Date: 2003-07-16
Speaker: TOM DAVIS (republican)
Chamber: H
State: Virginia

Mr. Speaker. I yield myself such time as I may consume. Mr. Speaker. I rise in support of H.R. 2122. the Project BioShield Act. This bill provides the government with the necessary tools to develop and purchase vaccines and other drugs to protect Americans in the event of a bioterrorist attack. The President first announced this proposal during his 2003 State of the Union address. It is the cornerstone of the administrations strategy to prepare our Nation against the possibility of a bioterrorist attack. The bill we are considering today was introduced by the gentleman from Louisiana . chairman of the Committee on Energy and Commerce. and was referred to the committee. as well as the Committee on Government Reform which I chair. and the Select Committee on Homeland Security. It is a good bill which serves a compelling national interest. As we tragically learned during the fall of 2001. our Nation is vulnerable to biological terrorism. Letters laced with anthrax caused the deaths of five individuals and thousands more had to be treated. The death toll could have been higher if there had not been an effective countermeasure to treat that form of anthrax. Unfortunately. there has been little progress in treatment for other deadly diseases. like smallpox. Ebola and plague. which effect few. if any. Americans. The reality is that there is little manufacturer interest in developing necessary treatments for these diseases because there is no significant commercial market existing outside of government. The absence of financial incentives has provided drug companies with little reason to make the substantial investment that would be required to develop treatments for these deadly diseases. Should the United States be attacked with any of these deadly pathogens. the needs for vaccines. tests and treatments would be great. and it would be immediate. H.R. 2122 is designed to ensure that our country is prepared. The bill provides the Secretary of Health and Human Services with a number of flexible acquisition tools based on existing streamlined procedures to promote research and development and procurement of necessary drugs and vaccines. These tools are instrumental to the success of the BioShield program. For example. the bill increases the simplified acquisition threshold for research and development projects from the current level of $100.000 to $25 million. This increase will help the Secretary promote sophisticated research and development projects by streamlining the acquisition process. The bill also authorizes the procurement of biomedical countermeasures. again using tailored. flexible acquisition tools for inclusion in the Nations stockpile using a special reserve fund. The Secretary would also have expedited authorities to award research grants and hire technical experts and consultants. During national emergencies. the bill would permit the government to make available new and promising treatments prior to approval by the Food and Drug Administration. The Committee on Government Reform. which I chair. held a hearing to examine the BioShield proposal on April 4. 2003. Witnesses from the government. academia. and pharmaceutical and biotech companies were supportive of the bill. They all recognize the need to create incentives for manufacturers to develop biomedical countermeasures. Our committee favorably reported the bill on May 22. Working in a bipartisan fashion with the gentleman from California . we unanimously adopted some amendments to ensure greater accountability in the acquisition process and to clarify the circumstances when biocountermeasures can be processed. Specifically. the amendments we approved permit the use of simplified acquisition procedures only when the Secretary. of Health and Human Services determines there is a pressing need for the procurement of specific countermeasures. The bill commits decisions about research and development projects to the discretion of the Secretary of Health and Human Services. However. we approved an amendment which preserves a limited right for companies to appeal to the General Accounting Office contracting decisions made by the Secretary. but appeals could not be used to stall the research and development procurement process. We also made some technical changes that seek to clarify the circumstances when the Secretary could use other than fully competitive procedures for research and development and production contracts.