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Challenges FDA faces in the New Century

Statement of

Bernard Schwetz D.V.M, Ph.D.
Acting Principal Deputy Commissioner
Food and Drug Administration


the Subcommittee on Agriculture, Rural Development, and Related Agencies
Senate Committee on Appropriations

May 10, 2001


Mr. Chairman, members of the Committee, my name is Bernard Schwetz and I am honored to be sitting before you today. As the Acting Principal Deputy Commissioner for the Food and Drug Administration, I appreciate the opportunity to discuss some of the accomplishments, as well as the challenges FDA faces in the new century. It's fair to say that this new century presents FDA with unprecedented challenges:

  • the rapid transformation of the science and technology that generates the products FDA must regulate;
  • increasing expectations of consumers with changing demographics and consumption habits to easily obtain medical and risk-related information;
  • the expanding and evolving composition of global trade and production; and,
  • emerging public health threats.

The United States is leading the world into an era of scientific achievements that can yield unprecedented gains for human health and nourishment. Industry's research and development pipelines abound with blueprints for hundreds of new and innovative products and processes that can literally transform life's experience, as we have known it. Such marvels of science as cell and gene therapy; genomics-based drugs; surgical robotics; and bioengineered plants and animals are in sight or within our grasp, and their potential for saving lives, improving the quality of life and enhancing the economy is enormous. But it also must be recognized that their potential for harm is enormous, if these new technologies are not appropriately overseen by individuals who understand them as well as by their proponents.

For many of these revolutionary products, the greatest hurdle is not in the realm of technology, but in the consumers' distrust of their dramatically different performance and features. The critical task of overcoming this formidable obstacle at the onset of the new age of technology is one of FDA's greatest challenges. The public expects that food set on the family table will be safe and wholesome; that new medical products, drugs, biologicals, and medical devices, available in a timely manner, will have demonstrated real benefits that outweigh their known risks; and, that the product information will be useful and understandable. To meet such high expectations, FDA must continually earn and re-earn, with each new technology, the trust of consumers. Day-in and day-out, this proud Agency must prove that it is up to this daunting challenge. A most recent example involves our efforts to manage the threat of Bovine Spongiform Encephalopathy (BSE or "mad cow disease") that has cost the European community billions of dollars, almost 100 lives, and has undermined the trust of Europeans in their governments.

A recent survey of five Federal regulatory agencies conducted by the Pew Research Center and Princeton Research Survey Associates, found that from 72 to 85 percent of consumers, health professionals, patients, and industry representatives said they trusted FDA to make the right decisions. The results placed FDA at the top of the survey's charts, with an overall favorable rating above 80%, more than twice the approval rate of government agencies in general. While we take great pride in such numbers and what they represent, technology is moving too swiftly for us to be content.

Each year presents even more challenges for FDA. Issues are increasingly complex and the breadth of FDA's responsibility ever expanding.While many of our constituents primarily focus on the product marketing application review process, it has become increasingly clear that FDA's eye must be equally focused on the full life cycle of all the products we regulate – post market as well as pre-market activities and developments. The changes and challenges facing us were never so apparent then when the successful mapping of the human genome was announced late last year. This has brought us to the threshold of a frontier that promises to transform the diagnosis, treatment and even prevention of diseases that today still cripple many in our society. Francis Collins, Director of the National Human Genome Research Institute at NIH, recently made a number of predictions about where genome research could lead in the next three decades. His forecast for the next ten years includes such things as genetic tests for a dozen medical conditions, and preimplantation genetic diagnosis, with primary care physicians practicing genetic medicine. There are hundreds of genetic tests under development and available in the United States. Only eight have been submitted to and approved by FDA. In 20 years, Dr. Collins predicts the availability of gene-based designer drugs to treat diabetes and hypertension, and cancer therapy precisely targeted to a tumor’s molecular fingerprint. For FDA this means coordinating drug and genetic diagnostic development hand-in-hand. In 30 years, it’s likely that comprehensive genomics-based health care will be the norm. Products will need to evolve from the research laboratory to well characterized therapeutics with established safety and effectiveness. To make these critical judgments, requires that FDA scientists remain on the leading edge in their specific scientific disciplines.

Substantial resources are needed to carry out FDA's mission. Research expenditures by the pharmaceutical industry alone have more than tripled since 1990. More and more complex products, which arrive at FDA's gate for preclinical and clinical studies design consultation, for marketing application review, and, for post-approval continuing reassessment are products of the growing NIH research budget and of academic and industry research fueled by NIH. We will ensure that FDA will not become a bottleneck in getting these public health breakthroughs to the public while serving as the trusted, independent, efficient gatekeeper it is now. Today, I would like to highlight some of FDA’s many accomplishments of the past year that impact all Americans and touch on the new and challenging responsibilities of the twenty-first century.


Over the course of the past several years, with your support, the FDA has made great strides in improving the safety of the nation's food supply. Through a food borne illness surveillance system known as FoodNet (partially funded through FDA), the CDC has documented reductions in food borne illness for a number of important food pathogens. These reductions reflect the hard work of not just FDA, but other Federal agencies, and our state and local counterparts.

The FDA has always maintained that the strength of our regulatory program comes from the underlying science base. Last winter, we published two draft risk assessments addressing listeria and vibrio parahemalytics and we have since held public meetings to hear public reaction to them. These risk assessments are also enabling FDA to play a leadership role internationally.

The safety assessment of antimicrobial drugs for use in food-producing animals includes monitoring for the development of resistance. Monitoring is done through the National Antimicrobial Resistance Monitoring System (NARMS), which was initiated in l996 as collaboration between the FDA, the Centers for Disease Control, and the United States Department of Agriculture. Its purpose is to prospectively monitor the antimicrobial resistance of human, animal, and animal product isolates of selected enteric bacteria. NARMS data have been used to initiate field investigations of outbreaks of illness marked by a pathogen which displayed an unusual antimicrobial resistance pattern; assess the human health impact of fluoroquinolone use in poultry; stimulate research in molecular characteristics of resistance emergence and transfer; and, improve our knowledge of risk factors associated with the development of an antimicrobial-resistant infection. NARMS data have also triggered broader research projects of prudent antimicrobial use in animals and in the role of the environment in the emergence and spread of antimicrobial resistance.


During this past year, FDA’s three major human medical product centers, the Center for Drug Evaluation and Research, (CDER), the Center for Biologics Evaluation and Research, (CBER), and the Center for Devices and Radiological Health, (CDRH), demonstrated strong scientific expertise and efficiency by reviewing over 17,100 marketing applications for drug, biologic, and device products. The outcome of these reviews was that approximately 16,600 total products were found to have the required scientific data for approval for marketing in the United States. Of these, there were 160 approvals of medications and medical devices that had never previously been marketed in any form in the USA. Many of these approvals represent an impressive advance in the prevention, diagnosis and treatment for serious and life-threatening diseases.

Groups that particularly benefit from these approved medications and medical devices include cancer patients, patients with heart disease, children, women, and the elderly. In addition, FDA's approvals strengthened surgical flexibility with several state-of-the-art devices that reduce the risks of complex surgical procedures.


Several products approved contributed to the prevention, early diagnosis or treatment of cancer, the second deadliest disease in the United States affecting eight million Americans. Two of the new cancer medications, Trisenox and Mylotarg, were approved for cancers of the white blood cells. For women, Nolvadex (tamoxifen citrate) was approved last year for a new use to reduce the risk of invasive breast cancer with preinvasive cancer of the mammary ducts.

Three of the cancer treatments approved were medical devices. A laser system was approved that enhances a physician's ability to distinguish small harmless growths from pre-cancerous growths in the colon. A surgical sealant was approved for sealing air leaks in lungs following the removal of cancerous tumors. A third device, for early cancer diagnosis, is the first mammography system that produces digital images on a solid-state receptor instead of analog images on a radiographic film. Early diagnosis remains the best weapon against breast cancer, which annually affects 180,000 women -- of which approximately twenty-five percent die of the disease.

An example of the cutting-edge research currently being conducted that will transform the way we diagnosis and treat cancer is the FDA/NIH Tissue Proteomics Program which is the only one of its kind in the world. This joint effort of CBER and the National Cancer Institute (NCI) focuses on the development and use of proteomic tools for the early detection of cancer and other diseases. The project’s accomplishments include the development of methods for early disease detection, the identification of new therapeutic targets and the discovery of new biomarkers for drug-induced patient toxicity. This bench-to-bedside model has resulted in a first-of-its-kind clinical trial that incorporates a “proteomic portrait” of the disease in human tissue that could lead to customized, patient tailored therapeutics. Currently, this research has identified over 150 proteins that are aberrantly expressed in human prostate, lung, breast, ovary, esophageal, and colon cancer. Furthermore, a new artificial-intelligence computer software system has been invented and developed to reveal protein patterns that can be used as surrogate markers of therapeutic efficacy, toxicity and early disease detection.

This is but one example of the work being conducted also at CDER, NCTR, and CFSAN concerning predictive modeling and standards modification using common databases and computational science.


Several new products approved last year for pediatric and obstetric use were either specifically designed for the youngest patients or were adult drugs now approved also for use in children. Approvals included: the OxiFirst Fetal Oxygen Saturation Monitoring System, which represents the first major technological development in fetal monitoring in three decades; Prevnar, a pneumococcal vaccine for infants and toddlers under the age of two which was designed to prevent invasive diseases caused by Streptococcus pneumoniae, including bacteremia, an infection of the blood stream that affects about 35,000 infants and toddlers in the U.S., and meningitis, an infection of the lining of the brain or spinal cord that is diagnosed in about 17,500 infants a year; and, Pulmicort Respules (budesonide inhalation suspension), the first anti-inflammatory corticosteroid formulated for inhalation using a nebulizer in the 1- 8 year-old age group.


FDA approved several other products to treat diseases that either exclusively or predominantly affect women. Remicade (inflixmab) was approved for the reduction in signs and symptoms of rheumatoid arthritis, which affects more than 8 million Americans, three-fourths of whom are women. Another approval was Novantrone, for the treatment of advanced or chronic multiple sclerosis. The disease affects up to 350,000 Americans, 66-75 percent of whom are women.

FDA also continued successfully working with the states and the American College of Radiology to monitor mammography facilities. This successful partnership helps assure high quality mammography services to women.


Examples of new products for patients with heart disease and the elderly include several novel devices and important medications. Two of the devices use catheters to deliver radiation inside a coronary stent following the reopening of a blocked artery. The radiation helps reduce the risk of new tissue growth inside the coronary stent and the resulting repeated narrowing of the artery. Among the products designed primarily for the elderly, Visudyne (verteporfin for injection) is the first therapy to slow vision loss in people with the classic type of "Wet Age-Related Macular Degeneration.


FDA has recently approved the first minimally invasive glucose meter (the Minimed System) for use in monitoring patients with diabetes. Most recently, FDA has approved the first non-invasive device used to detect trends and track patterns in glucose levels in adults. The device is used together with finger prick blood tests to monitor glucose blood levels. FDA and industry scientists need to continue to work together to make sure that the accuracy of the new devices is high enough for reliable home use.


Another important product that passed the FDA's rigorous review for safety and effectiveness last year included the first drug of a new class of antibiotics that addresses treatment for the emerging serious public health threat of vancomycin-resistant bacterial infections.


Finally, I am happy to report the approval by our Center for Devices and Radiologic Health of a promising new surgical system that incorporates cutting-edge robotics technology.

These products are only a small sample of the new drugs, biological products and medical devices the agency approved last year in its role of public health promoter. In addition, CDER issued 244 approvals of generic counterparts of original drugs. Generic drugs substantially reduce the cost of purchasing pharmaceuticals by typically offering price discounts from 50% to 75%. Similarly, CDRH cleared for market almost 3,500 so-called 510 (k) devices, products that are similar to devices already on the market.

In addition to approving a host of important new medical products in 2000, FDA has continued not only to meet - but also to exceed - virtually all of its product review and product development consultation performance goals under the Prescription Drug User Fee Act (PDUFA). For example, for the fifth straight year, FDA reviewed 100% of PDUFA marketing applications within the time frames agreed with Congress. Because of this review efficiency and thoroughness, last year, FDA approved 20 products classified as priority drugs -- drugs that have a real benefit beyond existing therapies -- in the median time of only 6 months. Moreover, although PDUFA goals specify review times and not approval times, actual approval times (FDA review time plus the time it takes companies to answer deficiencies identified by FDA) have decreased around 60% since the program started.


Each year more than 3 million Americans receive donated blood. While blood and blood-derivatives can be life saving, they can transmit undetected infectious disease. Assuring the safety of and preventing shortages in, the blood supply continues to be one of FDA's priorities.

Tissues have long been transplanted in medicine for widespread uses such as skin replacement after severe burns, tendons and ligaments to repair injuries, heart valves to replace defective ones, corneas to restore eyesight, and the use of human semen and implantation of eggs to help infertile couples. In recent years, scientists have developed new techniques, many derived from biotechnology, that enhance and expand the use of human cells and tissues as therapeutic products. These new techniques hold the promise of some day providing therapies for cancer, AIDS, Parkinson's Disease, hemophilia, anemia, diabetes, and other serious conditions. A GAO report, published in December 1997, supported strengthening requirements for tissue establishments. In January 2001, the Office of Inspector General published two reports, "Informed Consent in Tissue Donation, Expectations and Realities", and "Oversight of Tissue Banking". The latter report recommended that FDA expedite the publication of its regulatory agenda that requires registration of tissue banks, enhanced donor suitability screening and testing, and the use of good tissue practice. It also recommended that FDA increase the number of inspections of tissue establishments performed to enhance oversight.

FDA strengthens its public health promotion role in many other ways such as (1) refusing to approve products not shown to have real benefits that outweigh their known risks; (2) assuring adequate information on appropriate use for approved products; and, (3) monitoring and continually reassessing new data that are developed after products go on the larger general market in the U.S. Last year, FDA also issued 125 draft and final guidance documents to clarify requirements and facilitate industry's compliance with FDA's product efficacy, safety and quality standards.


FDA has also worked closely with international organizations to harmonize requirements and standards for the products we regulate. This work recognizes not only the international nature of our regulated industries but also our collective need to share expertise concerning new products in both the pre- and post-approval phases across all borders.

FDA is the recognized gold standard. Our regulatory approaches are often cited by officials in other countries. For example, in the wake of recent European food crises, including BSE and dioxin in meat and dairy products, European Commission President Romano Prudi advised the European Parliament that one way to prevent more food crises in the future would be to establish a European food agency modeled on the FDA. Numerous foreign delegations have visited FDA over the past year to discuss food safety regulation.

FDA is a leader in international food safety harmonization efforts through the Codex Alimentarious, and has worked with WHO and FAO to increase the profile of food safety issues around the globe.

In the area of drugs and biologicals, we now have more than 50 guidances that have been agreed-upon by FDA, its counterpart agencies in the European Union, Canada, and Japan, and the innovator drug and biologic industries in these countries. These guidelines cover very specific topics regarding drug and biologic pre-clinical and clinical testing, manufacturing, post-approval continual reassessment and regulatory submissions. One major advance in this effort has been an agreement on the content of periodic safety updates on approved products. With this agreement, we can now be assured that regulators in those regions will be able to receive the same safety information at the same time about products being marketed in their countries. In addition, we have agreed on electronic format and transfer standards to facilitate and to make even more efficient the electronic transfer of safety information between companies and regulatory agencies in these regions.

This terminology allows even more efficient and more accurate transfer of new post-approval safety data around the globe and facilitate better, more informed public health decisions about the ongoing safety profile of marketed products. Most recently, through this process, known as the International Conference on Harmonization (ICH), we have reached agreement on "A Common Technical Document" that will standardize the format for the major portions of a marketing application across these regions. With such a core document, a pharmaceutical or biologic firm seeking approval of a product in one or more of the participating countries will be able to submit essentially the same document to each country. The influence of ICH is now spreading even beyond the original regions as other nations build their regulatory infrastructures and use the ICH guidances as their own standards.

We've also made progress in the realm of international harmonization of medical devices. Along with our counterparts from the EU, Japan, Canada, and Australia, we are developing protocols that will permit harmonization among these five entities and their regulation of medical devices.

In the spirit of transparency, FDA's website, launched in 1995, provides another essential way of exposing the agency to the public we serve. Materials posted on the web include materials to be discussed at upcoming advisory committees, enforcement actions, talk papers, speeches, and educational information. Our website has received numerous awards from such quarters as Popular Science magazine, the Dow Jones Business Director, and Tufts University's Nutrition Navigator. Moreover, it is linked to 8,000 other health, consumer, medical, and educational websites.

These kinds of activities help prepare us for the global environment in which most of the products we oversee now exist. This helps us to more successfully bridge differences in government, language, and culture. In short, they prepare us for what is to come by providing a blueprint for harmonization around the world. This globalization of product development, testing, and ultimately trade, further highlights the need for a strong and robust FDA. As trade agreements and policies are negotiated, the maintenance of strong public support requires that a scientifically strong regulatory agency have a forceful voice in those discussions on matters that will affect the health of the American public.


Despite the significant strides made in the public health arena over the past few years, FDA faces formidable challenges in the near future. I would like to highlight some of these for you today. FDA's FY 2002 request totals $1.414 billion, an increase of $123 million over FY 2001. The increases over FY 2001 are targeted to specific initiatives to include: funds to prevent the spread of mad cow disease; to expand food safety activities; and, to protect human subjects in clinical trials. In addition, of the funds requested, $204 million will be derived from industry-specific user fees, including $20 million in new fees for food export certificates and import operations.


Cutting edge science and technology are providing us with new opportunities and challenges every day. Over the past few decades we have seen large investments by both the public and private sector in biomedical research and biotechnology that will result in the development of an abundance of new products that need to be assessed before entry into the marketplace and during their use. As these products enter the marketplace, they should change the very face of health care in America and should help us all lead longer, healthier lives. They should also bring enormous economic benefits by reducing the cost of health care. Having a high performing, science-based regulatory agency to render decisions regarding the safety and efficacy of these products reaps great public health benefits for all of us.

In FY 2002, FDA requests $40,000,000 to fund mandatory pay-related increases. This increase for base resources focuses on pay adjustments because personnel are so essential to accomplishing the Agency's mission. These resources will enable FDA to maintain current levels of performance, and to continue to improve the drug review process. Payroll increases are needed to cover about half of the staff involved in the drug application review process not supported by PDUFA user fees; to improve the ability to assure the safety of regulated products; to inspect and investigate domestic and foreign manufacturers; and, to participate in Mutual Recognition Agreements with countries to establish global standards for foods and pharmaceuticals. We need now, more than ever, your continued support to assure FDA is ready to respond to these challenges.


BSE is one of a group of progressive degenerative neurological diseases known as transmissible spongiform encephalopathies (TSEs). BSE is a TSE of cattle. TSE diseases are always fatal. There are six TSE diseases that affect humans, of which Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) are best known. vCJD is believed to be transmitted to humans by the consumption of food products contaminated with the agent of BSE.

Since the BSE epidemic began in 1986, more than 176,000 cases of BSE have now been confirmed in Great Britain. To date, over 90 human lives have been lost in Europe due to vCJD. Now cases of BSE in cattle have also been reported in other European countries. Here in the United States, we have been fortunate. To date, BSE has not been detected in our cattle herds and we have not had any patients diagnosed with vCJD. Based on the UK experience, if BSE were to be encountered in the US, it would have not only an obvious potential impact on our public health, but also a monumental impact on our beef industries, with initial US revenue losses estimated to reach over $15 billion. To protect consumers, it is essential to implement and monitor a multi-layered safeguard system to ensure that BSE regulations and guidance principles are followed. BSE has a potential impact on many biological products such as vaccines, cells or cell-derived products, and blood. It is important for the FDA to have an active research, review and inspection program to assure product safety.

Bovine-derived materials have traditionally been used in the manufacture of many biological products, including vaccines. To date, there are no reports of BSE contamination of pharmaceutical or biological products. To minimize the possibility of contamination in such products, the FDA recommended in the Federal Register on August 29, 1994, and again in 1996, that manufacturers not use materials derived from cattle that were born, raised, or slaughtered in countries where BSE is known to exist. The FDA referred manufacturers to the listing of such countries that is maintained by the U.S. Department of Agriculture.

In addition to FDA's regulation which prohibits the feeding of mammalian protein to ruminant animals, the Animal and Plant Health Inspection Service (APHIS), of the United States Department of Agriculture, has placed restrictions banning the importation of live ruminants and certain ruminant products from thirty-one countries. FDA, in conjunction and cooperation with APHIS, has issued a series of import alerts and bulletins regarding products, which FDA regulates. Many products regulated by FDA contain these banned substances and it is important to enhance and make as comprehensive as possible our BSE monitoring system to identify products that may pose a health risk and ensure they do not enter the US. FDA has also issued guidelines to Blood Centers to exclude potential donors who have spent six or more cumulative months in the U.K. between January 1, 1980 and December 31, 1996, from donating blood. At the Transmissible Spongiform Encephalothies Advisory Committee (TSEAC) in January 2001, the Committee recommended the deferral of donors who lived in France, Ireland or Portugal for a period of ten years between 1980 and the present. We need to continue to monitor BSE activities and revise our current policies as needed based on new information.

The focus for FDA and its partners in other agencies has been prevention. Using the best science known at this time, the U. S. has an aggressive multi-faceted program in place to try to prevent the establishment and spread of BSE. The Agency has committed to inspecting 100 percent of all feed mills, plus re-inspections of those establishments not in compliance by the end of FY 2001. Within the planned resources, this would have been impossible. FDA has looked internally at several other sources to redirect to BSE needs. We have tapped into the FDA contingency fund for the first time in several years plus moved priorities within the field portion of the Animal Drugs and Feeds program. BSE is a high priority, and the Agency is working to meet its commitments.

To prevent exposure of American citizens and food animals to the agent of BSE, the Agency is requesting $15,000,000 in FY 2002 for needed BSE activities. With this funding, FDA will increase monitoring of imports to ensure prohibited materials do not enter the United States; conduct targeted BSE inspections of all renderers and licensed and non-FDA licensed feed mills handling prohibited material, such as meat and bone meal on a yearly basis; provide training to federal and state inspectors on the current BSE situation; conduct market studies to identify food, dietary supplements, and cosmetic products containing spinal cord and other at risk products; conduct research on Chronic Wasting Disease (a TSE), which affects elk, deer, and other domestic game and pen-reared animals in the United States; and, conduct follow-up education on for-cause inspections of biological products, blood, and vaccines.


FDA is responsible for ensuring the safety of products produced and distributed by more than 100,000 domestic establishments. The Agency uses its inspectional authority, as directed by statute, to provide this assurance. For many establishments, the law requires FDA to conduct inspections at specified time intervals, such as once every two years. Resource constraints over the past several years have seriously impaired FDA's ability to meet its statutory biennial inspection requirements. By FY 2002, FDA will be responsible for ensuring the safety of almost 7 million line entries of imported products that cross our borders annually. The sources of many of these entries are diversified and include an increasing number of products from countries that are typically categorized as emerging economies, with developing regulatory infrastructures. FDA conducts sampling and end point product testing as a means of determining that imports have been properly produced.

To restore this seriously impaired capacity, FDA must increase foreign and physical port inspections and oversight of foreign producers to be able to maintain the safety of products on the market that we believe Americans expect and demand, additional funding of $25,000,000 is requested for imports and inspections. This includes $10,300,000 in budget authority and $14,700,000 in new import user fees. With this funding, FDA will increase inspections of domestic medical device manufacturers; surveillance of imported tissues and other imported biological products; sample analyses of domestic and imported drug products; criminal investigation of fraudulent drug imports; and, sample collection, analysis, and field exams of imported foods and dietary supplements. This increase will also allow us to improve public confidence in the standards of drugs, biological, and device products imported from the European Union, and intensify drug inspections in developing countries. FDA plans to expand import entry review resources to keep pace with the increase in line entries and modernize the OASIS import data processing system to provide import reviewers with more rapid and direct access to information necessary for entry decisions.

Inspections and import surveillance are the primary means of assuring the safety of marketed products. Consumers rely on the FDA to prevent dangerous and unreliable products from entering into commerce. Despite a decrease in the overall number of inspections, in FY 2000, FDA conducted 880 foreign inspections, which represented a twelve- percent increase over FY 1999. However, FDA physically examined less than one percent of all entries offered for import into the United States. While the FDA continues to undertake initiatives to improve the safety of imported products, there is often no substitute for physically examining these products.


FDA is responsible for ensuring that the benefits of approved products continue to outweigh their newly discovered risks after product approval. Historically, the Agency has primarily relied upon a voluntary, passive reporting system in which consumers, manufacturers and health professionals submit reports of suspected adverse product reactions to FDA or the manufacturers of the products who then, by regulation, must submit the reports to FDA. This voluntary system was designed primarily to signal the possible existence of new rare, but serious, side effects of marketed products, which are most often of a frequency that they could never be detected in routine clinical trial programs because of the size limitations of most product development clinical trial programs. About 1-3% of the total number of products approved each year have had to be removed later because of rare, but serious, new side effects discovered through this system. Each year FDA receives more than 350,000 of these kinds of reports of suspected product adverse reactions. These reports must be investigated, analyzed and acted upon promptly. While we have invested heavily in making this system more efficient, there are areas of post-approval product injury of which we believe we should be focusing to improve our abilities to make medical products safer.

For example, not all safety issues relate to direct toxicity of the medical product. Some product related injuries are the result of inappropriate use or erroneous use of the product, which, if it had been used properly would not have resulted in injury. The Department of Health and Human Services established a Patient Safety Task Force to integrate the collection of data on medical errors - including medication errors- to coordinate research and analysis efforts and, to collaborate on reducing the occurrence of injuries that result from medical errors. The task force's goal is to reduce medical errors by fifty percent over five years through the development of a coordinated, easy to use, confidential reporting system which will minimize the burden of reporting suspected medical errors or conditions that might result in medical errors. Biological product safety is also of concern, including vaccine safety, infectious disease risks, and blood and tissue safety to name a few.

To meet some of these challenges, FDA is adopting a systems approach, of which the most significant component is the identification of and response to adverse events that are reported in the U.S. With an increase in funding of $10,000,000, FDA plans to hire staff to analyze and evaluate the adverse event reports and determine appropriate responses; speed the identification and reporting of adverse events by enhancing existing data systems and linking them with other health care databases for reports involving medical devices, drugs and biologics; educate consumers and health care professionals on the importance of preventing and reporting medical errors; and, initiating a modernized AER system for dietary supplements. FDA plans to increase the number of annual inspections of clinical trials by more than 20 percent with an emphasis on high-risks trials.

Many patient deaths and injuries are associated with the use of FDA-regulated medical products. In medical devices, we estimate there are about 300,000 injuries related to device misuse annually, and we believe most of these errors are avoidable user errors that could and should be corrected. The FDA believes that roughly half of these deaths and injuries can be avoided by fully implementing its strategies. Thousands of lives and billions of dollars can be saved.


FDA is responsible for protecting patients involved in clinical trials, and ensuring that the data gathered from these trials concerning the safety and effectiveness of a product are accurate when included in the product application. To do this, FDA inspects stakeholders in all areas of the clinical trial process -- manufacturers, clinical investigators, institutional review boards (IRB), and contractors to ensure that the data FDA receives are accurate and reliable.

Enhanced protection for human research subjects becomes more complex not only with the increasingly complex nature of the products being tested, but also with the increasing complexity of the design of clinical trials, the numbers of research projects and study volunteers and the diversity of patient populations included in clinical trials increases. The death of a volunteer subject in a gene therapy study has triggered considerable public concern in this area.

Gene therapy involves the treatment of genetic diseases by trying to replace a defective gene. As the field has developed, it has expanded to include a broad range of different potential therapeutic interventions. FDA's scientific leadership in this area was no more evident than when earlier this year, researchers from our biologics program were able to verify that a vaccine used in a gene therapy protocol at St. Jude Children's Research Hospital contained no traces of HIV as previously suspected.

FDA, whose product reviews depend on the validity of clinical trial data, monitors the entire system. The Agency conducts about 1,200 trial-associated inspections per year (1,100 domestic and 100 foreign), some of which involve extensive interviews with IRB members and examination of their records, procedures, and responsiveness to participants’ concerns.

FDA’s efforts to protect human subjects generally emphasize education, outreach, and training programs for investigators and members of the IRBs.

FDA is requesting an increase in funding of $10,000,000 to increase the number of inspections by one-third, and in particular, target high-risk clinical trials. Inspections will cover clinical investigators, IRBs, sponsors, monitors, and contract research organizations. This increase will also focus on increasing scientific and regulatory training for FDA investigators to make them more efficient and effective; improving the inspection process for IRBs; and, enhancing follow-up compliance activities. We are also requesting funds to support the expansion of Medsun. We are establishing a network of hospitals to give statistically reliable data on device use and misuse. This will provide FDA and the community good feedback when problems occur.

Of the 1,200 trial-based inspections conducted annually, 600 are clinical inspections. This figure represents only two percent of the 30,000 clinical sites involving FDA-regulated products. The remaining inspections include Institutional Review Boards (300), sponsors/contract research organizations (75), and non-clinical (100) studies. While the Agency understands it cannot inspect every clinical study, added funds will enable FDA to increase its inspections and lower the risks to volunteers in clinical studies.


Each year, an estimated 76 million Americans get sick, more than 300,000 are hospitalized, and 5,000 die as a result of foodborne illnesses. The populations at greatest risk of serious illness are primarily the very young, the elderly, pregnant women, and those with compromised immune systems. The Centers for Disease Control and Prevention, (CDC) estimate that foodborne illnesses cost the nation more than $8 billion annually in medical expenses and lost productivity.

With your support over the past several years, FDA has made great progress in developing an integrated national food safety system. Working in collaboration with the Centers for Disease Control and Prevention, U.S. Department of Agriculture and state and local governments, we have put in place important prevention programs and, when food borne illnesses occur, we are identifying outbreaks of food borne illness earlier, translating into fewer deaths and illnesses. FDA's prevention programs include our seafood HACCP program, our Good Agricultural Practices program for fresh produce, our program for fresh sprouts, a greatly expanded import surveillance program, and a new HACCP program for fresh fruit and vegetable juices. These programs are science-based and are supported by a rigorous foundation of high quality research and risk assessment.

Although the U.S. food supply is among the world's safest, an increase in the variety of foods and convenience items has brought accompanying concerns about public health. In addition, the complexities of the food industry, from production to packaging, to shipping, are increasing.

The multi-agency Food Safety Initiative (FSI) initially focused on reducing the number of illnesses caused by microbial contamination of food and water. Recent efforts towards achieving this goal have included increased efforts in reducing Listeria monocytoges contamination and the development of inspection and testing programs for shell eggs to reduce the risk of Salmonella enteritidis illness will be necessary.

We must also position ourselves to broaden the original focus of the FSI from only microbial contamination to include chemical contaminants and pesticide contamination, and other food hazards as well including food allergens.

Over fifty bioengineered foods are now marketed in the United States, most of which contain improvements that resist pests or herbicides. USDA oversees the planting and field trials of the crops, EPA has oversight of the pesticides that are engineered into crops, and FDA evaluates the food safety and nutritional aspects of the food. Although drugs produced using biotechnology have been widely accepted, the topic of bioengineered foods has generated much controversy, particularly about whether these foods should be labeled as genetically modified

The latest concern has been over the strain of bioengineered corn, reported in several food products than were never approved by EPA for that use. Currently, FDA has a voluntary process through which companies marketing bioengineered foods consult with the agency on safety and other regulatory issues prior to marketing. Recently, we issued a proposed rule to make the voluntary process mandatory and to require companies to provide sufficient data to establish that the bioengineered food is as safe as its conventional counterpart. FDA also issued guidance for public comment as the appropriate labeling for foods developed through biotechnology. However, in response to growing public concerns over bioengineered foods, and concerns about our current process, additional strong scientific expertise is needed in this area to increase our oversight and our laboratory analysis capabilities.

In FY 2002, FDA requests a total increase of $14,700,000 for food safety activities, of which $9,400,000 is budget authority and $5,300,000 represents new fees for export certification. With the additional funding, FDA will:

  • Expand the scope of food safety inspection beyond microbial contamination of foods to include chemical and pesticide contamination as well as to prevent cross-contamination with food allergens;
  • Develop inspection and testing programs for shell eggs to reduce the risk of Salmonella enteriditis illness;
  • Develop, in conjunction with NCTR, new methodologies to identify adverse effects of genetically modified foods, drug residues in foods and antibiotic-resistant strains of bacteria, using new molecular biomarkers and methods identified through genomic and proteomic technologies; and,
  • Develop new risk assessment methods in collaboration with NCTR. New approaches will be validated for incorporating model uncertainties into microbial risk assessment.

Through a combination of FDA and State contract inspections, domestic firms that produce products at high risk of microbiological contamination have been inspected more frequently. Several years ago, such firms were inspected on the average of only once every three to four years. In FY 2000, FDA inspected over 90 percent of the 6,250 high-risk establishments. In FY 2001, the Agency expects to inspect 90 -100 percent of high-risk establishments.

Section 801 (e)(4)(B) of the Federal Food, Drug and Cosmetic Act authorizes the recoupment of fees of up to $175 for export certificates for drugs, animal drugs and devices. This section, however, does not cover the collection of user fees for export certificates for foods. FDA spends millions of dollars in food safety resources to support the specific needs of U. S. food exporters. The enactment of food export certification user fees will allow FDA to devote more attention and resources to food safety activities benefiting the entire population.


GSA is in the process of consolidating many of FDA’s headquarter facilities at the former site of the Naval Surface Warfare Center in White Oak, Maryland. Under the first phase of this project, the Center for Drugs Evaluation and Research (CDER) laboratory building is scheduled for completion in FY 2002. While GSA is responsible for the construction of this multi-year project, FDA is responsible for the actual move of staff and equipment, as well as certain telecommunication and equipment costs. FDA is requesting $6,000,000 for one-time costs to equip and occupy the CDER laboratory portion of the facility.

With the support of Congress, the construction of the new Los Angeles laboratory, which analyzes twenty-five percent of all imported food samples, is now underway. To complete the project on time and move from the present facility by March 2003, when our lease expires, FDA is requesting $3,000,000 for a total of $23,000,000 to complete construction of the new laboratory.

DHHS has also formed a financial working group to oversee streamlining of financial operations in an effort to enhance coordination, eliminate duplication of effort and develop unified approaches to financial management. To further improve the Agency’s financial management, FDA is requesting $8,300,000 to begin initial acquisition and implementation of a new financial system. The Agency is working to minimize costs by taking advantage of work already performed by other DHHS agencies similar to FDA in scope and transaction volume.

FDA is also requesting an increase in current user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments and approved products. The FY 2002 budget request includes $204 million in user fees. Of this amount $20 million are new fees for which authorizing legislation is needed -- $15 million for import activities and $5 million to provide certifications requested by food exporters. Drug and device exporters already cover such costs. PDUFA includes a total of $162 million, which includes an increase of $12 million for review of drug and biologic applications. MQSA includes $.5 million for inflation.


I thank you for the opportunity to share with you the breadth of FDA’s responsibilities. FDA touches the life of every citizen through the medicines we take or feed for our animals, the blood products we may need one day, through the food we eat, the cosmetics we use, and, the medical devices in use today. Americans expect FDA to remain vigilant, to promote their health and well being, and to protect them from unacceptable hazards to our population at large, and to assure that they are adequately informed about the myriad hazards about which they will have to decide as individuals whether or not they are willing to accept. Significant investments must be made to keep this agency strong and at the forefront of the science upon which its regulatory mandate is based. The returns on that investment will be an agency that is equal to the challenges it faces and able to keep the confidence and trust of the American public. A strong FDA is clearly good for the consumer and industry alike, which in turn is good for the economy and health of our great nation. I appreciate your interest and continued support of the agency and its public health mission. This year is expected to be another exciting one for the Agency and I look forward to working with you as we face the challenges ahead.