Department of Defense’s efforts to ensure servicemembers’ access to safe, high-quality pharmaceuticals
Statement of
Bryce H. P. Mendez
Specialist in Defense Health Care Policy
Before
Committee on Armed Services
Subcommittee on Personnel
U.S. Senate
Hearing on
“Department of Defense’s efforts to ensure
servicemembers’ access to safe, high-quality
pharmaceuticals”
April 30, 2024
Congressional Research Service
https://crsreports.congress.gov
TE10099
Congressional Research Service
1
Introduction
Chair Warren, Ranking Member Scott, and distinguished members of the subcommittee, thank you for the
opportunity to appear before you today to discuss the Department of Defense’s efforts to ensure
servicemembers’ access to safe, high-quality pharmaceuticals. My name is Bryce Mendez, and I am a
specialist in defense health care policy at the Congressional Research Service (CRS). CRS provides
Congress with policy research and analysis that is authoritative, objective, and nonpartisan in accordance
with our authorizing statute (2 U.S.C. §166).
As requested by the committee, my testimony today will provide an overview of Department of Defense
(DOD) medical research and development (R&D) capabilities, discuss how and why DOD uses those
capabilities to develop drugs and biologics, and how DOD aims to ensure that developed drugs and
biologics are safe and effective for human use.1 I will also discuss several considerations that Congress
may face with regard to DOD medical R&D and manufacturing of drugs and biologics.
Background
The U.S. military has a long history of contributing to the discovery of novel drugs, biologics,
prophylactics, and other medical countermeasures. Early and well-known contributions took place during
and shortly after the Spanish American War when the Army Surgeon General appointed Dr. Walter Reed,
a Major in the U.S. Army, to lead investigations into the causes of Typhoid and Yellow fever.2 At the time,
both infectious diseases, among others, plagued the U.S. military. For example, during the Spanish
American War in 1898, more servicemembers died from infectious diseases than combat-related injuries.3
In particular, Typhoid fever infected over 20,000 soldiers and killed 1,590 soldiers across the Army,
resulting in degraded fighting capabilities during the war.4
Towards the end of the war, President William McKinley appointed retired Army Major General
Grenville M. Dodge to lead an investigation (also referred to as the “Dodge Commission”) into the War
Department’s management of the conflict, including the root causes of infectious disease outbreaks across
the force.5 The commission found that, among other findings, preventive health measures could have been
implemented to protect servicemembers from infectious diseases of the time, military-supported
discoveries in medical science were necessary to fill knowledge and capability gaps and to attract interest
1 For the purposes of this testimony, CRS utilizes the U.S. Food and Drug Administration (FDA) definition for “drugs,” which
refers to substances recognized by an official pharmacopoeia or formulary; intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease; intended to affect the structure or any function of the body; or intended for use as a
component of a medicine but not a device or a component, part, or accessory of a device. CRS also utilizes the FDA definition
for “biologics,” which refer to a “wide range of products such as vaccines, blood and blood components, allergenics, somatic
cells, gene therapy, tissues, and recombinant therapeutic proteins.” For more on these definitions, see
https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms.
2 John R. Pierce, “Walter Reed - A Name for the Ages,” The Micrograph, December 22, 2022, at
https://medicalmuseum.health.mil/micrograph/index.cfm/posts/2022/walter_reed_a_name_for_the_ages; and Patrick Feng,
“Major Walter Reed and the Eradication of Yellow Fever,” The Army Historical Foundation, April 10, 2024.
3 Vincent J. Cirillo, “Journal of the History of Medicine and Allied Sciences,” Fever and Reform: The Typhoid Epidemic in the
Spanish-American War, vol. 55 (October 2000), p. 396.
4 Vincent J. Cirillo, Bullets and Bacilli: The Spanish-American War and Military Medicine (New Brunswick, NJ: Rutgers
University Press, 2003), p. 71.
5 U.S. Congress, Senate, Report of the commission appointed by the President to investigate the conduct of the War Department
in the war with Spain, Volume 1, 56th Cong. (Washington: GPO, 1900), pp. 1-734.
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among civilian medical researchers, and that the military could benefit from stockpiling medical supplies
during peacetime in order to prepare for future and emergent demands during wartime.6
After the war, the Army Medical School continued Dr. Reed’s work to explore the causes of Typhoid
fever and how to protect soldiers from infection. In 1908, the Army developed and produced their version
of a Typhoid vaccine building upon research conducted by the Royal Army Medical College and other
European researchers.7 Successes observed throughout the Army’s clinical trials of its Typhoid fever
vaccine resulted in a compulsory vaccination requirement in 1911 as a means to protect servicemembers
from the potential health threat.8 The Army’s historical investment of military personnel, expertise, and
resources to understand the causes of infectious diseases helped to inform future development of new
drugs, biologics, and medical technologies.
The lessons learned from the Spanish American War and other conflicts throughout American history
have laid the groundwork for both Congress and DOD to invest in, build, and sustain medical R&D
capabilities. Today, DOD conducts medical R&D as a means to protect servicemembers from current or
future health threats, respond to medical capability requirements of the joint force, and meet the research
directives of Congress.
DOD Medical Research and Development
Under Title 10, Section 4001, of the U.S. Code (U.S.C.), DOD administers a wide range of R&D
programs. DOD R&D primarily focuses on “basic research, applied research, advanced research, and
development projects” that are
• necessary to the responsibilities of such Secretary’s department in the field of research
and development; and either
• relate to weapon systems and other military needs; or
• are of potential interest to the DOD.9
In general, DOD conducts medical R&D based on the “needs of the National Defense Strategy and the
Joint Capabilities Integration and Development System” and in response to Congressionally Directed
6 Ibid; Vincent J. Cirillo, Bullets and Bacilli: The Spanish-American War and Military Medicine (New Brunswick, NJ: Rutgers
University Press, 2003), p. 153; James E. Hewes Jr., “The War Department From Root To Marshall,” in From Root to
McNamara: Army Organization and Administration (Washington, DC: U.S. Army Center of Military History, 1983); and
Edward Ranson, “The Investigation of the War Department, 1898-99,” The Historian, vol. 34, no. 1 (November 1971), pp. 78-99.
7 Frederick F. Russell, “Anti-Typhoid Vaccination in the American Army,” Journal of the American Public Health Association,
vol. 1, no. 7 (July 1911), pp. 473-479; Robert M. Hardaway III, “Contributions of Army Medicine to Civilian Medicine,”
Military Medicine, vol. 138, no. 7 (July 1973), pp. 409-412; and Rufus L. Holt and Arthur P. Hitchens, “Typhoid Vaccine: The
Technique of Its Preparation at the Army Medical School,” Public Health Reports, vol. 52, no. 26 (June 25, 1937), pp. 829-844.
8 John D. Grabenstein, Phillip R. Pittman, and John T. Greenwood, et al., “Immunization to Protect the US Armed Forces:
Heritage, Current Practice, and Prospects ,” Epidemiologic Reviews, vol. 28, no. 1 (August 2006), pp. 3-26; W. D. Tiggertt, “The
Initial Effort to Immunize American Soldier Volunteers with Typhoid Vaccine,” Military Medicine, vol. 124, no. 5 (May 1959),
pp. 342-349; and Andrew W. Artenstein, Jason M. Opal, and Steven M. Opal, et al., “History of U.S. Military Contributions to
the Study of Vaccines,” Military Medicine, vol. 170, no. Suppl 4 (April 2005), pp. 3-11.
9 10 U.S.C. §4001. For FY2024, Congress appropriated $148.3 billion for DOD research, development, test, and evaluation
activities (see explanatory statement accompanying P.L. 118-47, Congressional Record, March 22, 2024, p. H1644. For more on
DOD research and development (R&D) programs and historical funding amounts, see CRS Report R47564, Federal Research
and Development (R&D) Funding: FY2024, coordinated by John F. Sargent Jr.; CRS Report R44711, Department of Defense
Research, Development, Test, and Evaluation (RDT&E): Appropriations Structure, by John F. Sargent Jr.; CRS In Focus
IF10553, Defense Primer: RDT&E, by John F. Sargent Jr. Congressional offices may also contact Marcy E. Gallo, CRS analyst
in science and technology policy, for more on DOD R&D programs and funding.
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Medical Research Programs (CDMRP).10 DOD has three goals in conducting medical R&D, which are to
ensure that the joint force is “(1) better prepared, (2) better protected, and (3) better cared for throughout
the operational life cycle.”11 To achieve these goals, DOD organizes its medical R&D efforts under the
following focus areas:
• biomedical informatics and health information systems and technology;
• clinical and rehabilitative medicine;
• combat casualty care;
• medical chemical and biological defense;
• medical radiological defense;
• military infectious diseases; and
• military operational medicine.12
DOD Medical R&D Enterprise
The DOD medical R&D enterprise is composed of multiple entities. These entities include the Defense
Health Agency (DHA), Uniformed Services University of the Health Sciences (USUHS), the military
services’ medical departments, Defense Advanced Research Projects Agency, Chemical and Biological
Defense Program, and the Defense Threat Reduction Agency. DOD synchronizes these entities through
the Armed Services Biomedical Research Evaluation and Management Community of Interest (ASBREM
CoI).13 The ASBREM CoI serves as the primary coordination body for DOD’s medical research
community and to “prevent unnecessary duplication of effort.”14 While the ASBREM CoI helps advance
“communication, coordination, and collaboration” across the DOD medical R&D enterprise, individual
entities are responsible for resourcing and performing (or sponsoring) medical R&D projects and
activities.15
10 Department of Defense (DOD), “Department of Defense Strategic Medical Research Plan,” January 2019, p. 6, at
https://health.mil/Reference-Center/Congressional-Testimonies/2019/04/08/Strategic-Medical-Research-Plan. For more on the
National Defense Strategy, see CRS Report R45349, The 2018 National Defense Strategy: Fact Sheet, by Kathleen J. McInnis.
For more on the Joint Capabilities Integration and Development System, see pp. 3-4 of CRS Report RL34026, Defense
Acquisitions: How DOD Acquires Weapon Systems and Recent Efforts to Reform the Process, by Heidi M. Peters. For more on
Congressionally Directed Medical Research Programs, see CRS Report R46599, Congressionally Directed Medical Research
Programs: Background and Issues for Congress, by Bryce H. P. Mendez. Congressional offices may contact Alexandra G.
Neenan, CRS analyst in U.S. defense acquisition policy, for more on DOD acquisition policy; and John W. Rollins, CRS
specialist in terrorism and national security, for more on the National Defense Strategy.
11 DOD, “Department of Defense Strategic Medical Research Plan,” January 2019, p. 11.
12 Ibid., p. 6.
13 The role of the Armed Services Biomedical Research Evaluation and Management Community of Interest (ASBREM CoI),
formerly known as the ASBREM Committee, is to “promote the coordination and synergy of the DoD biomedical R&D efforts to
provide medical products and information” required to protect and sustain servicemembers. For more on the ASBREM, see
Department of Defense (DOD), Integrated DoD Biomedical Research and Development Strategy, Medical Innovation for the
Future Force, December 2017, p. iii, https://defenseinnovationmarketplace.dtic.mil/wp-content/uploads/2018/04/
ASBREM_Integrated_RD_Strategy_2017.pdf.
14 DOD Directive 6025.21E, “Medical Research for Prevention, Mitigation, and Treatment of Blast Injuries,” updated October
15, 2018, p. 1, at https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/602521p.pdf.
15 DOD, Department of Defense Strategic Medical Research Plan, January 2019, p. 8.
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DOD Medical R&D Funding
DOD has the second-largest departmental expenditures on medical research, after the National Institutes
of Health (NIH).16 Each year, DOD submits its funding request for medical R&D activities and projects as
part of the President’s annual budget request. Congress evaluates, adjusts, and appropriates discretionary
funding for medical R&D activities that DOD may, or may not, have requested. Congress appropriates
these funds through an annual DOD appropriations act; the funds are further distributed to the research
entities through numerous Research, Development, Test, and Evaluation (RDT&E) budget activities and
program elements.17 Since many DOD entities conduct or fund these activities, there is no consolidated
request, appropriations account, budget activity, or program element that incorporates the totality of all
medical R&D. One of the DOD accounts that funds medical R&D activities is the Defense Health
Program (DHP).18 The DHP account funds “medical and health care programs,” including certain
RDT&E programs.19 DOD often uses DHP RDT&E funding to resource medical research activities
throughout the medical R&D enterprise.20 Figure 1 shows the amount of RDT&E funding appropriated to
the DHP account between FY2017 and FY2024, and the amount requested by DOD for FY2025.
Figure 1. RDT&E Appropriations for the Defense Health Program Account
FY2017-FY2025 Request*
Source: CRS In Focus IF12377, FY2024 Budget Request for the Military Health System, by Bryce H. P. Mendez; CRS In Focus
IF11206, FY2020 Budget Request for the Military Health System, by Bryce H. P. Mendez; Explanatory Statement accompanying
P.L. 118-47, Congressional Record, March 22, 2024, p. H1718; and DOD, “Defense Health Program, Fiscal Year (FY) 2025
16 Research America, U.S. Investments in Medical and Health Research and Development, 2016-2020, January 2022, p. 7, at
https://www.researchamerica.org/wp-content/uploads/2022/09/ResearchAmerica-Investment-Report.Final_.January-2022-1.pdf.
17 For more on DOD appropriations for RDT&E, see CRS Report R44711, Department of Defense Research, Development, Test,
and Evaluation (RDT&E): Appropriations Structure, by John F. Sargent Jr.
18 For more on the DHP account, see CRS In Focus IF12377, FY2024 Budget Request for the Military Health System, by Bryce
H. P. Mendez; and Question 2 (“How is the Military Health System Funded?”) of CRS Report R45399, Military Medical Care:
Frequently Asked Questions, by Bryce H. P. Mendez.
19 10 U.S.C. §1100.
20 Defense Health Board, Improving Defense Health Program Medical Research Processes, August 8, 2017, pp. 9-14, 44-54; at
https://health.mil/Reference-Center/Reports/2017/08/08/Improving-Defense-Health-Program-Medical-Research-Process.
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President’s Budget,” March 2024, p. 1, at https://comptrol er.defense.gov/Portals/45/Documents/defbudget/FY2025/
budget_justification/pdfs/09_Defense_Health_Program/00-DHP_Vols_I_and_II_PB25.pdf.
Notes: *Dol ar amount represents DOD request for FY2025 DHP RDT&E. Since 1992, Congress has typically
appropriated additional dol ars to the DHP RDT&E account for the Congressionally Directed Medical Research Programs
(CDMRP). The FY2025 request does not reflect an amount for the CDMRP. RDT&E = Research, Development, Test, and
Evaluation.
DOD Capabilities to Develop Drugs and Biologics
DOD has existing capabilities to develop and manufacture (on a limited scale) drugs and biologics to
protect servicemembers from current or future health threats. These capabilities use different
manufacturing approaches, including strategic partnerships with public and private entities, to meet
certain medical R&D objectives and other military requirements for force health protection.21 These
partnerships can take many forms, including a contractual agreement, grant award, cooperative research
and development agreement (CRADA), or Other Transaction Authority.22 In addition, DOD typically
negotiates terms for medical technology transfer, allowing a partner entity to retain certain intellectual
property rights for further development or commercial use purposes.23
Army Pilot Bioproduction Facility
The Walter Reed Army Institute of Research (WRAIR) administers a “pharmaceutical manufacturing
facility” in Silver Spring, MD, known as the Pilot Bioproduction Facility (PBF). In 1953, the Army
Medical Department established the PBF as a government-owned, government-operated manufacturing
capability.24 The function of the PBF is to assist in the early development and small-scale production of
drugs and biologics to defend against “military-relevant infectious disease threats.”25 According to
WRAIR, the PBF is compliant with U.S. Food and Drug Administration (FDA) regulations on current
Good Manufacturing Practice (cGMP),26 certified for biosafety level-2 (BSL-2) research,27 and has
developed drugs and biologics to address Hepatitis A, Japanese encephalitis, Malaria, Zika, COVID-19,
and others.28 The PBF capability allows WRAIR to provide a test ground to produce and transition newly
21 DOD defines force health protection (FHP) as measures taken to “promote, protect, improve, conserve, and restore the mental
and physical well being of Service members across the range of military activities and operations.” For more on FHP, see DOD
Directive 6200.04, Force Health Protection (FHP), updated April 23, 2007, at
https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/620004p.pdf.
22 Army Medical Research and Development Command, “Medical Technology Transfer,” May 17, 2019, at
https://technologytransfer.health.mil/index.cfm?pageID=about_tech_transfer; CRS Report R45521, Department of Defense Use
of Other Transaction Authority: Background, Analysis, and Issues for Congress, by Heidi M. Peters; and DOD, “Other
Transactions Guide,” July 2023, at https://www.acq.osd.mil/asda/dpc/cp/policy/docs/guidebook/TAB%20A1%20-
%20DoD%20OT%20Guide%20JUL%202023_final.pdf.
23 Army Medical Research and Development Command, “Medical Technology Transfer,” May 17, 2019; WRAIR briefing and
discussions with CRS, October 2023; DOD Instruction 5535.08, DoD Domestic Technology Transfer Program, September 22,
2022, at https://www.esd.whs.mil/portals/54/documents/dd/issuances/dodi/553508p.pdf; and Defense Health Agency Procedural
Instruction 3201.05, Technology Transfer (T2) Program, June 20, 2019, at https://www.health.mil/Reference-Center/DHA-
Publications/2019/06/20/DHA-PI-320105.
24 Walter Reed Army Institute of Research (WRAIR), “Pilot Bioproduction Facility,” accessed April 5, 2024, at
https://wrair.health.mil/Collaborate/Pilot-Bioproduction-Facility/.
25 Ibid.
26 For more on current Good Manufacturing Practice (cGMP) regulations, see https://www.fda.gov/drugs/pharmaceutical-quality-
resources/current-good-manufacturing-practice-cgmp-regulations; and CRS In Focus IF11083, Medical Product Regulation:
Drugs, Biologics, and Devices, by Amanda K. Sarata and Hassan Z. Sheikh.
27 For more on laboratory biosafety levels, see https://www.phe.gov/s3/BioriskManagement/biocontainment/Pages/BSL-
Requirements.aspx.
28 Kenneth H. Eckels, “Product Development for the Warfighter,” presentation to the Association of the U.S. Army, Washington,
(continued...)
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developed drugs and biologics into “advanced clinical trials and licensure.”29 WRAIR partners with
public and private biomedical research entities to explore and develop drugs and biologics that address
current and future health threats.30
DOD Advanced Development and Manufacturing Biopharmaceutical Facility
The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-
CBRND), an office under the Chemical and Biological Defense Program, administers the DOD Advanced
Development and Manufacturing (ADM) Biopharmaceutical Facility located in Alachua, FL.31 The ADM
facility is a contractor-owned, contractor-operated facility that provides DOD with an “enduring
capability and infrastructure” to meet military medical requirements and the “capability for agile and
flexible advanced development and manufacturing” of medical countermeasures.32 In December 2010,
then-Assistant to the President for Homeland Security, John O. Brennan, transmitted a memorandum
calling for the Secretary of Defense to “establish agile and flexible advanced development and
manufacturing capabilities to support the development, licensure, and production of medical
countermeasures.”33 In response to this directive, on March 21, 2013, Army Contracting Command
awarded a $135.8 million contract to then-Nanotherapeutics Inc. to build and operate the ADM facility,
which provides DOD with “priority access” to the contractor’s manufacturing capabilities in order to
“produce medical countermeasures more quickly and more effectively than other drug makers.”34
According to JPEO-CBRND, the ADM facility is compliant with cGMP regulations, certified for
biosafety level-3 (BSL-3) research, and has developed biologics to address COVID-19, Botulism
neurotoxin, and other health threats.35
DC, July 25, 2017, at https://www.ausa.org/sites/default/files/army-medical-eckels.pdf; and WRAIR, “Pilot Bioproduction
Facility (PBF),” fact sheet, November 2022, at
https://wrair.health.mil/Portals/87/Documents/PBF%20Handout%202022_Updated_21NOV22_final.pdf.
29 Ibid; and WRAIR briefing and discussions with CRS, October 2023.
30 Ibid.
31 Kelly Burkhalter and Chris Southworth, “Enduring Capability: JPEO-CBRND evolves public/private partnership with National
Resilience,” JPEO-CBRND News, December 5, 2023, at https://www.jpeocbrnd.osd.mil/Media/News/Article/3607443/enduring-
capability-jpeo-cbrnd-evolves-publicprivate-partnership-with-national/#:~:text=Located%20in%20Alachua
%2C%20Florida%2C%20the,agents%20and%20emerging%20infectious%20 diseases.
32 SAM.gov, “A—Medical Countermeasure Manufacturing Advanced Development Manufacturing (ADM) Capability,”
Presolicitation Notice ID W911QY11R0023, August 9, 2011, at https://sam.gov/opp/6d98c844d9d76510d7cf6bfdeffcf33e/view.
33 U.S. Government Accountability Office (GAO), Biological Defense: Additional information that Congress may find useful as
it considered DOD's advanced development and manufacturing capability, GAO-17-701, July 2017, p. 7, at
https://www.gao.gov/assets/gao-17-701.pdf; and White House, Memorandum for the Secretary of Defense, “Medical
Countermeasures against Biological and Other Public Health Threats,” December 29, 2010.
34 DOD, “Contracts for March 21, 2013,” accessed April 8, 2024, at
https://web.archive.org/web/20130408205027/http://www.defense.gov/contracts/contract.aspx?contractid=5002; Kelly
Burkhalter, “Enduring Capability: JPEO-CBRND evolves public/private partnership with National Resilience,” JPEO-CBRND
News, December 4, 2023, at https://www.dvidshub.net/news/459375/enduring-capability-jpeo-cbrnd-evolves-public-private-
partnership-with-national-resilience; and Anthony Clark, “U.S. Department of Defense Expands Medical Countermeasure
Capabilities,” JPEO-CBRND News, December 20, 2016, at https://www.jpeocbrnd.osd.mil/Media/News/Article/2597346/us-
department-of-defense-expands-medical-countermeasure-capabilities/. In 2017, Nanotherapeutics, Inc. was renamed to Ology
Bioservices, Inc. In 2021, National Resilience, Inc. acquired Ology Bioservices.
35 Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), “Medical
Countermeasures Advanced Development and Manufacturing (ADM), accessed April 8, 2024, at
https://www.jpeocbrnd.osd.mil/Portals/90/fact-sheet_adm.pdf; JPEO-CBRND, “JPEO-CBRND Capabilities Catalog,” 2023, at
https://www.jpeocbrnd.osd.mil/Portals/90/Documents/JPEO-CBRND_Capabilities%20Catalog_20%20April%202023_Final.pdf;
and Hannah Feldman, Chris Earhart, and Traci Pals, “Toxic at Best,” JPEO-CBRND News, January 22, 2019, at
https://www.jpeocbrnd.osd.mil/Media/News/Article/2593990/toxic-at-best/.
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Ensuring Safe and Effective Drugs and Biologics
Prior to the enactment of the Federal Food, Drug, and Cosmetic Act (FFDCA; 52 Stat. 1040) in 1938, the
military administered its own procedures to ensure drugs and biologics used on servicemembers were safe
and effective.36 In 1964, DOD and FDA entered into a Memorandum of Understanding (MOU) to ensure
requirements enacted in the FFDCA, the Drug Amendments Act of 1962 (P.L. 87-781), and related
regulations were “fully met without jeopardizing or impeding the requirements of national security or the
requirements of Federal laws and regulations related to such use of drugs.”37 Under a 1974 MOU, DOD
agreed to adhere to the FDA regulatory requirements governing the “investigational use of new drugs and
medical devices in human beings,” informed consent, and Institutional Review Board procedures.38
Today, DOD generally adheres to FDA requirements and procedures designed to ensure developed drugs
and biologics are deemed safe and effective for human use.39
Congress has enacted several laws to provide DOD with a process to request a presidential waiver of
certain FDA requirements, including requirements for administering investigational new drugs or off-
label uses of a drug,40 and informed consent for certain “products authorized for emergency use.”41 In
addition, Congress has authorized DOD to request an expedited FDA review, approval, and clearance
process for certain medical products when there is an existing or “significant potential for a military
emergency, involving a specific and imminently life-threatening risk to United States military forces of
attack with an agent or agents, and the medical product that is the subject of such application, submission,
or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening
risk.”42
In January 2018, DOD and FDA outlined their initial work plan to enhance collaboration and coordination
to “see safe and effective products more efficiently reach those protecting our Nation.”43As of March
2024, DOD and FDA have 10 MOUs in effect that provide frameworks on how both federal entities are to
interact in the development of safe and effective medical products that serve the military’s needs,
facilitate information sharing, and to clarify interagency cooperation on issues relating to safety and
effectiveness of drugs, biologics, and other medical products.44
36 Guy R. Hasegawa, “Pharmacy in the American Civil War,” Pharmacy in History, vol. 42, no. 3/4 (2000), pp. 67-86.
37 Jeremiah J. Kelly, “Enhanced Engagement: The Evolving Relationship between FDA and DoD Regulatory Authorities,” Food
and Drug Law Journal, vol. 78, no. 2 (October 2023), p. 159, at https://www.fdli.org/2023/10/enhanced-engagement-the-
evolving-relationship-between-fda-and-dod-regulatory-authorities-open-access/.
38 FDA, “Memorandum of Understanding between the Food and Drug Administration and the Department of Defense
Concerning Investigational Use of Drugs, Antibiotics, Biologics, and Medical Devices by the Department of Defense,” MOU
224-75-3003, accessed April 8, 2024, at https://www.fda.gov/about-fda/domestic-mous/mou-224-75-3003. The regulatory
requirements include those specified in Parts 50, 56, 312, and 812 of Title 21, Code of Federal Regulations. DOD and FDA last
updated the MOU in 1987, which is still in effect.
39 For more on how FDA approves new drugs and biologics, see CRS Report R41983, How FDA Approves Drugs and Regulates
Their Safety and Effectiveness, by Hassan Z. Sheikh.
40 10 U.S.C. §1107. DOD Instruction 6200.02, Application of Food and Drug Administration (FDA) Rules to Department of
Defense Force Health Protection Programs, implements this statutory authority.
41 10 U.S.C. §1107a. DOD Instruction 6200.02, Application of Food and Drug Administration (FDA) Rules to Department of
Defense Force Health Protection Programs, implements this statutory authority.
42 P.L. 115-92.
43 FDA, “Initial Work Plan for Products Relevant to the Department of Defense (DoD), January 2018, at
https://www.fda.gov/media/110237/download.
44 FDA, “Domestic MOUs,” March 21, 2024, at https://www.fda.gov/about-fda/fda-memoranda-understanding/domestic-mous.
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Considerations for Congress
Defining the Role of DOD Manufacturing Capabilities
The role of DOD’s government-owned (sometimes referred to as organic) manufacturing capabilities is
limited to the early research and development phases of novel drugs and biologics intended to protect
servicemembers from certain health threats. Since the 1950s, the Army Pilot Bioproduction Facility (PBF)
has supported this function by conducting limited, in-house manufacturing of newly developed drugs and
biologics for the clinical trials process.45 WRAIR asserts that the PBF “fills a crucial need in a very
important part of the vaccine production pipeline” since the “the availability of independent facilities
willing to manufacture a full range of Phase 1 production under one roof is extremely limited.”46 Army
scientists have also suggested that facilities like the PBF “remove some of the risk perceived by
commercial partners looking for products emerging from early research and development phases,” while
acknowledging that DOD “does not have a suitable mechanism for manufacturing and fill/finish
capability” in late-stage product development and scaling.47
Congress could consider further defining or clarifying any role DOD has or might have in conducting in-
house manufacturing of drugs and biologics. Congress could direct DOD to expand, contract, or sustain
its drug and biologics manufacturing capabilities or capacity based on Congress’s assessment of needs to
mitigate broader supply chain resiliency challenges, to meet military requirements for medical
countermeasures, or to avoid unintended effects on the commercial market. Another question that
Congress could consider is whether or not DOD’s capabilities to manufacture drugs and biologics should
extend to non-military purposes (e.g., supporting the availability of medical countermeasures for public
health emergencies or to address existing drug shortages). In calendar year 2022, the FDA was notified of
1,293 potential drug and biological product shortage situations.48 An FDA-led interagency task force
found three major root causes of drug shortages:
• lack of incentives to produce less profitable drugs;
• the market does not recognize and reward manufactures for mature quality management
systems; and
• logistical and regulatory challenges make it difficult for the market to recover after a
disruption.49
Expanded DOD manufacturing capabilities or capacity could address some of these root causes since the
military is not a profit-driven entity and DOD adheres to quality management standards (e.g., cGMP
regulations) and quality control measures throughout the medical R&D and manufacturing continuum. If
Congress were to assess that DOD’s manufacturing capabilities should be used to mitigate national drug
45 For more on clinical trials, see CRS Legal Sidebar LSB10483, Testing, Testing, (Phase) 1-2-3: Legal Considerations for
Clinical Trials of Potential COVID-19 Vaccines, by Erin H. Ward.
46 Samir Deshpande, “WRAIR Re-launches Vaccine Manufacturing Facility,” Defense Visual Information Distribution Service,
May 6, 2021, at https://www.dvidshub.net/news/395778/wrair-re-launches-vaccine-manufacturing-facility. “Phase 1 production”
refers to small-batch manufacturing of drugs or biologics used to evaluate its safety in a small group of test subjects and to
identify side effects (i.e., Phase 1 clinical trial).
47 Jeffrey M. Osgood, Jeffrey W. Froude, and Sherri P. Daye, et al., “Cross-Cutting Lessons Learned During the COVID-19
Pandemic—the Walter Reed Army Institute of Research Experience,” Military Medicine, vol. 188, no. 1-2 (January-February
2023), pp. 158-165. “Fill/finish capability” refers to a portion of the manufacturing process that includes filling, labeling,
packaging, and quality inspection of drugs or biologics prior to distribution.
48 FDA, “Report to Congress, Drug Shortages CY2022,” June 7, 2023, p. 9, at
https://www.fda.gov/media/169302/download?attachment.
49 FDA, “Drug Shortages: Root Causes and Potential Solutions,” updated February 21, 2020, p. 6, at
https://www.fda.gov/media/131130/download?attachment.
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shortage issues, additional authorities or investments may be necessary. In 2019, the Defense Health
Agency Deputy Assistant Director for Healthcare Operations testified to the U.S.-China Economic and
Security Review Commission that DOD is “neither authorized, by law, nor funded to produce commercial
pharmaceuticals.”50 Congress could consider whether or not to provide an explicit authority,
appropriations, or parameters for DOD to expand its manufacturing capabilities for non-military purposes.
Congress also could assess whether DOD’s manufacturing capabilities should be utilized only for
military-specific requirements and to prevent a duplication of effort with existing whole-of-government
actions that “enable investment in domestic manufacturing.”51
Addressing Commercial Interest and Perceptions of Risk
Since at least 1990, DOD has identified concerns with its ability to “acquire and maintain the capability to
research, develop and manufacture medical countermeasures.”52 A 2009 study found that
biopharmaceutical companies had few incentives to work with DOD on the development of medical
countermeasures, citing “low profit margins, the risk of liability for adverse reactions to the products,
marginal federal funding … and inconsistent priorities” as obstacles to public-private cooperation in this
area.53 Some biopharmaceutical companies have expressed that certain incentives could be used by the
federal government to encourage companies to partner with DOD and other U.S. government agencies,
including
• direct incentives that provide a “steady revenue commensurate with shareholder
expectations” through guaranteed payments for developed and manufactured products, or
• indirect incentives that offer provisions to financially benefit a company’s commercial
efforts, including excess capability to produce commercial products in a government-
owned, contractor-operated manufacturing model, intellectual property rights, and
expedited FDA reviews and approvals.54
Congress could assess the effectiveness of DOD’s medical R&D and manufacturing approach on the
propensity of the commercial biopharmaceutical industry to work with the military. Congress has given
50 Testimony of Defense Health Agency Deputy Assistant Director for Healthcare Operations, in U.S. Congress, U.S.-China
Economic and Security Review Commission, “Exploring the Growing U.S. Reliance on China’s Biotech and Pharmaceutical
Products,” hearings, 116th Cong., 1st sess., July 31, 2019, at https://www.uscc.gov/sites/default/files/Priest%20US-
China%20Commission%20Statement.pdf.
51 Department of Health and Human Services, “Biden-Harris Administration Announces Actions to Bolster Medical Supply
Chain,” press release, November 27, 2023, at https://www.hhs.gov/about/news/2023/11/27/biden-harris-administration-
announces-actions-bolster-medical-supply-chain.html; and Executive Office of the President, National Science and Technology
Council, “National Strategy for Advanced Manufacturing,” October 2022, at https://www.whitehouse.gov/wp-
content/uploads/2022/10/National-Strategy-for-Advanced-Manufacturing-10072022.pdf.
52 Secretary of Defense Memorandum to the Assistant Secretary of Defense for Health Affairs, “Expansion of Industrial Base for
Biological Vaccine Production,” October 3, 1990, at
https://gulflink.health.mil/va/va_refs/n46en061/970107_sep96_decls48_0001.htm; DOD Memorandum for the Record, “Fourth
Tri-Service Task Force (Project Badger) Meeting,” October 26, 1990, at
https://gulflink.health.mil/va/va_refs/n46en067/102596_sep96_decls4_0002.htm; and GAO, Biological Defense: Additional
information that Congress may find useful as it considered DOD's advanced development and manufacturing capability, GAO-
17-701, July 2017, p. 1.
53 Thomas Fuerst, Kim Wallace, and Phillip Gomez, et al., Ensuring Biologics Advanced Development and Manufacturing for the
United States Government: A Summary of Key Findings and Conclusions, University of Pittsburgh Medical Center, October 6,
2009, pp. 1-2, at https://apps.dtic.mil/sti/tr/pdf/ADA506569.pdf.
54 Ibid., pp. 79-80; Bobby Clark and Jeff Callis, “Public Good vs. Private Gain: The Role of Public–Private Partnerships in Drug
Innovation and Pricing,” The Commonwealth Fund, June 8, 2022, at https://www.commonwealthfund.org/blog/2022/public-
good-vs-private-gain-role-public-private-partnerships-drug-innovation-and-pricing; and PhRMA, The Power and Promise of a
Collaborative Biopharmaceutical Ecosystem, March 2021, pp. 22-23, at https://www.phrma.org/-
/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/D-F/PhRMA_EcosystemMarch-Report_FINAL.pdf.
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DOD certain authorities and tools that it may use to generate interest among potential industry partners,
reduce regulatory barriers, and mitigate some associated risks. These include traditional and non-
traditional contracting approaches under the Defense Acquisition System,55 technology transfer
55 Traditional federal contracting mechanisms include those subject to the Federal Acquisition Regulation (FAR) and Defense
Federal Acquisition Regulation Supplement (DFARS), while non-traditional federal contracting mechanisms include Other
Transaction Authorities, procurement for experimental purposes, and R&D agreements. For more on DOD contracting
mechanisms, see CRS Report RL34026, Defense Acquisitions: How DOD Acquires Weapon Systems and Recent Efforts to
Reform the Process, by Heidi M. Peters; and CRS Report R45521, Department of Defense Use of Other Transaction Authority:
Background, Analysis, and Issues for Congress, by Heidi M. Peters. Congressional offices may contact Alexandra G. Neenan,
CRS analyst in U.S. defense acquisition policy, for more on DOD acquisition policy.
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opportunities, and a process for expedited FDA reviews and approvals. Congress could evaluate whether
DOD has used these authorities and tools as Congress intended, including whether or not it has been
utilized to alleviate industry concerns or to address commercial interest in doing business with the
military for advanced development and manufacturing of drugs and biologics.
Conclusion
Thank you for the opportunity to testify. I look forward to responding to any questions that you may have.
If additional research and analysis related to these issues would be helpful, CRS is prepared to assist.
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff
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Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of
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