The Food and Drug Administration (FDA) represents a pivotal position in national health and safety and successfully performs a wide-range of duties as a protector of public health in the United States. Last year the FDA reviewed the safety and efficacy of consumer products worth $1 trillion, and monitored more than 100,000 U.S. firms that manufacture or process these products. Agency inspectors annually screen almost 8 million shipments of import goods at our national ports of entry. Today heightened threats to our national security demand even more vigilance and scientific expertise from FDA personnel. The American Society for Microbiology (ASM), the largest single life sciences society representing over 40,000 scientists, strongly supports the Administration's FY 2003 budget request of $1.7 billion for FDA, an increase of $123 million, or nearly eight percent above the FY 2002 level.
Increased funding for the FDA will help to expand both science-based programs and well-trained personnel capable of responding to more urgent and more complex demands for public protection. The ASM also concurs with the programs given priority in the proposed budget: that is, enhancing FDA's already intensive counter-terrorism programs, expanding salary and staff resources, further emphasis in decreasing medical errors related to medical products, and continuing a strong defense against unsafe or ineffective consumer goods.
The widespread public trust in FDA activities is well deserved, as the agency for decades has reviewed carefully both new and on-the-market products, ranging from toothpaste to sophisticated medical lasers and tissue transplants. Most of the food consumed in the United States is under FDA surveillance as well, as are such health threats as microbial resistance to antibiotics and in-hospital medical errors. The ASM urges Congress to approve significant funding increases in supporting the FDA's focus areas of food safety, safe and effective medical products, and physical security of this country and its citizens.
Science for Safety and Security
The role of the FDA is a complex blend of law and science - consumer protection laws are upheld through careful reviews or evaluations based on the latest in science and technology. With the rapid scientific changes expected in coming years, the ASM believes it is essential that the FDA remains at the forefront of these changes. Up-to-date science is considered the agency's foundation, whether its personnel are enforcing regulations, reviewing new-product applications, or assisting in policy development. Among those current FDA responsibilities dependent on solid science are the federal efforts against antimicrobial resistance among pathogenic microorganisms, attempts to understand and prevent transmission of bovine spongiform encephalopathy (BSE, or "mad cow disease"), and responsibility for the safety of bioengineered foods and other products. Cutting-edge areas under FDA purview will include medical imaging, stem cell-derived products, biosensors, new drug delivery systems, robotics, organ replacements, products from transgenic organisms, and more.
Only by staying ahead of the scientific curve can the FDA maintain its credibility as the nation's principal protector of product safety and efficacy. The short-staffed agency must be able to train additional researchers and inspectors, as well as strengthen its extramural research grant programs. Given the FDA's role in new-product approval, the failure to provide adequate scientific resources to an already overburdened organization could hinder both public health and public safety initiatives. In the past, the agency has worked efficiently to improve processes such as the review of new drugs, which has been shortened from an average of 30 months to a year, and the number of new drugs appeared annually has increased by almost 40 percent. Such efforts have persisted within the framework of solid scientific expertise.
The ASM strongly supports efforts to increase and enhance FDA's science research base. FDA must be given the resources to keep pace with accelerating technology and to take advantage of scientific opportunities to best serve the American public. Basic research by the FDA contributes to the Agency's ability to adapt to constant changes in its consumer constituency and respond to future public health threats.
Counter-Terrorism at the FDA
The FDA has a well-deserved reputation of being able to assess threats to public safety and managing those risks. Recent events of terrorism and bioterrorism have altered specific FDA goals for the coming year, but these goals fall firmly within the agency's long-standing approach of risk identification and prevention. The FDA will focus on three areas identified as security issues: safe and effective medical products to treat victims of an attack, food safety, and physical security of FDA facilities and programs. The FDA has been entrusted with two functions within the national response to terrorism, that is, to facilitate the ready supply of medications to prevent or treat terrorism-related injuries, and to prevent the intentional contamination of consumer products such as food and pharmaceuticals. Included in the President's FY 2003 counter-terrorism budget is $159 million for FDA.
In recent months, the specter of bioterrorism shifted from theory to threat, and then to reality. In 2000, the FDA approved a drug for treatment of post-exposure inhalational anthrax, in anticipation of such dire events. The agency now is a partner B along with the NIH, the CDC, and others B in a new vaccine/drug development continuum devoted to the prevention and treatment of such diseases as smallpox and anthrax. The FDA will continue its regulatory functions, as all of its centers focus on new biologics (vaccines and antibiotics), rapid diagnostic devices, and additional trained personnel specializing in bioterrorism. Other FDA counter-terrorism goals for the coming year further reflect the agency's wide-ranging responsibilities, including a doubling of the number of physical exams of import goods and an intensified laboratory analysis of suspicious items, as well as the inspection of imported goods coming through 45 ports of entry not previously examined. In all of these efforts, the FDA adheres to its stated principles of using solid science as a basis for accurate decision-making; maintaining strong collaborations with industry, government, and other stakeholders; regulating products throughout their use by the public; and considering the global nature of product development and consumption.
The balance between benefits and risks of a proposed new product is the central question asked by FDA personnel each time they evaluate new drugs and biologics (vaccines, blood products, gene therapy, biotechnology products), medical devices, or food additives. Such risk assessment is absolutely vital to our national health and must be well-funded from year to year. While the FDA does not itself develop new products, it thoroughly assesses laboratory data in both pre- and post-market reviews of consumer goods, a costly responsibility. The FDA recently negotiated with product manufacturers to use industry funds for product/device review. This is the first time that resources will be allowed for risk management activities of products after they enter the marketplace. The ASM recommends that FDA-regulated areas such as blood product assessment be adequately funded. United States investments in biomedical research, promises advances such as animal organ transplants and cellular and gene replacement therapies. These new products must each be evaluated by one or more of the FDA's research centers before entering the public health arena.
At the Center for Biologics Evaluation and Research (CBER), FDA investigators oversee biological products such as blood, vaccines, therapeutics and related devices. They will be responsible for implementing new regulations governing tissue and cell transplants, made more important with today's increases in reconstructive surgery and with the potential uses for animal tissues in treating human disorders. FDA monitoring of transplantation tissue like bone, skin, and corneas includes donor screening to prevent spread of communicable diseases and rigorous record-keeping by medical centers. The agency is in the process of revising its regulations, part of its on-going efforts to refine and strengthen disease prevention. CBER also regulates human gene therapy products, expected to be a major source of medical treatments in the future. Genomics, informatics, and transgenic animals are just some of the cutting-edge advances about which FDA scientists must be thoroughly trained, as entirely new types of products enter the regulatory system. In February, for instance, the FDA approved the first nucleic acid test system to screen whole blood donors for infections with both HIV and hepatitis C virus, providing earlier and more sensitive detection of contaminated blood.
Other FDA institutes likewise deal with burgeoning products to be reviewed within the context of innovative science. Last year the Center for Drug Evaluation and Research (CDER) approved 66 new drugs, 24 of which contained ingredients never before marketed in this country. Ten drugs received priority status because of their clear benefit to public health, including a new oral treatment for chronic myeloid leukemia that the FDA approved in a record 2.5 months. The CDER also continues to watch more than 10,000 drugs currently on the market, as well as drug advertising to assure it is truthful. The Center for Devices and Radiological Health (CDRH) contends with more than 20,000 firms worldwide that produce more than 80,000 different medical devices for the U.S. market, from contact lenses to heart valves. Among the thousands of products approved last year was a skin substitute made of human fibroblast cells, used to help heal diabetic foot ulcers. Over the past five years, through streamlined efforts by the CDRH, approval times for novel, high-potential medical devices declined by about half, to 12 months.
The use of many thousands of medical products too frequently results in adverse events, causing harm to patients. Recent studies suggest that drug- and device-related mistakes are the single greatest cause of preventable patient injury. Annual estimates of the damage in the United States include up to 100,000 deaths, more than 3 million hospital admissions, and an economic cost ranging from $20 million to $75 million. The FDA records more than 350,000 reports of adverse events annually, but believes that about half of the deaths and injuries could be avoided through strict adherence to its patient safety initiatives. These include clarifying instructions to physicians and patients and expanding requirements for reporting adverse events. The CBER and the CDC, for example, jointly manage the Vaccine Adverse Event Reporting System, a post-market surveillance system to collect information on vaccination side-effects. The FDA also has pioneered the international harmonization of drug standards; as a result, producers in the United States, the European Union, and Japan are coordinating event reporting and drug instructions.
Nutritious food flows into American homes, restaurants, and markets from overseas and from domestic producers, in large part due to the diligence of FDA inspectors and scientists. Each year about $240 billion of food is produced in the United States, while an additional $15 billion worth is imported from every part of the world. Roughly 80 percent of this abundant food supply is the responsibility of the FDA, which regulates all but meat, poultry, and some egg products controlled by the U.S. Department of Agriculture. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) have a tremendous responsibility in assuring that this food is safe, wholesome, and free from disease.
In the United States foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year. Annual hospitalization costs exceed $3 billion, plus the cost from lost productivity may be an additional $8 billion. Food-related outbreaks of infections from such pathogenic bacteria as Escherichia coli and Listeria continue to plague Americans. Control of foodborne illness is increasingly complicated because of emerging pathogens like E. coli O157:H7 and the BSE agent; the fact that more food is prepared and consumed outside the home; and the dramatic movement worldwide of food imports and exports. Other factors likewise causes problems, such as the link between antibiotic use in animal feeds and rising incidences of human infections by antimicrobial resistant bacteria. Consequently, the FDA rightly argues for tighter controls and more education both among consumers and within the food production industry.
Last year, the FDA took specific steps to strengthen procedures that prevent unsafe food from entering the United States, and to widen its domestic efforts against food-related health threats. Using funds from the FY 2003 budget, the agency plans to double the number of physical exams of food imports performed last year. It is a partner in the multi-agency National Food Safety Initiative, with the goal of "effective detection, response, and control of foodborne and waterborne pathogens." It also is part of a coordinated effort, the Egg Safety Action Plan, intended to cut in half the number of salmonella-caused illness due to contaminated eggs by 2005. Drawing from its considerable experience in information gathering and dissemination, the FDA participates in several nationwide surveillance and emergency response systems; e.g., PulseNet, which collects DNA "fingerprints" of bacteria that may be foodborne pathogens. CFSAN initiated widespread use of the Hazard Analysis and Critical Control Point (HACCP) system that inserts preventative controls at the most contamination-susceptible points within food production processes. Thus far, CVM inspectors have collaborated in nearly 10,000 inspections of animal feed facilities, searching for sources of the "mad cow disease" pathogen.
The FDA in an Era of Complexity
Today's complicated social, scientific, and economic pressures are demanding more and more from FDA resources and personnel, creating a clear and present need for increased support. The ASM is concerned that growing shortages in trained staff and scientific capabilities will diminish the FDA's traditional role as protector of public health. The FDA has a labor-intensive, science-based mission that necessitates sufficient numbers of well-trained employees. Most (60 percent) of the agency's budget, in fact, goes towards payroll costs, and nearly half of its employees are "in the field" inspecting and educating. The number of import shipments of foreign-produced products under FDA review rose from about 1.5 million in 1992 to 6 million in 2000. FDA investigators are now able to sample less than 1 percent of all foods entering the United States, due to the large volumes imported.
Challenges faced by the FDA are changing along with society and science in this era of increasing complexity. An aging population of Americans changes the types of new medical drugs and devices needed most urgently. Advances in human genetics and artificial intelligence create both unforeseen opportunities and unanticipated problems that must be reviewed carefully by the FDA. Radiation safety issues and the intentional release of chemicals or microbial pathogens have forced recognition of bioterrorism as an FDA priority. More than 100 million people consulted the internet last year for medical advice from FDA sources, raising the agency's public outreach efforts to new levels. International trade has formed an interlocking worldwide web of inspections, product review, and education campaigns. Adapting to these changes is critical, if the FDA is to continue to protect public health and national security.