The American Society for Microbiology (ASM) is pleased to submit the following statement on the Fiscal Year (FY) 2013 appropriation for the Food and Drug Administration (FDA). The ASM is the largest single life science organization in the world with more than 38,000 members. The ASM strongly supports the leadership role of the FDA in protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, the US food supply, and other consumer and health related products.
The ASM believes that the Administration’s FY 2013 request of $4.5 billion for the FDA, which includes almost $2 billion in current and proposed user fees to be collected from regulated industries, should be increased by Congress because the net increase for the Agency is only $11.5 million. Within the FDA budget, spending initiatives would increase by nearly $40 million, but these are offset by program cuts of almost $30 million and the proposed increase of $11.5 million. The proposed budget will not be adequate to sustain core functions and to fund the FDA’s expanding responsibilities for the $2 trillion in products that it regulates. The FDA may also be cut by an additional 8 percent in FY 2013 if the budget sequestration occurs for discretionary programs under the Budget Control Act. Such a potential cut for FDA would severely damage its ability to carry out its mission to assure the safety of foods, drugs, and biologics. The ASM believes it is vital to public health and safety to keep the FDA well funded. The FDA needs sufficient resources and continued sustained funding increases to ensure a 21st century, science based regulatory agency that can keep pace with scientific and technological advances and handle a burgeoning list of mandates including the Food Safety Modernization Act.
The ASM supports the additional appropriations to fund the China Import Safety Initiative of $10 million, the Advancing Medical Countermeasures Initiative of $3.5 million and the FDA Regulatory Science and Facilities funding of $17.7 million to equip the new biological sciences building on the White Oak campus. However, information technology funding is cut by $19.7 million and there are other offsets from FDA program areas. With a number of antiquated information systems, it is especially critical for FDA to continue to modernize its IT systems and enable it to collect necessary data from industry, health care records, and consumers. The FDA’s mission, responsibilities and global outreach are growing each year and the Agency requires more funding to accomplish its tasks, even during this time of fiscal constraints. The investment in FDA is also important to two of the largest sectors affecting the US economy: the US food industry and the medical products industry.
There are countless examples of FDA’s contributions to the health and well being of people. In recent months, FDA has assisted in recalling multiple food products, including cantaloupes that were contaminated with Listeria bacteria, producing the deadliest foodborne outbreak in the United States in over 30 years. FDA also investigated sources associated with the rising incidences of severe Cronobacter infections in infants, and approved the first four strain vaccine against seasonal influenza. FDA scientists have evaluated new drugs, diagnostic tests, and a myriad of other medical products.
FDA Funding Ensures the Safety of the US Food Supply
FDA personnel, facility inspections, product testing, outbreak and recall responses, and food producer and consumer education together help safeguard the nation’s $1 trillion food industry. The proposed FY 2013 budget includes new food related user fees and pay increases for Commissioned Corps personnel. However, we are concerned that the budget would decrease available funding for the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and Office of Regulatory Affairs (ORA). Their scientific expertise and enforcement authority are integral to prevent the estimated 28.7 – 71.1 million US. foodborne illnesses that occur annually and cost our economy an estimated $77.7 billion per year.
In recent years, multiple government reports and public health stakeholders have urged heightened protection against foodborne illnesses like those caused by Salmonella bacteria. FDA partnerships with other federal agencies and with state and local health and agriculture officials have joined to improve prevention strategies. Today, the FDA, through its Transforming Food Safety Initiative and its Foods and Veterinary Medicine Program, operates under its new authorities and responsibilities mandated by the Food Safety Modernization Act signed January 2011. The expanded mandates from the FSMA require sufficient resources to assure proper implementation.
Contamination of the US food and animal feed supplies is an ever present possibility, given the long list of disease causing agents in the environment and the innumerable points of entry into the food production pipeline. FDA estimates that reducing foodborne illness by just 10 percent would prevent 5 million cases annually, a figure that would result in substantial savings in health care costs alone. And there is potential to prevent many more.
FDA regulates $417 billion worth of domestic food and $78 billion of imported food, involving about 167,000 registered domestic food establishments and 254,000 registered foreign facilities. An estimated 15 percent of the US food supply is imported from 200 countries, comprising over 22 million food lines annually. In FY 2011, CFSAN participated in more than 1,000 foreign facility inspections. Growing food imports are placing greater demands on the FDA resources and require greater scrutiny and oversight of the imported food supply. This cannot be done without additional financial and personnel resources.
FDA Funding Improves Regulatory Science to Protect Public Health
In 2011, FDA released its strategic plan for advancing regulatory science and described in the plan is “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA regulated products.” Among the eight priority areas identified for improvement are implementing a new prevention focused food safety system and facilitating development of medical countermeasures against national security threats. FDA also released a report outlining a new initiative to stimulate biomedical innovation, increase medical product development, and train the next generation of regulatory scientists.
The proposed FY 2013 budget allocates resources to build science capabilities under this FDA strategic plan, to continue what has been an agency focus in recent years. The ASM agrees there must be cutting edge science underlying FDA’s protective regulatory mission, capabilities only possible if FDA is properly funded. FDA investigators must be equipped with new rapid detection technologies to identify unsafe consumer products and trace the source of contamination. Both laboratory and surveillance tools must be the best available, to support FDA authority to seize unsafe foods and other goods and stop noncompliant producers.
FDA science routinely informs agency standards and guidances that regulate food safety, and solid science is vital to successfully identify and contain contaminated food imports, unsanitary processors, or illegal drug residues in animal feed. In 2011, CFSAN evaluated the scientific bases of nearly 400 draft food safety regulations and rules submitted for review by members of the World Trade Organization, one example of FDA science’s role in public health.
The FDA Medical Countermeasures Initiative, which clearly depends upon the most current science and technology, would receive an additional $3.5 million in the Administration’s FY 2013 budget. Although the increase is welcome, it is insufficient to sustain and grow this important initiative. Since its beginning in August 2010, MCM projects have evaluated drugs, diagnostic tests, and vaccines directed against chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases. FDA’s MCM related efforts also contribute to the general understanding of infectious diseases and ways to control microbial pathogens. The FY 2013 budget would strengthen MCM regulatory science through R&D partnerships with industry, academia, and other federal agencies. FDA components like its Center for Biologics Evaluation and Research (CBER) will develop new MCM evaluation tools; animal models, diagnostic tests, and better manufacturing approaches to ensure US preparedness against these threats.
The ASM supports the increased funding in the Administration’s FY 2013 budget to develop additional investigative tools and methods. CFSAN and CVM scientists, in partnership with industry and academia, will continue to develop their technical capacity and expertise in mitigating foodborne illnesses. Other FDA centers are creating networks of outside scientific experts to complement their internal expertise, or have released reports on their scientific activities to improve risk assessment and management strategies. FDA recently awarded university grants to establish two regional Centers of Excellence in Regulatory Science and Innovation (CERSI), which will advance both science and specialist training. A significant increase in the FY 2013 budget also will help equip the new Life Sciences Biodefense Laboratory at FDA’s White Oak facility.
The ASM urges Congress to increase the Administration’s FY 2013 budget for the Food and Drug Administration. We are disappointed that there are not greater resources allocated to key FDA research centers. FDA initiatives and core programs, like those focused on food safety or drug development, must receive sustained funding increases to continue the protective mission unique to FDA.