The American Society for Microbiology (ASM), the largest single life science organization in the world, comprised of more than 42,000 members, appreciates the opportunity to provide written testimony on the Fiscal Year (FY) 1999 budget for the research programs of the Food and Drug Administration (FDA).
The ASM represents scientists working in academic, governmental and industrial institutions worldwide. Microbiologists are involved in research to improve human health and the environment. Microbiological research is directly related to agriculture involving foodborne diseases, new and emerging plant and animal diseases, soil erosion and soil biology, agricultural biotechnology, and the development of new agricultural products and processes. The ASM's mission is to enhance the science of microbiology, to gain a better understanding of basic life processes, and to promote the application of this knowledge for improved health, and for economic and environmental well being.
The FDA is a science based government agency and FDA research is an important component of the nation's overall biomedical research program. Every FDA decision which influences public health must be based on the highest quality, most current science. Scientists within the FDA are required to provide rapid evaluations and ensure the safety of new products submitted to the Agency before release to the public. Research supported by the FDA in the Center for Biologics Evaluation and Research (CBER) contributes to the knowledge base that results in new product development by industry and helps to improve the quality of life for the nation.
CBER's intramural research provides timely, objective evaluations of new, high technology products. The Science Board Subcommittee on Research, a panel of outside reviewers drawn from academia, industry and government, recently affirmed the need for FDA's intramural research program. This program enables FDA to recruit and retain high caliber, cutting edge scientists capable of conducting original scientific experiments not being duplicated elsewhere.
The development of the Hemophilus influenzae type B vaccine, which has almost eradicated an important cause of childhood meningitis, mental retardation, and death is an example of CBER's unique scientific environment which contributed to the development of the breakthrough polysaccharide conjugate technology on which this and other lifesaving vaccines are based. This vaccine is estimated to save the United States between $150-$400 million per year in health care costs, well in excess of the FDA's research budget.
The ASM is concerned that the level of funding for FDA's CBER research activities essential to the Agency's mission has been in serious decline and has eroded the science base at the FDA. In order to protect and enhance the public health through regulation of biological and related products such as blood, vaccines and other biological therapeutics, CBER requires adequate scientific resources. During the past three years, the Center's research budget has been cut in half. In FY 1995, CBER had $14.5 million available for research. In FY 1998, the sum available is estimated to be $6.9 million. Additionally, during the next two years about one third of CBER's research positions will be cut. The ASM recommends that CBER's budget for research be restored to at least the FY 1995 level of $37 million in FY 1999.
FDA - Food Safety Initiative
The ASM supports the Administration's request of a $50 million increase for FDA to implement the agency's role in the President's Food Safety Initiative, including $25 million to ensure the safety of imported fruits and vegetables. These additional resources will help establish a new national early warning system to detect outbreaks of foodborne illnesses by enhancing microbiological monitoring and surveillance activities related to pathogen reduction. The FDA has also been charged with creating a federal emergency response system which will improve existing channels of communication between the Federal agencies responsible for investigating foodborne illnesses. Additional funds will be targeted at implementing the seafood HACCP (Hazard Analysis Critical Control Points) regulations and expanding the HACCP principles to non-seafood establishments, retail food service operations and to slaughter of animals used for human consumption. Food safety educational activities and materials will be developed and disseminated to consumers and to food service employees to communicate the need for appropriate food safety behaviors. The agency will also improve microbial risk assessment methods to facilitate the development of more effective risk reduction strategies and regulations focused on specific hazards. Funds will also be devoted to more applied research targeted at improving the nation's ability to detect foodborne pathogens rapidly and accurately from farm to table.
FDA - Antibiotic Resistance
The ASM supports additional resources for the FDA's Center for Veterinary Medicine to enhance oversight of antibiotic supplemented animal feeds. Investigation and surveillance of animal feeds suspected to cause antibiotic resistant bacteria of consequence to human health is necessary. Increased resources will enhance the surveillance of antibiotic resistance in bacteria associated with food and animals that impact human health through drugs and other therapies used in food animal populations.
Thank you for the opportunity to provide testimony on the FDA research programs. The ASM hopes that its recommendations will be useful to the Subcommittee. We would be pleased to respond to any questions.