HHS Public Health Emergency Medical Countermeasures

Thank you, Craig [Admiral Craig Vanderwagen].

I would like to note that Admiral Vanderwagen was confirmed in March as this nation’s first Assistant Secretary of Preparedness and Response, and since then he has been providing exceptional leadership. He was also deeply involved before.

As I walked in today, he noted that this meeting is all about building coalitions throughout the government. One of his responsibilities is to build that coalition. He leads the Public Health Emergency Countermeasures Enterprise that we formed last July.

The Enterprise, as you probably know, brings expertise and resources from throughout the government. It includes all of the HHS relevant operations. That would be CDC and FDA and NIH. But it also includes our partners, partners from the Department of Defense, Homeland Security, and Veterans Affairs. 

Workshops like the one that we’re in today are part of the Enterprise’s work.

We have people working on preparedness at the state level. We have people at the private enterprise level. We obviously have them from the federal government. We’re sharing experiences, and we’ll learn from each other in our efforts. It’s all about building the coalition.

This is the second workshop that I have attended like this one. Many of you were here at the first workshop, which was last September.

May I note that that was a great success? It was a great success because it began to develop, I think, an enhanced dialogue about government and industry, and the needs that we all have in being able to prepare.

It has fostered transparency in our efforts. We have taken the comments that we heard last year at the workshop, and we put them into what I believe you have seen over the course of the last year in our work.

This year’s workshop continues to carry us down the path. We’re looking for constructive feedback, and we want to continue to learn;, and, for that reason, we’re very pleased that you are here.

Last year, I began by talking about a personal experience that I had while I was governor of Utah during the Olympic Winter Games of 2002. Many of you will have heard that story, but I would like to, again, begin by just referencing it.

You will recall that in 2002, we had just experienced the anthrax attacks that took place in Florida, and in Washington, D.C., and in New York. The nation was still reeling. We were still feeling a sense of terror that comes with the prospect of that vulnerability.

A few months after that had occurred, the Olympic Games were scheduled to start. I was at the figure skating competition, and I got a call from the Department of Public Safety informing me that I needed to come to the command center.

The short version of a long story is, when I got there, I was told that there was an anthrax positive warning at a monitor at the international airport. Over the course of the next three hours, we waited to determine if, in fact, it was real, or if it was not.

It was a live-fire exercise that I’ll never forget. We actually had to make a decision as to whether we close the international airport, having the effect, of course, of turning the Olympic Games—one of the great gatherings of all humanity—into the “Terrorism Games,” or whether we took the inherent risks involved, and weighed the moral risk of potentially knowing that the airport had been contaminated.

We made what I think was a good decision. We stood everyone up. We waited and found that it was, in fact, a false read.

I referenced that in September of last year, and again today, because it was among many of the learning moments that I have had with respect to preparedness. It was a galvanizing moment in my mind about all of the things that needed to be done.

If there had really been anthrax in that airport that day, and we did not have the technology to test for it there in the terminal, lives would have been lost.

The thought of having airplanes coming in from 90 different communities, the potential of walking through that terminal, and then getting on other airplanes and flying out to other cities—we could have had a massive homeland security incidence.

And I remember sitting, thinking through that wait, “If this is real, there is a sense of sinister brilliance here that I don’t even want to contemplate.” But, gratefully, at that point, we did have the technology, and, more importantly, it was a false read.

But that’s why good coordination and planning are so essential. And it’s essential down to every community. As I thought through that that day, it became evident to me that this would involve potentially homeland security, medical, and law enforcement people from every community in the country, because we wouldn’t know the reach of it.

There’s no way that the federal government could have swooped down at that moment in large scale and distributed medications over a large area effective enough to meet the need.

We are good about getting supplies to stockpiles. But from there, it has to be the states who have distribution plans, to put pills in the palms of people at the right moment.

I mention this because preparedness is a responsibility that we all share. We share it at every level of government, and every level of society. In a moment of crisis, if we’re not able to deliver medicines to people over a broad area, people will die. We need distribution plans for emergency medical countermeasures.

Recently, we have been testing different methods of getting medicines into the hands of people. We’re using the post office. You may be aware that in two major cities, Seattle and Philadelphia, HHS and the U.S. Postal Service have joined with state and local officials to work on an innovative solution to this distribution problem.

These cities conducted trial deliveries of boxes that could have contained antibiotics in an emergency. Instead of having the masses convene on a central hub, we took the supplies to people using the postal delivery service as the means.

So far, the tests have gone very well and have offered us important alternatives to some conventional thoughts on mass distribution.

Another trial program, that’s taking place currently in St. Louis, involves sending kits of antibiotics to people in advance so that we could see if they would store the drugs properly without using them.

So far, I must report that the test appears to be successful, and it may allow us to develop another successful model for distribution of emergency medical supplies at the community level.

Now, these trial programs demonstrate what’s possible when we start to look at the problem and make plans. We need to keep learning. We need to keep thinking. We need to build our stockpiles of medical countermeasures and other supplies, but we need to work on distributions, and different methods of accomplishing it. We need to understand how we can reach people with accurate and reliable information.

I appreciate what all of you are doing to make this process increasingly effective. By being here today, you demonstrate your dedication to that cause. I’m grateful for the investments that all of you are making to protect this country.

And now, I would like to tell you about some of the federal government’s efforts in preparedness and what we have accomplished during the last year; though, I want to admit right up front, there’s still a lot to be done.

In December of 2006, President Bush signed into law the Pandemic and All-Hazards Preparedness Act. The Act has given HHS a set of new tools, and a new set of duties, and a new structure to bolster our preparedness.

As I mentioned, it established Admiral Vanderwagen’s office at HHS to coordinate civilian preparedness and responsibilities by the federal government. He will be describing the strides that his office has made during the last year in more detail in just a minute, but I want to note that the law that the President signed established the Biomedical Advanced Research and Development Authority, or BARDA, as all of you know it, within HHS.

BARDA facilitates research and development. It makes acquisitions of medical countermeasures that are critical for public health emergencies. Carol will be taking a few more minutes later to talk about BARDA.

The Act also gave HHS the authority to make advance payments for countermeasures that are in development. These payments help reduce the risk of those that are developing interventions that are badly needed. They also help to ensure the countermeasures make it into the market.

HHS acted under this authority for the first time in June. We contracted with Bavarian Nordic of Copenhagen, Denmark, to manufacture and deliver 20 million doses of the next generation smallpox vaccine. It was a $500 million contract. Letting it means that we’ll have enough vaccine to provide ten million immune-compromised people in the United States a safer smallpox vaccine.

These are new tools and new structures, and they complement our means of being able to fulfill the mission of the federal government in this coalition.

Since we met last year, Project BioShield has actively been stocking the shelves of the National Stockpile. Over the past three years, we have added four medical countermeasures to the stockpile, and we have contracts to place two additional products into place very soon. These will protect us from anthrax, and radiological and nuclear incidents. And later this year, we’ll be delivering the antitoxin for botulism that will begin in a stockpile soon.

We will also continue to build our stockpile in other ways. This fall, we’ll be requesting proposals to develop additional countermeasures for radiation sickness and second-generation anthrax vaccines.

One lesson I believe that we all continue to learn—certainly I have as Secretary—is that preparedness is a process of learning. It’s a process of adapting, and it’s a process of growing. No place has that been more evident, than what we have done to prepare for a pandemic.

All of us are aware that the avian H5N1 influenza is a highly pathogenic virus, and it continues to spread around the world. Over 300 people have contracted the disease. Thus far, 200 of them have died. And, while in a world of billions of people, that may seen small, all of us know that it’s just a matter of time before a pandemic strikes.

We don’t know if it will be the H5N1 virus that will spark that pandemic, but there’s no reason to believe that this century will be different than centuries past.

Over the past year and a half, our federal government has made steady progress in building the nation’s defenses and planning for the future.

We have licensed the first H5N1 vaccine for humans, and we have added enough vaccine to our stockpile to be able to treat six million people.

We have committed over a billion dollars to expand our nation’s cell-based influenza vaccine production capability over the next five years.

We have held flu summits in every state and every territory in the country.

We have launched a series of television and radio public service announcements in English and in Spanish to raise awareness of pandemic influenza planning.

We have maintained the federal government’s authoritative website, pandemicflu.gov.

We have used a number of innovative ways of working with the media. One of the more interesting is that we have held six media roundtable exercises, where we have invited the media to come in as participants to participate in learning how we can best fulfill each other’s important roles during a pandemic influenza.

We have held the first blog summit that I know of in the federal government, where we involved the public in a conversation over a lengthy periodof time. It was a remarkable success, not just the summit itself, but what led up to it, and the takeaway that we all achieved as a result.

A pandemic would pose a unique challenge for all of us. Everyone would need to be vaccinated, but we can’t start making vaccine until we have the virus. We estimate that it would take 20 weeks to identify the virus, and to isolate it, and to find a suitable vaccine for mass production.

We’re working to build a robust production capacity that would provide a vaccine for all Americans within six months. To meet the first wave of a pandemic, however, we still need to use the stockpile of the pre-pandemic virus vaccine that I have spoken of already.

To date, we have stockpiled enough antiviral medications to treat nearly 50 million Americans, and more is obviously needed. Our goal is to have 81 million courses on hand to be able to contain a pandemic at its start.

In June, we awarded contracts worth over $130 million to two vaccine producers to retrofit their facilities and to increase their capacity. I visited one of these facilities less than two weeks ago as it completed its work under the contract.

As a result, these plants will now begin to produce vaccine for the National Stockpile year-round instead of just the three months that they were able to before while they weren’t producing the annual flu vaccine.

These contracts will boost our domestic pandemic vaccine manufacturing capacity by 16 percent.

We have invested over $130 million in the development of adjuvants to carry our vaccine supply as far as possible in a pandemic, and there is great success to be reported there.

These activities are critical. But as I mentioned before, for a comprehensive approach to preparedness, stakeholder outreach has to take place. And that’s where building a coalition—as the Admiral points out—at meetings like this is so important.

We’re reaching out in many ways beyond this particular conference. BARDA Industry Day will be held on Friday, August 3. It will be the first of its kind. This is an effort to allow companies interested in working with the federal government to showcase their advances in emergency medical countermeasures.

As announced at last year’s workshop, we’re instigating a pandemic portal for product development. It’s medicalcountermeasures.gov. BARDA anticipates this site will go live later this summer.

You can take advantage of looking at the site that we have in the exhibit just outside the room.

In June, I announced the establishment of the National Biodefense Science Board. This Board will provide guidance on preparing for all kinds of threats, natural and manmade.

The Board will consist of 13 voting members. They will be appointed by the Secretary ofHealth and Human Services from among leading experts throughout the public health and medical community. We’re currently reviewing over 200 nominations for membership on that board.

So, we have a lot going, and we have come a long way since our last meeting. But, as we all know, there’s a lot to do, and we have to be constantly looking for ways to remove barriers, and to reduce industry risk to promote the kind of innovation it takes for us to succeed.

We have to maintain good lines of communication among all parts of this coalition—the federal government, the state government, local and tribal governments, and between the government and the private sector—so we can maximize the work that we do together.

An example of how we can do this is for the federal government to alert our partners to opportunities to acquire medical countermeasures to protect populations. This increases overall national preparedness, and we need to continue to aggressively pursue the strategies that we have inthis vast and important enterprise and our pandemic influenza planning documents.

I deeply appreciate the part that all of you play in building our nation’s capacity to respond. It is, in fact, a coalition. And your commitment is not only admirable, but it’s absolutely necessary.

The federal government cannot mount an effective response to the threats that we face as a nation without partners at every level of government and throughout society. And so I thank you very much today for being here, and for your continued commitment to making America a safer and a healthier place.

Last revised: March 13, 2008