Food and Drug Administration - FY 2009

The American Society for Microbiology (ASM) appreciates the opportunity to submit testimony in support of increased appropriations for the Food and Drug Administration (FDA) for fiscal year 2009. The ASM continues to believe that the FDA budget request is below the amount required to ensure that public health is protected through research and science based regulatory activities. The FDA regulates products worth nearly $1.5 trillion annually, about 20 percent of consumer spending in the United States. Repeated reports of contaminated or otherwise defective foods and other products, both domestic and imported over the past year, illustrate the crucial need for a strong FDA.

The Administration’s proposed FY 2009 FDA budget requests nearly $2.4 billion, a net increase of $130 million, or 5.7 percent over FY 2008. The request includes $1.77 billion in budget authority and $628 million as industry user fees. The budget plan funds a full time equivalent staff increase of 526, a much needed addition to the FDA’s over extended workforce. It also includes funding increases earmarked for food safety activities and for medical product safety and development, identified by the Agency as two priority initiatives for FY 2009.

The ASM believes that greater investment in the FDA is required and recommends that Congress increase the FDA budget by $375 million.

Challenges confronting FDA, such as rapidly changing new product technologies, recently led Agency leadership to solicit a year long evaluation of the science underlying the FDA’s broad sweeping directive to safeguard consumers. Released last November, the study report decries the deteriorating state of FDA science and calls for a doubling of agency funding over the next two years, conclusions supported by the ASM and others concerned by chronic shortages in FDA budgets and personnel. The report, FDA Science and Mission at Risk, found that the number of appropriated personnel in 2007 was roughly the same as 15 years earlier. It describes twenty unfortunate years of fiscal neglect, during which 123 additional statutes have been enacted increasing the FDA’s already heavy workload.

As the nation’s scientific regulatory agency, the FDA must stay at the leading edge of science and technology. In 2007, US consumers purchased roughly $2 trillion worth of imported products from 825,000 importers, shipped into the country through more than 300 ports of entry, elements of the inexorable shift toward economic globalization. The FDA assures the safety, efficacy, and security of many of these products, including human and animal drugs, biological products, medical devices, and more. Its mission also encompasses regulating vast numbers of domestic products and most of the nation’s food supply, educating the public with accurate, science based information, and encouraging innovation in medicines and other goods for public consumption. Each year, FDA review prompts multiple recalls of unacceptable or fraudulent products. The agency also evaluates an impressive list of new products, which last year included approved treatments for HIV infection, breast cancer, and hemophilia.

Protecting America’s Food Supply

The proposed FY 2009 FDA budget allocates $662 million for food protection activities, a $42.2 million increase over FY 2008, in part to support the Protecting America’s Food Supply initiative to improve FDA efforts against foodborne illnesses. In November 2007, the FDA presented its new food protection plan, coordinated with the just released strategic plan of the Interagency Working Group on Import Safety. Using a risk based approach to identify potential threats to the food supply before problems arise, the FDA food protection plan will emphasize early intervention and reprioritize food safety issues to better utilize limited agency resources. The budget increase also will help facilitate new agreements just reached with China that address import safety issues, two Memoranda of Agreement on food, feed, drugs and medical devices signed last December.

From production to consumption, the life cycle of the US food supply typically involves a series of processes, facilities, and human handlers, opening multiple opportunities for contamination and foodborne illnesses. Outbreaks associated with fresh leafy greens and packaged dairy are recent examples. Last year, peanut butter contaminated with Salmonella bacteria in the processing plant sickened more than 300, hospitalizing at least 50 patients and forcing costly recalls. In March 2007, the FDA released its Final Guidance for Safe Production of Fresh-Cut Fruits and Vegetables as one step to address the growing problem of microbial contamination of fresh produce. In FY 2008, federal economists expected US agricultural imports to reach a record $75 billion. Food imports have risen sharply in the past five years, increasing by over 10 percent a year at twice the historical rate of import growth. Rising food imports and other factors guarantee that problems will persist and the FDA must heighten its vigilance over the nation’s food supply.

In January 2007, the Government Accounting Office (GAO) designated the federal oversight of food safety as a high risk area for the first time, warning that related federal programs are “in need of broad-based transformation” to reduce risks to public health and to the economy. In its evaluation report, the GAO pointed out that the FDA, responsible for regulating about 80 percent of the US food supply, receives only about 24 percent of federal expenditures for food safety inspection. Each month, FDA field inspectors reject hundreds of import shipments deemed filthy, decomposing, contaminated with drug residues, or otherwise unfit. Unfortunately, inspectors evaluate roughly 1 percent of the estimated 9 million food and food ingredient shipments entering the United States annually, as staff shortages coincide with rapidly expanding import numbers.

In 2006, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) regulated an estimated $417 billion worth of domestic food and $49 billion worth of imported food, as well as $60 billion in cosmetics and $18 billion in dietary supplements. The $182 million proposed for CFSAN in FY 2009 is an increase of $10 million over FY 2008 and includes an additional 31 full-time employees, for a total of 811 FTEs to handle the workload. Increases for CFSAN also will target five areas for improvement: preventing contamination, prevention through mitigation, import enhancements, surveillance, and prevention through research.

Modernizing Medical Product Safety and Development

Under the Administration’s FY 2009 proposal, the FDA’s Medical Product Safety and Development initiative receives an additional $17.4 million to enhance the safety of human and animal drugs, blood, human tissues, and medical devices. The broad ranging initiative will address both imported products and the need for more new product innovation among US industries. The proposed budget increase also will help implement the Food and Drug Administration Amendments Act enacted by Congress last year that sets new requirements for FDA food, drug and medical device programs. The budget increase will be distributed among the FDA centers and field activities specifically assigned oversight of human drugs, biologics, animal drugs and feeds, medical devices and radiological health, or toxicological research. Current programs need additional funding for modernizing laboratories, hiring more field staff, and improving import safety. The total FY 2009 budget authority proposed for initiative related programs is $887 million, to be supplemented by $21.5 million in user fees.

The recently released report on FDA science provides compelling arguments that the FDA regulatory system responsible for this initiative is overloaded and underfunded. The importance of a fully funded FDA is clear, based on the statistics. In 2006, the Center for Devices and Radiological Health (CDRH) regulated manufacturers with sales of $110 billion. The Center for Drug Evaluation and Research (CDER) oversaw $275 billion in pharmaceutical sales, 2,500 US manufacturers, and 2,500 foreign manufacturers. The Center for Biologics Evaluation and Research (CBER) typically reviews more than 800 new products every year. The Center for Veterinary Medicine is responsible for products tied to more than 10 billion food producing animals, 200 million pets, and more than 90,000 manufacturers.

Each year, the FDA reviews new products and evaluates questionable consumer goods under its huge mandate to protect and improve public health. In 2007, the agency’s field force investigated pet food contaminated by tainted wheat gluten imported from China, with more than 100 brands of food recalled by manufacturers. The FDA also approved a unique two hour blood test that marks a significant advance in rapidly detecting drug-resistant staph infections. CDER approved a total of 88 new products, including the first drug to treat all degrees of Alzheimer’s disease and a new breast cancer drug that can replace a current one poorly tolerated by many patients. It also approved or tentatively approved 682 new, less costly generic drugs, a 33 percent increase over the previous year. This February, FDA advisors endorsed a new formula for next year’s flu vaccine that, unlike most years’ vaccines, would include all new influenza virus strains. Through its CBER programs, the FDA improves donated blood supplies by assessing additional testing as needed, in FY 2007 approving screening tests for West Nile virus, Chagas disease, and early detection of hepatitis C virus and HIV-1.

ASM Recommendation for the FDA in FY 2009

The FDA already regulates more than 375,000 facilities worldwide in nearly 100 countries. The volume of FDA regulated imports has doubled over the past five years. Approximately 15 percent of the US food supply is imported and for some items like seafood and fresh fruit, market share reaches 60 to 80 percent. If current market trends persist, the beleaguered agency’s workload will continue to expand rapidly inside the United States and elsewhere. It is essential that FDA science capabilities, research and field personnel, and infrastructures also expand to meet these challenges. Although the Administration has proposed an increase of $130 million for the FY 2009 budget for the FDA, this budget increase is still inadequate. The ASM believes the FDA could use a $375 million increase based on the professional judgment budget of the FDA Science Board. We believe the Science Board Report has provided a sound basis for the allocation of new resources for the food supply, biological sciences with emphasis on drug safety, science reorganization, scientific capability including training and a visiting scientist program, and information technology.