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Anthony S. Fauci, M.D.
Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Department of Health and Human Services
April 4, 2003
Mr. Chairman, members of the Committee, I appreciate the opportunity to discuss Project Bioshield with you today. As you know from the legislative language, the purpose of Project Bioshield is to accelerate the research, development, purchase and availability of effective medical countermeasures against chemical, biological, radiologic and nuclear terrorism.
Project Bioshield is a three-pronged program. First, it increases authorities and flexibility for the NIH to expedite the research towards the development of critical medical countermeasures. Second, it establishes a secure funding source via a mandated appropriations authority for the purchase of such countermeasures. And third, it establishes an FDA Emergency Use Authorization for critical countermeasures. I will briefly discuss the first two components of the plan, with a focus on how they relate to our work at the NIH. My colleague, FDA Commissioner McClellan, will discuss both procurement issues and the FDA emergency use authorization.
The NIH research system has served us extraordinarily well for decades. NIH employs traditional funding mechanisms that include grants, contracts, cooperative agreements and other partnerships, as well as time-tested personnel functions - a system that has resulted in numerous major advances that have improved the health of the Nation, including the development of interventions for emerging and re-emerging infectious diseases.
However, the events of September 11, 2001 and the subsequent anthrax attacks have changed -- probably forever - how the biomedical community responds to emerging threats. We are now in a wartime mode, and are compelled to modify the way we do business without compromising the elements that have made us successful.
With regard to the first component of Project BioShield, the legislation provides for a number of special authorities at NIH that will have the aggregate effect of expediting the research process. This is the "push" towards countermeasure development. Among these, Bioshield provides for expedited peer review of grants and contracts without compromising scientific, technical and programmatic standards. It also streamlines procurement authority, bolsters authorities for acquisition and renovation of facilities, expedites personal services contracts and provides flexibility with regard to personnel authority. We feel that these expanded authorities will considerably hasten the pathway from basic research concept to effective countermeasure.
Let me switch gears and speak briefly about the mandated appropriations authority for the procurement of countermeasures. We at NIH and DHHS have had numerous occasions to discuss the development of countermeasures with companies ranging from small biotech firms to "Big Pharma" -- these are industrial partners that are essential to bringing countermeasure development to fruition. Many of these firms are willing to help in the development of biodefense countermeasures, but the fact remains that they are businesses and are not non-profit organizations, and they need a tangible incentive to get involved.
When it is evident that a given product has a potential to make a profit, no incentives are needed to engage industry. However, when you are dealing with a product for which there is no guarantee of a return, or for which the market in tenuous, these companies clearly need some assurance that there will ultimately be a return on their investments. Without such assurances, they will simply pursue the development of other products.
When we meet with companies, we hear one of two things. First, they may already be involved in the early stages of development of biodefense countermeasures on their own initiative, and are willing to take on a fair amount of risk, but they want assurances, if they are successful, that there will be a market for their product. Many state quite frankly that they do not want to be vulnerable to the vicissitudes of the cyclical appropriations process.
The other scenario is when we are trying to engage reluctant companies to get involved. In this instance, we do as we are doing now; we push with discretionary research dollars. However, that does not seem to be enough. With Project Bioshield, we would further be able to tell these companies that they can partner with us such that if at their end they meet certain milestones and come up with a licensable countermeasure, they have our assurances that there will be money available to them for advanced development -- and ultimately purchase. These are examples of the "pull" in the process.
In summary, the accelerated development of effective countermeasures against terrorism requires a new research paradigm, and new ways to engage our industrial partners. Project Bioshield will help us meet the challenges of bioterrorism effectively and expeditiously.
Thank you again for the opportunity to testify today about this important initiative to improve our Homeland Security. I will be happy to take any questions you may have.
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