This profile focuses on the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). For a more general overview of HHS and its relevance to biosecurity, see:

Dept. of Health and Human Services (HHS)

HHS plays a crucial role in healthcare, public health, medical research, and social services. The department is responsible for preparing for and responding to biological threats of any kind, including via agencies like CDC, ASPR, NIH, and FDA.

Overview

The Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services (HHS) responsible for protecting public health by ensuring the safety, efficacy, and security of products impacting the health and well-being of the American public. FDA can approve or reject vaccines, therapeutics, and diagnostics, and the agency has fairly broad discretion¹ over what evidence to accept when evaluating health products.

FDA’s involvement in biosecurity and biodefense centers mostly on expediting the development and approval of medical countermeasures and on preventing adulteration of the food supply. The agency also plays a role in discussions regarding regulatory frameworks for emerging biotechnologies that may have dual-use potential and ensuring the resilience of the US food supply.

Background on FDA

• Government context: FDA is an agency within the Department of Health and Human Services, one of 15 executive departments in the US government. 
• Mission: promoting and protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and the nation’s food supply, as well as cosmetics, tobacco, and radiation-emitting products. Additionally, FDA supports national counterterrorism efforts by securing the food supply and fostering the development of medical products to address public health threats.
• Main activities: regulating food and drugs, approving new medical products, conducting research, monitoring product safety, enforcing regulations, and providing public health information.
• Budget: $6.1 billion in FY24 
• Staff: ~18,000 employees
• Brief history: FDA’s modern regulatory functions began with the 1906 Pure Food and Drugs Act, and it received its present name in 1930. FDA’s role in biosecurity has become more prominent since the anthrax attacks of 2001, leading to laws like the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004, which expanded FDA’s authorities to respond in times of health-related crises, including its Emergency Use Authorization (EUA) which enabled the accelerated authorization of the COVID-19 vaccines. The 2011 Food Safety Modernization Act gave FDA more authorities, including writing rules designed to stop attacks that poison the food supply.

Organizational structure

FDA is led by a Commissioner appointed by the President and confirmed by the Senate. The Commissioner is supported by the Office of the Commissioner, which serves as the central administrative and executive office and includes sub-offices that handle policy, legislation, scientific integrity, and global regulatory operations. 

The agency comprises six centers, each of which focuses on regulation and oversight related to the product domains for which FDA is responsible. Centers oversee activities like product evaluation, research, and compliance related to that area.

In addition, the agency includes offices with cross-cutting functions supporting the entire agency in areas such as policy development, legislative affairs, regulatory operations, and scientific integrity.

Biosecurity and pandemic preparedness in FDA

FDA’s role in biosecurity has expanded in recent years, driven by emerging biological threats and the need for rapid response. Areas of focus include:

1. Medical countermeasure (MCM) development: FDA works to expedite the development and availability of MCMs, including vaccines, therapeutics, and diagnostic tools for biological threats. Importantly, the agency can issue Emergency Use Authorizations (EUAs) to allow the use of unapproved medical products or unapproved uses of approved products during public health emergencies.
2. Food defense: FDA works to protect food from acts of intentional adulteration or tampering, including but not limited to terrorist attacks designed to cause mass casualties.

In 2022, the White House published the government-wide National Biodefense Strategy and Implementation Plan. The plan provides a helpful overview of the role of various departments and agencies in US biosecurity planning, assigning them roles as “Lead” or “Support” for each sub-goal. While FDA is not listed as lead on any of the plan’s sub-goals, it supports several sub-goals, including responsible biological research and safe lab practices; innovation in PPE, diagnostics, vaccines, antivirals, and pathogen-agnostic therapeutics; and research into rapid response approaches.

Major recent biosecurity-related developments at FDA

During the COVID-19 pandemic, FDA’s role was to ensure the rapid development and availability of diagnostics, treatments, and vaccines. The agency did so primarily by issuing Emergency Use Authorizations (EUAs) throughout the pandemic for vaccines, convalescent plasma, therapeutics, and medical devices (including PPE and diagnostics). FDA also played a pivotal role in the success of Operation Warp Speed, accelerating the development and distribution of vaccines, which demonstrated the agency’s ability to drive innovation at a rapid pace while maintaining its rigorous regulatory standards.

More recent biosecurity-related developments are listed below (not comprehensive):

FDA offices working on biosecurity policy

There are several FDA offices and centers particularly relevant to those interested in biosecurity, including (not comprehensive):

Medical countermeasure (MCM) development:

• Office of the Chief Scientist (OCS): coordinates scientific collaborations, lab safety, tech transfer, scientific integrity, professional development, and research at the National Center for Toxicological Research (NCTR). Most relevant for biosecurity, it oversees OCET and ensures biosafety in FDA laboratories.
  • Office of Counterterrorism and Emerging Threats (OCET): plays an important interagency role by leading internal and external communications and programs related to counterterrorism policy (focusing on bioterrorism), public health emergency preparedness, and global health security. OCET represents FDA for HHS’ Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and DOD’s MCM programs, and it coordinates FDA’s Medical Countermeasures Initiative (MCMi).
  • Office of Laboratory Safety (OLS): responsible for biosafety practices across FDA laboratories.
  • National Center for Toxicological Research (NCTR): non-regulatory arm of the FDA conducting scientific research, particularly in toxicology and regulatory science. Based in Jefferson, Arkansas.
• Office of Security and Emergency Management (OEM): coordinates emergency response activities involving FDA-regulated products, including inter-agency activities related to emergency preparedness and response. 
• Center for Biologics Evaluation and Research (CBER): regulates and promotes the safe and appropriate use of biological products for human use. CBER’s offices organize efforts across disease-area divisions, labs, and researchers. CBER also plays a role in promoting the development of MCMs. Offices of particular interest might include:
  • Office of Vaccines Research and Review: oversees vaccine development and approval, including labs dedicated to respiratory and special pathogens.
  • Office of Blood Research and Review: oversees blood research, including a lab dedicated to emerging pathogens.
  • Office of Tissues and Advanced Therapies: regulates cellular and gene therapy products that could be relevant for biosecurity applications.
• Center for Drug Evaluation and Research (CDER): regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
  • Counter-Terrorism and Emergency Coordination Staff (CTECS): provides CDER with scientific, regulatory, and policy assistance for drug development initiatives relating to MCM, and coordinates emergency activities involving CDER-regulated products.
  • Office of Infectious Diseases (OID): oversees the development, review, and regulation of applications as well as issues related to toxicology for drug and biologic products reviewed by its three divisions: The Division of Anti-Infectives (DAI), the Division of Antivirals (DAV), and the Division of Pharm/Tox for Infectious Diseases (DPT-ID).
• Center for Devices and Radiological Health (CDRH): regulates medical devices (and radiation-emitting products), which includes diagnostics and devices related to COVID-19 and other pathogens.

Food safety:

• Human Foods Program (HFP): oversees all FDA activities related to food safety and nutrition.
  • Office of Coordinated Outbreak Response, Evaluation & Emergency Preparedness (CORE+EP): serves as the focal point for food-related emergency preparedness and response and leads response for all emergency-related food activity, including counterterrorism efforts. 
  • Office of Integrated Food Safety System Partnerships (OIFSSP): maintains the Integrated Food Safety System (IFSS) and other food safety programs.
  • Office of Microbiological Food Safety (OMFS): responsible for mitigating the risk from and addressing instances of pathogen-related foodborne illness. 

Working at FDA

FDA recruits professionals from diverse backgrounds, including science, medicine, public health, project management, and policy. 

To find open positions, visit FDA’s Careers page (or visit USAJOBS and filter for “Food and Drug Administration”). Follow FDA on LinkedIn, and specifically the FDA Recruitment Network, to stay updated on new job postings. The FDA has a career resources page dedicated to Administrative careers (non-scientific, non-medical).

Notable early-career opportunities (e.g. internships, fellowships) at FDA include:

• FDA (internships):
  • Regulatory Pharmaceutical Fellowship Program: a 2-year program to train fellows on one of six tracks focused on drug information, medication safety, regulatory advertising and promotion, regulatory affairs and policy, biopharmaceutical manufacturing, or regulatory science. 
  • Research and Science Traineeship Program (FRST Program): a research opportunity for pre- and post-doctoral scientists and physicians having a background or interest in any field of science related to FDA mission programs. Stipends and durations vary but may not exceed 5 years.
  • Fellowship in Genomic Science and Health Equity: trains fellows to use genetic and pharmacogenomic approaches to advance minority health and equity, focusing on research, regulatory sciences, and barriers to clinical trial participation.
• Fellowships facilitating placements at HHS and its operating divisions:
  • Presidential Management Fellowship (PMF): a 2-year full-time executive branch fellowship for graduate degree holders. HHS offers more PMF placement opportunities than any other federal agency.
  • Horizon Fellowship: a 1-2 year full-time US emerging technology policy fellowship facilitating job placements in the executive branch, Congress, or think tanks for early- and mid-career scientists and technologists.
  • AAAS Science and Technology Policy Fellowship: a 1-2 year full-time executive branch and congressional fellowship for science PhDs and engineers.
  • Robert Wood Johnson Foundation Health Policy Fellowship: a 1-year full-time executive branch fellowship focused on health and biosecurity policy for mid-career professionals.
  • Oak Ridge Institute for Science & Education (ORISE): provides primarily research-based fellowship and internship opportunities in collaboration with federal agencies for undergraduates, graduates, and postgraduates. They have opportunity pages for CDC, FDA, and NIH or you can filter their available opportunities page by institution.
  • The US Public Health Service (PHS) Commissioned Corps: a uniformed service of public health professionals. PHS officers can be assigned to work in ASPR, FDA, CDC, NIH, and other parts of HHS, and are sometimes deployed in response to public health emergencies, such as hurricanes or COVID-19.

Further reading

• FDA Medical Countermeasures Initiative (MCMi) reports and annual program updates
• FDA MCMi monthly newsletter
• FDA page for updates on Highly Pathogenic Avian Influenza (HPAI)
• AI and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER
• Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, FDA (January 2021)
• FDA response to mpox
• The book Reputation and Power by Daniel Carpenter provides a definitive history of the FDA. See also this book summary and this interview with the author.

Footnotes

Other agency profiles

Department of Commerce (DOC)

Department of Defense (DOD)

Department of Energy (DOE)

Department of Health and Human Services (HHS)

Department of Homeland Security (DHS)

Department of State (DOS)

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