When the anthrax attack happened in the fall of 2001, I was working at the Center for Civilian Biodefense Studies at the Johns Hopkins Bloomberg School of Public Health. It is fair to say that most public health professionals as well as governmental and other health-related organizations were taken completely by surprise. It was a time marked by considerable uncertainty with respect to the extent of the attack; the number of people who had been exposed; how best to prevent illness in those potentially exposed; how best to treat those who had become ill; and how to prevent additional exposures and illnesses.

My role in the response was primarily one of facilitating information sharing to foster more effective response activities. I, along with my colleagues, organized working groups and built informal networks to identify and share critical clinical information and, later, to disseminate lessons learned. We worked closely with U.S. government officials at the federal, state and local levels and with first responders in the medical and public health communities.

At the time it was very clear that we faced numerous challenges. There was no rapid test to help determine who needed prophylactic antibiotic treatment to prevent potential illness, there were limited supplies of antibiotics, and there was considerable uncertainty regarding how long prophylactic treatment was necessary to prevent illness. There also was a limited supply of anthrax vaccine and a lack of clarity on how best to use it in response to the attack. In addition, there was fear that subsequent attacks would ensue in rapid sequence, and we all knew that capacity at the state and local level to deliver medical countermeasures to large numbers of people was sorely inadequate.

Since the 2001 anthrax attack, preparedness has improved considerably. However much work remains to be done, and if an anthrax attack occurred today, the nation would still face many of the same challenges as in 2001. Although our nation’s armamentarium of medical countermeasures to respond to an anthrax attack has been bolstered, there is still uncertainty regarding how clinicians would manage patients and how public health practitioners would manage the public health emergency. In the event of a large-scale attack, difficult decisions would have to be made on how best to use life-saving resources in a resource-constrained environment. In addition, the capacity to deliver medical countermeasures to large numbers of people and to surge medical care in a mass casualty event is still lacking in many areas.

Recognizing that our nation needs to continue to improve its capability to respond to bioterrorism and emerging infectious disease threats, this past year the President announced a new initiative to increase our capacity to respond faster and more effectively to these threats. As part of this initiative (outlined in the 2010 Public Health Emergency Medical Countermeasures Enterprise Review), the U.S. Food and Drug Administration (FDA) launched its Medical Countermeasures Initiative (MCMi) in August 2010.

I have the privilege to help lead this effort along with the dedicated professionals that I work with at FDA. The mission of the MCMi is to build on the substantive work under way at FDA to promote development of medical countermeasures by enhancing FDA’s regulatory processes, fostering the establishment of clear regulatory pathways for medical countermeasures and facilitating the efficient use of available medical countermeasures by establishing effective regulatory policies and mechanisms.

The new initiatives launched as part of the Enterprise Review have put the United States in a position to begin fully leveraging advances in science and technology to develop innovative, safe and effective medical countermeasures and the systems to deliver them. These initiatives —along with the significant U.S. government investments in bioterrorism preparedness to date— have put the United States on a trajectory to achieve substantial gains in preparedness and significantly reduce the risks posed by bioterrorism and emerging infectious diseases.

The biggest challenge to preparedness efforts today is complacency. The United States will continue to face a substantial threat from bioterrorism (and emerging infectious diseases) for the foreseeable future. Indeed, bioterrorism is seen as a growing threat as advances in technology will continue to make biological weapons increasingly accessible to state and non-state actors as well as increasing their potential lethality. As such, we must continue and increase our preparedness efforts, which will require an appreciation of the long timelines, risks and high costs associated with developing medical countermeasures and the systems to deliver them; a significant and ongoing investment of resources; abroad-based effort, involving governmental entities at all levels, academia, industry and health professionals; and the continued commitment of our leadership.

This writing reflects the views of the author and should not be construed to represent FDA’s views or policies.

Luciana Borio, M.D.,Acting Director, Office of Counterterrorism and Emerging Threats and Assistant Commissionerfor Counterterrorism Policy, Food and Drug Administration

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