The American Society for Microbiology (ASM), the largest single life sciences society representing over 40,000 scientists, recommends that Congress increase the Administration's proposed Food and Drug Administration (FDA) budget of $1.7 billion for FY 2004, which represents an increase of $59 million over FY 2003, or only 3 percent. Sufficient financial resources must be allocated to the FDA in order for this crucial agency to continue its science-based oversight of public health and safety. The FDA's current priorities reflect its diverse roles in protecting and improving the well-being of individual Americans, ensuring homeland security against potential terrorist attacks, reducing the numbers of adverse health events associated with the food supply and health care products, distributing accurate information about FDA regulated products, and basing its decisions on solid science.
The agency has been and will be responsible for much of the nation's countermeasures against potential biological and chemical terrorist attack. But the FDA's long-standing responsibilities also influence the day-to-day, ordinary aspects of American life. In 2002 alone, the FDA evaluated and approved for marketing nearly 5,000 new drugs, biologics, medical devices and animal drugs. At the same time, its personnel monitored about eight million import shipments. Consumers spend 25 cents of every consumer dollar - nearly $1.5 trillion - on products regulated by the agency, including therapeutic drugs, medical devices, and most of the nation's food supply. Public trust in the FDA reflects how well the agency fulfills these broad-based and complex responsibilities.
The ASM urges Congress to fully support the FDA's role as protector of public health. Adequate funding will ensure that the agency still can perform counter-terrorism, consumer product safety, and food safety within the context of scientific research, complete and accurate information, and productive collaborations with stakeholders.
Science-Based Security and Safety
The protective mission of the FDA is a complicated mixture of law and science - as the numbers of new products, food imports, and potential health threats increase, so do the added regulations, invested stakeholders, and revised responsibilities. The ASM recognizes that the FDA's principal strength is the up-to-date information from which the agency determines its new-product evaluations and its regulation enforcement. Only strong funding will assure that this science-based decision-making continues at all of the FDA's research centers. Research by agency personnel, combined with data gathered from outside research groups, ensure that safe and effective products reach the market and that these products remain safe after market approval. In the approval of new vaccines or the inspection of shellfish, FDA personnel rely on the latest in scientific evidence and technology. New technologies like nucleic acid amplification testing (NAT) have significant potential in protecting the nation's health and thus must be included among the FDA's diverse research capabilities. The agency's Center for Biologics Evaluation and Research (CBER), which is responsible for the safety of the nation's blood supply, has in recent years approved NAT-based blood testing procedures. These tests currently screen all donated blood in the United States for HIV and hepatitis C infection, and the FDA is studying their potential to screen for West Nile virus (WNV). Concerned with any new and emerging health threat, CBER scientists also are conducting studies and gathering extramural evidence on innovative WNV vaccines and treatments. This characteristic scientific readiness against new threats like WNV infection and bovine spongiform encephalopathy (BSE or "mad cow disease") should be supported with adequate funding.
Counter-Terrorism and Project Bioshield
Unfortunately the threats to public health have expanded dramatically to include both real and potential acts of terrorism and bioterrorism. The political environment overseas further intensifies the dire possibilities for biological and chemical terrorism against American citizens, and thus intensifies the crucial protective role of the FDA. Part of the Administration's proposed FY 2004 budget for the FDA falls under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - a reflection of the FDA's deserved reputation for assessing and managing such threats. In his recent State of the Union address, President Bush announced Project BioShield, a science-based program that further enlarges the FDA's counter-terrorism activities and increases pressure on the agency's funding resources.
Under Project BioShield, research and public health agencies - in particular the FDA and the National Institutes of Health - will collaborate with the new Department of Homeland Security to develop and make available more modern, up-to-date diagnostic tests, drugs, and vaccines against intentional attack with biological and chemical weapons. The program authorizes further stockpiles of the latest vaccines or drugs against such bioweapons as the infectious agents of smallpox, anthrax, and plague, as well as botulinum toxin and Ebola virus. The FDA also will be responsible for limited emergency-use authorization of promising medical countermeasures that have not completed standard review protocols. To do so, agency scientists must be fully informed on all scientific advances in medicine. Medical innovations such as recombinant DNA technology and molecular engineering, which are being studied in a number of other diseases, have potential against bioterrorism agents as well.
The Bioterrorism Act of 2002 mandated a comprehensive plan to protect against the intentional contamination of food and water supplies and of medical therapeutics and devices. As the food regulatory arm of the federal government, the FDA is responsible for developing the appropriate food safety measures. The agency also assures the adequate and safe supply of drugs and devices important to the nation's health, and thus has multiple roles within the war on terrorism.
The FDA's Center for Food Safety and Applied Nutrition (CFSAN) has already completed a number of activities aimed at enhancing the security of the national food supply. During FY 2002, more than 600 new food inspectors and laboratory personnel were hired and more than 34,000 food import examinations conducted. The CFSAN's intramural research program shifted more resources to developing rapid test methods for microorganisms and chemical agents considered serious bioterrorism agents. The Center also initiated a nationwide Laboratory Response Network to identify local laboratory capabilities related to intentional contamination. Classified threat assessments done by CFSAN personnel have delineated the relative risks of contamination among different categories of food. New regulations currently under review include registration with the FDA of all domestic and foreign food-related facilities with U.S. markets, and tighter regulations covering imported foods and food-origin record keeping. Under the 2002 legislation, the FDA likewise works with other federal agencies to assure adequate supplies of therapies and vaccines that might be needed against bioterrorist attacks. Within the past year, the agency's Center for Drug Evaluation and Research (CDER) released evaluations of drugs for inhalation anthrax and called for scientific studies on new treatments for human plague. It also approved use of a drug to counter nerve gas poisoning among U.S. military personnel in combat and announced effective use of treatment for human contamination with radioactive substances.
The FDA mission against terrorism depends on the ability to mount a rapid and effective response against a range of possible weapons and avenues of attack. Along with the requisite scientific efforts made throughout the agency, effective countermeasures also depend upon well-coordinated cooperation with agencies at all federal, state, and local levels, as well as advanced information-sharing systems. Concerned by the potential for bioterrorism, the ASM urges the Congress to place a high priority on significant funding for all branches of the FDA.Consumer Product Safety To safeguard public health, the FDA has the primary responsibility for ensuring that safe and effective products reach the marketplace and that those products remain safe and effective. This includes synthetic drugs, biologics, blood for transfusion, vaccines, medical devices such as cardiac implants and hearing aids, cosmetics and more. Not only is the FDA responsible for approving the sale and/or use of these products in a timely manner, it must track unfortunate outcomes such as medical errors involving FDA-approved products and the development of antimicrobial-resistant microorganisms. All these efforts require the FDA to have expertise in knowledge management, information gathering systems, quantitative risk assessment and computer modeling, plus the capability to rapidly disseminate information to the public and the private sectors. Within this complex regulatory environment, the FDA is trying to streamline procedures while encouraging research on a broader range of specific diseases. Last year the FDA's approval of nearly 5,000 new drugs, biologics, medical devices and animal drugs represented an increase of almost 400 new products over 2001. They included a new diphtheria-pertussis-tetanus vaccine for children and a new drug to treat non-Hodgkins lymphoma. But there were few advances against certain serious diseases such as diabetes and obesity. In response to unmet needs, in January the FDA announced an initiative to improve the development and availability of innovative medical products, involving all of the agency's medical product review centers - i.e., biologics, drugs, devices, and veterinary medicine. It will shorten the amount of time for FDA review without diminishing standards, and facilitate new product development through better industry guidelines on specific diseases and technologies. The initiative also identified three key areas of emerging technology that will receive more FDA resources: pharmacogenomics/ pharmacogenetics, cell and gene therapy, and novel drug delivery systems. As elsewhere in the FDA, academic, industry, and patient groups will be solicited as partners in the discovery process.
Despite evaluation and regulation of products, adverse events do occur. Medical errors related to drugs are estimated to cause from 40,000 to 100,000 in-hospital deaths each year. An Institute of Medicine report estimates that these adverse events increase the nation's hospitalization bill by up to $17 billion annually, and that drug-related problems outside the hospital may add another $76-plus billion to the nation's health care costs. Each year the FDA's MedWatch program and CDER's adverse event report system receive more than 250,000 reports associated with FDA-regulated drugs. CBER and the Centers for Disease Control and Prevention jointly manage the Vaccine Adverse Event Reporting System, another post-market surveillance system. The FDA and its centers are working nationally and internationally to reduce the incidence of these errors, through education of patients and health care professionals and in some cases withdrawal of the product from the marketplace.
The misuse of antimicrobial drugs has had other serious side-effects of particular concern to the ASM membership - the emergence of disease-causing microorganisms resistant to the drugs traditionally used to treat infectious diseases. The CDC estimates that half of the 100 million prescriptions written by U.S. physicians each year are unnecessary, a practice that inevitably increases the numbers of resistant bacteria. About 70 percent of bacteria that cause infections in hospitals are now resistant to at least one of the drugs most commonly used to treat those infections. A Harvard study just published concludes that there likely will be a sharp rise in the strains of Streptococcus pneumoniae resistant to both penicillin and erythromycin. The FDA, concerned about the waning usefulness of traditional drugs, announced this February new drug labeling directed at physicians and designed to reduce antimicrobial prescriptions.
Although foodborne illness still accounts for about 76 million illnesses in this country, the U.S. food supply is among the safest in the world. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for safeguarding 80 percent of all food consumed (the Department of Agriculture regulates meat, poultry, and some egg products). The Center and the FDA field inspectors are responsible for $240 billion worth of domestic food, $15 billion worth of imported foods, and $15 billion worth of cosmetics. Products are inspected for microbial and chemical contamination and for false labeling, while increasingly more production facilities are examined for FDA-developed Hazard Analysis and Critical Control Point protocols. The FDA's stewardship of food safety has emerged as a major component of the war against terrorism.
Like all other groups within the FDA, the CFSAN has a tremendous responsibility of impressive scope, yet it strives to make science-based decisions and policies and to disseminate accurate and timely information. Not only does the FDA succeed admirably in its efforts to protect the American public, but, it is respected internationally for its global influence. The ASM urges the Congress to appropriate an aggressive FDA budget and thus continue the robust and highly diverse ways in which the FDA preserves public health and national security.