FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

This Appendix contains a status report on FDA's progress in developing and measuring long term, quantifiable outcome goals that will improve the health and well-being of the American Public. . The Agency is exploring approaches for developing a measurement capability, and strategies for achieving outcome success in four areas of FDA responsibility:

1. Medical Product Safety
2. Foodborne Illness Reduction
3. Counter Terrorism
4. Managing the Risk Associated with BSE (Bovine Spongiform Encephalopathy)

In each of these areas, FDA is attempting to strengthen its outcome measurement and achievement capability through the following efforts:

Examining the linkage between FDA program efforts and ultimate health and safety outcomes; and evaluating possible performance indicators for these end outcomes which may be relevant for FDA.

Exploration of intermediate outcome measures which may serve as good leading indicators of ultimate health outcomes. Many of these intermediate measures are more proximate to FDA efforts and therefore may be more within the influence of Agency actions. The Chart below outlines the broad linkages between FDA efforts and outcomes at different stages:

Identification of data sources that will serve as valid and reliable sources of information on the selected intermediate and end outcome measures. In some cases these data sources have been identified; in many other cases the search for such sources is still underway.

Formulation of data strategies to make databases more accessible and useable for FDA. In some cases data sources are in place, but are not collecting information in categories that would be relevant for FDA. To illustrate, representatives of the Agency's Food Safety and Nutrition Program are working with CDC to augment their foodborne illness morbidity and mortality information so that it is collected for products that FDA regulates. In other cases, data must be purchased from outside sources; and in still other instances, such as adverse event reporting systems, the databases have to be constructed This takes time and considerable investment of resources.

Analysis and evaluation, as appropriate, to strengthen our understanding of the relationship between FDA program efforts and both intermediate and end health outcomes. An effort will also be made to identify studies that have already been completed, and which may contribute to our understanding of these relationships.

A discussion of progress in outcome measurement and achievement follows for each of the areas identified above:

1. MEDICAL PRODUCT SAFETY

FDA will work to establish relationships between availability of new medical products as a result of Agency product approvals, widespread use of these products to treat disease, and reduced incidence of the disease. To illustrate: Following approval of a new molecular entity (NME) intended to improve survival following a stroke, the Agency would monitor its use in the patient population suffering from strokes. Usage data might be tracked through data sources that track the number of drug prescriptions written. Once the utilization of the NME in the stroke population was determined, then the effect on mortality in the population treated could be investigated in various ways, including: 1) extrapolating to the affected population the results of existing studies that have examined relationships between use of stroke products and stroke mortality/morbidity rates; 2) original in-house analysis of use-disease data through such techniques as statistical inference and mathematical modeling; 3) funding outside researchers to conduct studies that examine quantitative and qualitative studies of the health status of patient groups. The Agency can use internal and external data sources to track an indicator. External data sources, such as data tapes from Center for Medicare and Medicaid Services within the Department of Health and Human Services (CMS), could link the products the federal government is funding with a defined set of patients. Information from IMS, a company that collects market data, might be useful to verify an increase in the number of prescriptions while National Center for Health Statistics could provide longitudinal data to track changed health status.

FDA will also explore the use of post-market information to determine the safety of products on the market as well as the use of these products. Both product safety and safe use of products are intermediate outcome indicators that could be partial predictors of positive health outcomes. One measure of product safety would be the number of product recalls. Examination of recall data should lead to reasons for product failures - e.g., failure of prosthetic hips - and to subsequent correction of these problems through Agency and/or industry actions. FDA's adverse event and medical error databases will serve as increasingly rich sources of information to determine significant problems associated with product use, and enable the Agency to isolate reasons for these problems so that appropriate intervention strategies can be designed. These monitoring systems will require time in order to establish a baseline to identify and reduce the number of negative health outcomes from adverse events.

2. FOODBORNE ILLNESS

Consuming foods is an event that touches every American life daily. To maintain public health requires a nutritious, wholesome and safe food supply. The impact of eating contaminated food can be so widespread that it remains a high priority for public health officials to reduce foodborne disease. Through scientific investigation and assembling of characteristics for certain foodborne outbreaks, public health officials have developed many databases and networks to respond in such an event. It is appropriate, therefore, to use such health outcomes data, contaminant surveillance data, firm/facility compliance data, and other survey data to measure the broad success of food safety programs. Many infections and intoxications are often caused by foodborne microbial pathogens, and trends in their occurrence are especially relevant to assess the effectiveness of food safety programs. The Agency is exploring the long-term outcome goal to reduce the rate of infections and mortality caused by key foodborne pathogens tabulated by Center for Disease Control (CDC).

Exploring intermediate outcome measures is the first step toward realizing the long-term goal. Some of these measures would focus on preventing contaminated food from reaching the consumer. For example, FDA's Center for Food Safety and Applied Nutrition (CFSAN) could measure food handling or food processing practices that are known to contaminate food and then determine changes in practices after introduction of new FDA regulations or programs that are likely to affect these practices. As another example, CFSAN could sample foods for pathogen contamination by various factors such as food type, seasonality and geographic location that are associated with specific illnesses. Targeted sampling could be done before and after FDA program activities that are expected to prevent or reduce food contamination. The number of import examinations that target the most suspicious products and the number of domestic inspections aimed at high-risk food establishments could be another measure to keep contaminated products from consumers. As a partner with states, military installations and tribal nations, the Agency encourages adoption of the Food Code. Other measures could be aimed at increasing the capabilities and capacity of State and Federal laboratories, by actions such as increasing the number of laboratories in the National Laboratory Response Network, which analyzes and identifies the causes of foodborne illnesses.

Current data sources allow the Agency to use valid and reliable information in developing, implementing and monitoring its science-based regulatory programs. For instance, the Foodborne Diseases Active Surveillance Network (FoodNet) is the principle foodborne disease component of CDC's Emerging Infections Program (EIP). FDA, in collaboration with CDC, nine states, (California, Colorado, Connecticut, Georgia, New York, Maryland, Minnesota, Oregon and Tennessee), and the U.S. Department of Agriculture (USDA) is part of FoodNet. This effort consists of active surveillance for several foodborne diseases and related epidemiologic studies designed to help public health officials better understand the epidemiology of foodborne diseases in the United States. Foodborne diseases included in FoodNet are infections caused by bacteria such as Salmonella, Shigella, Camppylobacter, Escherichia coli, Listeria monocytogenes, Yersinia enterocolitica, and Vibrio and parasites such as Cryptosporidia and Cyclospora Other data sources at CDC, including foodborne disease outbreak surveillance data, also provide important public health outcome indicators.

A key CFSAN effort is to formulate strategies for working with CDC to facilitate collection of foodborne illnesses by categories relating to FDA-regulated foods using FoodNet. This effort is designed to link FDA-regulated products with foodborne pathogens that are having a severe impact on the American public's health. Also key to our efforts is data collection from industry, academia and private sources. For example, FDA recently worked with the Joint Institute for Food Safety and Applied Nutrition and National Food Processors Association to obtain information related to the foodborne pathogen Listeria monocytogenes in ready-to-eat foods. Information has been collected on consumer behaviors and understanding about food handling, processing and pathogens. Additional strategies on research, inspections, surveillance, standards and education will be designed in coordination with key federal agencies (e.g., CDC, FSIS), tribal nations, state governments, academia and our stakeholders. For example, FDA has developed and implemented prevention strategies for seafood, juice, fresh fruits and vegetables, and sprouts. Epidemiological data combined with intermediate data, such as pathogen counts and production and handling variables, can measure the effectiveness of these programs.

The Foods Program will continue to analyze and evaluate information from all sources, conduct and participate in research, surveillance and education and coordinate initiatives with our partners to address those factors in our purview that could lead to lower incidences of foodborne pathogens. Our efforts are focused on tying FDA programs in selected areas with compliance and tracking the results via public health outcome databases. For example, for Vibrio which appears in shellfish, FDA is working with the National Seafood Sanitation Program to educate fisherman about the risk factors that could lead to their products becoming infected and harming consumers. Since Vibrio is tracked by FoodNet and by the Gulf coast Vibrio Surveillance Program, the agency might be able to determine the success of this effort. Similarly, the Agency developed the Egg Safety Action Plan with egg producer associations to control Salmonella contamination on whole shell eggs. The results might be seen in outbreaks that are recorded in FoodNet and Salmonella Enteritis outbreak surveillance by CDC. For Norwalk-like viruses that appear in food contaminated from retail workers and contamination of molluskan shellfish, the Agency could develop a surveillance system to track the future incidences.

The Foods program will continue to develop a list of priority research needs annually. The Agency is mindful that as a leader in food safety, communicating these needs to other agencies, academic, industry partners and our stakeholders is critical to achieving its health outcomes.

3. COUNTER TERRORISM

The Agency is exploring the feasibility of establishing long term outcome goals that will demonstrate FDA's contribution to the Nation's preparedness to minimize the effect of potential terrorist threats. Two measures, in particular, are being examined: ensuring safe and effective medical counter measures; and developing a National laboratory capacity to test for terrorist agents in food products.

Medical Counter Measures - One intermediate measure being investigated is the ability to assure that FDA regulated products in the National Pharmaceutical Stockpile (NPS) will be approved as safe and effective, and will be appropriately labeled to treat the medical consequences of biological, chemical, or radiation attacks. The Agency is also examining measures that would be able to track the proportion of these products that might have to be deployed while they are still in experimental or investigational status. The aim would be to minimize the number of these agents that are experimental and have not been approved as safe and effective.

FDA is examining several strategies and indices for increasing the supply of critical drugs, biologicals and devices that would be useful medical countermeasures. Also being considered are strategies for increasing efficient and timely access to products in the National Pharmaceutical Stockpile. The Agency's commitment to this effort reflects a philosophical change from passive observer to active participant, where FDA works proactively to develop medical products and offers incentives for market behavior.

Other related strategies include:

• Removing regulatory roadblocks that impede the development and approval of medical countermeasures - e.g. increase the use of the regulation that allows animal tests as the sole evidence of efficacy for drug and biologic approval;
• Ensuring, where appropriate, that counter terrorism indications are approved for all products.
• Fostering the development of products that can be used as medical countermeasures through various incentive programs - particularly where commercialization opportunities are not otherwise obvious;
• Exploring expansion of current grant programs to encourage firms to produce the necessary data for drug approval or labeling changes.
• A key overarching strategy is to communicate effectively with constituents in the counterterrorism community. Specifically, outreach to health professionals, health organizations, and other federal agencies to educate and enlist their resources will be formalized. To illustrate: FDA will coordinate post-event data collection with federal agencies (e.g., Center for Disease Control and Department of Defense) and state and local authorities to ensure they are aware of the type of information required by Subpart H and I approvals. Health professionals and patients will be encouraged to provide clinical follow-up data to federal agencies when marketed medical countermeasures are prescribed for other than labeled indications (off-label use, i.e., cidofovir for vaccinia complications).

To support the overall outcome measurement effort, there are numerous data sources the Agency could explore to support approval of products and assure they are labeled to address the consequences of a terrorist attacks. First is the varied literature on drug use that is aimed at medical professionals. A second source is unpublished data from companies, other government agencies, academia and foreign governments reflecting experience with counter terrorism products of interest. Finally, certain offices within FDA may have historical data from numerous sources that could be reviewed for support of product approvals.

National laboratory capacity - FDA is considering the development of intermediate outcome measures that will gauge the capacity of the Nation to rapidly and accurately test for the presence of terrorist-introduced hazardous agents into the U.S. food supply. Ideally, there should be some level of laboratory analysis capacity in every state with the capability to conduct biological and/or chemical and/or radiological testing of foods. Laboratories with these capabilities should be located in those geographic areas with high concentrations of domestic food processors and food imports.

State laboratory capacity will be part of The Food Emergency Response Network (FERN), which consists of both state and FDA laboratories that are committed to analyzing food samples in case of a biological and/or chemical and/or radiological terrorist event. This effort is a component of Center for Disease Control's (CDC) much larger Laboratory Response Network (LRN), a network of state/government public health laboratories developed to provide normal and surge capacity for samples resulting from a public health emergency caused by a select agent. The LRN focuses on clinical testing, whereas the FERN focuses on food testing.

The FERN will be based on a number of characteristics. The Federal government, or an organization contracted by the government, will conduct research to develop rapid methods of analysis of food samples. Laboratories will be strategically located across the country using criteria such as concentration of food imports and domestic food processors. In the event of a catastrophe, the system is designed to handle sudden surges in samples for analysis. As envisioned, this means that a laboratory is capable of analyzing sudden increases in volume of samples or for multiple agents. To support this infrastructure, a national data sharing system, eLEXNET, is intended to provide a mechanism by which multiple government agencies have the ability to rapidly share food safety data.

Further, a baseline of state laboratory capabilities to identify gaps and develop strategies to fill these gaps in normal and surge capability would be established. Capability data could be secured through a survey instrument or physical exam of the state laboratories.

Several measures are being considered to evaluate the quality and quantity of national laboratory capacity.

First, laboratories joining the FERN, could be documented, tracked, and measured through proficiency testing. Proficiency testing is a training technique to test the laboratory's ability to analyze and identify an unknown contaminant in a food sample. (Measure #1)

Second, the availability of equipment necessary to conduct certain tests could be monitored. For example, each chemical or radiological lab might be expected to include: the presence of liquid chromatograph-mass spectrometers, gas chromatograph-mass spectrometers, fourier transform infra-red spectrometers, ion chromatographs, and inductively coupled plasma mass spectrometer. (Measure #2)

Third, a minimum number of courses that must be taken by laboratory personnel would be established. These will include handling chemical, radiological, and biological contamination. (This may have to be further broken down to training of each of the potentially identified microorganisms, e.g. B. anthracis, etc.) Training will also include instruction on the operation of key instruments and using FDA procedures to detect contaminants. Training records will be maintained by Office of Regulatory Affairs' (ORA's) Division of Human Resource Development, which is responsible for training programs for FDA and state officials. (Measure #3)

4. BSE (Bovine Spongiform Encephalopathy)

FDA is exploring outcome measures that would gauge the readiness of the industry to prevent the spread of the disease and minimize any potential impact on the U.S. economy.

The Harvard BSE (Bovine Spongiform Encephalopathy) Risk Assessment indicated that if a case of BSE were detected in the United States, a high compliance rate with the FDA feed rule would prevent the spread of the disease and would in fact lead to its elimination over several years.

Consistent with this conclusion FDA will continue to inspect 100% of all known renderers and feed mills processing products containing prohibited material annually; and ensure that at a minimum 92% of firms are in compliance with the feed rule through inspection and enforcement actions. The Agency will also continue to explore intermediate outcome measures that link our program efforts [rule making, inspectional effort] to assurance that beef continues to be protected from BSE hazards; and consumer confidence in these products remains high.

Previous Page | Table of Contents | Appendix C

Office of Planning Home Page
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Office of Planning