The American Society for Microbiology (ASM), the largest single life science society with a membership of over 43,000, appreciates the opportunity to submit testimony in support of the FY 2005 budget for the Food and Drug Administration (FDA). The FDA serves as the science-based protector of public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the food supply, consumer products and by responding to new challenges of bioterrorism and food defense. The FDA also advances health care by taking steps to improve and ensure new medical product development based on biomedical research. It is critical that FDA maintain the highest level of public trust in all of its activities and increased funding is vital to its success and its critical mission initiatives.
The ASM supports the Administration’s FY 2005 budget request of $1.8 billion which represents an 8.8 percent increase over the FY 2004 funding level. This increase will enhance security of the nation’s domestic and imported food supply and support stronger FDA review of medical devices, better protection against bovine spongiform encephalopathy (BSE), and more efficient work output through further consolidation of FDA facilities. The increase recognizes the important activities of the FDA in improving patient and consumer safety and responding to new challenges of bioterrorism and food defense. The FDA is a principal partner in inter-agency homeland security strategies.
Science-based decision making and a well-trained workforce make the FDA an effective and reliable guardian of public health. As the U.S. population grows and threats to public safety persist, demands on the FDA are multiplying in number and complexity. Changes in global trade and international politics affect the FDA mission as well. Last year for instance, the FDA conducted nearly 80,000 imported food examinations, up from 12,000 in 2001. The agency must remain highly responsive both to on-going consumer needs and to unexpected emergency situations. In 2003 the FDA activated its Emergency Operations Center to respond to the first reported U.S. case of BSE and to participate in a two-city, full-scale counterterrorism exercise of a simulated detonation of a nuclear device and the release of the pneumonic plague pathogen.
Food Defense and National Security
Over the past three years, the FDA has worked to improve food security by adding more inspections of imported food, trained investigators, and port of entry security measures. Protecting the food consumed by over 290 million Americans demands major effort from the FDA and its staff. The agency directly oversees the safety of about 80 percent of the nation’s food supply and assists the U.S. Department of Agriculture (USDA) on the remainder. Nearly half of the proposed $149 million budget increase, an amount of $65 million, would further broaden the FDA’s capabilities to guarantee and defend the national food supply to an FY 2005 total of $181 million.
This allocation would support the key food defense strategies already being implemented by the agency: increase food security awareness among public and private stakeholders; develop advanced capacities to identify specific threats or attacks on the food supply; design additional protection to shield the food supply from terrorist attack; fine-tune rapid coordinated response capability in the event of a foodborne terrorist attack; and enhance the capacity for a quick recovery if such an attack did harm any residents of the United States.
Of the proposed $65 million increase, $35 million would establish a joint FDA-USDA network of qualified investigative laboratories, the Food Emergency Response Network (FERN). Throughout its long history, the FDA has optimized consumer protection by collaborating with states, other federal agencies, law enforcement, industry, academic institutions and others in the areas of research, information exchange, and emergency responses. The FERN program will continue this tradition by creating a nationwide network of federal and state laboratories capable of testing thousands of food samples for biological, chemical, and radiological threat agents. It will add 15 FDA-funded state laboratories to the 10 labs planned for FY 2004, all to possess advanced instrumentation and pathogen containment capabilities. The program also incorporates FDA research on new testing methods that could shorten the time needed to detect foodborne threats. The FDA will expand to 104 the number of state health and agricultural laboratories connected through its electronic network, eLEXNET, to facilitate exchange of lab data critical in first-alert situations.
Basic research underlies every application applied by the FDA in its search for possible foodborne health hazards. Within the FY 2005 increase, $15 million would fund intramural and extramural research on methods development, characteristics of specific foodborne pathogens, and new prevention technologies to improve food safety – results subsequently would help shape new guidelines and performance standards for the food production industry. Better understanding of how pathogens survive in foods during processing and storage and of the doses of pathogens needed to cause disease will provide superior prevention protocols. FDA funded research also discovers new microbiological, chemical, and radiological methods to detect and identify biothreats found in food.
Surveillance constitutes a large part of the FDA’s protection of the food supply. In FY 2005, the FDA intends to conduct nearly 26,000 inspections of domestic food production firms, almost 11 times the investigations done in FY 2001. FDA inspectors also will perform 97,000 import-food field inspections, more than 60 percent over last year and seven times the number in FY 2001. The $7 million within the proposed FY 2005 increase earmarked for increased food inspections would help alleviate the burgeoning potential of contaminated food imports, though many thousands of imported food shipments would remain left unchecked. The FDA will soon implement its component of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which among other measures will require the registration of food facilities and advance notice of food imports. In the FY 2005 food defense increase, the FDA also would receive $5 million for its role in the new interagency Biosurveillance Initiative developed to improve the federal government’s capability to rapidly identify and characterize bioterrorist attacks. When in place, the Biosurveillance Initiative will shorten the time needed to alert the nation to such an attack. Towards this goal, the FDA will coordinate existing state and federal food surveillance networks to facilitate communications on outbreaks and other events related to foodborne illness. The remaining $3 million of the proposed funding increases for food defense would upgrade the FDA’s intra-agency communication system used by personnel during emergencies.
Contamination of the food supply not only threatens public health; the economic and political ramifications are enormous, as evidenced by costly export embargoes recently triggered by fear of BSE in meat products. More than 30 countries have banned the import of American beef, in response to last December’s discovery of an imported BSE-infected dairy cow. The federal government just announced that up to 300,000 U.S. cattle may be tested for BSE each year, which would require some new, FDA-approved rapid screening test to succeed. The President’s budget includes more than $8 million to fund new FDA safeguards against BSE. This would increase FDA’s funding to stop BSE to $30 million in FY 2005.
Most of the $8 million will be used for field activities under the FDA’s Animal Drugs and Feeds program, including an additional 920 risk-based inspections, 600 targeted sample collections/analyses, and at least 2,500 state inspections of animal feed firms. Animal feed contaminated with the BSE agent is the only known route of BSE transmission. As the agency responsible for animal feeds used in food production, this year the FDA will inspect 100 percent of feed mills and renderers. The FDA’s more aggressive approach to BSE also will involve evaluating new commercial BSE screening tests like polymerase chain reaction techniques and educating even more food producers on new and updated regulations. In January, the FDA announced additional, more-rigid safeguards to prevent potentially BSE-contaminated animal parts from entering either the food supply or health care products.
Medical Products and Public Safety
The ASM supports the Administration’s proposed FY 2005 funding levels for FDA regulation of medical-use products, including medical devices, human drugs, and biologics such as vaccines and gene therapies. The budget includes $252 million for the Medical Devices program, a $26 million increase over FY 2004. The program plans to more rapidly review new products, while increasing the number of products reviewed in a time period. The Human Drugs program would receive $499 million, an increase of $23 million, and the Biologics program, $173 million, or $4 million more than last fiscal year. All medical products are evaluated by the FDA for safety and efficacy before entering the U.S. marketplace. In FY 2003, the FDA approved 466 new and generic drugs and biological products, following extensive science-based evaluations. Agency personnel also monitor the 10,000 drugs already on the market. FDA oversight of these products has both public health and national security significance, under the goal of more quickly reviewing new products and making them available to the nation’s health care systems and defense agencies and to the public.
FDA is the only government agency involved with the approval of products necessary to prevent or treat human exposure to terrorist agents. Given the unpredictability of emergencies, the FDA must be able to respond to product needs at any point along the product production pipeline. The Administration has included $5 million in the FY 2005 budget proposal to support the FDA’s role in Project Bioshield, an inter-agency initiative to ensure medical readiness in the event of war or a catastrophic event. The FDA’s role in Project Bioshield is the expedited review of specialized products and medical countermeasures for at-risk populations, such as the military, first responders, those near nuclear facilities, and others. FDA plans collaboration with the CDC on plague in African countries, and with the National Institute of Allergy and Infectious Diseases on studies to determine the lowest effective antibiotic dose to treat pneumonic plague. Like the other federal agencies involved in Project Bioshield, the FDA must be able to respond quickly and correctly to emergencies, using its best science-based capabilities.
The ASM recommends continuing commitment and support by Congress for the important public health protection work of FDA. Increased funding will help enable FDA to perform its responsibilities to ensure access to safe and effective medical countermeasures against potential biological, chemical or radiological terrorism, consumer product safety, food safety, accurate product information and safe and effective drug and device evaluations. Additional funding will help to ensure that FDA can develop and maintain a highly skilled scientific workforce and that science based decision-making continues to be strong at all of FDA’s research centers.