The American Society for Microbiology (ASM) is pleased to submit the following testimony on the Fiscal Year (FY) 2010 appropriation for the Food and Drug Administration (FDA) research and regulatory programs. The ASM is the largest single life science organization in the world with about 42,000 members. The ASM mission is to enhance the science of microbiology, to gain a better understanding of life processes, and to promote the application of this knowledge for improved health and environmental well-being. The ASM recommends an appropriation of $2.25 billion for the FDA in FY 2010, a $386 million increase over the FY 2009 budget.
The FDA is responsible for the evaluation of domestic and foreign foods and consumer products to protect the public health and safety. Funding levels for sometime have significantly fallen below amounts needed to enable the FDA to fulfill its growing oversight for nearly one-quarter of the US Gross National Product. The ASM appreciates the estimated $1 billion for food safety anticipated in the President’s proposed FY 2010 budget. However, serious budget shortfalls in the past have diluted FDA’s ability to respond to escalating, often unmet demands on its personnel and resources not only in food safety, but also across the agency. Each year, the nation spends nearly $1.5 trillion on FDA regulated goods. It is essential that FDA have state-of-the-art scientific capabilities and a fully staffed contingent of scientists if the United States is to maintain its economic competitiveness. FDA’s mission is not only to ensure product safety but to also stimulate and facilitate innovation.
Since January, the FDA has approved new drugs for diabetes and malaria, a rapid diagnostic test to detect the avian influenza H5N1 virus in minutes rather than hours, and the first approved drug made with materials from genetically engineered animals. Threats to public health persist, including sporadic food borne illnesses linked to everyday foods like tomatoes, peanuts, and recently, alfalfa sprouts. FDA’s regulatory responsibilities cover the bulk of US domestic and imported foods, plus medical devices, drugs, food additives, blood and vaccine products, and cosmetics. Since 2001, its mission has also expanded to counterterrorism and homeland security. Several external reviews of FDA performance have confirmed in recent years that inadequate funding for the agency has undermined efforts to protect public health in the United States.
A Safe and Secure US Food Supply Depends on FDA Excellence
Regulating food in the United States is an enormous task. Food expenditures exceed $1.1 trillion annually. In the past five years, the volume of imported products has doubled, with 60 percent categorized as food or food-related products, and is predicted to triple by 2015. Yet the FDA examined less than 1 percent of the 7.6 million fresh produce lines imported from fiscal years 2002 to 2007. This year, the nation will import agricultural products worth an estimated $81 billion, continuing the steady trend of rising US consumption of imported food. The number of identified food borne disease outbreaks has tripled since the early 1990s. Each year, about 76 million people contract a food borne illness in the United States, about 325,000 require hospitalization, and about 5,000 die. The US Department of Agriculture (USDA) estimates medical costs and lost wages associated with just five of the major food borne illnesses reach $6.9 billion annually, and total costs are likely much higher. The Centers for Disease Control and Prevention (CDC) has enumerated more than 250 different food borne diseases and more causative agents continue to be found. FDA actions thus far this year have included the current recall of Salmonella-contaminated pistachio products; a consumer warning about certain cheeses that could contain Listeria monocytogenes, bacteria that can cause serious and sometimes fatal infections; and advisories to food preparers about possible norovirus in some domestic oysters.
As food moves from farm to table it encounters innumerable points for possible contamination, either accidental or deliberate. To mitigate failures in our highly complex food supply, the FDA’s ongoing Protecting America’s Food Supply initiative integrates food safety and food defense. In November 2007, the FDA launched its Food Protection Plan with a three-pronged strategy of expanded prevention, improved intervention, and more rapid response to events like disease outbreaks. The FDA also participates in the multiagency Action Plan for Import Safety, publishing in March its final rule on required prior notice of foreign food shipments arriving at US ports. Unfortunately, these and other FDA food safety programs have been consistently underfunded to the detriment of public health.
The following are examples of FDA’s enormous responsibilities:
The FDA regulates about 80 percent of the US food supply, responsible for $417 billion worth of domestic food and $49 billion in imported food annually.
In the United States, the agency oversees more than 136,000 registered domestic food facilities (over 44,000 food manufacturers and processors, plus roughly 113,000 warehouses that include storage tanks and grain elevators).
FDA personnel collaborate with staff at other federal agencies and state and local authorities to regulate more than 2 million farms, 935,000 restaurants and institutional food facilities, and 114,000 supermarkets, grocery stores, and other food outlets.
Over 300 US ports receive products from more than 150 countries/territories. In the last decade, the number of food entry lines has tripled, shipped from approximately 200,000 FDA registered foreign facilities that manufacture, process, pack, or store food consumed in the United States.
In 2008, the CDC concluded that the incidence of the most common food borne illnesses had changed very little in the previous three years, a grim plateau in preventing diseases caused by Salmonella, Escherichia coli and other food borne pathogens. The disturbing report joined other official reports, expert committee reviews, and publicized disease investigations that abundantly demonstrate the importance of improving food safety in the United States. In November 2007, FDA’s own Science Advisory Board published a highly critical report concerning the state of science at FDA and the ability to undertake its massive mission. Last September, the Government Accounting Office (GAO) published its negative review of the FDA’s oversight of domestic and imported fresh produce, citing funding shortages and too few FDA inspectors as contributing factors.
Nationwide outbreaks of food-related illness grab headlines, exact high costs for the food industry, and force health officials to scramble to conduct the scientific detective work and implement preventive strategies to contain the problem. These outbreaks absorb significant FDA resources and personnel, like the far-reaching fallout from Salmonella-contaminated peanut products that is still rippling through the US food industry. Health officials have reported more than 600 cases of disease tied to consumption of the suspect products, leading to the voluntary recall of more than 2,100 products in 17 categories by more than 200 companies, and the list continues to grow. In January, the FDA expanded the recall list to include pet food products that contain peanut paste made by the company, which has declared bankruptcy. The large number of products and brands, magnified by the large quantities of some products, makes this one of the most complex food recalls in US history.
FDA Oversight of Drugs, Vaccines, and Diagnostics Protects US Consumers
Just as FDA’s responsibilities in food safety have increased enormously over the past decade, so has its responsibility in other areas, especially drug safety, including adverse events as well as contamination both from microbial and chemical sources. We share the concerns detailed in the 2006 Report on Drug Safety and the Science Board Report.
The steady release of new therapeutic drugs, vaccines, and diagnostic tests by the US private sector helps protect the nation from infectious and other types of diseases. Several divisions within the FDA focus on evaluating both new and on-the-market products, assuring product safety and efficacy on behalf of health care providers, their patients, and the general public. Limited FDA budgets in recent years have not fully met the massive volume of responsibilities involved in this wide-ranging oversight, which includes detailed science-based lab analyses of new and established products, data assessment of incident reports, guidance statements and product alerts to the public and to health care providers, recall of unsafe products, and more.
Recent shortages of vaccines commonly used against rabies and Haemophilus influenza type b (Hib) have underscored the importance of FDA-approved vaccines regulated by the agency’s Center for Biologics Evaluation and Research (CBER). Before development of Hib conjugate vaccines, about 20,000 US children had Hib infections each year, including 12,000 cases of bacterial meningitis of which about 5 percent died. Since the nation’s Hib immunization program began in the early 1990s, incidence has decreased 99 percent. In developing countries, Hib remains a major cause of respiratory infections in infants and children. Unfortunately, a voluntary recall of Hib vaccine by a US manufacturer in December 2007 resulted in shortages that have since been implicated in small Hib outbreaks in Minnesota and Pennsylvania. In June 2008, a French supplier of rabies vaccine temporarily halted production to upgrade its facilities, prompting US officials to issue alerts regarding priority use of limited vaccine supplies. To maintain adequate immunization coverage, the FDA not only monitors already approved vaccines, but also evaluates the latest vaccine technologies. This March, the agency approved a vaccine to prevent Japanese encephalitis (JE) that was developed using cell culture technology, making it the only JE vaccine available in the United States. Found mainly in Asia, the viral disease affects about 30,000 to 50,000 people each year, resulting in 10,000 to 15,000 deaths. It is rarely seen in the United States, but there have been cases among those traveling to Asia.
FDA scientists who evaluate new products must be able to assess leading-edge product development methodologies. For example, CBER researchers just completed a “proof-of-concept” study of a test using nanotechnology to detect quickly the smallest amount of anthrax toxin. Based on research at the Center for Devices and Radiological Health (CDRH), the FDA approved in March the first DNA test that identifies the two types of human papillomavirus (HPV) responsible for the majority of cervical cancers among US women. HPV is the most common sexually transmitted infection in the United States, causing more than 6 million new cases each year. The Center for Drug Evaluation and Research (CDER) assures that all prescription and over-the-counter drugs are safe and effective, overseeing a regulatory portfolio of many thousands of products. In 2007 alone, CDER approved nearly 80 drugs and biologics, a laborious process that demands singular scientific capabilities.
The FDA also plays a key role in addressing the issue of antimicrobial resistance through its initiatives on monitoring and surveillance of antimicrobial resistance, facilitating the appropriate use of products and tests for infectious diseases, educating the public and health professionals about safe and effective use of antimicrobials, and assuring accurate product labeling.
Science at FDA Needs More Resources, Trained Personnel
The ASM is very concerned about the perceived weaknesses in FDA science and the possible negative impacts on the nation’s health. The 2007 Science Board report conducted a thorough external review of science and technology across the agency. It identified several problem areas within the agency where FDA science was not keeping pace with the private sector, for example, the expertise necessary to evaluate products related to nanotechnology, robotics, systems biology, and especially genomics. The report also indicted inadequate computing capabilities used for surveillance and incident reporting, and a dwindling workforce of those trained in science-based investigation and research. In the 2008 GAO report on FDA’s oversight of fresh produce, the agency acknowledged that it lacks resources for funding crucial extramural or internal research to understand produce contamination by pathogens such as E. coli O157:H7 or Salmonella. The FDA remains the nation’s foremost regulatory agency, but optimal oversight of increasingly complex products and systems requires fully equipped FDA laboratories with leading-edge capabilities. This is of particular concern with regard to tissue based products and screening for adventitious infectious agents.
Research programs within the FDA focus on supporting the agency’s regulatory role with the necessary science and technology tools. Understanding the latest advances in multiple scientific disciplines is essential for FDA regulators, evidenced by the agency’s conclusion last year that meat and milk from clones of cattle, swine and goats are safe to eat, based on years of FDA study and analysis. The Center for Food Safety and Applied Nutrition (CFSAN) conducts food, cosmetic, and color additive safety research to protect the public from illnesses, contaminants, or other threats from consumer goods. Its scientists study the emergence or re-emergence of food borne microbial pathogens and evaluate or develop new lab methods needed to investigate outbreaks. The Office of Regulatory Affairs (ORA) also funds research activities to inform policy and regulation, plus contributing to the nation’s food defense efforts. ORA-supported research includes validation of detection methods for potential bioterrorism agents like Clostridium botulinum neurotoxin. The FDA has identified critical areas of needed research that include rapid test kit development, confirmatory methods, virology, biotechnology, in-vitro testing, and laboratory enhancement. To remedy these technological gaps, increased funding for FDA research is needed. As detailed in the 2007 Science Board Report, the continued underfunding of the Critical Path Initiative to bring FDA science into the 21st Century is a particular problem.
Last year, additional funding in the FY 2009 budget did add more than 1,300 new skilled employees. The second hiring phase, with a target of 1,400 additional staff, is underway, including chemists, microbiologists, and medical officers. However, critical personnel needs still remain, especially in the filed of genomics, information technology, and risk communication. The agency also leverages resources through partnering with other stakeholders, for example, the National Center for Food Safety and Technology, a research consortium whose members investigate new molecular tools to study antimicrobial resistance among pathogens and other emerging food safety issues. In September, the FDA awarded $5.2 million in grants to various state and local agencies to enhance food and feed safety including the first Rapid Response Team cooperative agreements with six US states to create RRT teams able to respond to all food hazard incidents in the farm-to-table continuum. Also included were grants to upgrade chemistry labs to better analyze food samples collected by the FDA or other agencies, part of the ongoing effort to boost the surge capacity of state health department laboratories. However, this level of research funding is woefully inadequate given the cost of this type of research and the unfunded research priorities across the agency.
ASM Recommends a Substantial Increase in FDA Funding
The ASM urges Congress to support the irreplaceable role of the Food and Drug Administration in protecting public health and safety. Repeated cautionary reports have warned of besieged and deteriorating FDA capabilities in the face of soaring imports, new product lines, and issues about drug safety. The ASM recommends $2.25 billion for the FDA appropriation in FY 2010.