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Remarks As Delivered at the BioShield Stakeholders MeetingGood morning. I'd like to first express the fact that this conference is not a casual endeavor. It is a very serious effort on the part of the Department, those who have committed themselves to learn how to undertake our mission in a direct way, in a cooperative way, in a streamlined way. We're here to talk about the progress we've made in the days since our country was under biological attack-what we've learned about preparedness, and how we can do better in the future. Five years ago, we were, in fact, under attack. The anthrax attacks afflicted people in many areas-Florida, Washington, and New York-but affected every single one of us in a very personal and direct way because we began to feel less than safe. A few months after those attacks, it was 2002 and I was Governor of Utah. I had a closer, more personal brush with the fear of bioterrorism. On the third or fourth night of the Olympic Games, I was at the figure skating competition, and I got a call from the head of the Department of Public Safety. "Governor, we need you to come to the Command Center, now. We've got a problem-a positive indication of anthrax at the airport." As I left the arena, moving as rapidly as I could through the crowd and sped toward the Command Center, a lot of things began to piece together into a scenario in my mind. I was told as I walked by the head of public safety that [the anthrax indicator was on] a monitor that had been placed right at the top of the C Concourse at the Salt Lake International Airport. It was about 7:00 PM at night. I knew exactly what that meant. Salt Lake City is a major airport hub. With the traffic of the Olympics, there would be tens of thousands of people arriving on planes, changing planes, walking through the concourse and getting on other planes, and transitioning on to 90 or 100 additional cities. If the readings were true, not only would those in that airport be contaminated, but literally people traveling to over 100 different cities would have received a white powdery substance. They would be in a potential race against death. It was a frightening moment in that respect. As I said, the scenario played out in my mind. About 60 days prior to that we had done a sweep of the international airport and found some 200 people who were there without proper documentation. It was just after 9/11, and so we were all hypersensitive about terror having come here for the first time. I could imagine a cell that had been put into place well in advance of the Olympic Games, knowing that it would be the focus of the world. I imagined one of these people getting active and slipping something into the ventilator system of the airport laced with anthrax, quietly, silently, without notice. It was a dramatic moment, because I had been told that the same monitor had not only been tested once, it had been tested four times. It had tested positive all four times. But the more definitive test was at the lab. And I would not know for the next two-and-a-half hours if it was anthrax or simply a false read. As Governor, I had the benefit of having the best people on the ground who could advise me. We concluded after consultation that, rather than close the airport, we should call in the hazmat teams and have them positioned and ready for action, knowing full well that if we had to close the airport, it would have changed the focus for three-and-a-half billion people from the humanitarian event of the Olympics to a terrorist event, whether it was true or not. Likewise, we had the possibility that if it were true, and we didn't close the airport, we would needlessly subject thousands of people-tens of thousands of people all in cities all over America - to the substance. We made the right decision. We had the hazmat teams in place for two-and-a-half hours. I stood outside the laboratory waiting for the definitive read. The best news call I had all those Olympics was the notification that it was a false read. But it was a live-fire exercise. And the fear of terrorism, and the possibility of bioterrorism, became quite evident to me, as I'm sure it has all of you. Very few people heard about that event because, as I indicated, it proved to be a false alarm. But I learned a lot about the fear, and I learned a great deal that has helped to guide me as we've gone forward in preparation for bioterrorism. The effects of emergencies are excruciatingly local: And so must our preparation be. In a moment of crisis, if we are not able to deliver medicines to people over wide areas in short time frames, people die. But the preparation of those medicines begins years before. All of us understand that the development of medical countermeasures is a painstaking, costly process. I appreciate deeply what all of you do in that process. I understand the risks you are taking financially and otherwise, and I'm grateful for the investment that you've made to be here today. Preparedness is a process of learning, adapting, and growing. We're facing new threats from terrible new weapons, and so we've got to learn how to become better prepared as we go forward. There have been difficulties along the way. But we are dedicated to making that process better, to finding problems, and to fixing them. I'm here today to make commitments to you that we are prepared to continue to improve, that we will become a better business partner than we are, the Government in general, and the Department of Health and Human Services specifically. I'm going to talk briefly about the process that we're already in, and have already gone through. And most of all, I'm going to talk about the ways we can improve going forward. We're better prepared today than we were five years ago. Medical countermeasures are being made. Stockpiles are being filled. Spending has increased substantially:
Project BioShield was created to nurture markets where none previously existed, and to incentivize the development of medicines that might not otherwise have been built. So, passage of Project BioShield allowed us to take significant steps forward in medical countermeasure development and acquisition. Since that time:
And today, I'm pleased to announce that The National Institute of Allergy and Infectious Diseases (part of the National Institutes of Health) has issued five awards totaling $4 million to fund the development of products that eliminate radioactive materials from the human body following radiological or nuclear exposure. We've also become more focused in preparing against the threat of pandemic influenza. To increase the capacity and speed of vaccine production, we have awarded more than $1 billion in contracts to develop cell-based technology for vaccines against both seasonal and pandemic influenza. We are also investing heavily in vaccine and antiviral advanced research and development, not only the advanced research, but also the development process of procurements. These are important steps. But much, much more must be done. We need to get better at this. I've observed at least two places that we can improve: The first is the internal challenge of speed. In this case, speed is life. The second is the external challenge of private sector participation, including transparency, liability, and funding. Today's workshop is an example of our efforts to increase transparency. This Stakeholders Workshop is the first of its kind, intended to solicit stakeholder participation and to receive your honest input as we move forward. I believe it will become a regular event. In addition, HHS is beginning to actively reach out nationwide through smaller events to solicit input and expertise. We're also developing a Stakeholders Portal. The Stakeholders Portal will be a web-based system through which those in industry and the research and development community can reach the people they need in the federal government, whether they're looking at a basic level of research or focused on end-stage development. In addition to greater transparency, we're also trying to provide more reliability and better predictability. That's where the "Public Health Emergency Medical Countermeasures Enterprise" comes in. The "Enterprise" of activities consists of three things:
We will publish a national strategy and subsequent implementation plans that will serve as a road map, a way for industry and the public to understand the Federal government's priorities as they relate to countermeasure research, development and procurement. The draft of that Strategy was published in the Federal Register about three weeks ago, on September 8th. It describes the direction that we anticipate taking, both within the Department and in partnership with you, but it is still a work in progress. It requires your input and your expertise. That strategy is intended to be a foundational document, a document that defines our principles and criteria for priority-setting, but its footing will not be sound unless you, our target stakeholders, contribute. The 30-day comment period is already about half over. So, I ask you-I urge you-to take a hard look at the draft strategy and then comment on it. The deadline is October 10th. We need your help on this. I hope you'll take advantage of this workshop to speak candidly and freely about the Strategy document. We're planning on a robust discussion at this afternoon's panel and breakout session. Your thoughts and your comments will be used in crafting the next step, the HHS Implementation Plan. That plan will be published and made publicly available early next year. It will detail which medical countermeasure should be developed next and in which quantities in the near, the mid, and the long-term timelines, all the way out to 2023. The plan stretches out for many years to allow those of you doing research and development to devote the resources that might be necessary to develop the countermeasures. This is part of our effort, not only to streamline and become more transparent, but also to become a better and more predictable partner. The Office of Public Health and Emergency Preparedness will coordinate HHS efforts to streamline the way we do business in HHS, as well as with other Federal partners as the Enterprise continues to develop.
He'll be talking much more about that later today, so I'll simply make two points in passing:
For example:
Their presence here today is an indication of the commitment of this entire Department to this effort. It's essential that agencies and departments work together to speed product development and approval. Again, as I indicated, speed is life. So we'll continue to look for ways to break through the interdepartmental barriers that may naturally impede our efficiency. We'll also continue to look for and utilize the tools that are available to make further improvements. As the Secretary, the BioShield Act has provided me with tools that are necessary to assist me in renewing and revitalizing the operations I spoke of. One of those tools is the ability to make an advanced payment, essentially mini milestone payments to a company, that when used right, can be an essential tool for getting products to the people. We recognize the challenges, including financial, in bringing a product to licensure, and will use this authority when appropriate to ensure the success of the BioShield project. We know that liability issues have been a major concern, and a potential concern, to companies. You have identified these issues as a barrier in numerous meetings on both BioShield and pandemic flu. I am pleased that Congress passed the Public Readiness and Emergency Preparedness (PREP) Act in response to those concerns. This action is welcome relief that I hope will responsibly address industry concerns, and I intend to use this authority as appropriate. I also recognize that there is a so-called "valley of death" in which many companies struggle with a lack of needed cash flow to carry through late-stage research and development to a product after it is ready for market. In response to that need, HHS has proposed $160 million for advanced development in the FY 07 budget to support promising candidates while shifting risk away from Project BioShield acquisition programs. I expect that additional funding will follow in subsequent years. In addition to current authorities, we appreciate the ongoing efforts of Congress to address the problems posed in Project BioShield acquisitions that are related to:
We're working with the Congress to achieve a breakthrough on the Biodefense and Pandemic Drug Development Act. The bill will provide several new tools that are needed to increase our supplies of countermeasures and make this country safer. It supports much needed late stage research and development funding, will allow us to make milestone-based payments under BioShield, and will include simple and limited antitrust exceptions that will bolster work that's already underway. Therefore, I urge that Congress pass this measure as soon as possible. I'm determined to work with every tool available to me. And I am determined to continuously improve the way we do business at HHS. This needs to be a partnership of preparedness, one in which we grow together and work together toward the common goal of making this nation safer in an era of terrible weapons and emerging diseases, thereby increasing the safety and health of the nation. We've come a long way from the fearful days of five years ago. But much more must be done. The threat has not passed. But hope is always to the vigilant, the active, the brave. So let's continue to make ready. Let's go forward in action and preparation. We are committed to the success of Project Bioshield, and to making HHS a better business partner. I believe we can become more prepared than we've ever been before, but it will demand our greatest efforts and our best performance. I opened by talking about my experience at the Salt Lake City Olympics. I look back on that experience as the turning point for me in understanding what needs to be done. So let's promise-let's commit-to continue to prepare. We can be better prepared today than we were yesterday, and more prepared tomorrow than we are today, by doing what we can to make America a safer and healthier place. Thank you. Last revised: September 26, 2006 |
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