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The way I'd like to proceed is to make some very general comments about our mandate in counterterrorism or what does FDA do in this area. I'd like to go over our strategic plan, which has been updated and made comprehensive in the past year. I'll talk briefly about how we're organized across the agency, and then proceed to talk about the scientific issues that I've selected for discussion this morning.
If we take a step back and look at the sort of big picture of the agency, I think we can see FDA responsibilities in counterterrorism in the context of our dual identity in both public health and law enforcement.
On the law enforcement side of things in counterterrorism, FDA seeks to basically assure the safety and security of our regulated products. And this is the whole range of products we regulate: 80 percent of the nation's food, animal feed, the blood supply, radiation-emitting instruments, and the wide range of medical products that are used in this country--drugs, vaccines, and devices--as well as other biologics, I should mention.
On the public health side, we are looking specifically at our role to facilitate the availability of safe and effective medical countermeasures across the three risk areas in counterterrorism, and that is, to respond to the care of individuals who have been exposed to biological, chemical, or nuclear agents.
FDA regulations apply across the board to both the civilian and military populations, and I think when we think globally about these two groups in our country, there are some generalizations we might be able to make when we look at the public health needs of these two groups.
As I put this slide together over the last few weeks, I really had to question some of these statements. I would say these are general trends, and I'm sure we can find exceptions in both of these areas. By and large, civilians carrying out the activities of everyday living operate in areas of lower risk than do active-duty military. The civilian population includes special groups--children, the elderly, pregnant women--who may represent special medical needs.
Public health actions in counterterrorism are most likely to follow a sentinel event, such as a disease outbreak, as we saw last fall with the occurrence of the anthrax outbreak in this country. Again, I don't think a hard and fast rule, but something to keep in mind when we look at the needs of the military population, and that is, they have the potential to operate in the areas of highest risk--deployment to theaters of operation where there may be knowledge of or high risk for exposure to weapons of mass destruction. The population medically tends to be more homogeneous. These are generally healthy young adults. And in certain instances, the need for public health actions may really precede any sentinel event, but be more preventive measures.
Let me turn now and talk a little bit about just what the program areas are in counterterrorism. What are we doing?
One way to look at this is to contrast the agency's level of involvement and breadth of programs before the 11th of September last year compared to after that date.
These side-by-side bulleted lists give a sense of the changes that took place at that time. Before the 11th of September, our budget for counterterrorism was somewhere on the order of $8 million. The activities were largely focused on the availability of medical products for biological events, that is, an adequate supply of drugs, vaccines, and biologicals; and much of the activity was focused in the Centers for Drugs and Biologics.
In the wake of the attacks of September 11th, the anthrax outbreak in this country, and the deployment of military forces to Central Asia, the agency really took a very broad look at all of the different activities that needed to come under counterterrorism and how those were going to be organized.
Our budget grew substantially. In 2002, that was somewhat in excess of $159 million. Counterterrorism became the new name of what we were doing. It was recognized, I think, about the 12th or 13th of September that we needed to drop the bio and understand that there were many categories of threat agents out there beyond the biological. And it encompassed now the full range of products regulated by FDA and certainly necessitated total agency involvement.
It was during this period that the agency's Strategic Plan in Counterterrorism, as it came to be named, underwent a substantial review and was an attempt to bring in this total agency involvement. And these are the four general areas that encompass what came under the rubric of counterterrorism, and it still does.
Goal Area 1 is the safety and security of our regulated products. It also gets referred to by the traditional law enforcement activities that are encompassed by that: deterrence, detection, investigation, and interdiction--happily referred to usually as DDII.
Goal Area 2 is the availability of safe and effective medical countermeasures.
Goal Area 3 refers to the agency's activities in emergency preparedness and response.
And Goal 4 really was set off by itself more because it has elements of each of the three preceding goals, and that is radiation safety.
I'm now going to talk a little bit about each of these goal areas to show how we have set various strategies within them.
The safety and security of FDA-regulated products may be looked at from three different angles: how we regulate imported products, how we assure their safety in domestic commerce, and how we integrate our information systems to assimilate this very large body of data that we collect on the vast array of products we regulate.
A very large component of these efforts is our food safety and security programs, and I think because I'm going to be followed by Mr. Levitt, I am going to defer to him to talk more extensively about that subject.
The medical countermeasures area I think we can look at in three very broad strategies in which FDA gets involved. The first of these is research and development. As an agency, we provide substantial regulatory guidance to those sponsors of products, be they drugs, biologics, or devices, that are seeking an indication for a counterterrorism-related need.
Secondly, we have a substantial role in assisting in the stockpile and inventory of these products. This was illustrated very graphically to us during the anthrax outbreak last year. We were in very close communication with the manufacturers of the various drugs that were being given out as post-exposure prophylaxis--ciprofloxacin, doxycycline, and some of the penicillin products--in order to assure that there were adequate supplies, that manufacturing was understood, the available quantities in inventory were known to us and communicated to the various other parts of the government that needed to know that.
Lastly, in the medical countermeasures area is the issue of deployment. When a number of our regulated products would be used in this setting, there can be the need to collect data on how they were used and what the outcomes were regarding both safety and efficacy in the patients who received them.
Some of the regulatory mechanisms that make these products available, such as the accelerated approval regs, the new animal efficacy rule, or the investigational new drug regulations, warrant that outcomes data be collected, and much of our planning in counterterrorism looks at how we will go about doing that in what is likely to be a large-scale and rapidly evolving public health emergency.
Emergency preparedness and response encompasses a broad array of activities here in the agency, including our crisis management, what we do in emergency operations and exercising to prepare for terrorist events; our security programs for our personnel, our buildings, our documents, our communications; and I think that's the bulk of those categories. I'm just trying to think if I've left anything out.
No, I think that's pretty much it for that.
Lastly, I'll move on to radiation safety, which, as I mentioned earlier, encompasses the three areas I've already described. We have responsibility for the safety of radiation-emitting instruments of all kinds, and this again was illustrated to us when FDA got involved in discussions of what was a safe and effective way to irradiate the mail that had been potentially contaminated by anthrax spores last fall and winter.
We participated in the discussions of what would be appropriate doses of radiation to use in order to accomplish the task at hand and at the same time not overexpose the operators of the equipment to excessive radiation.
There's a broad array of medical countermeasures that are needed in the event of a radiological or nuclear attack. A number of those are under development, and those developers or sponsors receive substantial regulatory guidance from the agency in manufacturing issues, safety and effectiveness, much as any other product does.
Lastly, FDA has certain responsibilities in emergency response in a radiation event, and those two are subsumed under the Counterterrorism Strategic Plan.
The breadth of our counterterrorism activities is clearly handled across the agency, and our office is responsible for coordinating those and serving as a point of contact for those outside of the agency who have any kind of counterterrorism-related inquiry.
We are in the process of beginning to form our Office of Crisis Management. I mention it here simply to point out the three functional areas that are coming together to work, and that is our Office of Security Operations, Policy and Planning, our Office of Emergency Operations, and Counterterrorism.
I thought perhaps one way to illustrate how we assemble ourselves in counterterrorism is to take a look from first the outside and then the inside. Counterterrorism-related queries that come to the agency can come from a very, very broad array of sources. Certainly industry, academic investigators, foreign governments, our own government agencies, state and local governments, and the occasional concerned private citizen may bring to our attention issues relating to product development, new ideas in technology, issues regarding the security of our regulated products, and any of those are appropriate to bring to our office.
Some of the more common questions we handle are whether or not FDA is truly involved--is this a matter of FDA jurisdiction or does it belong to another agency?--whether or not we are funding any of these initiatives or can we assist people in finding where they might do that; and then if the product does belong in FDA, we serve as a guide to assisting in it getting placed in its appropriate regulatory home.
Inside the agency, counterterrorism operates through a steering committee. There are any number of points of contact across the agency that are part of this steering committee. The five product centers, the Office of Regulatory Affairs, and the National Center for Toxicological Research all have ongoing scientific presences on the steering committee. In addition, there are a number of other functions across the agency that are needed and also serve on our steering committee.
As I put together my remarks for this morning, I tried to choose a sampling of scientific issues that I thought illustrated both the breadth of what is going on and also a common theme, and that is, the need for us to develop standards in a new arena, building on regulatory precedent as a guide. And I think one of the messages that is repeatedly driven home to me when we think about the risks posed by terrorist activities is they introduce the element of the unknown. They introduce agents to which we do not have a lot of experience responding, and they introduce new needs for regulatory action for which we may not have a lot of precedent. And I'll describe a few of those now to try and illustrate this. I'd like to look at certain questions in the area of medical countermeasures, in food security, and in radiation safety.
This is a list that has been making its way around a lot recently. It is the Category A list of biological agents. It was compiled in 1999 and published by the CDC. It represents the efforts of a number of government agencies looking at biological agents that are capable of causing serious disease or death, and for which there seems to be some information that there is capability somewhere out there for someone to use them.
The diseases they cause--smallpox, anthrax, plague, botulism, tularemia, and hemorrhagic fevers--have very much been in the news, I think, some represented more than others. But one of the things I take home from looking at a list like this is that these are rather exotic agents when we think about disease. These are not commonly encountered agents in human disease. I think a couple of them may be more common in animal disease. But, nonetheless, up until the relatively recent past, we were not really thinking about what we had in our medical countermeasure armamentarium to deal with them.
So when we think about the development of drugs and biologics, one of the first things we recognize is that we're looking at the need to understand efficacy and safety of products that will have indications for which there is very little regulatory precedent. Up until last year, there had been a total of, I think, 18 cases of inhalational anthrax in this country. We still have had experience now with less than 30. That is a substantial paucity when we think about the kinds of information we need when we want to understand how a product works.
Similarly, the last case of smallpox in this country was in 1947. The antibiotic era was just getting started then. The antiviral era had not even begun. These are diseases with which we have very little regulatory precedent for development of products.
The understanding that these are rare diseases, and certainly unethical to introduce into human populations for the purpose of study, turns us to the use of animal models to better understand the products that do need to be developed. And one of the biggest questions that we are wrestling with now, both in drugs and biologics, is what are appropriate endpoints, what are appropriate animal models in which to develop these endpoints to understand how these products work.
These types of experiments raise fairly quickly two other fairly important issues. One of them is the availability of non-human primates for the conduct of these studies. While a primate model is not required by the animal efficacy rule or for the study of product efficacy, primates are often the most appropriate animal to use, and certain species of them are in limited supply and warrant that we think strategically about how to use those resources in order to get the most information and the most useful products.
Similarly, the laboratory space that's available to conduct these experiments needs to be a fairly specialized environment with certain safety features and certain laboratory expertise among its personnel that is not really widely distributed. And, again, building this up and understanding how we bring together laboratory facilities, experimental animal availability, and then getting the right models to do this in are substantial tasks.
I'm actually going to skip over this particular example in the interest of time and, rather, move on to a discussion of some of the issues about the development of diagnostic devices. I think I've made the point repeatedly now that we are looking at a new range of biological agents to assay.
If we take a step back and look at the evolution of the outbreak of disease caused by the intentional use of a biological agent, one of the things we will readily recognize is making an accurate diagnosis is a very, very important step and a very early step in the evolution of the outbreak. There are clearly public health and infrastructure and economic consequences linked to the information we would get from the diagnosis of such a disease and, therefore, putting an especially bright light on the need for good diagnostic tools.
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