By:  Luciana Borio, M.D.

FDA plays a pivotal role in thinking about the unthinkable: preparing for a chemical, biological, radiological or nuclear event that could result in mass casualties.

But the 2001 anthrax attacks in the United States, the 2009 influenza pandemic, and last year’s nuclear accidents in Japan demonstrate the critical need to plan for the unthinkable.

Food, medical products, and the blood supply are all essential elements when such events occur. As the regulatory agency responsible for their oversight, that means FDA is central to a successful response to these deliberate or unintentional threats.

Coordinating FDA’s efforts to think about the unthinkable is the Office of Counterterrorism and Emerging Threats (OCET).

The office provides strategic leadership and coordination, working closely with other offices within FDA, Federal and State partners, like the Centers for Disease Control and Prevention and the National Institutes of Health, as well as academia, and industry to make sure we can respond quickly and appropriately to counter and minimize the effects of these types of public health emergencies.

Part of preparing for the unthinkable is the development of medical countermeasures—the vaccines, therapeutic drugs, diagnostic tests, and other medical equipment and supplies.

In 2010, FDA launched its Medical Countermeasures initiative (MCMi), to make sure that such products are available. OCET is working closely with the medical product centers to enhance the product review processes by identifying and helping to resolve the scientific, legal, regulatory, and policy gaps that may be slowing development of medical countermeasures; working to modernize the regulatory and policy framework to support preparedness and response; and advancing regulatory science for MCM development and evaluation.

FDA’s drug, device, and biologics programs are fostering the development of MCMs in several high-priority areas and encouraging the use of advanced manufacturing technologies. Examples of key areas of focus include:

• diagnostics and therapies to treat the multiple manifestations of acute radiation syndrome;
• the special needs of pediatric patients and pregnant women;
• next-generation diagnostic tests; and
• care for American soldiers exposed to trauma or CBRN threats.

We are also working to speed MCM deployment and facilitate pre-event planning and positioning of MCMs at the local level.   

At FDA, science underpins virtually every regulatory decision we make. Through our MCMi regulatory science program, FDA is helping build the innovative scientific tools we need, tools like new testing models and other techniques to address the challenge of determining whether a new countermeasure is effective in treating an outbreak of anthrax, the effects of radiation exposure, or plague. Clearly these products can’t be tested on humans, so new models must be developed to accurately reflect human response.

And we’re making good progress. Just recently, an FDA Advisory Committee meeting considered data and voted unanimously on the significance of studies using animal models in evaluating the effectiveness of fluoroquinolones for treating humans with pneumonic plague. 

Next week we will be showcasing our many, scientific collaborations at a two-day public seminar, the MCMi Regulatory Science Symposium. By clicking on the Program Agenda, you can get a quick picture of the broad number of topics we’re working on.

I also invite you to visit FDA’s MCMi Web page to read further about this important part of our mission to promote and protect public health.

Dr. Luciana Borio is Assistant Commissioner for Counterterrorism Policy and
Director, Office of Counterterrorism and Emerging Threats