The American Society for Microbiology (ASM) wishes to submit the following recommendations for increased funding for the critical public health programs of the Food and Drug Administration (FDA). Included in the FDA's jurisdiction are public health areas of concern to the ASM: microbially contaminated food products, drug treatments for infectious diseases, clinical laboratory test standards, expanding antibiotic resistance, and global trade as it affects public health. The responsibilities of the FDA have rapidly expanded and as a result, there is an urgent need for more resources.
The FDA is responsible for both scientific evaluation and regulatory enforcement, and must respond to a daunting array of challenges quickly and carefully, while maintaining the public's trust in its ability to do so. To protect public health, the agency oversees the safety of both new and on-the-market products by performing and collaborating in a diverse spectrum of research. The results of such research directly improves product safety, quality and effectiveness. This research also facilitates product development in areas of new and emerging technology. In addition, the FDAcommunicates to the public and other agencies the best information available on safe use of products. The FDA is part of each American's life, every day through its assessment of medical and food products as well as consumer goods and the FDA is expected to be a highly competent, independent gatekeeper of public safety. The ASM urges Congress to recognize the essential nature of this responsibility and the high standards with which the FDA responds to its challenges.
Science at FDA
The ASM strongly supports a budget increase to improve the FDA's scientific base. Increasing numbers of products are being presented to the agency to ensure their safety and effectiveness prior to marketing, challenging it to recruit and retain high-quality personnel to undertake rigorous, science-based evaluation. New resources will be needed to safeguard fully the American public, through well-informed decision-making based on leading-edge scientific knowledge. In this century, accelerated changes in science and technology will complicate further the approval processes overseen by the agency. This will press the FDA to stay not only current, but at the forefront, in fast-moving scientific specialties. Good science is the foundation of good regulatory decisions. With U.S. research funding expanding, it is clear that, if the FDA is to maintain its role as a trusted guardian of public health, science at the agency must receive additional support from Congress and the Administration.
Not only will scientific information become more complex, but related social and economic issues will further expand and complicate FDA's responsibilities. Last year's announcement of the successful mapping of the human genome epitomizes the FDA's expanding challenge. Experts predict that there will be gene-based drugs to treat diseases such as diabetes and hypertension, as well as cancer therapies tailor-made against each tumor's own genetic profile. Genetic science will result in potential benefits, problems, and products heretofore unknown. The swirling ethical controversy also underscores the importance of the FDA's tradition of educating the American public about new products as well as monitoring the safety and effectiveness of new products after they are approved. At present, there are hundreds of genetic tests in development in the United States, but thus far fewer than a dozen have been submitted to and approved by the FDA. It is important that the FDA be given sufficient resources to make possible timely and fair evaluation of the expected flood of gene-based products and procedures. In addition, the FDA needs to be able to take full advantage of the new fields of toxicogenomics and pharmacogenetics to better predict drug toxicity and responsiveness to therapies, respectively.
Vigilance by FDA and other public health agencies has significantly improved the safety of the nation's food supply over the past several years. During 1996-1999, there was a 20 percent decrease in illness due to the nine most common food pathogens. Multi-agency program efforts such as the Food Safety Initiative and the current fight against importation of meat products contaminated with the mad cow disease pathogen, have contributed to such victories. But the rising percentage of food prepared outside the home and the global nature of our food supply - along with new emerging infectious diseases and antibiotic resistant pathogens - are creating a more demanding environment for food safety. Each year, an estimated 76 million Americans get sick, more than 300,000 are hospitalized, and 5,000 die as a result of foodborne illnesses. As a result, medical expenses and lost productivity annually cost an estimated $8 billion. The FDA carries a large share of the federal responsibility to protect even more Americans from foodborne illnesses.
FDA personnel consistently respond to changing needs, while maintaining the high standards of scientific excellence necessary in peer-review of products submitted for FDA approval. This year, the FDA plans to increase the percentage of high-risk domestic food establishments inspected once every year to 100 percent. Within the past year, the FDA approved irradiation for shell eggs and for sprout seeds and approved use of UV radiation for apple juice, both as a result of an expedited review process now in place for new technologies. The FDA, in cooperation with the Centers for Disease Control and Prevention, is working to reduce by 50 percent cases of illness due to Salmonella in eggs by 2005, and eliminating them by 2010. This January the FDA directed fruit and vegetable juice processors to begin operating under Hazard Analysis and Critical Control Point (HACCP) principles during production. HACCP requires a science-based analysis of potential hazards in all steps of processing and implementing control or corrective measures as needed. The rule responds to foodborne illness outbreaks associated with fruit products over the past several years, like those caused by E. coli and Salmonella bacteria. The FDA estimates there are between 16,000 and 48,000 cases of juice-related illnesses each year. The new HACCP rule is expected to prevent at least 6,000 cases.
New challenges to food safety include situations previously unknown, such as bioengineered foods and antibiotic resistance. Over 50 bioengineered foods are now marketed in this country, and many more are expected. Collaborative federal oversight of these foods includes FDA evaluation of safety and nutritional aspects of each food product. Recently, the agency issued a proposed rule to make mandatory the now-voluntary process of consulting with FDA scientists by bioengineered-food marketers. The FDA also assesses the safety of antimicrobial drugs used in food-producing animals primarily as growth promotors, a practice suspected as one cause of the alarming rise of antibiotic resistance among microbial pathogens. Since 1996 the FDA, CDC and USDA have collaborated on the National Antimicrobial Resistance Monitoring System, which includes monitoring health-care acquired resistant infections in 300 hospitals in 15 states. Inappropriate use of antimicrobials by health care providers also contributes to the problem. This January, the partner agencies released their final action plan to combat antimicrobial resistance. The FDA needs a significant increase in funding in order to implement the recommendations of this final action plan. Within that plan, the FDA will help develop systems to monitor patterns of antimicrobial drug use in human medicine, in agriculture, and in consumer products.
As protector of the American consumer, the FDA oversees the efficacy and safety of new health care products and procedures, as well as on-going review of those already approved. Strains placed on the U.S. health care system by growing costs and patient numbers also affect those working to regulate health care. Each year the FDA reviews more than 350,000 reports of suspected product adverse reactions, each of which has to be investigated, analyzed and acted upon in a timely manner. An estimated 44,000 to 98,000 Americans die each year from preventable medical errors, at a cost as much as $29 billion. The FDA has established a Patient Safety Task Force with the goal of reducing medical errors by fifty percent over 5 years, through better data collection, coordinated analysis efforts, and collaboration with health care providers to include an easy-to-use confidential reporting system.
During the past year, the agency's three medical product centers reviewed more than 17,100 marketing applications for drug, biologic, and device products. About 16,600 were approved, 160 of which were new types of medications or medical devices indicative of leading-edge medical research. Among them were the first drug approved from a new class of antibiotics designed to treat vancomycin-resistant bacterial infections and the first drug approved in a new class of anti-fungal agents for patients unresponsive to traditional therapy. Also approved was a pneumococcal vaccine for infants and toddlers that will help combat blood infection found in about 35,000 U.S. youngsters each year and meningitis diagnosed in about 17,500 annually. A new diphtheria-tetanus-pertussis vaccine will lessen children's exposure to mercury by reducing or eliminating particular preservatives through different production methods. Yet much remains undone due to resource shortages, including personnel needed to review products and inspect facilities, that must be remedied by increased funding. For example, each year the FDA is able to inspect only 28 percent of drug-manufacturer facilities, and only 16 percent of high-risk medical device facilities.Efficient and accurate science-based expert review of products and facilities is likely to result in appropriate reactions to product safety and effectiveness. Thus, competence in basic and clinical science creates a balanced environment that is both protective of public health, yet understanding of the product development process and the data truly needed to assure that safe and effective products become available to patients in a timely manner.
Last year, the FDA also assumed a responsibility formerly held by the CDC: to categorize commercially marketed diagnostic tests as part of a process established by the 1988 Clinical Laboratory Improvement Amendments (CLIA). Designed to create quality standards for all laboratory testing, the categorization component of the CLIA will be done by the FDA's Center for Devices and Radiological Health. Tests are grouped based on their potential risk if misused. Support for a strong science base will enable FDA to understand the complexity of tests and ensure the accuracy of test results so that tests can be properly categorized.
Globalization clearly will stress and strain resources at the FDA. International trade in foodstuffs, pharmaceuticals, and medical devices expands the already impressive breadth of FDA responsibilities. This can create serious challenges to federal agencies charged with protecting human health. Dramatic headline examples include the struggles against importation of animals or animal products contaminated with mad cow disease (BSE, or bovine spongiform encephalopathy). Since 1986, there have been more than 176,000 cases of BSE confirmed in cattle in Great Britain. Health officials now believe that the fatal disease is transmitted to humans through ingestion of contaminated beef-containing products. To date, it has not been detected in cattle in the United States, but the FDA is on high-alert against that possibility. If an outbreak did occur here, economic losses in U.S. beef industries are expected to exceed $15 billion. Slaughtered infected cattle may be incorporated into animal feeds, a common mode of spread for BSE, and the FDA needs to be vigilant in stopping shipments of contaminated products from Europe. The agency and state officials intend to inspect an estimated 9,500 feed mills to enforce the ban on feeding animal proteins in this country. Other FDA-oversight products like drugs, vaccines, dietary supplements and cosmetics also contain beef-derived substances, further complicating the inspection process.
Responding to international trade in therapeutics, the FDA has formulated more than 50 drug production guidances agreed upon with the European Union, Canada and Japan. Countries also have agreed upon electronic formats to speed regulatory processes and communications among national agencies and production companies, as well as accepted an international terminology to expedite transfer of safety data around the globe. Recent attendees at the International Conference on Harmonization reached agreement on methods to standardize the format of product marketing applications. The FDA has been a leader in international harmonization related to food and product safety, but coming years will create greater challenges as trade relationships evolve. The globalization of product development, testing, and trade is one of the very compelling reasons to maintain a strong FDA through sufficient funding.
Finally, in the interest of national security, resources are required for FDA to ensure the development and licensure of new vaccines, for smallpox, anthrax and other biological agents that might be weaponized for use in a biological attack against American citizens. It will be critical to have Congress' support for the development and approval of vaccines, diagnostics, therapeutics and anti-toxins necessary for response to certain biological or chemical agents. FDA has been working in conjunction with CDC, NIH, DOD, academia and private industry to move this effort forward. Additional resources will enable FDA's momentum on counter bioterrorism to continue.
This new century will present the FDA with new challenges - as science and technology change even more rapidly, consumers expect even more protection, and global trade and production further strain agency resources. There always will be hundreds of new products and processes awaiting FDA approval, some of which will transform public health. Emerging infectious diseases, the threat of bioterrorism, antibiotic resistance among microbial pathogens, and controversies around issues such as genetic medicine and human experimentation will redefine the FDA's day-to-day activities. No matter what changes occur, however, solid science must continue to be the basis of whatever the FDA does to ensure America's public health. The ASM urges Congress to recognize the importance of the FDA in so many areas of consumer protection. The high level of public trust in the FDA is the result of sustained Congressional support in recent years. To remain so vigilant, the FDA must be expanded and strengthened as regulatory challenges themselves expand and change.