Food and Drug Administration - FY 2008

The American Society for Microbiology (ASM) appreciates the opportunity to comment on the FY 2008 budget submission for the Food and Drug Administration (FDA). The ASM is the largest single life science Society with over 42,000 members, who work in academic, clinical, government and industry laboratories and are involved in research and diagnostic testing. The Society has a special interest in the activities of the FDA which are critical to safeguarding the health and welfare of the public. The ASM supports an increase in funding for FDA activities, which are expanding because of scientific innovations, rapid globalization and new and reemerging diseases. The ASM urges that the FDA budget be increased and specifically recommends a significant increase for FDA Food Safety activities. An increase in the FDA budget will better equip the agency to address new public health issues and additional funding for food safety programs will help to protect the safety and quality of food consumed in the United States.

The FDA has enormous responsibilities that affect the public every day. About 20 percent of consumer spending in the United States buys FDA regulated products, an annual expenditure of nearly $1.5 trillion. The FDA plays a critical role in overseeing and evaluating new products with significant potential to greatly improve public health and reduce costs to society. Annual spending on health care in the United States reached nearly $2 trillion in 2005. Last year, FDA approved an array of new cost containing medical advances, including vaccines to fight cervical cancer, shingles, and gastroenteritis. FDA scientific and support staff must be prepared to respond to disease outbreaks, like those recently linked to contaminated salad greens and peanut butter. It is essential that FDA receive the federal funding which it needs to meet its changing and expanding regulatory responsibilities.

The proposed FY 2008 budget for FDA includes $1.64 billion in budget authority and nearly $444 million to be collected as industry user fees, an overall 6.8 percent increase above the FY 2007 request. The FY 2008 budget authority includes a net increase of $95.3 million to subsidize high priority initiatives identified as crucial by the FDA and external reviewers. The ASM agrees that this is a justifiable and wise investment in these priority initiatives, which include strengthening food safety, modernizing FDA drug safety programs, and assuring FDA expertise and infrastructure upgrades.

Strengthening Food Safety

Foodborne disease continues to be a problem in the United States. In 2006, FDA investigators helped pinpoint the sources of pathogens in familiar products sold at grocery stores and restaurants, by testing contaminated spinach and lettuce, oysters, and peanut butter. More than 250 foodborne illnesses are recognized by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Federal officials estimate that each year about 76 million become sick, more than 300,000 are hospitalized, and 5,000 die from foodborne illnesses. The high priority initiative to enhance food safety includes much needed improvements like hiring experts in fresh produce microbiology, enhancing geographic information systems (GIS/GPS) to better map disease outbreaks, and expanding genomic databases used in screening imported foods.

The FDA’s food program regulates $417 billion worth of US produced foods, $49 billion in imported foods, and $59 billion in cosmetics, from point of entry or production to point of sale. Global marketing, the threat of bioterrorist agents added to foods, changing American diets, and the rapidly growing diet supplement industry converge to further complicate FDA efforts toward a safe food supply. CFSAN personnel oversee consumer products as diverse as tattoo inks and infant formula. In FY 2006, they inspected lettuce farming and processing operations in California, completed construction of a high level containment laboratory to develop methods for identifying biothreat agents, established a repository of pathogenic Escherichia coli O157:H7, and augmented advanced research tools for pinpointing sources of contamination by specific bacterial strains.

The FY 2008 budget request includes $10.6 million to strengthen the FDA’s food safety activities, as part of the overall $467 million allocated to the agency’s Foods Program (a 4 percent increase over FY 2007). The proposed increase in FDA’s food safety activities is not sufficient to provide the resources needed to ensure adequate protection and programs based on the best science. The FDA is responsible for ensuring the safety and quality of 75 percent of the food consumed in the United States. Despite the fact that additional funding was provided to FDA in the 2007 Joint Resolution, no increase was provided for food safety. The food safety program must, therefore, absorb infrastructure and payroll costs at the expense of funding critical program needs. When the FY 2008 CFSAN food safety request is compared to funding for food safety in the 2007 Joint Resolution, the net increase in FY 2008 is only $1 million. The proposed increase for food safety activities at CFSAN would be at the expense of current CFSAN programs.

FDA food safety activities are not able to keep pace with the demands to protect food in this country. The two primary centers within FDA that address food safety are CFSAN and the Office of Regulatory Affairs (ORA). In FY 2004, CFSAN was authorized 901 FTEs, with a major focus on addressing food safety issues. Since then, several additional responsibilities have been delegated to the Center for regulatory oversight, including nutritional claims, food allergens, nanotechnology, and food security, and major reductions in appropriated personnel positions have occurred. In FY 2008, only 756 FTEs have been proposed for CFSAN. In addition, in FY 2004 2086 FTEs were appropriated for ORA, the inspection program of FDA. About 30 percent of the ORA is allotted to food inspection, which equates to 626 inspectors. In FY 2008, 1946 FTEs have been proposed for ORA, which equates to 584 for food inspectors. Currently, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) has approximately 7600 inspectors for approximately 6500 meat and poultry processing facilities. FDA has about 600 food inspectors for over 50,000 food processing facilities which the agency oversees. The FDA would need at least 58,500 inspectors to be on par with the USDA-FSIS meat and poultry inspection program. Both FDA’s CFSAN and the foods program within ORA are woefully under funded to adequately accomplish the tasks required to verify the safety of the US food supply. Addressing gaps in inspection and compliance, enhancing scientific risk assessment, management and analysis, and science based food standards are examples of areas in need of new resources to provide adequate public health protection to the nation’s food supply. The ASM recommends the FDA Food Safety programs be appropriated an additional $75 million to strengthen CFSAN and ORA Food Safety activities.

The FDA’s Center for Veterinary Medicine (CVM) regulates animal drugs and feeds used to care for a momentous number of animals: 9 billion chickens, 266 million turkeys, 97 million cattle, 61 million pigs, 11 million sheep and goats, 130 million dogs and cats, and 5 million horses. The current recall of 60 million containers of pet food by a major Canadian manufacturer, following reports of kidney failure in dogs and cats, is the most recent example of CVM’s rapid response to consumer complaints. The FDA quickly alerted the public and the media of the potential threat to pet health, while CVM personnel are onsite at the company’s US plants to search for any connection between the reported cases and product processing. The FY 2008 budget requests $106 million to support FDA’s supervision of animal drugs and feeds, roughly a 7 percent increase. CVM programs slated to receive a funding increase include an interagency effort against the rising incidence of drug resistant microorganisms. In September 2006, the FDA released its third annual retail meat report, based on laboratory testing for resistance among meat associated microorganisms, part of the interagency National Antimicrobial Resistance Monitoring System. The FDA also issued an order last year that prohibits the extra label use in poultry of two classes of human anti influenza drugs, to avoid emergence of resistant strains of type A influenza that include the avian H5N1 virus. Other FY 2008 funding targets are vigilance against Bovine Spongiform Encephalopathy (BSE) in cattle and evaluation of genetically modified animals as human food sources. Emerging infectious diseases and cutting edge science force regulators to adapt, to acquire new scientific methods and evaluate previously unknown food safety issues. Last December, the FDA issued three draft documents on the safety of animal cloning, concluding that meat and milk from clones and their offspring are safe as food, but asking producers to refrain from selling such products until final documents are released following public comment. The three documents illustrate the breadth and complexity of FDA oversight of specific food sources: a draft risk assessment, a proposed risk management plan, and a draft guidance for industry.

Modernizing Drug Safety

In 2006, two reports released by the Institute of Medicine (IOM) warned health officials about high numbers of prescription drug dispensing errors and about problems with drug safety oversight. The first report estimated that at least 1.5 million preventable adverse drug events (ADEs) occur each year in the United States. The report also concluded that preventable ADEs in hospitals alone could be costing the US economy about $3.5 billion annually in treatment expenses, adding that the extra cost of drug error related illness and death in the ambulatory setting had already reached an estimated $177.4 billion by 2000. In response to these crises in prescription errors, the proposed FY 2008 budget specifically requests nearly $9 million to modernize FDA’s drug safety programs. The FDA expects the FY 2008 initiative to revolutionize the agency’s ability to identify drug safety issues, by collecting surveillance numbers from more databases, acquiring the latest scientific tools to evaluate drugs and patient reactions, hiring specialist investigators to detect and resolve problems, and improving communication on safety to all stakeholders.

The proposed FY 2008 budget sets aside nearly $571 million for the FDA’s ongoing oversight of human drugs, a 10 percent increase over FY 2007. Without adequate funding, the quality of drug oversight will deteriorate at the same time as regulatory demands are expanding steadily. Each year, the FDA’s Center for Drug Evaluation and Research (CDER) evaluates growing numbers of new and on-market drug products, routinely investigating adverse medical events and clarifying consumer information included in packaging. In 2006, the FDA approved several significant new drugs after extensive research and review, including the first inhaled insulin for self treatment by adult patients, the first drug patch for depression, the first drug treatment for a rare glycogen storage disease (Pompe disease, designated an FDA orphan drug), and the first drug for dementia of Parkinson’s disease. Throughout the year, the agency announced a number of drug labeling changes based on adverse event reports. The FDA also contributed to ongoing counterbioterrorism initiatives, approving a nerve agent treatment for use by civilian emergency personnel and generic versions of a drug already FDA approved for inhalational anthrax.

Improving Generic Drug Review

The budget requests $5.6 million to improve the evaluation of new generic drugs and $15.7 million in new generic drug user fees to be collected from drug manufacturers to underwrite the rapidly expanding generic drug industry. In 2005, prescription drug sales accounted for roughly 10 percent of the $2 trillion in total health care spending (about $200.7 billion), making medications the third largest spending category. During the past six years, generic drug applications to the FDA’s Office of Generic Drugs (OGD) increased by 158 percent (793 in FY 2006), and the OGD estimates that 857 applications will be filed in FY 2008. The FY 2008 request to fund the FDA’s generic drug initiative recognizes this expanding demand on FDA oversight. The agency already has implemented steps to improve program efficiency, to shorten turn around time for applications. It estimates that funding for the FY 2008 initiative will permit approval of as many as 550 generic drugs annually, reducing US prescription drug costs and making more treatments available to more patients. In FY 2006, the FDA approved or tentatively approved a record 510 new generic drug applications. Among those approved were 13 HIV/AIDS drugs and medications for hyperlipidemia, depression, osteoarthritis, and high cholesterol.

Modernizing Biologics Safety

The initiative to modernize drug safety, which is allocated $11.2 million in the FY 2008 budget, includes more than $2.2 million to enhance safety assessments of biologics, blood and blood products, human tissue, cell and gene therapies, vaccines, and allergenic products. Statistics from 2006 reveal the extent of products regulated by the FDA’s Center for Biologics Evaluation and Research (CBER): more than 14 million units of blood and blood products transfused, over 235 million vaccinations administered, and more than one million human tissues transplanted. Funding would expand postmarket surveillance, strengthen adverse event assessment, and improve communication with the medical community and other partners. The overall FY 2008 budget for the Biologics Program would be $216 million, a 10.8 percent increase over FY 2007 that properly recognizes safe biologic products save lives and economic resources. CBER scientists must be able to evaluate cutting edge product development, including their involvement in the nearly 250 new gene therapy studies presently overseen by the Center. CBER oversight has been highly effective; for example, the risk of HIV and hepatitis C transmission through blood transfusion has been reduced from 1 in 100 units in the 1980s to less than 1 in a million units today. Cost effective vaccines in particular are credited with saving thousands of lives and millions of dollars in health care costs. In 2006, CBER approved new vaccines against three pathogenic viruses that cause significant death and disability: human papillomavirus (cervical cancer, sexually transmitted disease), herpes zoster virus (shingles), and rotavirus (gastroenteritis in infants and children).

Improving Medical Device Safety

A high priority initiative proposed in the FY 2008 budget would help the FDA better evaluate the safety of a wide range of medical devices marketed in the United States. Of the $285 million allocated to the Medical Devices Program, about $7.2 million will fund specific advances in safety analysis and consumer information provided by the Center for Devices and Radiological Health (CDRH). As elsewhere in the FDA, demands on CDRH staff are being intensified by global market forces, rapidly advancing technologies, and shifting population demographics. In FY 2006, CDRH received over 150,000 adverse event reports requiring review and in some cases follow up actions to protect the public health. Last year, FDA personnel continued collaboration with the Federal Trade Commission and eBay to make certain that unapproved medical devices were not being sold on the website. The CDRH also approved innovative devices with significant health enhancing potential, including the first easy to use portable lead poisoning test system, a device that will reduce brain damage in some hospitalized infants by keeping the head cool, a rapid diagnostic test for avian influenza viruses based on polymerase chain reaction (PCR) technology, and a sensor that wirelessly transmits blood glucose readings in real time for use by diabetics at home. The CDRH recently provided the scientific support for a large clinical trial of digital mammography, showing that the new technology was significantly more accurate than standard film mammography among patients with dense breasts, under age 50, or pre and perimenopausal. In FY 2008, CDRH expects to certify new mammography facilities after evaluation of their technological expertise, plus examine and recertify one third of the more than 8,900 existing mammography facilities in the United States.

ASM Supports the Proposed FDA Budget for FY 2008

The ASM supports an increase of $75 million in the proposed budget for food safety and asks the Congress to appropriate the funding necessary to strengthen FDA regulation of foods, drugs, medical devices and other products that affect the public health. The ASM reminds the Congress that without its highly skilled staff of scientists and professionals, the FDA will not succeed in fully protecting US public health with activities that are based on the best science available. If the agency does not receive adequate funding, it will be forced to reduce the number of safety officers, onsite inspectors, product reviewers, and laboratory researchers so necessary to effective and efficient oversight of FDA regulated products.