Margaret A. Hamburg, M.D. testifies before the U.S. House Energy and Commerce Committee

Margaret A. Hamburg, M.D. testifies before the U.S. House Energy and Commerce Committee

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Margaret A. Hamburg, M.D.

Commissioner U.S. Food and Drug Administration

Testimony of Margaret A. Hamburg, M.D.
Vice President of Biological Programs, Nuclear Threat Initiative
House Energy and Commerce Committee

Mr. Chairman and members of the Committee: I appreciate your far-reaching interest in Homeland Security and particularly your attention to the public health and bioterrorism threats that are the focus of this hearing, and I thank you for the chance to participate in this hearing. My name is Margaret (Peggy) Hamburg. I am a physician and a public health professional, currently serving as Vice President for Biological Programs at NTI, a private foundation, co-chaired by Ted Turner and Sam Nunn, whose mission is to reduce the global threat from weapons of mass destruction. Previously, I have served as Assistant Secretary for Planning and Evaluation in the Department of Health and Human Services in the last Administration; as New York City Health Commissioner for six years, under both Mayor Dinkins and Mayor Giuliani; and as Assistant Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health. I have spent much of my time over many years working on bioterrorism preparedness and response, and I welcome this opportunity to offer my views on the new Department of Homeland Security and improving US defenses against bioterrorism.

Events this past fall – including the attacks of September 11 and the dissemination of anthrax through the postal system – demonstrated our nation’s vulnerability to terrorism, and underscored both the importance and complexity of homeland defense.

I applaud current efforts to give greater authority and accountability to our homeland security program, including the creation of a new federal Department of Homeland Security. There is a strong rationale for consolidating some of the many departments and agencies that share similar functions or provide various aspects of what is needed for comprehensive preparedness and response. Both the Administration’s Bill to establish a Department of Homeland Security and S. 2452 to establish a Department of Homeland Security and a National Office for Combating Terrorism as introduced by Senator Lieberman and colleagues, offer important opportunities to strengthen leadership, focus and coordination of essential programs and policies. However, they also raise a number of concerns.

Preparing our nation against the threat of terrorist attack requires well-defined authority, accountability and coordination across an exceedingly broad array of agencies and activities. The existing Office of Homeland Security, despite the yeoman efforts of Governor Ridge and his staff, is clearly not structured for the task. A new cabinet-level Department of Homeland Security can potentially improve coordination of U.S. government activities such as border security, customs procedures and aspects of emergency response. But improving coordination of activities related to bioterrorism prevention, preparedness and response is a greater challenge.

In my testimony this morning, I want to briefly raise a number of issues that apply broadly to the creation of a new Department of Homeland Security, then focus my attention specifically on the biological threat.


The attacks of September 11 followed by the anthrax attacks have created great political pressure on the White House and Congress to take action to improve homeland security. Just as President Bush refused to be rushed with his post-September military response in Afghanistan and delayed the strikes until they could be timed for maximum effectiveness, so must Congress – in creating a Department of Homeland Security, act deliberately, with full analysis and without undue haste, before taking steps it will find hard to reverse. We need to move forward only after the most careful consideration of our goals and how best to achieve them. Several important concerns come to mind:

Need for a Strategic Framework

The creation of a new Department of Homeland Security represents an ambitious reorganization which will be difficult to implement and disruptive to many functions of government. Even under the best of circumstances, this restructuring will cost time and momentum in current programs. Thus the goals must be defined before legislation is passed, so the benefits of the new structure outweigh the costs of achieving that structure. We should be very clear about what we are doing and why – spelling out goals and objectives, as well as the related roles and responsibilities of the various partners.

Need for Balance

Current plans require that a great many agencies and agency components be pulled into one large Department focused primarily on terrorism preparedness and response. At the same time, this new Department of Homeland Security will still be responsible for dealing with a broad range of other activities. Many of these more routine activities will be important to the core Departmental mission because they will, on a regular basis, allow for the practice of systems that would be recruited into service in the event of an attack (e.g. disaster response and sheltering, FEMA). Similarly, routine non-terrorism activities might serve to identify unusual patterns or situations that might signal an impending terrorist event (e.g. monitoring shoreline for drug-runners or boating accident rescues, Coast Guard). However, there is serious concern that when you create a Department as diverse as this one would be, you will either lose focus on the organizing mission of countering terrorism or you will fail to effectively support those other routine functions. It is hard to imagine a Department remaining honed in on terrorism preparedness and response while responding to mudslides, hurricanes and fires, monitoring the fisheries, searching out drug traffickers, controlling hog cholera and investigating outbreaks of disease. It is also hard to imagine effective leadership for such a diverse array of tasks, requiring an equally diverse array of professional backgrounds and expertise.

Need to Address Existing Weaknesses (Not Just Move Pieces Around)

Given the above concerns about managing this complex and varied new Department, serious questions must be raised as to how the Department will remedy known weaknesses in certain of its component agencies and activities. Reorganizing defective components will not improve performance. Some of the problems may benefit from new leadership or enhanced attention and scrutiny, but without a clear game plan and focused strategy, others may continue to fester, or worse, their continuing dysfunction may be amplified in a new and confusing bureaucracy. A host of personnel, budgetary and jurisdictional issues may add to the difficulties of providing appropriate oversight, management and operational accountability.

Need to Maintain Program Connectivity/Coherence

In several domains, but particularly with respect to bioterrorism, the creation of a new and distinct Department may serve to disconnect certain functions such as bioterrorism surveillance, laboratory networks and response from the infrastructure needed to respond to routine, non-intentional public health issues. The response to a disease outbreak, whether naturally occurring or intentionally caused, will require the same critical components. Most likely, we will not initially know the cause of an emerging epidemic. What is more, our overall infrastructure for infectious disease recognition and response is far from robust. We must be careful not to further fragment our capacity, and inadvertently undermine our own best interests. We must also avoid the unnecessary development of duplicative systems at a time of limited resources.


As our nation struggles to respond to the concerns posed by bioterrorism, both the nature of the threat and the role of public health, medicine and science continue to be poorly understood and underemphasized. The threat of bioterrorism is fundamentally different from other threats we face, such as “conventional” terrorism or attack with a chemical or nuclear weapon. By its very nature, the bioweapons threat – with its close links to naturally occurring infectious agents and disease – requires a different paradigm.

Designing that paradigm is proving to be a difficult challenge. Public health has never been traditionally viewed as an element of national security. Consequently, those who specialize in national security are largely unfamiliar with the public health system – what it is, how it works and why it is important to our overall mission of protecting the nation. It is not surprising that the various Commission Reports (e.g. Hart-Rudman) that have looked at national security/terrorism issues and current legislative proposals for the creation of a federal Department of Homeland Security have had trouble conceptualizing an appropriate organizational approach that includes bioterrorism preparedness and other biodefense activities. In fact, there is no clear and simple answer to the question of how best to organize the components of an effective bioterrorism prevention, preparedness and response program.

Critical Elements of a National Response

Certainly, before a major reorganization of the agencies and activities involved in biodefense, we must understand how these components need to mobilize and work together in every stage of defense – from prevention, to preparedness, to response. Accomplishment of this task would greatly benefit from a thorough and complete critical analysis of our response to the anthrax attacks.

It is stunning and disappointing that we haven’t undertaken a systematic review of what happened. And I strongly recommend that an independent and comprehensive after-action review of the response to the anthrax letters be undertaken. It should be done in a rigorous fashion, looking within and across the relevant agencies of government, at all levels, and at the relationships with private sector organizations. We cannot afford to let these incidents go by without taking stock of what happened, what should have happened (but did not), and what needs to be done to improve response in the future. This must be more than a listing of lessons learned. It needs to be a well-researched report, with thoughtful and informed analysis, identification of gaps in preparedness and response, and realistic recommendations for improvement. To the best of my knowledge, no such exercise is currently underway in a crosscutting and systematic manner. Even as the aftermath and the investigation of the of the anthrax letters is still unfolding, there is still a real urgency to undertake such a process, before significant events fade from memory and before new events and priorities overwhelm us.

Such an analysis would give us indispensable insight into how we should structure our national response to bioterrorism, and how we should incorporate the following four essential elements.

(1) Prevention. Every effort must be made to reduce the likelihood that dangerous pathogens will be acquired or used by those that want to do harm. This must include improving intelligence, limiting inappropriate access to certain biological agents and establishing standards that will help prevent the development and spread of biological agents as weapons.

(2) Strengthening public health. Rapid detection and response will depend on enhanced disease surveillance and outbreak investigation from a well-trained cadre of public health professionals, educated and alert health care providers, upgraded laboratories to support diagnosis, and improved communications across all levels of government, across agencies and across the public and private sector.

(3) Enhancing medical care capacity. We must improve treatment for victims of an attack by enhancing local and federal emergency medical response teams, training health professionals to diagnose and treat these diseases, developing strategies to improve the ability of hospitals to rapidly increase emergency capacity, and providing necessary drugs or vaccines where they are needed through the National Pharmaceutical Stockpile.

(4) Research. A comprehensive research agenda will serve as the foundation of future preparedness. Perhaps most urgently, we need improved detectors/diagnostics, along with better vaccines and new medications. Some of these activities are already underway, but need to be strengthened and extended. Other programs and policies still need to be developed and implemented. All are essential for homeland security. Yet it is important to note that while certain aspects of these activities are required to respond to the threat of bioterrorism specifically, these programs are just as important for the day-to-day, routine activities of public health and medical care.

Potential Benefits of Housing Biodefense Activities in a New Federal Department

There are certain real advantages to be gained from placing these programs within a new federal Department of Homeland Security. First and foremost, the biological threat, and the necessary programs to address it, is of profound importance to our national security. These activities require greatly enhanced priority and support. By residing within this new Department, they may be more likely to command that needed attention and support. Furthermore, experts in biological weapons threats, biodefense and public health preparedness must be full partners at the national security table, participating in strategic planning, policymaking and program design and implementation. Being part of the Department of Homeland Security might help to institutionalize this important participation.

In addition, legitimate concerns have been raised that if not housed within this new Department, crucial public health and bioterrorism programs may be neglected, and important operational public health and biomedical defense functions may not be integrated with national security objectives{{footnote:O'Toole, Tara. "Creating the Department of Homeland Security: Consideration of the Administration's Proposal." Testimony before the House Subcommittee on Oversight and Investigations, June 25, 2002}}.

Clearly, there is an urgent need for improved coordination and integration of bioterrorism programs and policies across agencies of government. The current patchwork – of programs that address bioterrorism prevention, preparedness and response, including research – is inadequate and unacceptable. These need to be brought together into a collective programmatic vision, and implemented in a manner that sets priorities, supports synergy, identifies gaps and avoids unnecessary overlap or duplication. To date, this has proved a difficult challenge. One might argue that the most effective way to address this concern is to pull these activities together under one roof.

There might be additional benefit of centralizing aspects of biodefense activities under one roof from the perspective of certain state and local government entities as well as private sector entities – including the medical care system and the pharmaceutical industry – all of whom are essential partners in combating bioterrorism and should also be integrated into an effective vision and framework for action. Looking at the federal government from the outside, it can be very confusing to discern where and how best to interact with the system. Again, the creation of a unified site within a Department of Homeland Security might reduce confusion, strengthen the ability to work across levels of government, and support the kinds of public-private partnerships that will prove essential to success.

Potential Disadvantages of Inclusion in a New Federal Department / Recommendations

While there clearly are benefits to be gained by moving certain aspects of bioterrorism and related public health issues into a consolidated new Department of Homeland Security, a serious cost/benefit analysis has to consider how best to ensure that our overall governmental effort is maximally effective.

Organization of Bioterrorism Activities

As currently envisioned, the Administration’s proposal for a Department of Homeland Security would seek to develop a single, government-wide, comprehensive and integrated research and preparedness plan to prevent chemical, biological, radiological and nuclear (CBRN) attacks, to reduce our nation’s vulnerabilities to terrorism and to minimize damage and assure effective response should an attack occur.

This approach is intrinsically troubling – from the point of view of biodefense – because, as I noted earlier, the bioterrorism threat has some very distinctive features as compared to “conventional” terrorism or other weapons of mass destruction. Past experience tells us that many so-called bioterrorism programs failed to achieve their potential because they were addressed within the framework of CBRN or “Chem/Bio”. There was an underlying assumption that these problems could be effectively approached with a “one size fits all” model, but in reality, such programs simply failed to address the biological component.

Meaningful progress against the bioterrorism threat depends on understanding it in the context of infectious and/or epidemic disease. It requires different investments and different partners. Until the distinctive nature of bioterrorism is fully taken into account at the level of policy, our nation's preparedness programs will continue to be inadequately designed: the wrong first responders will be trained and equipped; we will fail to fully build the critical infrastructure we need to detect and respond; the wrong research agendas will be developed; and we will never effectively grapple with the long-term consequence management needs that such an event would entail. We may also miss critical opportunities to prevent an attack from occurring in the first place.


(1) Any new Department of Homeland Security must be staffed at the highest levels of leadership and decision-making with individuals who have significant expertise in public health, infectious disease and biodefense/bioterrorism.  

(2) An Undersecretary for Biological Programs should be appointed to oversee and integrate the various activities going on within the Department of Homeland Security that relate to the biological threat. In addition, that individual should serve as liaison to the various other Departments with significant responsibilities and programs in the biological arena.

(3) An external advisory group for biological programs should be established with the responsibility of reviewing the appropriateness and comprehensiveness of biological threat related programs, policies and resource allocation / budget priorities.  

Emergency Response/Role of Public Health Infrastructure

As noted earlier, a bioterrorism attack would differ in fundamental ways from other forms of terrorist assault. The requirements for effective bioterrorism preparedness and response are, for the most part, substantially different as well. Biological terrorism is not a “lights and sirens” kind of attack. Unless the release is announced or a fortuitous discovery occurs early on, there will be no discrete event to signal that an attack has happened, and no site you can cordon off while you take care of the casualties, search for clues and eventually clean up and repair the damage. Instead, a biological terrorism event would most likely unfold as a disease epidemic, spread out in time and place before authorities even recognize that an attack has occurred. We would see the first evidence of attack only after people begin appearing at their doctor’s office or emergency rooms with unusual symptoms or an inexplicable disease. In fact, it may prove difficult to ever identify the perpetrators, the site of release, or even to determine whether the disease came from a natural outbreak or a terrorist attack.

Under most circumstances, the “first responders” to a bioterrorism event will be public health officials and health care workers. “Ground zero” will be in hospitals, health care facilities and laboratories. The “battlefield” response will come in the form of disease diagnosis, outbreak investigation, treatment of the sick and public health actions required to stop continuing contagion and stem disease. How swiftly we recognize and respond to a potential attack will dramatically influence our ability to reduce casualties and control disease. All of these recognition and response functions are more closely tied to public health and medical care activities than to the emergency response required for other types of catastrophic terrorism or even other kinds of natural disasters.

In the months since 9/11, the Bush administration – through programs developed and administered by the HHS Office of Public Health Preparedness (OPHP) and the Centers for Disease Control and Prevention (CDC) – has made some progress in building the programs necessary to strengthen public health infrastructure for bioterrorism within this broader context of infectious disease. If these programs are carved out of their current habitats and moved into this new Department, it will disconnect bioterrorism preparedness from other essential components of infectious disease response and control, thin out already limited expertise, and complicate the ability of our public health partners at the state and local level to work together effectively. If the nation develops two parallel systems for infectious disease surveillance and response – one (that for bioterrorism) of which is only really activated and practiced in a crisis – the likely outcome will be to weaken and fragment our nation’s capacity to respond to infectious disease – whether occurring naturally or caused intentionally.


(1) HHS and CDC should continue to have direct responsibility for programs related to the public health infrastructure for infectious disease recognition, investigation and response, including bioterrorism.  

(2) A public health professional with appropriate background and experience could be placed within the Department of Homeland Security, perhaps with dual reporting to the DHS Secretary and the HHS Secretary. This individual could then work closely with the CDC Director to achieve mutually agreed upon public health priorities for bioterrorism preparedness and response  

(3) The Department of Homeland Security should assure greater coordination, collaboration and program integration among the components of government doing infectious disease surveillance activities (e.g. DOD, USDA, Wildlife and Forestry).  

Biodefense Research

Further investments must be made in biomedical research to develop new drugs, vaccines, rapid diagnostic tests and other medical weapons to add to the arsenal against bioterrorism. At the same time, it is also essential that we improve technologies to rapidly detect biological agents in environmental samples and develop other technologies to protect the health of the public. We must learn more about how these organisms cause disease and how the human immune system responds so that we can develop better treatments and disease containment strategies to protect us in the future. In addition, we must also devote more attention and resources to “systems research,” in an effort to understand more about such issues as personal protective gear, environmental safety and decontamination.

Success will require collaboration among many agencies of government (HHS, DOD, DOE, USDA and others), academia and the private sector. Coordination of the development and budgetary support for such a comprehensive, integrated biodefense research agenda could certainly be offered under the auspices of the proposed Department of Homeland Security. This could help make sure that investment supports both national security needs and research and development priorities. It would also help integrate the bioterrorism-related research activities of the various mission agencies, including threats to humans, animals and crops. Hopefully, this would help foster proper recognition and support for elements of the research enterprise which are currently undervalued/under-resourced – such as the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and the Department of Agriculture’s animal health research facility, Plum Island. It would also help identify program gaps, overlaps and opportunities for synergy.

At the same time, the role of the Department of Homeland Security should be that of coordinator/facilitator. The actual design and implementation of the research agenda and its component programs must remain at the level of the mission agencies, where the scientific and technical expertise resides. With a few possible exceptions, it would be unrealistic and inefficient to build the kind of sophisticated scientific expertise necessary to take on the direct conduct or management of research and development activities across a broad range of disciplines and technologies at the level of this new Department.


(1) A research coordination office could be established within the Department of Homeland Security and charged with responsibility for assuring the development and funding support for a comprehensive, integrated biodefense research agenda. This research coordination office could also help support the integration of threat and vulnerability analysis with the process of setting the research agenda. Such a research coordination office might also be effectively placed within a strong White House Office of Homeland Security, where it could work across the full set of cabinet agencies, including the Department of Homeland Security, to ensure a comprehensive, integrated and appropriately funded biodefense research agenda. An individual with appropriate scientific background and experience should head this office.  

(2) Given the fact that HHS is the primary department with responsibility for biomedical research, and the unique role played by NIH, resources to support the NIH biodefense research agenda should remain within that Department.  

(3) An external advisory mechanism should be established to encourage ongoing communication and collaboration with academic and industry partners. New mechanisms must be developed to engage participation from outstanding scientists from academe and industry, and to bring new young scientists into these endeavors.  

(4) The highest level of government commitment is needed to address the national crisis in the development and production of new vaccines and antimicrobial drugs – a crisis that is growing in urgency in light of the bioterrorism threat. A new Department of Homeland Security, working closely with the appropriate agencies of government (e.g. FDA, NIH, DOD), industry and Congress, could lead such an effort, or it could be undertaken directly from the White House.  


Mr. Chairman and Members of the Committee: Government has no more important mission than protecting the lives of its citizens. A new Department of Homeland Security and a heightened defense against bioterror go directly to the heart of that mission. These tasks are as complicated as they are crucial. I thank you for the depth of the interest you’ve exhibited by holding this hearing. I stand ready to help in any way I can. And I would be happy to answer your questions – now or in the future.  

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