107th Congress

Report: FY 2003 HOUSE APPROPRIATIONS HEARING ON BIOTERRORISM - Hearing Before the House Appropriations Subcommittee on Labor, Health and Human Services, and Education - May 1, 2002

Members Present

Ralph Regula (R-OH), Chairman; Roger Wicker (R-MS); Don Sherwood (R PA); Nancy Pelosi (D-CA); Nita Lowey (D-NY); Ernest Istook (R-OK); Dan Miller (R-FL); and Randy ADuke@ Cunningham (R-CA)

Witnesses

Claude Allen, Deputy Secretary, U.S. Department of Health and Human Services (DHHS), accompanied by Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases (NIAID), NIH; Charles Curie, Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA); David Fleming, Acting Director, Centers for Disease Control and Prevention (CDC); Elizabeth Duke, Administrator, Health Resources and Services Administration (HRSA).

Purpose of Hearing: This hearing was held to receive information on the DHHS budget request for FY 2003 for bioterrorism-related activities, specifics on programs of the represented agencies, and efforts to coordinate activities within the Department and across government. Members were particularly interested in DHHS planning and coordination with other Federal agencies, state and local governments, and first responders in the public health setting. They also wanted to know what is needed to ensure national preparedness in the event of a deliberate bioterrorism emergency. All witnesses appeared on a single panel, with Deputy Secretary Allen delivering a formal statement and agency representatives presenting brief oral remarks.

Opening Statements

Mr. Allen thanked the committee and introduced the panel. He stated that within the FY 2003 DHHS budget request, a total of $4.3 billion is provided for bioterrorism. Of this request, $2.3 billion is for the public health emergency fund and $1.75 billion is for NIH. The NIH dollars will go to expand basic and clinical research on vaccines, therapies, and diagnostic tests for bioterrorism agents, as well as malaria, tuberculosis, and HIV/AIDS. Additionally, within the Department's request, $10 million is provided for state and local infrastructure development by SAMHSA. Finally, within the Department's request, $159 million is for product research at the Food and Drug Administration (FDA). This funding provides a total of $650 million for vaccines and pharmaceuticals and will insure that the nation's hospitals are prepared and antibiotics are available to all Americans.

Opening Remarks

Dr. Fauci, highlighted development of NIH's strategic plan and research agenda to combat bioterrorism and characterized the entire Department's activities as biodefense rather than bioterrorism. The NIH's strategic plan for biodefense will include the research and development of vaccines, diagnostics, and therapeutics. The research agenda will focus on vaccine development of category A agents which include anthrax, smallpox, botulism, and ebola. Dr. Fauci said vaccines represent a large part of our biodefense armamentarium. The $1.75 billion requested for NIH in FY 2003 will support research on the basic physiology of bioterrorism agents, development of vaccines, diagnostics, and therapeutics, and new and upgraded research facilities. Citing the need for definable outcomes, Dr. Fauci noted successes made possible through funds provided for biodefense activities in FY 2002. He briefly highlighted the smallpox dilution studies, which will enable expansion of the vaccine stockpile, anthrax pathogenesis studies, and ebola challenge studies in monkeys that are expected to proceed into clinical trials by the end of this year. Dr. Fauci noted the greatest biological threats as those that are naturally occurring, and said we must build a sustainable effort that will last well beyond any deliberate bioterrorism release.

Mr. Curie stated that FY 2003 will be the first request that SAMSHA has made for bioterrorism funding. The focus of this funding will be on mental health and substance abuse resources regarding crisis intervention and knowledge dissemination. Dr. Curie further reported that in FY 2002, SAMHSA provided $1 million to New York City following 9/11, $6 million to all other areas affected by the attacks, and $28 million within the $150 million donated by the Federal Emergency Management Agency (FEMA).

Dr. Fleming stated that CDC's request totals $1.6 billion for the pharmaceutical stock-pile. Of this amount, $300 million will be for CDC preparedness for a bioterrorism attack. Another $100 million of the total is for a construction of a new research lab in Fort Collins, CO. This funding will allow the CDC to deliver four million doses of antibiotics anywhere in the United States within 5 hours of a request. Finally, the budget request provides $940 million for state and local infrastructure preparedness efforts.

Dr. Duke requested $618 million for health resources and discussed five bioterrorism programs in her introductory remarks. One program requests $235 million for hospital preparedness. Examples of the other programs include $283 million for hospital infrastructure, $60 million for education and curriculum development, and $21 million for poison control.

Questions

Chairman Regula

Mr. Regula asked Mr. Allen if there is a bioterrorism master plan within DHHS. Mr. Allen replied that there is a new office in the Office of the Secretary for bioterrorism-related activities. All DHHS agencies are coordinating relevant efforts through this new office, as are the U.S. Departments of Defense and of Justice.

Mr. Regula inquired about the shortage of flu vaccines and whether or not there will be another shortage this fall. Mr. Allen replied that FY 2002 monies have induced pharmaceutical companies to take a larger role in vaccine development for next year. Dr. Fleming replied that there is a short time-line for flu vaccine production because a new vaccine must be developed each year. He stated that the CDC is committed to making sure there is large enough supply next year.

Mr. Regula said this will be the fifth year of the NIH doubling effort. He asked Dr. Fauci if the extra money going toward bioterrorism research will limit funding for other areas. Dr. Fauci replied that past experience has shown that positive spinoffs occur from accelerated research in a particular area; these spinoffs benefit many other disease areas of interest as well.

Mr. Regula asked Drs. Duke and Fleming if there was a communications network within community health centers. Dr. Duke replied that HRSA is building an integrated health system, and Mr. Allen replied that $500 million of the FY 2003 request is for communications improvements.

Mr. Regula inquired whether or not we are better prepared today than before September 11. Mr. Allen replied that we are absolutely better prepared, but room for improvement still exists.

Mr. Regula asked about the availability of push-packs. Dr. Fleming replied they are indeed available and that the CDC can get a push-pack to anywhere in the country within 5 hours.

Mr. Wicker:

Mr. Wicker asked if agencies are using bioterrorism as a means to increase their budgets. Mr. Allen replied that much of the money will go to improve our public health system. Specifically, the money will be used to serve basic public health infrastructure. Furthermore he stated the bioterrorism improvements cannot be realized until there is a better public health infrastructure.

Mr. Wicker asked what specific bioterrorism acts for which DHHS have contingency plans. Dr. Fauci explained that smallpox is a substantial threat. There is a major effort to dilute smallpox vaccinations so that by the end of this calendar year, there will be enough smallpox vaccines for every individual in the United States.

Mr. Sherwood:

Mr. Sherwood inquired about the vaccine donated by Adventis Pasteur. Mr. Allen explained that this is a 50-year-old vaccine, and it would only be used in an emergency situation. Mr. Allen further replied that he would supply a further response for the record.

Mr. Sherwood asked that since we are concentrated on bioterrorism efforts, will we be able to make some headway on issues that are not bioterroism related. Dr. Fleming stated that we are trying to increase linkages between the public health system and the health care delivery system.

Mr. Miller:

Mr. Miller asked if the Government is doing a better job of keeping track of bioterrorism agents. Mr. Allen replied that CDC is required to regulate the transfer of specific agents. Mr. Fleming stated that there is more that can be done in tracking, and that many agents are naturally occurring which makes them difficult to regulate.

Mr. Miller asked how the $521 million request for construction will be used by NIH and whether it is a one-time expense. Dr. Fauci stated that these funds will be used for a BSL 4 facility in Montana, a BSL 3/4 facility at Fort Detrick, regional centers of excellence that will have BSL 3/4 capabilities, and for training of researchers. Dr. Fauci further stated that there would be a one time expense for the building itself and that some funds would be freed up after construction is done. However, in the out years these monies would be used for the continuing costs for training and research.

Mrs. Pelosi:

Mrs. Pelosi asked about smallpox vaccine side effects and if research is being done on a dead smallpox vaccine. Dr. Fauci explained that a dead smallpox vaccine is the third generation of smallpox vaccine development and an integral part of the intermediate to long-term NIH bioterrorism strategic plan.

Mrs. Pelosi asked how DHHS is collaborating with the U.S. Department of Education to protect children. Dr. Allen stated that $10 million is going to communities to protect children and DHHS is heavily collaborating with the U.S. Department of Education on this effort.

Mr. Cunningham:

Mr. Cunningham inquired about research on the effects of the anthrax vaccine on military personnel, especially women who may become pregnant. Mr. Allen explained that human subjects= protection is of upmost importance to DHHS. He explained that DHHS works very closely with U.S. Department of Defense on this effort. Dr. Fauci further emphasized that anthrax vaccine research is being conducted to make sure it is not only effective, but also improved in toxicity and safety. Dr. Fleming added that CDC has requested and received monies for relevant studies and that they are already underway.

Ms. Lowey:

Ms. Lowey expressed her concerns about hospital preparedness. Dr. Duke replied that there is a lot more that needs to be done for hospital preparedness, but that this area is one of HRSA=s top priorities in FY 2003.

Mr. Istook:

Mr. Istook asked about the possibility of making the smallpox vaccine available to the general public on a voluntary basis. He also expressed concern about the ability of ring vaccination to contain an outbreak. Mr. Allen replied that we need to make sure enough vaccines are available to everyone in the United States before it will be allowed on a voluntary basis. He explained that there are complications due to international issues and the globalization of the United States in widespread vaccination. Dr. Fleming explained that ring vaccinations were successful in containing smallpox in Europe. He stated however, that more research is being done to determine more effective methods for controlling an outbreak.

Prepared by Rosalind Gray, OD/OLPA, May 13, 2002