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FDA needs to work with its community of stakeholders and develop a systematic approach to address the problem of over 2 million injuries and deaths a year occurring as a result of consuming/using FDA-regulated products. The ideal approach should be comprehensive, involving the participation of regulatory agencies, health care givers, the regulated industry, and the consumers/patients themselves. Components of this system include:
There is strong stakeholder support for improving the data collection, analysis, and dissemination of information from the existing Adverse Event Reporting System and for some of the new data collection initiatives. A few indications of these views follow:
FDA has initiated several programs for gathering information on adverse events/injuries associated with the misuse or failure of FDA-regulated medical products and foods. These include the following:
MedWatch
MedWatch covers drugs, biologics, medical and radiation-emitting devices, and special nutritional products, such as medical foods, dietary supplements, and infant formulas. The MedWatch form is used for voluntary and mandatory reporting of adverse events and product problems by health professionals; the reports are sent on to the appropriate FDA component for analysis and follow-up action. Over 140 health professional and industry organizations have joined the MedWatch effort as MedWatch Partners and actively support the program by promoting the importance of reporting serious adverse events or product problems to their members.
Adverse Events Reporting System (AERS)
With its new computer system, the Adverse Events Reporting System (AERS) is expected to form the basis for a revitalized pharmacovigilance program for the United States. AERS continues to be developed and will be relied upon by both CDER and CBER over ensuing years to provide accurate, accountable data for the performance goals identified for injury reporting.
FDA is responsible for monitoring the market for adverse effects of medical devices. FDA expects to receive over 63,000 postmarket reports in FY 1998, including mandated reports from medical device manufacturers; voluntary reports from medical device professionals received through the problem reporting program (MedWatch); and results of field inspections. FDA currently is managing the huge numbers of reports in three phases. During the first phase, the reports are screened for completeness and entered into the data management system. During the second phase, the reports are analyzed for similar events, judged for severity, and searched for trends. The final phase focuses on action, such as issuing safety alerts and notifications to users (i.e., health professionals and patients) warning them of concerns and advising them how to prevent future occurrences.
Some manufacturers have been granted approvals to submit summary reports quarterly for adverse events involving specific devices. This summary reporting system is being expanded and will produce usable information at a smaller cost to both FDA and the industry.
FoodNet
FoodNet is the product of a cooperative venture among USDA, CDC, and FDA; it attempts to estimate the incidence of foodborne illness that is not revealed in obvious outbreaks. Most foodborne illness occurs in ways that appear sporadic and unrelated to each other. FoodNet, which has the ability to provide more comprehensive information through sources such as case-control studies and surveys of laboratories and physicians, can help FDA and its federal colleagues link illnesses that have a common cause, no matter where they occur.
National Antimicrobial Resistance Monitoring System (NARMS)
The National Antimicrobial Resistance Monitoring System (NARMS) was established in January 1996 as a collaborative effort among the FDA, USDA, and CDC. The system was initiated in response to public health issues associated with the approval of fluoroquinolone products for use in poultry. The NARMS program monitors changes in susceptibilities to 17 antimicrobial drugs of zoonotic enteric pathogens from human and animal clinical specimens, from healthy farm animals, and from carcasses of food-producing animals at slaughter. The objectives of the system include: to provide descriptive data on the extent and temporal trends of antimicrobial susceptibility in Salmonella and other enteric organisms, to facilitate the identification of resistance in humans and animals as it arises, and to provide timely information to veterinarians and physicians. The ultimate goal of these activities is to prolong the lifespan of approved drugs by promoting prudent and judicious use of antimicrobials and taking appropriate public health action.
Vaccine Adverse Events Reporting System (VAERS)
CBER and CDC jointly oversee the Vaccine Adverse Events Reporting System (VAERS), which receives mandatory reports as required by the National Vaccine Injury Act about adverse effects from vaccines. CBER and its colleagues are discussing electronic submission of reports, which would provide more rapid access of the VAERS data to manufacturers.
Prompt identification of new, previously unrecognized problems with FDA-regulated products has the potential to decrease morbidity and mortality associated with those products and maximize the safety of approved products. Thousands of deaths and injuries could possibly be avoided, or their consequences reduced, through a comprehensive strategy aimed at finding out why incidents occur and implementing strategies to prevent them from occurring again.
One of the Agency's primary objectives is the development and implementation of a system for improving the quality of information on adverse events and product defects associated with FDA-regulated products. This system needs to address issues of injury reporting by focusing on three areas: surveillance and epidemiology; research; and education and outreach. FDA believes that such a system would maximize the safety of FDA-regulated products through increased reporting of potentially dangerous adverse events or product problems to FDA or the manufacturer. Increased reporting provides greater assurance that a potential problem with a marketed product will be discovered and appropriate corrective action will be taken, and it ensures systematic feedback to the health care community and the public. None of these systemic improvements are possible without adequate funding.
Surveillance and Epidemiology
Research
Methodologic and surveillance research efforts designed to understand the causes of, and the factors contributing to, product-related injuries are critical to reducing the number of FDA-regulated product injuries. Research will be initiated in "human factors sciences" to identify labeling and product interface design features that may cause or contribute to use error, a leading cause of avoidable deaths and injuries.
Education and Outreach
Improving feedback to health care professionals and consumers is critical to the improvement of adverse event reporting. Rapid dissemination of findings on injuries to the relevant stakeholders and the education of the medical community require additional resources. The Agency has begun to collaborate with other agencies and professional groups to produce teleconferences that convey general information or product-specific information, nationwide.
An integrated science-based system for reporting, monitoring, and evaluating food and cosmetics-based adverse events is necessary to make fundamental regulatory decisions and policies. This system will depend on a research program aimed at understanding how health care professionals, as well as the public, can better recognize product-problems, and on a related research program on methods of analyzing the data. The clinical evaluation of adverse events and the determination of risk assessment requires medical officers and other trained personnel to take follow-up actions, make clinically-based decisions, and report activities to FDA's existing staff.
The table provided in this section links FDA's statutory requirements with performance goals in the FY 1999 Performance Plan, illustrating the Agency's efforts to consolidate several systematic approaches into one performance system.
Highlighted below are key performance goals for FY 1999 in the area of adverse event reporting. These performance goals deal with creating new, active surveillance systems, or with improving passive reporting programs to make them more useful and available. For more complete identification of performance goals and statutory requirements see the table at the end of this section.
Implement AERS for the electronic receipt and review of Adverse Drug Report (ADR) reports
Evaluate pilot efforts for new postmarket surveillance system
Increase the number of reports on device events that are received and processed in summary form by using electronic reporting
Develop baseline surveillance data on foodborne illness under the FoodNet program
Improve public access to information on adverse events with Special Nutritionals
Increase the number of human and animal isolates in National Antimicrobial Resistance Monitoring System (NARMS)
| Statutory Authority | Relevant Statute and/or Regulation | Relevant FY 1999 Performance Goals | FY 1997 Performance Baseline | FY 1998 Performance Baseline |
|---|---|---|---|---|
| Applicants must report to
FDA adverse drug experience
information. CDER CBER |
FD&C Act, Section 505; Public Health Service Act, Section 2101-2134; 21 CFR 314.50, 314.80-81, 314.98, 314.540, and 600.80 | By the end of FY 1999, implement the AERS for the electronic receipt and review of voluntary and mandatory ADR reports. | Implementing the core system is currently under way and will be completed by FY 1998 | FY 1998: Pilot, five firms electronic entry uncoded only. Periodic reports only. |
| Plan and implement a sentinel
user reporting system CDRH |
FD&C Act
Section 519(b)(5) |
Evaluate pilot efforts for new sentinel device reporting system as alternative to universal user facility reporting | Not applicable | Recruit 24 pilot facilities |
| Device user-facilities are
required to report adverse
events CDRH |
FD&C Act
Section 519(b)(1) |
Increase the number of low-risk postmarket reports received and processed in summary form. The total number of summary reports will be increased from 20,000 in FY98 to over 25,000 in FY99. This will be done by using innovative surveillance methods and improving quality and analysis needed for Safety Alerts and other actions. | Not applicable | FY 1998: 20,000 reports received in summary form |
| CFSAN | Work with CDC and other federal agencies to develop baseline surveillance data on foodborne illnesses required to evaluate the effectiveness of, set better priorities for, and determine appropriate outcomes for the Food Safety Initiative. | Sentinel Sites expanded to provide better coverage of the representative areas of the United States | Expand the demographic diversity and size of the population covered by FoodNet by increasing the number of active surveillance sites from 7 to 8. Begin implementation of PulseNet, which provides data required to do more rapid and accurate tracebacks to determine the causes of foodborne outbreaks. | |
| CFSAN | By the end of FY 1999, improve public access to timely information on adverse events related to dietary supplements, infant formulas, and medical foods by increasing the frequency of public releases of information in the Special Nutritionals Adverse Events Monitoring System from two per year to four per year. | Two releases in FY 1997 | The requisite hardware and software systems need to be purchased for integration of current Center-based limited capability systems. | |
| CVM | Assure that food derived from animals and animal products is safe for human consumption by increasing the number of human and animal isolates in the NARMS database | Salmonella isolates: 1,287 human, 2,391 veterinary | Salmonella isolates: 2,000 human, 3,000 veterinary |
FY 2000 Performance Goals are not identified in this Plan. Specification of these goals is dependent upon final determination of the President's FY 2000 Budget Submission to Congress.
FDA's ability to access the scientific and technical expertise necessary to carry out its mission must be enhanced, i.e., improving the science infrastructure, by upgrading the status of its facilities and equipment; augmenting and targeting its science expertise toward important new health enhancing technologies; and linking its science information to external sources.
Upgrade Facilities and Equipment
FDA's current science capability, both internally generated and externally coordinated, supports a wide range of risk management activities, covering the life cycle of Agency-regulated products. The integrity of the science base should be sustained by state-of-the-art equipment and facilities, but at a minimum they must be in good repair. The present status of this infrastructure, in many cases, is considerably less than adequate. For instance, replacing the FDA's Los Angeles laboratory and expanding the Arkansas regional facility will provide the physical tools necessary to meet FDA's obligations.
Augment and Target Science Expertise
Although FDA's science efforts are supporting current efforts in premarket review, postmarket safety assurance, and product use monitoring, these programs are falling short of meeting the Agency's statutory mandates and public expectations. As the programs are enhanced to meet expectations, the Agency's access to state-of-the-art science must be expanded. This will be accomplished both through strategic recruitment of needed expertise and through creative collaboration with outside institutions. Because FDA must regulate increasingly complex products, the Agency's science capabilities must be able to keep pace with new scientific developments. Further, the science expertise must be positioned so that appropriate risk assessments can be targeted toward emerging technologies that are significant in protecting public health and which must reach the market place quickly.
Link Science Information to External Sources
FDA must make strides in linking its science information bases to external sources so that synergies can be realized and appropriate information can be brought to bear on risk assessment and risk management decisions promptly. If FDA does not enhance its ability to link its science information with other outside sources, it will lose comparability and communicability with these sources. Further, it will not be as able to capitalize on cost-effective use of science information to support regulatory decisions.
Stakeholders strongly support the need for FDA maintaining a strong and well-linked science base to support increasingly complex regulatory judgements. A few illustrations of these views are indicated below:
FDA is expanding its access to scientific expertise through creative collaboration with the broader scientific community. This is being accomplished through several approaches:
Industry-Government-Academic Collaboration
Industry-government-academic collaboration enhances the Agency's scientific expertise, thereby using added resources that would otherwise be unavailable to the government. Examples of these collaborations are below.
Interagency Collaboration
Encouraging interagency cooperation allows the substantial expertise of other government scientists to focus their efforts on similar problems. For example, working with other agencies allows the FDA to prevent illness and epidemics. The Agency collaborates with the NIH to speed drug and vaccine development so these products can reach consumers more quickly. This interagency cooperation also allows the Agency to determine modes of infection and thereby educating scientists, which could lead to new testing methods.
Exchanging Scientific Expertise
Industry and FDA collaboration provides an atmosphere to encourage the exchange of scientific expertise. The FDA sponsors workshops on cutting-edge topics such as gene therapy and Simian Virus and DNA vaccines. The FDA/National Institute of Dental and Craniofacial Research (NIDCR) model MOU allows for use of scientific expertise on panels and as consultants to the CDRH's device group. Added to these face-to-face contacts, Agency scientists are encouraged to publish in professional journals so their non-government peers can learn from their work.
Information Technology
Information technology is a tool that allows FDA scientists to learn about new discoveries and to increase their abilities to review applications. For the Agency to produce excellent scientific work, FDA scientists must be aware of the latest developments and theories quickly and in a timely fashion so they can incorporate them into their work. Facing these scientists is the daunting task of accessing a voluminous amount of new information, which is generated too quickly for one person to follow. To assure this knowledge is incorporated into Agency decisions, FDA scientists use information technology to access databases of latest discoveries located in-house and in external scientific databases.
Information technology (IT) tools go beyond finding articles with new theories and approaches. The Agency uses IT tools to validate computer models to speed reviews. For instance, FDA scientists can review a comprehensive database on carcinogenicity of over 700 drugs. IT tools also are used to validate computer models in a timely manner so application decisions can meet statutory requirements.
Section 903 of the FD&C Act, as amended by FDAMA, requires FDA to carry out research relating to foods, drugs, cosmetics, and devices in realizing the intent of the Act. Section 903 also requires FDA to consult with experts in science, medicine, and public health and otherstakeholders in carrying out its mission. In addition, FDAMA law (Section 414) mandates policies that foster collaboration between federal agencies and other science-based agencies.
FDA's plan for meeting these statutory requirements will encompass a variety of actions intended to enhance its science capabilities. One approach is for the Agency to conduct research projects that identify the causes of and factors contributing to product-related injuries. For instance, Agency scientists are examining labeling and product features that can be altered to prevent product-related accidents. To conduct these research efforts, the Agency will maintain and strengthen its in-house scientific expertise by expanding innovative and successful programs (e.g. in-house Fellows programs).
The Agency will continue to enhance its scientific collaborations with the larger scientific community by initiatives with the University of Maryland, Georgetown University, and other institutions of higher learning. Similarly FDA will strengthen the Agency's science base linkage to external sources to provide comprehensive science underpinning for important national health initiatives, such as working closely with CDC and USDA in the establishment of NARMS.
In addition to these steps, the Agency is developing improved methods to detect food pathogens and to assess health risks more rapidly so that consumers can implement preventive measures.
The table below links the performance goals and measures with the science-related statutory requirements. FDA's main statute, the FD&C Act, provides broad authority to the Secretary to authorize research efforts. Performance Goals illustrate two types of efforts. The first identifies development of methods or products that can be applied to a specific health risk problem. For instance, one goal calls for studies on antibiotic resistance of foodborne pathogens.
The second type of goal identifies a long-range systemic solution to a range of problems. Illustrative of this type is a multi-year research plan to improve methods for detection, control, and prevention of microbial contamination. A measure for this type of goal is more difficult to establish. Because scientific progress often results from diverse efforts, measuring this goal is an incremental process of small steps. In this goal, establishing relationships with stakeholders is a major step.
Highlighted below are key performance goals for FY 1999 in the area of science. Several goals enable the Agency to put science behind methods for quickly detecting potentially high-risk products. Other goals focus on collaborating with key stakeholders to increase science's role in regulatory policy. For more complete identification of performance goals and statutory requirements see the table at the end of this section.
Implement a multi-year research plan to develop and improve methods for the detection, control, and prevention of microbial contamination on fresh produce.
Develop model to assess human exposure to a variety of foodborne pathogens.
Work with industry and academia to develop new techniques for eliminating pathogens on fresh produce.
Support product review by developing faster, more accurate tests on mechanisms of toxic actions.
Demonstrate a model toxicity knowledge base to support and expedite product review.
Develop better models to predict risk for cancer, reproductive, developmental, neurological, genetic, and acute toxicological outcomes.
| Statutory Authority | Relevant Statute and/or Regulation | Relevant FY 1999 Performance Goals | FY 1998 Performance Baseline |
|---|---|---|---|
| The Secretary, through the Commissioner, shall be responsible for executing this Act and for research relating to foods, drugs, cosmetics, and devices in carrying out this Act. | FD&C Act, Section 903(d)(2)(C) | Develop and begin implementing an interagency
research plan that more effectively coordinates
the food safety research activities in FDA and
USDA Formalize PQRI collaboration Identify specific issues and areas of research focus and develop research protocols Identify priority material for standard development Use model animal and cell culture transgenic systems to evaluate risk to the human genome. Conduct case-control molecular epidemiology studies to assess breast and prostate cancer in African-American women/men. Computer-based predictive system is being used as model for rodent and human hormone-binding proteins. Present at a scientific forum a unifying approach to safety assessment for both carcinogenic and non-carcinogenic effects. Screen animal products and environments for a microorganism harboring antibiotic resistance. |
FY 2000 Performance Goals are not identified in this Plan. Specification of these goals is dependent upon final determination of the President's FY 2000 Budget submission to Congress.