Food and Drug Administration - FY 2000 Testimony

The American Society for Microbiology (ASM) appreciates the opportunity to provide written testimony on the Fiscal Year (FY) 2000 budgets for the research and education programs within the Food and Drug Administration (FDA).

The ASM is the largest single life science organization in the world with more than 42,000 members who are scientists and administrators working in academic, governmental and industrial institutions worldwide. ASM members are involved in research on problems related to human health, the environment, agriculture and energy. Microbiological research is directly related to food and agriculture in the areas of 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 mission of ASM is to enhance the science of microbiology to better understand 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 current, highest-quality science. Scientists within the FDA are required to provide rapid evaluations and ensure the safety of new products before they are released to the public.

Research 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 ASM is concerned that funding for CBER research activities essential to FDA'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 four years, the Center's research budget has been cut in half. In FY 1995, CBER had $14.5 million available for research. In FY 1999, the sum available is estimated to be $7.1 million. Additionally, by the end of FY 1999, nearly one third of CBER's research positions will have been eliminated. The ASM recommends that CBER's budget for research be restored to at least the FY 1995 level of $14.5 million in FY 2000.

Food Safety and Antibiotic Resistance

The ASM urges the Congress to agree to the Administration's request of a $30 million increase for FDA to carry out its role in the President's Food Safety Initiative. The Center for Food Safety and Nutrition (CFSAN) is to receive $26 million in additional funding while the Center for Veterinary Medicine (CVM) will receive nearly a $4 million increase.

Within CFSAN, the bulk of the increase will be directed toward inspections, evaluations and compliance efforts. FDA also intends to expand resources for training, education, guidance and partnerships with the states. FDA also intends to develop an integrated food safety network to standardize food safety standards at federal and state levels.

Within the CVM, additional funding will be targeted toward improving foodborne pathogen surveillance, increasing coordination with states, expanding the National Antimicrobial Resistance Monitoring System, and developing import tolerances for veterinary drugs. In addition, CVM also intends to use the increased funding for educational programs on the judicious use of antibiotics, expanded research efforts for identifying and detecting pathogens more quickly, and continued risk assessment activities. The ASM supports these endeavors.

Additional funding for CVM to monitor antibiotic resistance is essential. Drug-resistant infections in humans have been on the rise in recent years. When infections are caused by a resistant pathogen, medical treatment is severely compromised. The ASM urges Congress to support funding for CVM to address this increasingly alarming trend. It is essential that FDA conduct relevant research and that adequate resources are available for appropriately-trained personnel needed to deal with the complex and challenging issue of antibiotic resistance.

Bioterrorism

Unfortunately, the threat of a biological attack against American citizens must be taken seriously, and U.S. preparedness is essential. In the event of an attack, the public health infrastructure will bear the greatest burden, but there is also increased pressure to develop new vaccines for smallpox and anthrax. The ASM encourages the Congress to provide $13.4 million to FDA to create a fast-track approval process for new vaccines and therapeutics for biological and chemical agents that are considered possible weapons.

Although the USDA has not requested funds to address a potential bioterrorist attack, the ASM reminds the Subcommittee that the threat of bioterrorism not only affects people through a direct attack but also indirectly through contamination of water and food supplies. The USDA is one more federal agency that needs to prepare in the event of an intentional release of biological or chemical agents on crops, livestock or water supplies.

Conclusion

ASM recognizes the difficult situation the Congress faces this year regarding caps on discretionary spending levels. We encourage you to give serious consideration to these requests, however, because the investment of federal dollars in the programs indicated above is amply returned. Our citizens' health and security are at stake. ASM thanks the Subcommittee for the opportunity to provide testimony on various programs within FDA and hopes that its recommendations will be useful.

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