Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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February 7, 2000
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The President's budget request for the Food and Drug Administration in fiscal year (FY) 2001 (Oct. 1, 2000-Sep. 30, 2001) totals $1.39 billion, $175.9 million over the enacted level for the current fiscal year. The biggest part by far of the requested 14.5% increase is earmarked for initiatives to help make safe and effective products available in a more timely manner and to help ensure their highest level of safety once they have reached the market. The request includes a total of $202.6 million for existing and new user fees.
The requested budget is primarily focused on assuring continued product safety in the years ahead by strengthening the agency's scientific expertise, capacity and infrastructure, a goal designated by Commissioner Jane E. Henney, M.D. as a major priority for the agency.
Extensive investment in FDA's scientific core is essential for effective public health protection in an era when unprecedented technological progress, globalization of trade and widespread use of electronic communication are revolutionizing the food and health care industries and commerce.
In recent years, the pharmaceutical industry's burgeoning investment in research has resulted in the introduction of new classes of potent drugs and biotechnology breakthroughs; medical device technology has expanded beyond x-rays and CAT scans to embrace robotics, miniaturization and novel bio-materials; medical research has reached the threshold of gene therapy; and mushrooming imports and pharmaceutical outlets on the Internet are changing the consumption and distribution patterns of regulated products.
While these developments promise enormous benefits to patients and consumers, they also entail potential public health hazards that FDA can only prevent by making optimum use of state-of-the-art scientific know-how backed by adequate operating resources.
In 1999, FDA was successful in a number of areas.
In the pharmaceutical arena, the agency met or exceeded, for the seventh year in a row, virtually all of the demanding goals of the Prescription Drug User Fee Act. Infusion of these additional resources has enabled FDA to reach such a high level of product review efficiency that the United States has become the country of choice for the introduction of new drugs and biologics developed world-wide.
To protect the nation's food supply, FDA and the collaborating federal, state and local agencies last year completed all three milestones in the planning of a nationally integrated food safety system: created a coordinating body, established work groups, and solicited input from stakeholders. In addition, FDA developed a method to detect as many as 13 foodborne pathogens from one sample to facilitate faster removal of potentially dangerous foods from the market. The funding support to date has allowed for mechanisms that have been remarkably successful. Several outbreaks of foodborne illness have been mitigated, resulting in fewer deaths and illnesses.
Overall, FDA has continued its modernization and streamlining program. The agency accomplished many of the tasks identified in the Statutory Compliance Plan, a part of the FDA Modernization Act that had been developed in close consultation with the agency's stakeholders, and achieved particularly good results in improving its science and analytical base for regulatory decisions. FDA has also taken many important steps to maximize the availability and clarity of information about new products and its review processes.
To keep abreast of the relentlessly growing challenges of new technologies, expanding and changing demographics, and the emergence of new viruses and other public health risks, FDA needs additional resources to support continued strides forward. The FY 2001 budget request is designed to make such advances possible by including many initiatives to enhance the agency's scientific and physical capacity, including the following program upgrades:
Bringing new technologies to market: +$22.9 million, 63 full-time employees (FTEs). As new technologies and products emerge at an increasingly rapid rate, FDA has to make prompt regulatory decisions to avoid delays that could postpone the availability of critically needed treatments, especially for our growing population of the elderly and for immune-compromised patients.
FDA's request would be used to strengthen its science base and increase the efficiency of the premarket application review program by enhancing the agency's ability to evaluate any potential risks associated with new biotech foods; expedite reviews of generic and animal drugs; improve the safety of children's vaccines and the quality and safety of the blood supply; work to reduce the risk and severity of influenza; and step up reviews and develop safety and effectiveness standards for the re-use of high-risk medical devices.
Internet drug sales: +$10 million, 77 FTEs. The Internet's great potential for enhancing legitimate commerce and service to consumers is being abused by unscrupulous individuals who sell drugs online in violation of public health laws. Patients who buy prescription drugs from such Websites are at an increased risk of side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients in unapproved medicines.
Because these illicit sales are growing at a rapid pace, FDA during the first quarter of FY 2000 reassigned part of its investigative staff from other priority efforts and devoted over 30,000 staff hours to probe hundreds of unlawful Internet drug outlets. In FY 2001, FDA's goal is to reduce the illegal promotion, sales, and distribution of prescription drugs on the Internet while conducting a public education campaign to help consumers shop for pharmaceuticals from ethical online outlets. The agency plans to use the latest hardware and software to identify the pharmaceutical Internet sites that pose the greatest threat, and support a rapid response team to put them out of business. FDA would also continue working with the U.S. Customs Service, the Drug Enforcement Administration, and the U. S. Postal Service to monitor drug imports coming into the country from all sources.
Medical errors: +$12.8 million, 25 FTEs. A recent study by the Institute of Medicine estimates that up to 100,000 Americans may be dying each year as a result of preventable medical errors occurring within the complex modern health care system. Estimated costs for these medical errors is as high as $80 billion a year. While most medical errors involve health professionals and the use of medical products, FDA's role is to improve patient safety by eliminating features that contribute to these mistakes. The agency's Adverse Event Reporting System (AERS), is designed to carry out three tasks: receive adverse event reports from hospitals, physicians and others in order to find harm resulting from pharmaceuticals; enable the agency to understand such harm through expert safety analysis; and trigger FDA action when necessary to prevent more harm by informing or warning health professionals and patients.
The FDA's adverse event reporting systems receive more than 300,000 reports a year, but require information technology enhancements for the data to be promptly sorted and analyzed. The requested funds would enable FDA to build more capacity for product monitoring across the agency, strengthen its potential for multi-factor adverse event analysis, and improve the agency's risk communication to health care providers and patients.
AERS for dietary supplements ($2.5 million, 2 FTEs) and animal drugs ($0.6 million, 3 FTEs). Dietary supplement sales have nearly doubled in the past five years to $12 billion a year and are expected to nearly double again by 2006. These products are not subject to FDA's review and approval for safety and effectiveness, and their manufacturers are not required to report adverse events associated with their use. FDA has to be prepared to track any adverse events reported to the agency in order to protect the mushrooming number of Americans who rely on dietary supplements to enhance their quality of life and health.
One essential requirement is to include dietary supplement adverse drug events in a modern, integrated science-based system for monitoring and evaluation.
The agency also needs to increase the document processing staff and provide better maintenance and enhancements for AERS Oracle database for animal products surveyed by FDA's Center for Veterinary Medicine. FDA receives annually 12,000 adverse event reports involving 1,200 animal medications and feeds and at present has a backlog of 6,000 such reports waiting to be evaluated.
Inspectional activities: +$13.5 million, 89 FTEs. FDA's ability to physically verify the safety of domestic and imported products in recent years has considerably eroded in all product areas, falling significantly short of the minimum inspection obligations required by the FDA Modernization Act.
Even in conjunction with its State regulatory partners, FDA is able to annually inspect less than a third of the domestic firms in its purview. Import entries have skyrocketed from 1.5 million in 1992 to 5.5 million in 1999, including a 14% increase in FY 1999. Less than 1% of import entries are physically examined by FDA inspectors. The number of FDA or FDA-contracted domestic and foreign inspections for foods, drugs and devices -- excluding the user fee-supported mammography -- has decreased 21% since 1991, while the consumption and use of these products has increased exponentially. The requested additional funding, if approved, will prevent further decline in FDA's inspectional effort.
Buildings and facilities: +$20 million. FDA's Los Angeles District annually reviews nearly 1.2 million import line entries, (almost 24% of the agency's total). Built in 1961, the laboratory that carries out this critical function is in dilapidated condition and located in a high crime area. Previous appropriations have provided sufficient funds for the purchase of land and design of a new building for the lab and the district office. The funds requested this year would cover the first construction phase and avoid shifting the lab work to other laboratories away from the port of entry, which would delay the product reviews and increase the cost of the program. The request also includes a proposal for advanced funding of $23 million for FY2002 for the final phase of the construction.
Food safety initiative: +$30 million, 131 FTEs. The President's Food Safety Initiative is a long-range, inter-agency program based on a working partnership among FDA, Centers for Disease Prevention and Control (CDC), U.S. Department of Agriculture, states, academia, industry and consumers. FDA's request for FY 2001 would, among other things, ensure annual inspections of high-risk food establishments and enhance the supporting laboratory analyses; work with states to implement audit programs to ensure consistent application of regulations and develop consistent nationwide food safety standards; implement the Hazard Analysis Critical Control Point system for fruit and vegetable juices; develop and evaluate on-farm intervention strategies and/or technologies to improve testing methodologies for Salmonella Enteriditis; and complete the National Antimicrobial Resistance Monitoring System by adding national and international data collection sites.
Countering bioterrorism: +$11.5 million, 26 FTEs. FDA is in a unique position with regard to antibioterrorism activities. FDA is the pivotal point that makes it possible for the Centers for Disease Control, Office of Emergency Preparedness, Department of Defense and others to carry out activities in the Department-wide antibioterrorism initiative. Every drug, therapeutic, vaccine, anti-toxin administered to humans, every diagnostic tool used clinically must have already been reviewed and approved by FDA. This means that in the event of a bioterrorist attack, the pharmaceuticals, the rapid diagnostics and the vaccines to be used must have already completed the FDA review process for safety and efficacy. Thus, the success of the antibioterrorism initiative depends on FDA's involvement.
Proposed new user fees: +$19.5 million, 108 FTEs.
Seafood inspection transfer: +$12.7 million, 139 FTEs. FDA is requesting the transfer of the Seafood Inspection Program -- currently under the Department of Commerce -- which is funded by $12.7 million in fees paid by the seafood industry for services. The program provides voluntary inspections and certification services for fish and fishery products.
Current law user fees: +$5.2 million, 45 FTEs. User fees authorized by current laws include $149.3 million under the Prescription Drug User Fee Act (PDUFA), $15.1 million under the Mammography Quality Standards Act (MQSA), export certification fees of $1.5 million, and certification fund of $4.5 million and includes increases for federal payraise and inflation.
Other requested increases: +$14.8 million. The agency estimates that it will need an additional $5 million to increase leveraging contracts with state and local stakeholders to conduct more checks on compliance with FDA's rule to protect youth from the use of tobacco; $5 million to move the Center for Food Safety and Applied Nutrition to the new facility in College Park, MD; and $4.8 million to cover the increased rent charged by the agency General Services Administration.
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