Food and Drug Administration - FY 2001 Testimony

The Food and Drug Administration (FDA) plays an essential role in protecting the nation's health. The Agency enters the 21st century with rapidly expanding responsibilities and an urgent need for more resources. The American Society for Microbiology (ASM), which represents over 42,000 members, believes the Administration's proposed FDA budget for FY 2001 is a good first step toward providing increased support for the critical public health activities of the FDA. The nearly $1.4 billion budget requested for FDA by the Administration represents an increase of 13 percent, or $176 million over the FY 2000 enacted level.

Providing an adequate budget for the FDA is essential because the nation's burgeoning medical and food research efforts will result in steadily increased numbers of products before the FDA for review. This review must be based on solid, state-of-the-art science, which requires financial resources and trained personnel. The FY 2001 budget request recognizes the importance of FDA's traditional dual roles: that of ensuring the highest level of safety for already marketed products, and that of ensuring in a timely fashion the release of new products that benefit the American public.

FDA research should be recognized as an important component of the nation's overall biomedical research program and should receive increased attention and funding. Every FDA decision which influences public health must be based on current, highest quality research.

With its focus on the microbiological sciences, the ASM fully appreciates the complexity and critical nature of the FDA's efforts to manage health risks to humans and animals, to develop new scientific research within the Agency itself, and to interact effectively with the public, industry and academia alike. Several specific areas of the FDA mission are of particular interest to the ASM membership and demonstrate the need for additional resources: FDA research in the Center for Biologics Evaluation and Research (CBER) which enables FDA to respond to scientific and technological advances, vaccine safety, blood safety, gene therapy safety and diagnostics related to infectious diseases; FDA capacity to respond to food safety involving foodborne pathogens and antibiotic resistance acquired by pathogenic microorganisms and to reduce the number of deaths from medical errors; and FDA participation in U.S. bioterrorism preparedness to ensure an adequate program in this country.

FDA Research

The ASM strongly supports budgetary increases to improve FDA's science base. The FDA must be given the resources to keep pace with accelerating technology and to take advantage of scientific opportunities to best serve the American public.

Basic research by the FDA's Center for Biologics Evaluation and Research contributes to the Agency's ability to respond to escalating product market in a timely and knowledgeable manner. The ASM recommends adoption of the Adminstration's FY 2001 budget request for increased support of CBER and its research efforts, at a time when the demands on the FDA's expertise are growing rapidly.

To ensure the fruits of the nation's biomedical research successes, the FDA will face complex, often unexpected, demands in this new century, as both science and public needs change and change again over time. We can predict challenges, such as continued safety of our blood supply and enlarging stockpiles of vaccines to counter potential bioterrorism. Others, such as still unknown microbial pathogens and expanding antibiotic resistance, can only be anticipated. Not only must the FDA have at hand the latest in known technology, it must consistently develop innovative ways to eliminate future threats to public health and remain able to adapt rapidly to ever new challenges.

In the past 20 years, expenditures in drug research have increased seven-fold, resulting in more and more potential products in need of science-based evaluation by the FDA. Although the FDA is not a basic research agency, it must be able to respond to constant changes in both its consumer constituency and the challenges it faces daily. Thus research is an important component of its broad based mission. In the face of a rapidly shifting research environment, the FDA, like all research agencies, must stay at the forefront of scientific knowledge, through both the efforts of its own scientists and the communication with others involved in safeguarding public safety. It must be able to recruit and retain high quality personnel capable of adapting to consumers' concerns, changes in the marketplace, the varied threats to public health, and new processing practices by the growing numbers of product producers. This enormous task mandates strong fiscal support from the Congress, sustained over time and into the future.

Food Safety and Antibiotic Resistance

The ASM commends the Congress' and the Administration's support in recent years of the national Food Safety Initiative, a collaborative program of the FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture. The $30 million requested by the Administration for this important initiative in FY 2001 will support program goals already underway, including expansion of domestic food inspection, development of nationwide standards for on-farm and in-plant preventive controls, further research on molecular methods to rapidly identify foodborne pathogens, and completion of the National Antimicrobial Resistance Monitoring System.

The Food Safety Initiative is just one example of science-based success in the past year. In addition to the National Antimicrobial Resistance Monitoring System, two other national systems to assure food safety are now in place: FoodNet, a foodborne disease tracking system, and PulseNet, a computerized database of bacterial DNA subtypes to help determine whether scattered disease outbreaks are due to a common food source. The FDA recently developed a method to detect as many as 13 foodborne pathogens in one suspected food sample. Several outbreaks of foodborne illness were shortened in the past year, in part through the efforts of the FDA and its partners in food safety.

Food production and consumption patterns have changed considerably in recent decades. New foodborne pathogens, more meals prepared and eaten away from the home, more complicated food processing methods multiply the possibilities of contamination. Some foodborne pathogens have become far more deadly in recent years, such as pathogenic E. coli and antibiotic resistant Salmonella. The local food market is now part of a global grocery store, a system of imported and exported foods that must be regulated by the FDA. And the populations most vulnerable to foodborne diseases, such as children and the elderly, have increased to account for as much as 25 percent of the U.S. population further complicating the FDA's mission as protector of public health.

Medical Errors

As the nation's population ages and becomes more diverse, the health care system becomes more stressed, more susceptible to human and technological errors. This has been and continues to be a major area of concern to the FDA, as the federal agency charged with product safety. A recent study by the Institute of Medicine estimated that nearly 100,000 Americans may be dying each year as a result of preventable medical errors. Part of this disturbing situation can be attributed to human error, part to an exploding array of drugs, medical devices, blood and other biological products used in health care settings.

The $12.8 million requested to respond to preventable medical mistakes will help assure the safety of vaccines, therapeutic agents, blood products, medical devices and other tools used by the U.S. health care industry -- an important step toward minimizing the number of deaths.

Bioterrorism

Unfortunately, the threat of a biological attack against American citizens must be taken seriously, and U.S. preparedness for an emergency response is essential. There is need to ensure expeditious development and licensure of new vaccines for smallpox, anthrax and other biological agents that might be weaponized. The ASM recommends that Congress provide the requested $11.5 million to FDA to help counter bioterrorism and work, in collaboration with NIH, CDC, DOD, academia and private industry, to ensure the development of vaccines, diagnostics and therapeutics to be used in response to selected biological and chemical agents. The FDA needs resources to expeditiously review and approve new drugs, therapeutics, vaccines and anti-toxins against biological warfare agents in the interest of national security and public health.

Conclusion

Through its many and diverse responsibilities, the FDA provides the United States with not only an improved national health but a collective peace of mind. Much of its work is never recognized, as the FDA often works behind the scenes to benefit the American public. The Agency provides tangible results such as prevention of foodborne disease through systematic monitoring of production facilities and screening of the blood supply. FDA approval of the Hemophilus influenzae type B vaccine will save the United States an estimated $150 to $400 million annually in health care costs. The FDA is also targeting as a principal concern medical errors, which are estimated to cost as much as $80 billion a year. FDA researchers contribute as well to the scientific knowledge base, thus enhancing new product development by industry and public research organizations, and helping the United States remain a world leader in new product development.

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