relevant, objective, and open to the public; (2) act promptly to
complete their work; and (3) comply with reasonable cost controls and record keeping
requirements. The act requires that committee memberships be “fairly balanced in terms
of the points of view represented and the functions to be performed.” See Pub. L. No. 92-
463, 86 Stat. 770 (1972) (codified, as amended, at 5 U.S.C. app.).
Page 18 GAO-23-106529 Potential Political Interference
Case Study Example: Centers for Disease Control and Prevention (CDC) Recommendations on COVID-19 Booster
Shots
In 2021, leaders from the Department of Health and Human Services (HHS) announced that COVID-19 booster shots would
soon be available to all fully vaccinated adults, prior to CDC’s advisory committee meeting on booster recommendations.
CDC’s guidance on booster shots differed, in part, from the CDC advisory committee’s recommendations. While the CDC
director is not required to accept the advisory committee’s recommendations, according to CDC officials, experts told us
that greater transparency in this process, including why the administration’s announcement preceded the advisory
committee’s review, could have helped to avoid actual or perceived political interference. For example, experts said CDC
could have explained what other factors or data led CDC to issue guidance that differed, in part, from its advisory
committee‘s recommendation.
Source: GAO roundtable discussion with 11 experts. | GAO-23-106529
Expert Perspective on Reducing the • Political Appointees. Experts told us that the number of political
Number of Political Appointees appointees in an agency may make the agency more vulnerable to
“If there is a different kind of appointment political pressure; therefore, limiting the number of appointees could
authority that leads to more professional make it more difficult for political appointees to influence the work of
expertise, longer tenure, more of a sense of
professional commitments, that is probably the agencies. One expert noted that there are many agencies across
better as a firewall against interference in the government that are led by career officials and not political
science.”
appointees, which could make it easier to withstand political pressure.
Source: Statement from GAO’s roundtable of 11 experts. |
GAO-23-106529
We previously reported that the selected HHS agencies each had
between two and five political appointees serving in key senior leadership
positions as of August or September 2022, which can increase political
influence over agencies. 33 Politically appointed positions at selected
agencies include the CDC Director, the FDA Commissioner, the NIH
Director, and the Assistant Secretary for Preparedness and Response. In
addition, the number of political appointees increased from 2016 through
2020 at CDC, FDA, and ASPR, but has since declined at CDC and FDA
as of 2022. Political appointees—who generally serve at the pleasure of
the President—can make and advocate for agency policy on behalf of an
administration. Therefore agencies with more political appointees are
more likely to be subject to partisan politics and responsive to the White
House.
• Agency Scientific Integrity Liaison or Ombudsman. Experts said
that designating an agency scientific integrity liaison or ombudsman
who is dedicated to ensuring scientific integrity on an ongoing basis
could help agency officials better understand the scientific integrity
process, including how to report potential political interference.
According to experts, this would be in keeping with the January 2021
33See GAO-23-105415. There are four major categories of political appointees:
presidential appointees with Senate confirmation; presidential appointees; non-career
employees in the Senior Executive Service; and Schedule C employees.
Page 19 GAO-23-106529 Potential Political Interference
Expert Perspective on Scientific Integrity presidential memorandum that requires all agencies to designate a
Officers scientific integrity official. This official would be responsible for leading
“As others have argued, the benefits of having training and outreach initiatives related to scientific integrity policy and
a scientific integrity officer there, someone
dedicated to trying to make sure this work is would serve as a neutral point of contact for receiving questions about
ongoing…save[s] so much in so many or allegations of compromised scientific integrity. 34
different ways. People would understand what
the process is. People would understand what One expert told us that while such a role is important, there can be
their protections are. And it can prevent these
different types of integrity violations and
staffing issues as those positions are often neglected. Further, the
political interference that we have been expert also told us the effect of an ombudsman could be limited given
mentioning here, which has enormous other priorities agencies may have. According to HHS, the department
consequences on literally the entire culture of
the agency.” designated an interim scientific integrity official within the Office of the
Source: Statement from GAO’s roundtable of 11 experts. | Assistant Secretary for Planning and Evaluation, an office that advises
GAO 23-106529
HHS on policy development in health and science, among other
things. According to HHS officials, as of June 2023, HHS is in the
process of recruiting for this position. Officials noted that the duties of
this position will be included in HHS’s updated scientific integrity
policy when it is published in February 2024.
Expert Perspective on Overall Caution of Experts highlighted that a multi-layered approach to protect against
Professionalization and Structural potential political interference—a “web” of safeguards—might yield the
Changes
best results. Experts also told us that procedural safeguards may be
“We don’t want to be strict in processes
professionalization and structure changes [so]
better in protecting against political interference than safeguards that
that we make it impossible for well-intentioned require individual action. As we previously noted, we have made
policy change to take place in the government recommendations related to several of the safeguards identified by
with these agencies that we are talking
about.” experts, including that HHS and agency heads should ensure that (1)
Source: Statement from GAO’s roundtable of 11 experts. | procedures for reporting and addressing potential political interference in
GAO-23-106529
scientific decision-making are developed and documented, including
adding a definition of political interference to these policy documents and
(2) employees and contractors performing scientific activities in HHS
agencies receive training on how to report allegations of political
interference in scientific decision-making.
We provided a draft of this report to HHS for comment. HHS provided
Agency Comments written comments on a draft of this report, which are reproduced in
appendix II, and technical comments, both of which we incorporated as
appropriate. In its response to our draft report, HHS outlined actions the
agency has taken to implement the 2021 presidential Memorandum on
Restoring Trust in Government through Scientific Integrity and Evidence-
34The White House, Memorandum on Restoring Trust in Government Through Scientific
Integrity and Evidence-Based Policymaking (January 27, 2021).
Page 20 GAO-23-106529 Potential Political Interference
based Policymaking, which include making a draft of the HHS scientific
integrity policy available for public comment in July 2023, launching a
scientific integrity website, and developing a portal for reporting
allegations regarding scientific integrity in HHS’s work. HHS noted that
the department was not in the position to confirm or deny the accuracy of
the content of the case studies presented to expert panelists at the
roundtable. To develop the case studies we provided to the panelists as
examples of allegations of potential political interference, we reviewed
agency policies and procedures, prior GAO reports, relevant reports from
Congress and other stakeholders, and internal documents. We also
spoke with former government officials and relevant stakeholders.
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 will be available at no charge on
GAO’s website at http://www.gao.gov.
If you or your staff have any questions about this report, please contact
me at (202) 512-7114 or at FarbJ@gao.gov. Contact points for our Office
of Congressional Relations and Office of Public Affairs can be found on
the last page of this report. Other major contributors to this report are
listed in appendix III.
Jessica Farb
Managing Director, Health Care
Page 21 GAO-23-106529 Potential Political Interference
List of Requesters
The Honorable Patty Murray
Chair
Committee on Appropriations
United States Senate
The Honorable Bernard Sanders
Chair
Committee on Health, Education, Labor, and Pensions
United States Senate
The Honorable Gary C. Peters
Chairman
Committee on Homeland Security and Governmental Affairs
United States Senate
The Honorable Elizabeth Warren
United States Senate
The Honorable James E. Clyburn
House of Representatives
The Honorable Paul D. Tonko
House of Representatives
Page 22 GAO-23-106529 Potential Political Interference
Appendix I: Objective, Scope, and
Appendix I: Objective, Scope, and
Methodology
Methodology
This report describes actions that experts believe selected Department of
Health and Human Services (HHS) agencies could take to protect against
potential political interference, or political influence that seeks to
undermine an agency’s impartiality, nonpartisanship, and professional
judgment. 1 This appendix provides additional information on our expert
roundtable discussion, expert selection process, and selected case
studies provided to experts during the roundtable.
To address our research objective, in May 2023, with the assistance of
Expert Roundtable the National Academies of Sciences, Engineering, and Medicine (National
Discussion Academies), we convened a 2-day virtual roundtable of 11 experts to
discuss (1) how to define and recognize political interference and (2)
actions selected HHS agencies can take to protect against political
interference. 2 To facilitate this discussion, we provided experts with
information on six instances of potential political interference that were
identified by GAO and others. All six case studies occurred during the
COVID-19 pandemic response; involved events at the Centers for
Disease Control and Prevention (CDC), Food and Drug Administration
(FDA), National Institutes of Health (NIH), or Administration for Strategic
Preparedness and Response (ASPR); and had bipartisan identification as
a significant instance of potential political interference. We did not ask the
expert panelists to determine whether political interference occurred in
any of these examples.
We analyzed the roundtable transcripts to identify common themes
discussed by and key statements of experts regarding potential actions
HHS agencies could take to protect against political interference. We did
not poll expert participants or take votes on approaches discussed during
the roundtable. Consequently, we do not provide counts or otherwise
quantify the number of experts agreeing to an approach. Further,
1For the purposes of this report, we adapted a definition of “political interference” from a
2017 report by the National Academies of Sciences, Engineering, and Medicine (National
Academies), which states that undue external influences are those from outside an
agency that seek to undermine its impartiality, nonpartisanship, and professional
judgment. See National Academies of Sciences, Engineering, and Medicine, Principles
and Practices for a Federal Statistical Agency: Sixth Edition. (Washington, D.C.: 2017).
According to the National Academies, it provides independent, objective analysis and
advice to the nation, including the federal government, and conducts other activities to
solve complex problems and inform public policy decisions.
2This roundtable was planned and convened with the assistance of the National
Academies to better ensure that a breadth of expertise was brought to bear in its
composition; however, all final decisions regarding meeting substance and expert
participation were made by GAO.
Page 23 GAO-23-106529 Potential Political Interference
Appendix I: Objective, Scope, and
Methodology
because experts were generating and discussing ideas as part of a free-
flowing group discussion, the number of times a concept was or was not
repeated does not necessarily indicate the level of consensus on that
concept. Throughout the report, we use the term “experts” to refer to
more than one expert.
The options for specific actions we present in this report were identified
by the experts. We did not analyze or evaluate the options and their
inclusion in this report should not be interpreted as GAO or any federal
agency or department endorsing any of them. The options are not listed
in any specific rank or order. We did not assess how effective the options
may be, or the extent to which program design modifications, legal
changes, and federal financial support would be needed to implement any
given action or combination of actions. However, we report considerations
experts noted concerning the potential effectiveness of specific actions.
To the extent HHS has any ongoing activities related to these actions, we
included such information.
The 11 experts selected for our 2-day virtual roundtable represented a
Expert Selection broad spectrum of views and expertise and a variety of professional and
academic fields. For example, they were former federal agency officials;
academic researchers, including in the field of political science; and
leaders of non-profit organizations. 3 We selected the experts based on
their experience and knowledge that could be relevant to discussions of
potential political interference and recommendations from the National
Academies. Specifically, we sought the participation of those with current
or prior experience in the following categories: (1) academic researchers
working in this field, including political scientists, (2) former federal
agency officials who had experience at the selected HHS agencies, and
(3) relevant experts from non-profit organizations. When selecting
experts, we considered (1) type and depth of experience, (2) published
work and its relevance to our research objective, (3) and present and past
employment history. Table 1 lists the 11 selected experts and their
affiliations at the time of the roundtable.
3The comments of the experts represented the views of the experts themselves and not
the organizations with which they are affiliated, and are not generalizable to the views of
others in the field.
Page 24 GAO-23-106529 Potential Political Interference
Appendix I: Objective, Scope, and
Methodology
Table 1: Alphabetical List of Expert Participants in GAO Expert Panel to Identify Actions Selected Department of Health and
Human Services Agencies Could Take to Protect Against Potential Political Interference, Held May 1-2, 2023, and Institutional
Affiliation at the Time of Roundtable
1 Lisa Bressman, JD Vanderbilt University
2 Daniel Carpenter, PhD Harvard University
3 Anita Desikan, MPH Center for Science and Democracy at the Union of Concerned Scientists
4 Steven K. Galson, MD, MPH Boston Consulting Group
5 Ali S. Khan, MD, MPH, MBA University of Nebraska
6 Martha Kinsella, JD Brennan Center for Justice
7 Lauren Kurtz, JD Climate Science Legal Defense Fund
8 David E. Lewis, PhD Vanderbilt University
9 Nicole Lurie, MD, MSPH Coalition for Epidemic Preparedness Initiatives
10 William Schultz, JD Zukerman Spaeder
11 Daniel Sosin, MD, MPH, FACP New Mexico Department of Health
Source: GAO. | GAO-23-106529
To help identify any potential biases or conflicts of interest, we asked
each expert who participated in the roundtable to disclose whether they
had investments, sources of earned income, organizational positions,
relationships, or other circumstances that could affect, or could be viewed
to affect, their views on actions to protect against potential political
interference. None of the experts reported potential conflicts that would
affect their ability to participate in the roundtable.
We selected six instances of potential political interference that we
Selected Case identified as part of prior work and presented them to the expert panelists
Studies as case studies. As part of our prior work, we spoke with a bipartisan
selection of eight former agency heads and other stakeholders to obtain
their opinions on which events occurring at CDC, FDA, NIH, and ASPR
during the COVID-19 response were significant instances of potential
political interference. In addition to these interviews, we reviewed relevant
government inquiries and reports on related topics. 4 Based on these
discussions, we produced a list of 44 events to consider selecting as case
studies.
In fall 2021, we conducted a second round of case study selection to
consider additional instances of potential political interference of which we
4Government inquiries refer to congressional reports, statements from the administration,
and other official government documents.
Page 25 GAO-23-106529 Potential Political Interference
Appendix I: Objective, Scope, and
Methodology
were made aware from May 2021 through November 2021. In the second
round of selection, we assembled a list of relevant instances of potential
political interference from hotline reports we received, semi-structured
interviews we conducted, stakeholder reports, and government inquiries. 5
From those sources, we produced a list of five events to consider in our
second round of case study selection. To determine which of the five
identified events had bipartisan identification as a significant instance of
potential political interference, we contacted the eight former agency
heads with whom we spoke earlier in the engagement for their opinions.
Five of the eight officials responded with feedback.
In February 2023, we used the lists from both rounds of case study
selection to judgmentally select six case studies from this list of events
that: (1) had bipartisan identification as a significant instance of potential
political interference as determined by assessments made by at least one
Republican and one Democratic former political appointee whom we
interviewed or public statements made by a current member of Congress;
(2) involved potential deviations from agency policies or procedures; and
(3) provided variation in terms of the agency involved and topic matter in
question. See table 2 for the six selected case studies of potential political
interference.
5The confidential hotline—consisting of an email account and voicemail inbox—was
created to collect agency employees’ opinions and perspectives related to issues of
scientific integrity and political interference at the selected agencies. The confidential
hotline was available to selected subcomponents at CDC, FDA, NIH, and ASPR over a 2-
month period. We conducted the semi-structured interviews with 16 employees, including
managers and non-managers, from three of the four selected agencies—CDC, FDA, and
NIH. Specifically, we collected information on employee perspectives on their agency’s
implementation of its scientific integrity policy, their agency’s ability to protect against
political interferences, and their familiarity or experience with instances of potential
political interference.
Page 26 GAO-23-106529 Potential Political Interference
Appendix I: Objective, Scope, and
Methodology
Table 2: Six Instances of Potential Political Interference at Selected Department of Health and Human Services Agencies
Provided to Participants in GAO Expert Panel, Held May 1-2, 2023
No. Potential Political Interference Described in the Case Study
1 Allegations that the Food and Drug Administration (FDA) was pressured to issue an emergency use authorization for
hydroxychloroquine and chloroquine for treatment of COVID-19.
2 Allegations that the development of the Centers for Disease Control and Prevention’s (CDC) school reopening guidance
inappropriately involved teachers unions.
3 Allegations that the White House directed the National Institutes of Health (NIH) to terminate a grant for a project studying
how coronaviruses spread from bats to people.
4 Allegations that the White House pressured the CDC Director to adopt different recommendations on COVID-19 booster
shots than the recommendations made by CDC’s advisory committee.
5 Allegations that political appointees within the Department of Health and Human Services sought to edit CDC’s Morbidity
and Mortality Weekly Report article summaries and titles.
6 Allegations that political pressure influenced CDC in its decision to lift the mask mandate for fully vaccinated individuals.
Source: GAO. | GAO-23-106529
To develop the case studies, we reviewed agency policies and
procedures, prior GAO reports, relevant reports from Congress and other
stakeholders, and internal documents.
Page 27 GAO-23-106529 Potential Political Interference
Appendix II: Comments from the Department
Appendix II: Comments from the Department
of Health and Human Services
of Health and Human Services
Page 28 GAO-23-106529 Potential Political Interference
Appendix II: Comments from the Department
of Health and Human Services
Page 29 GAO-23-106529 Potential Political Interference
Appendix III: GAO Contact and Staff
Appendix III: GAO Contact and Staff
Acknowledgments
Acknowledgments
Jessica Farb at (202) 512-7114 or FarbJ@gao.gov
GAO Contact
In addition to the contact named above, Ray Sendejas (Assistant
Staff Director), Amy Leone (Analyst-in-Charge), Sam Amrhein, Margot Bolon,
Acknowledgments Jenny Chanley, Amanda Cherrin, Kaitlin Farquharson, Sandra George,
Douglas G. Hunker, Eric Peterson, Corinne Quinones, Lisa Rogers,
Ethiene Salgado-Rodriguez, Rebecca Sero, Sharon Silas, and Walter
Vance made key contributions to this report. Anna Beischer, Adam
Brooks, Joycelyn Cudjoe, Cynthia Khan, Amelia Koby, Rob Marek,
Priyanka Panjwani, Amy Pereira, Caylin Rathburn-Smith, Roxanna Sun,
and Candice Wright also made important contributions.
Page 30 GAO-23-106529 Potential Political Interference
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