March 27, 2003
Good morning. Mr. Chairman, Members of the Committee, thank you for inviting me to testify on Project Bioshield.
Before I begin, Mr. Chairman, I thought it would be helpful to give you a brief update on SARS. As we speak, scientists from a number of countries are working around the clock to solve the mystery of SARS. They are still exploring several avenues, but they say it is more than likely that SARS will turn out to be a virus in the corona family-the same family as the common cold. So far, the lessons we can draw from SARS are that surveillance is critical, and that surveillance works. Early detection of a pattern of symptoms gave scientists critical time to start investigating this disease.
Mr. Chairman, my goal at HHS is to do everything I can to ensure that Americans are strong, healthy, and independent. Every time we take a dollar from the taxpayers, we must be confident that we can use that dollar to promote their health, security, and independence better than they can. That's our solemn responsibility, and one that I take very seriously. Private investment should drive the development of most medical products. Bioterrorism is different, of course, because everyone hopes those products will never be needed.
The attacks of September 11th made it clear that the threat of terror is graver and more imminent than at any time in modern history. The anthrax attacks made it clear that the threat of terrorism includes weapons of unprecedented power and ingenuity, and that we need to be prepared.
We've already done a great deal. Today, the United States is better prepared than ever to meet the threat of terrorist attack with a biological, chemical, radiological, or nuclear agent. The national stockpile of medical countermeasures is large, and getting more extensive all the time.
But that stockpile may not be enough. Unfortunately, the medical treatments available for many pathogens have improved little in decades. The smallpox vaccines available today hardly differ from those of the 1960s. Some treatments for radiation and chemical exposure have not changed much since the 1970s. And some diseases, such as Ebola, have never had an effective medical countermeasure.
These diseases lack effective or modern treatment in part because they are rare. By contrast, the treatment of the vast majority of common, naturally occurring illnesses has improved dramatically as a result of continuing innovations from biomedical research and development. Heart attacks were often fatal in the 1970s, but they are much less so today. And better detection and therapeutic options have significantly improved survival rates for many kinds of cancer over the last 20 years.
We must bring that sort of progress to the rare yet deadly threats posed by bioterrorists. And that's why President Bush announced Project BioShield. He would spend roughly $6 billion over ten years on new countermeasures to prepare America for a bioterror attack. This proposal would speed up research and approval of vaccines and treatments and ensure a guaranteed funding source for their purchase--just the latest in our forward-looking efforts to protect the homeland.
For example, the President's budget foresaw and prepared for an influenza outbreak. It proposes to spend $100 million to ensure the nation has an adequate supply of influenza vaccine in the event of a pandemic. Due to the constant changes in the circulating influenza strains, we cannot stockpile influenza vaccine, and the current manufacturing methods might not meet the Nation's needs in the event of a pandemic.
Funds will be used for activities to ensure a year-round influenza vaccine production capacity and the development and implementation of rapidly expandable production technologies. We will work closely with industry to accomplish these goals.
The bill before you today, the Project BioShield Act of 2003, has three main parts. First, it would give the Department, working through NIH and the National Institute of Allergy and Infectious Diseases, new authorities to speed research and development in promising areas of medical countermeasures against potential bioterrorism agents. Second, it would create a permanent, indefinite funding authority to spur development of medical countermeasures for inclusion in the Strategic National Stockpile.
Third, in a national emergency, the bill would allow me to suspend the full, lengthy FDA approval process, if a product in the approval pipeline is urgently needed and has great potential to protect, diagnose, treat, or prevent a serious disease caused by a bioterror agent.
In other words, we will use NIH to push research through the process, and our procurement authority to pull treatments into the stockpile.
I look forward to discussing all three parts of the bill.
The President has made improving our nation's health and health care one of his biggest priorities for the year. By working together, we can make it one of our proudest achievements. I look forward to all the work, and I know our discussion this morning will get things rolling.
Thank you, Mr. Chairman.
Last Revised: March 31, 2003