The Administration’s FY 2007 budget request of $1.95 billion for the FDA includes $1.55 billion in budget authority and $402 million in industry user fees, a total increase of $70.8 million or 3.8 percent over the FY 2006 budget. Despite the proposed increase, the FDA’s budget continues to be constrained, especially in view of the increasing demands on the FDA related to food safety, pandemic influenza, new and emerging infectious diseases, such asWest Nile and Mad Cow Disease, drug safety, and initiatives to advance innovation in medical product development. The ASM recommends that Congress provide additional funding for the FDA to increase its FY 2007 proposed budget. Increased support for the FDA will enable the Agency to enhance programs that protect against unsafe healthcare products, unhealthy foods, and health challenges from bioterrorism or natural disasters. The FDA regulates products that account for almost 25 percent of US consumer spending, including 80 percent of our national food supply and all human drugs, vaccines, medical devices, tissues for transplantation, equipment that emits radiation, cosmetics, and animal drugs and feed. Together these products are worth nearly $1.5 trillion annually and affect the daily lives of people.
Protecting America’s Health – Pandemic Preparedness
The specter of a potential influenza pandemic requires increased resources for preparedness. Recent research has found that viruses responsible for the three influenza pandemics in the past century carried genes from avian influenza viruses. In the current H5N1 outbreak, the World Health Organization has confirmed about 186 human cases although thus far the virus does not spread readily from human to human. If viral mutations make human-to-human transmission a tragic reality, however, a deadly pandemic could cause millions of human deaths and billions in economic costs. The FDA request for FY 2007 asks for $55.3 million for pandemic preparedness, an amount $30.5 million more than the FY 2006 level.
The FDA provides unique support to the recently launched National Strategy for Pandemic Influenza, a broad, multi-agency effort to better prepare the United States for any pandemic influenza. This federal response targets three primary goals: detect and contain outbreaks wherever they occur; ensure that federal, state, and local communities are prepared; and stockpile vaccines and antiviral drugs through accelerated development of new vaccine technologies and greatly increased US production capacity. Last December, when the Department of Health and Human Services (DHHS) announced its Pandemic Influenza Plan as part of the federal strategy, the ASM endorsed its priority of increased vaccine manufacturing capacity (enough vaccine for all Americans within six months of a domestic outbreak). At present, there are not nearly enough vaccines and antiviral drugs to meet federal goals. The ASM is concerned that adequate funding be given to the FDA, which will be a central figure in vaccine and antiviral development and manufacturing. Heightened output using new technologies will further burden the FDA’s product evaluation process, already stretched by research responses to emerging infectious pathogens like SARS and West Nile virus.
Scientists at the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) will shoulder much of the Agency’s growing vaccine and antiviral contribution towards pandemic preparedness. Researchers from the FDA and their private-industry partners will tackle the critical issues of expanding US capacity for traditional egg-based vaccine production, the technological transition to cell-culture-based vaccine production, and development of innovative vaccines and therapeutic drugs. Through the FDA’s Critical Path Initiative to get products to market more quickly, accelerated approval can help expedite the federal stockpile of vaccines and antivirals needed to counter pandemic influenza.
The FDA not only assures the safety and efficacy of new products, but agency personnel also provide technical support to manufacturers from laboratory to market. In early March, the FDA issued two sets of draft recommendations to aid manufacturers in developing vaccines, one for seasonal, one for pandemic influenza. Seasonal influenza is an ever present threat to American health and with pneumonia, it remains the leading infectious cause of US deaths. The two guidances also address some promising higher-output technologies for vaccine production, such as cell culture and recombinant manufacturing. The scientific advances from the FDA’s influenza activities will undoubtedly heighten protection against infectious diseases in general, as well as production of antiviral vaccines and drugs in particular. Efforts by the influenza preparedness programs also will improve the safety of our national food supply. Scientists from the FDA are developing new methods to detect antiviral drug residues in food, while FDA communications personnel are creating public guidelines on food preparation in the event that avian influenza reaches poultry flocks in the United States.
Protecting America’s Health – Food Security and Safety
The FDA oversees about 80 percent of the nation’s entire food supply, with only the exception of meat, poultry, and some egg products regulated by the Department of Agriculture (USDA). Within the FDA, the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Regulatory Affairs are responsible each year for goods worth $417 billion in domestically produced foods and $49 billion in imported foods. In FY 2007, the agency’s Prior Notice Center is expecting to process daily up to 20,000 notifications of food import shipments. The FDA’s food safety efforts involve reams of regulations, constant laboratory testing with the latest methods, and field inspections of producers and handlers from among the 420,000 FDA-registered food establishments here and abroad. The Administration’s proposed FY 2007 budget requests about $450 million for the FDA foods program, an increase of $11 million over last fiscal year. Within this total, $178 million is earmarked for protecting our food against deliberate attacks, a $20 million increase over FY 2006.
The CFSAN conducts research typically not conducted by industry or other research agencies, which provides the basis for regulating the food-producing and processing industries to ensure a safe and nutritious food supply from farm to table. It provides the scientific basis for nutrition labeling regulations and guidance, identification of foodborne pathogens, the development of mitigation and prevention strategies, as well as identifying and recommending the adoption of innovative technologies that reduce public health concerns related to foodborne pathogens. The ASM is concerned with the proposed $5.2 million reduction for the CFSAN in FY 2007, and the redirection of resources from base programs that includes cuts to the CFSAN’s research program and the loss of 64 full-time employees (FTE). With the current increasing trends in importation of produce, the FDA needs to strengthen its role in this area, including better sampling and real-time microbiological testing procedures, and more inspectors to provide a greater assurance of public health protection.
Protecting the nation’s food supply from bioterrorism is one of the FDA’s priority initiatives for FY 2007, specifically through improved prevention strategies and plans, advanced screening methods to detect microbial food contamination, and outreach to industry, state, and local stakeholders. The FDA’s Food Defense Initiative is part of an interagency strategy involving the Department of Homeland Security, the USDA, and other government entities. Because of countless possibilities for intentional and accidental food contamination, the ASM supports the aggressive measures taken by the FDA to inspect, detect, and prevent unsafe foods. For example, in FY 2005, the FDA conducted more than 86,000 import security reviews to identify any imported food and feed products that might be intentionally contaminated. Much of the FY 2007 budget increase would expand the FDA’s Food Emergency Response Network (FERN) and the Internet-based data exchange system used by health labs at all levels, the Electronic Laboratory Exchange Network (eLEXNET). FERN is a network of federal and state laboratories designed to guarantee the analytic surge capacity to respond to any attack on the US food system. By the end of FY 2006, the network will incorporate 10 federal and 10 state labs; the additional FY 2007 funds will expand the network into six more state labs. Funds also support related basic food defense research and other surveillance linkages among federal, state, and local responders.
Although impressive in its quantity, quality and diversity, the food supply system in the United States nonetheless remains vulnerable to accidental cases of foodborne infectious diseases. Health officials report that each year these diseases are responsible for an estimated 76 million illnesses, more than 300,000 hospitalizations, and 5,000 deaths. The USDA has estimated that each year the most common foodborne pathogens cost the US economy as much as $6 billion through direct medical costs (acute and chronic cases) and lost productivity. The ASM commends the FDA regulatory and research programs that address health risks related to foods, cosmetics, and animal feed and drugs, many of which involve microbial pathogens. Globalization of our food sources has diversified American diets, but it also greatly increases the possibilities for contamination as we eat more fresh produce, once-unfamiliar foods, and products from less-regulated import sources. Oversight of the new genetically engineered foods and recent dramatic growth in the diet supplement industry also stretches limited FDA food safety resources.
An estimated 118,000 illnesses occur each year in the United States due to eggs contaminated with Salmonella bacteria (Salmonella caused infections alone account for $1 billion yearly in direct and indirect costs). In 2006, the FDA expects to publish its final rule to the states and the egg industry to prevent Salmonella contamination during production, with the intent of reducing the annual human cases by at least 33,500. The agency uses on-going surveillance of US foodborne disease outbreaks to detect any incidents with products regulated by the FDA. It also has several emergency response plans to address sudden threats to food safety, for example, post-Katrina deployment to assess stored-food sources in the Gulf Coast, and the BSE Emergency Response Plan to quickly evaluate with the USDA any report of bovine spongiform encephalopathy in US cattle. For FY 2007, BSE research/detection will be one of the two highest-priority programs at the FDA’s Center for Veterinary Medicine, along with reduction of antimicrobial resistance in humans now linked to antibiotics fed to food animals.
Protecting America’s Health – Biomedical Frontiers
The new Critical Path to Personalized Medicine will be the FDA’s top scientific policy initiative for at least the next five years, created “to accelerate the field of personalized, predictive, and preemptive medicine.” Economic experts predict that by 2015 the United States will pay out about 20 percent of its gross domestic product on health spending. The FDA is seeking to more efficiently evaluate pre-market biomedical products. The critical path initiative is the Agency’s response to recent stagnation in new product development due to problematic clinical trials or manufacturing procedures that disallow approval FDA from the FDA. By using cutting-edge molecular biology technologies, the FDA expects to modernize the medical product development process with cooperation from private industry. These technologies also will enable scientists from the FDA to evaluate and encourage superior therapies personalized or tailored to individual groups of patients, reducing the time-consuming need to approve products for broad use and paving the way to less-expensive clinical trials and more effective drugs. The new molecular-based technologies also are expected to help predict which patients would benefit from a particular therapy and which might suffer ill effects. The ASM agrees with the FDA intent to stimulate private industry use of new generations of scientific tools, in order to expedite technology transfer and to help maintain US science-based competitiveness in an expanding global healthcare market.
The ASM strongly recommends an increased budget for the FDA, which would benefit its important programs and provided need resources for priority initiatives.