# FDA Plan for Statutory Compliance > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A98-31387 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** November 24, 1998 - **Citation:** 63 FR 65000 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0339] FDA Plan for Statutory Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``FDA Plan for Statutory Compliance'' (the plan). This document is the agency's response to section 406(b) of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which requires the Secretary of the Department of Health and Human Services (the Secretary) to develop a plan bringing the agency into compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (the act). DATES: Written comments may be submitted at any time. ADDRESSES: Submit written comments on the plan to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit e-mail comments to ``FDAD[email protected]''. E-mail comments should be labeled as comments and identified with the docket number found in brackets in the heading of this document. Submit written requests for single copies of the ``FDA Plan for Statutory Compliance'' to the Dockets Management Branch (address above). Enclose one self-addressed adhesive label to assist that office in processing your requests. Copies of this plan are available on the Internet at ``http://www.fda.gov/opacom/7modact''. FOR FURTHER INFORMATION CONTACT: Steven H. Chasin, Office of Planning and Evaluation (HFP-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5207. SUPPLEMENTARY INFORMATION: I. Background On November 21, 1997, the President signed FDAMA into law. Section 406(b) of FDAMA requires the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, to develop and publish a plan bringing the Secretary into compliance with each of the obligations of the Secretary under the act. The plan is to be reviewed biannually and revised as necessary, in consultation with the groups listed in the previous sentence. The plan must address the following six objectives: (1) Maximizing the availability and clarity of information about the process for review of applications and submissions made under the act; (2) maximizing the availability and clarity of information for consumers and patients concerning new products; (3) implementing inspection and postmarket monitoring provisions of the act; (4) ensuring access to the scientific and technical expertise needed by the Secretary to meet the obligations of the Secretary under the act; (5) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in the act for the review of applications and submissions made under the act and submitted after November 21, 1997; and (6) eliminating backlogs in the review of applications and submissions described previously by January 1, 2000. Over the past several months, the agency held a series of meetings with its stakeholders. The process of consulting with agency stakeholders began with a careful examination of FDA's stakeholders vis-a-vis the products regulated by the agency and the perceived interest of these groups in FDA's processes. A total of eight open public meetings were held where agency stakeholders had an opportunity to provide their perspectives on a variety of issues/questions. Six of the eight meetings were focused specifically on FDA's product centers; one briefing for health professionals provided an opportunity for health professionals to offer input to FDA under the broad guidance of section 406(b) of FDAMA; and an agency-wide meeting was held to capture the perspectives of those who could not attend previous meetings and to provide an opportunity to explore recurring themes from previously held meetings. In addition to the open public meetings focused specifically on section 406(b) of FDAMA, agency staff used a variety of ongoing interactions with stakeholders as opportunities to talk about the stakeholder consultation process and to invite comments to the docket. II. The Plan The agency plan for statutory compliance has been developed in response to the requirements outlined in section 406(b) of FDAMA. The plan presents a blueprint for carrying out all of the agency's statutory obligations, including provisions of the act, as well as its other mandates. The plan outlines FDA's strategic directions for the next 5 years and presents an operational plan for fiscal year 1999 and 2000. The plan is a dynamic document which will be modified as ongoing consultations with FDA stakeholders render new and more effective strategies. The act itself builds upon a long history of recommendations from advisory committee members, industry representatives, and consumers to help the agency respond to new challenges while still fulfilling its mission and mandates. It was Congress' belief that FDA could address these challenges by re-engineering several of its regulatory processes to achieve greater efficiencies and by buttressing its considerable risk assessment and risk management expertise through productive, collaborative relationships with key external stakeholders. III. Comments Interested persons, may at any time, submit written comments to the Dockets Management Branch (address above) regarding this plan. Two copies of any comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in brackets in the heading of this document. Submit e-mail comments to ``FDAD[email protected]''. E-mail comments should be labeled as comments and identified with the docket number found in brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. The text of the plan follows: BILLING CODE 4160-01-F Food and Drug Modernization Act of 1997--FDA Plan for Statutory Compliance November 1998 Table of Contnets Executive Summary Part One: Strategic Framework Purpose Scope The Mandated Strategic Framework FDA's Strategic Management Approach Mission Development Emerging FDA Challenges Analysis of the Gap Between What is Expected of FDA and Its Actual Performance Stakeholder Consultation Identification of Agency-wide Objectives and Strategic Directions [[Page 65001]] Part Two: FDAMA Plan for FY 1999 Objective A: Information about Review Processes Objective B: Information about New Products Objective C: Implementing Inspection and Postmarket Monitoring Provisions Subobjective C1: Assuring Product Safety Subobjective C2: Adverse Event Reporting Objective D: Science and Research Objectives E and F: Eliminating Backlogs Appendices Executive Summary: FDA Plan for Statutory Compliance Purpose The FDA Plan for Statutory compliance addresses requirements set forth in Section 406 of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The Plan identifies those actions necessary to bridge the gap between what FDA is required to do by statute and what it is able to accomplish with current resources. FDAMA has presented FDA with an opportunity to close that gap by working in concert with its community of stakeholders to protect the health and well-being of the American public. This Plan is a positive first step. It outlines bold and innovative approaches to meet the increasingly complex public health challenges of the 21st century. FDA, however, is unable to meet all of these challenges with its current level of resources. Innovation and creative collaboration with stakeholders will enhance this effort, but significant additional resources, as well as prioritization of FDA activities, are essential if FDA is to meet its statutory requirements on a sustained basis and to meet public expectations. The successful implementation of this Plan depends on commitment of resources by both FDA and its stakeholders. Scope The Plan specifically addresses each of the objectives stipulated by Congress in FDAMA Section 406(b). These objectives, when achieved, will result in the following outcomes: stakeholders who are well informed about and involved in the Agency's new products and regulatory processes; comprehensive monitoring of industry practices and product use; regulatory decisions that are supported by a sound science base; and on-time reviews of new products prior to market entry. To accomplish these objectives the Plan outlines FDA's strategic directions over the next 5 years and specific performance goals for Fiscal Year (FY) 1999. The Plan was developed in close consultation with a wide range of stakeholders, including consumers and patients, industry, health professionals, and other public sector regulators. The end product represents the collective views of FDA's senior leaders and its community of stakeholders. The Plan FDA Challenges in Fulfilling Its Mission: FDA must address several key challenges now and in the future for the Agency to successfully meet its statutory requirements and to fulfill its health promotion and protection mission. These include: research and development-fueled pressures on regulatory responsibilities; greater product complexity driven by breakthroughs in technology; growth in recognized adverse effects associated with product use; unpredictable new health and safety threats; awareness of citizen-stakeholders and their more targeted needs; emerging regulatory challenges in the international arena; and increased volume and diversity of imports. The ability to formulate successful solutions to these challenges depends on innovative approaches used by FDA, creative collaboration with stakeholders, prioritization of FDA activities, and an adequate investment of resources to implement these approaches. Stakeholder Views: FDA's senior leadership listened carefully to the viewpoints of its many stakeholders prior to the development of this Plan. These opinions were expressed during a series of public meetings held during the summer of 1998. Several productive suggestions surfaced from these discussions. Two general themes emerged: (1) Greater stakeholder involvement: Stakeholders want to be ongoing contributors to FDA's future strategies. Effective collaboration can raise the likelihood that these strategies will be successful. Stakeholders also want to be well-informed about FDA's regulatory processes. Consumers and patients want clear information about new products, and they want to receive the information in a timely manner. (2) Balanced, risk-based FDA decisions: Stakeholders agreed that FDA priorities should be risk-based, and also believe that the Agency should balance timely premarket review programs with the need for effective postmarket inspection and surveillance. They urged the Agency to continue to develop a strong scientific and analytical basis for regulatory decisions. Some urged FDA to rely more on third parties and others want more direct FDA regulation. Current Innovations/Reinventions: While stakeholders have made useful suggestions for enhancing Agency programs, FDA had already begun steps to improve its approach to public health protection and is continuing this effort. This has been accomplished both through redesign of internal programs and via collaborative efforts with outside parties. New, critically important medicines are now reaching the market more rapidly as a result of more efficient Agency review processes and the automation of these processes. Since 1993, the medium approval time for new drugs has been substantially reduced, from 20 months to around 12 months in 1997. FDA is collaborating with its regulatory colleagues as well as the regulated industry to develop national systems of consumer protection. Two examples are cited: FDA is working closely with the U.S. Department of Agriculture, the Center for Disease Control and Prevention, and the states to develop a comprehensive network for ensuring safety of the American food supply. FDA is also coordinating with the international regulatory community and the U.S. Customs service to increase assurance that imports entering the country are safe. Strategic Directions for the Future: FDA's senior leadership identified the following strategic directions in order to focus the Agency's energies on meeting the objectives set forth in the Plan: Establish risk-based priorities--Focus resources on those health and safety risks that most directly threaten the well-being of U.S. consumers. Strengthen the scientific and analytical basis for regulatory decisions--A strong science base must underpin each of the Agency's regulatory decisions. Work more closely with external stakeholders-- Collaboration with stakeholders will result in more effective solutions to public health problems. Continue to re-engineer FDA processes--Re-engineering will result in regulatory simplification and more cost-effective ways to run FDA's internal processes. Adopt a systems approach to Agency regulation--Regulatory approaches in the future will look for total problem solutions, rather than piecemeal review and enforcement decisions. Capitalize on information technology--Information technology will help to improve both internal efficiency and communication with stakeholders. The six strategic directions outlined above will guide FDA's efforts to meet the FDAMA objectives. Many factors over the next several years will have an impact on FDA's ability to meet these [[Page 65002]] objectives including the outcome of a risk-based priority system, the success of third parties in the regulatory process, improvements in technology and systems engineering, and the synergies created by greater collaboration with other federal agencies, as well as FDA's external stakeholders, new statutory mandates, and emerging public health responsibilities. Reinvention will enable FDA to make up some of the difference between current performance and FDAMA objectives. Additional resources will also be necessary over the next 5 years in order for the Agency to satisfy its statutory requirements and to meet public expectations. The body of this Plan identifies the major areas where FDAMA calls for FDA to meet statutory requirements, such as premarket reviews, injury reporting, and product safety assurance. It also discusses areas where there are not statutory requirements, but where there is general agreement on what time frames for reviews and inspections are appropriate and what other work needs to be accomplished to meet FDAMA objectives. FDA would be hard pressed to meet all of the FDAMA objectives with current resources and operating procedures. For example, in FY 1999 the Agency estimates it can accomplish roughly one- half to three-quarters of its statutory inspectional workload with current funding (See FIGURE 3). Plan Organization Part One of the Plan, the strategic framework, provides the broad Agency-wide context of the Plan. This includes: (1) development of a clear mission statement; (2) assessment of challenges that FDA faces in fulfilling its mission; (3) analysis to the gap between what is expected of FDA and its actual performance; (4) consulting FDA's stakeholders on future directions; and (5) a statement of Agency-wide objectives (Section 406(b)) and strategic directions to achieve the objectives. Part Two of the Plan maps the specific plan for achieving each 406(b) objective, including strategies and performance goals that can be used to manage toward the objectives. In Part Two, the specific performance targets for FY 1999 are established based on the Agency's existing resources, reinventions, and collaborative arrangements. FY 2000 performance targets currently are being developed as part of the FY 2000 Budget process and are not included in the Plan. Part One--Strategic Framework Purpose The FDA Plan for Statutory Compliance addresses requirements set forth in Section 406 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (see Appendix A). The Plan identifies those actions necessary to bridge the gap between what FDA is required to do by statute* and expected to do by the public--and what the Agency currently is able to accomplish with existing resources. A high- performing FDA working in concert with its stakeholders is absolutely crucial to promote and to protect the health and well-being of the American public. Given the myriad escalating technological, economic, and health risk challenges, this will not be an easy task for FDA. The passage of FDAMA presents FDA with an opportunity to demonstrate innovative and bold approaches in meeting these challenges for the 21st century. This Plan is one positive step toward moving FDA into conformance with the views of Congress and the Agency's stakeholders. This document demonstrates that FDA already is making great progress in managing health risks--a job that is becoming more complex and often fraught with uncertainty and unpredictability. The Plan also highlights the fact that the Agency clearly is unable to meet all of the challenges it is expected to address with its curent level of resources. Innovation and creative collaboration with external stakeholders will certainly enhance the Agency's abilities to reduce health risks in the long run; but additional resources are essential to help FDA fulfill its statutory mandates. [*Statutory requirements encompass all provisions of the Federal Food Drug and Cosmetic Act (FD&C Act) and its amendments, including FDAMA.] Scope The Plan specifically addresses the six objectives stipulated by Congress in FDAMA Section 406(b): Maximize the availability and clarity of information about the process for review of applications and submissions. Maximize the availability and clarity of information for consumers and patients concerning new products. Implement inspection and postmarket monitoring provisions of this Act. Ensure access to needed scientific and technical expertise. Establish mechanisms, by July 1, 1999, for meeting time periods for the review of all applications and submissions. Eliminate backlogs in the review of applications and submissions by January 1, 2000. To achieve these objectives, the Plan identifies Agency-wide strategic directions for the next 5 years, and specific performance goals for Fiscal Year (FY) 1999. Thus, the total plan presents a picture of the Agency's long- and short-term future that will be reviewed and modified as part of ongoing discussions with FDA's stakeholders, with future Department of Health and Human Services (DHHS) leadership and other parts of the Administration, and with Congress. The Mandated Strategic Framework This Plan is one element of a total strategic framework mandated by FDAMA that enables FDA to address increasingly complex public health challenges. This framework, outlined in Section 903 of the Federal Food, Drug, and Cosmetic Act as amended by FDAMA (see Appendix A), contains the following key elements: 1. An augmented mission statement for FDA, which places new emphasis on more resource-intensive consultation and cooperation with stakeholders as a crucial ingredient in public health protection and promotion [Sec. 903(b)(4)]. 2. A charge to the Secretary of Health and Human Services to foster collaboration among science-based agencies throughout the federal government. Such coordination is necessary to strengthen the science capabilities that underpin federal responsibilities to ensure a safe food supply and related to development, evaluation, and monitoring of new medical therapies [Sec. 903(c)]. 3. Stipulation of general powers that are necessary for carrying out Agency responsibilities, including research and education [Sec. 903(d)]. 4. A requirement that FDA develop, after consulting with stakeholders, a plan for bringing the Agency into compliance with each of the obligations under the Act (The FD&C Act), and revise that plan as appropriate with stakeholder input [Sec. 903(f)]. 5. A provision for FDA to prepare and publish an annual report that compares planned versus actual performance [Sec. 903(g)]. These elements reflect certain broad themes. First, the Agency should devise and implement strategies in a more open, multi- organizational environment. Congress emphasized throughout FDAMA that consultation, collaboration, and synergy-building [[Page 65003]] with external organizations are paramount to FDA achieving its mission of protecting and promoting public health. Simply put, FDA cannot do the job alone. Second, Section 903 provides FDA with a more systematic approach to strategic management. The essential elements are clearly articulated: a clear mission, consultation with stakeholders, a plan based on stakeholder input to carry out the intent of the mission, and provision for ongoing feedback, accountability, and adjustment to the plan. The Agency recognizes the importance of this plan for action accountability, as outlined in Section 406(b) of FDAMA, and in establishing an ongoing dialogue with stakeholders to continually improve strategies. Third, Congress has recognized that an array of capabilities including public education and research [Section 903(d)(2)] are essential elements required to carry out its responsibilities under the Act. The six objectives outlined in FDAMA 406(b) also explicitly stipulate education and scientific expertise as being central to the Agency's modernization plan. Successful public health promotion and protection decisions depend upon a well-developed science infrastructure and an informed public. Without these two elements, desired health outcomes are not possible. FDA's Strategic Management Approach Figure 1 illustrates how FDA is integrating the mandates in Section 903 to form the components of an effective strategic management process. As the figure illustrates, effective implementation of the FDAMA plan depends upon several elements: (1) development of a clear mission statement; (2) assessment of challenges that FDA faces in fulfilling its mission; (3) analysis of the gap between what is expected of FDA and its actual performance; (4) consulting FDA's stakeholders on future directions; (5) a statement of Agency-wide objectives [406(b)] and strategic directions to achieve the objectives; (6) a specific plan for achieving each 406(b) objective, including strategies and performance goals that can be used to manage toward the objectives; and (7) a budget that adequately funds the plan. Part One of the Plan provides the broad Agency-wide context--steps 1 through 5 above. Part Two of the Plan maps the specific plan for achieving objectives. In Part Two, the specific performance targets for FY 1999 are established based on the Agency's existing resources, reinventions, and collaborative arrangements. FY 2000 performance targets currently are being developed as part of the FY 2000 Budget process and are not included in the Plan. Many factors influence FDA's choice of performance levels, including: extrapolations of past performance, anticipated workload, creative re-engineering to improve internal efficiencies, successful collaboration with FDA's outside stakeholders, and strategic priorities. BILLING CODE 6160-01-M [[Page 65004]] [GRAPHIC] [TIFF OMITTED] TN24NO98.004 BILLING CODE 4160-01-C [[Page 65005]] Mission Development Over the years, Congress has dramatically expanded the responsibilities of the FDA. The Federal Food and Drugs Act of 1906, the first national statute enacted by Congress to regulate the American food and drug supply, gave FDA's predecessor agency the authority to remove adulterated or misbranded foods and drugs. In ensuing years, Congress enacted a series of statutes that expanded FDA's responsibilities in a number of directions, including: new product areas (cosmetics, biologicals, and medical devices.); additional product characteristics (e.g., efficacy as well as safety); and additional perspectives from which to monitor products (e.g., monitoring prior to market introduction as well postmarket monitoring). Beginning in 1996 with the passage of the Animal Drug Availability Act (ADAA) and continuing in 1997 with the passage of FDAMA, Congress enhanced FDA's mission in ways that recognized the Agency would be operating in a 21st century characterized by increasing technological, trade, and public health complexities. To meet these challenges, Congress added explicit phrasing to the Agency's mission statement to ensure that FDA would coordinate its own efforts with regulatory counterparts worldwide. In addition, Congress recognized that external scientists, medical experts, and public health experts must play an increasing role in Agency responsibilities. It defined a new emphasis to be placed on regulatory processes and required more interaction with stakeholders. Through FDAMA, Congress intends to ensure timely availability of safe and effective new products that benefit the public, and to ensure that our nation continues to lead the world in new product innovation and development. DAMA defines FDA's new mission as follows: The Administration shall-- (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that-- (A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation; (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and (4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products. Emerging FDA Challenges FDA must address a wide range of challenges that serve as potential obstacles to successfully carrying out its health protection mission in the 21st century. To the extent that these challenges remain unaddressed, a gap between expectation and performance will persist. This Plan represents a blueprint for addressing these challenges, thereby narrowing the gap. Key challenges that FDA faces now and in the near future include: 1. Research and development-fueled pressures on regulatory responsibilities; 2. Greater product complexity driven by breakthroughs in technology; 3. Growth in recognized adverse effects associated with product use; 4. Unpredictable, new health and safety threats; 5. More targeted needs and awareness of citizen-stakeholders; 6. Emerging regulatory challenges in the international arena; 7. Increased volume and diversity of imports; and 8. Federal budget constraints. Each of these challenges is discussed briefly below. Research and Development-fueled Pressures on Regulatory Responsibilities Each year, FDA-regulated firms add more than $2 billion to domestic research and development efforts. For pharmaceuticals alone, this effort currently exceeds $20 billion total, which is triple the effort of only 10 years ago. The growth in research budgets at public agencies such as NIH surely will result in a greater number and wider variety of products that FDA must, by statute, regulate. More importantly, the speed of product development also is accelerating. By streamlining the commercial review process, FDA has helped to reduce the time between discovery and Agency evaluation. But this streamlining also gives the Agency very little time to develop a regulatory framework to handle new technologies. Thus, it is imperative for FDA to continue to engage in close interaction with industry in the early stages of product research and development. The volume, variety, and speed of new product development presents FDA with the twofold goals of: (1) ensuring that consumers enjoy timely public health benefits from these products; and (2) minimizing the health risks associated with consumers' use of these products. FDA resources devoted to premarket review of these products must be carefully allocated so that both goals are addressed. The Agency's current level of resources, however, cannot adequately address both goals in all of the product areas for which the Agency has responsibility. Greater Product Complexity Driven by Breakthroughs in Technology Product complexity continues to increase. FDA-regulated products will be characterized by unprecedented technological sophistication, while also providing unparalleled health benefits for the U.S. public. The continued benefits of genetic engineering warrant particular attention. New products generated by the biotechnology revolution cover a broad spectrum, including: genetic probes that serve as powerful diagnostics; genetically engineered drug and gene therapies; and biotechnology-based food modifications such as protein-enhanced vegetables. Increased understanding of the human genome, as well as of the genetic make-up of other organisms (genomes of other animals and plants), will yield many new and different products and applications. The number of sources that produce these new genetically engineered products continues to escalate. The number of biotechnology firms grew dramatically from the early 1980s through 1993, so that by 1993 there were 1,272 firms, more than a threefold increase over the pre-1981 number. By April 1997, nearly 300 biotechnology drugs were in development, tripling the number that were in development in 1989. FDA must have access to the necessary scientific expertise to be able to address the complexity of these new products, and to provide sound regulatory decisions. Microprocessor and miniaturization technologies are rapidly expanding and enabling significant improvements in implantable medical devices such as pacemakers, cochlear implants, and closed-loop medicine delivery systems that monitor conditions within the body and administer treatments as required. Progress in artificial intelligence has increased companies' ability to apply pattern recognition techniques in such [[Page 65006]] products as Pap smear readers and neural net classifiers. New combination products, such as food-drug and drug-device combinations, will continue to be generated through the application of biotechnology techniques. Such developments foster improved versions of products already developed and approved, as well as entirely new products. New biological-based products will require the development of new data profiles, because the data used to determine the safety of chemical-based products of the past are neither sufficient nor appropriate for predicting the safety of these new products. Biotechnology also is being used to develop new assessment tools. More emphasis is being placed on new approaches to assess the product safety of food, dietary supplements, and health care products. These tools include bioassays to improve safety assessments of carcinogencity and to address emerging concerns of neurotoxicity, immunotoxicity, and developmental toxicity. Growth in Recognized Adverse Effects Associated With Product Use New technologies have provided an explosion of innovative diagnostic and therapeutic health products. The consequences of this explosion, however, include a parallel expansion of adverse effects associated with product use. Although the benefits realized from these products still greatly outweigh the problems associated with consumption, these problems must be addressed. To illustrate, FDA received more than one-quarter million reports of suspected drug- related adverse effects in 1997, and this number of adverse reports continues to increase annually. FDA estimates that nearly one million patient injuries and deaths each year are associated with the improper use of FDA-regulated products. Additional injuries and deaths occur under conditions of proper use and accidental injury. For example, of the more than 70,000 injury reports related to medical devices received annually, approximately 25 to 40 percent of the injury or death reports may be attributed to device misuse or operator error. Injury reports received by FDA only represent between 1 and 10 percent of all injuries associated with the use of medical devices. Using these figures, as many as 400,000 incidents per year resulting in patient injury or death may, at least in some way, be attributed to the user-device interaction. Currently, the FDA Center for Food Safety and Applied Nutrition (CFSAN) receives reporting on food additives, cosmetics, and special nutritionals from the field offices and other sources. To achieve efficiency in monitoring and responding to adverse events, the Center is proposing the establishment of an integrated adverse event reporting system for food and cosmetic products. As the Agency develops more comprehensive adverse event reporting systems, particularly in collaboration with other institutions, the number of reported adverse events likely will increase. If surveillance capability does not expand, the magnitude and severity of product use problems will, to a large extent, remain unknown, and the health risks will be unaddressed. Unpredictable, New Health and Safety Threats FDA continues to face a range of threats to public health that appear in a random and discontinuous pattern. For example, crippling infectious diseases such as tuberculosis are reemerging, bovine spongiform encephalopathy (BSE) became epidemic in the United Kingdom and was unexpectedly linked to the human disease, Creutzfeld-Jakob disease (nvCJD), and more virulent and antibiotic-resistant bacteria have been discovered in food products around the world. These unpredictable threats, coupled with the growing incidence of disease- causing organisms' resistance to existing drug therapies, challenge both industry and FDA to bring innovative, safe, and effective treatments to the market rapidly. The Agency also must address crises that require emergency responses, whether they are the discovery of pesticides in selected imported products, Escherichia coli outbreaks, or intentional product tampering. These events are byproducts of several factors, including continually expanding global trade; new entrants into domestic industries--particularly where emerging technologies are present; and economic pressures on regulated firms to reduce costs in order to ensure short-term survival. The unpredictable nature of a significant portion of FDA's compliance activity also acts as a severe limitation to fulfilling statutory mandates of inspectional coverage. FDA is attempting to augment its inspection capability with strategies that call for collaboration with states, use of third parties to verify industry compliance, and augmenting industry quality control mechanisms. But even these augmentation strategies require front-end investments to develop systemic capabilities such as data validation, data sharing, and auditing to determine whether protocols are in place. In addition, some stakeholders oppose other third-party involvement. Consequently, in the short run FDA--even in conjunction with collaborators--will not be able simultaneously to satisfy statutory inspection requirements and address all current health and safety threats. More Targeted Needs and Awareness of U.S. Citizens- stakeholders A more knowledgeable and diverse consumer population is escalating expectations for more information, as well as information that is more tailored to their particular needs, concerning the safety of FDA- regulated products. American consumers have become more health- conscious during the 1990s and are seeking more information on the impact of medical products and food on their health. FDA must distinguish between the risks perceived by consumers and their actual risks, and respond accordingly. Based on the additional information that FDA provides, consumers are playing a larger role in protecting their own health. The elderly population provides a good illustration of why FDA must target its information and regulatory policies to fit the needs of particular market segments. Although the elderly are by no means the only segment with special needs, their numbers have become much more prominent in the general population. By the year 2000, Americans aged 75 and older will be the fastest growing group. The elderly (those over 65) have disproportionately high health care demands. Challenges associated with this patient subpopulation, such as multiple drug interactions, different physiological characterizations and reactions to drug regimens, and the need for better medical device design for home self-diagnostics and therapies, will become more acute. These challenges will require greater inclusion of the elderly in clinical testing for drugs, medical devices, and other FDA-regulated products. Further, the increasing educational needs of the elderly will require more focused education programs, including specific dietary information and foods targeted to their nutritional requirements. The elderly population and food service workers who prepare food for the elderly also will require special education initiatives concerning proper food handling, because as the population ages it becomes more susceptible to foodborne diseases. [[Page 65007]] Emerging Regulatory Challenges in the International Arena FDA participates in the world community of developed, underdeveloped, and developing economies and regulatory authorities. Radical changes in the dynamics of the world structure are underway, driven by several forces: (1) an increasing number of global and multinational firms that produce FDA-regulated products; (2) increasing sophistication of unified economic, political, and regional entities (e.g., the European Union [EU] and Pacific Rim countries); and (3) the response to these conditions on the part of regulatory/standard-setting entities. The larger drug, biological, device and food firms now operate as multinational companies. New products will be developed, produced, and marketed through a highly networked and global commercial system. The system will have great power to satisfy consumer needs, but will be much more complex to monitor for potential risk than has been the case in the past. This situation will require sophisticated international regulatory responses. Further, the regulatory response by U.S. interests must preserve the delicate balance at the international level between preventing unnecessarily high-risk products from entry into the country, while providing access to novel, important therapies or foods to the American public. The multinational and global firms are sharing center stage with an increasingly organized set of regional economic and political entities such as the EU, Pacific Rim organizations, North America Free Trade Act (NAFTA) participants, etc. These entities are amassing the economic and political power to attract world trade. The pace of their development is often uneven, but the longer term direction is clear. Raw materials and joint ventures that stretch across national borders are all becoming international elements for FDA to regulate where previously these were purely domestic phenomena. The Agency must now make new decisions on how (or if) to manage each of these new elements. Increasingly, FDA must take into account the global trade implications of its decisions. Organizations such as the International Committee on Harmonization (ICH), the International Standards Organization (ISO), the Global Harmonization Task Force, the International Cooperation on Harmonization of Technical Requirements of Registration for Veterinary Medicinal Products (VICH), and Codex are becoming increasingly important in the determination of the level of acceptable product safety, quality, and efficacy for products trading in the international arena. FDA must maintain a viable voice as standards are prepared and speak with a voice that represents the interests of all of its stakeholders, whether they are consumers, patients, health practitioners, or the regulated industry. Increased Volume and Diversity of Imports Imported products regulated by FDA represent a significant component of total U.S. consumption. In some sectors, such as seafood, the percentage of total consumption represented by imports is approximately 50 percent. FDA's responsibilities in the import arena continue to expand, without a corresponding increase in resources to do the job. To illustrate: The volume of imports has grown steadily over the past few decades. By 1998 an estimated 4 million FDA-regulated import line items arrived in the U.S. The number of food items, representing the majority of those imports, increased by 21 percent over the last year alone! During that same period, FDA resources to address imports remained essentially level. And the complexity is increasing--the reality of a truly global economy is adding significant regulatory challenges for FDA. These products are originating in countries that often have less developed health/safety regulatory structures. The increase in volume, variety, and sources of imports may be accompanied by increases in novel pathogens, microbial contamination, and other public health concerns and regulatory challenges for FDA. Developing countries, which once provided raw materials for U.S. manufacturers, and assemblers are increasingly providing finished products to the U.S. market. This conversion could increase the risks associated with such products. Federal Budget Constraints Recent budget proposals and appropriations acts have addressed emerging public health issues (such as AIDS) and long-standing public health problems that received insufficient attention in the past (including reducing youth tobacco use, improving food safety, and accelerating prescription drug approvals). While those problems continue to need attention, inflation has reduced real resources available for FDA's other public health responsibilities, which are necessary to meet the obligations delineated in FDAMA. These include inspections to ensure product safety; review of devices, food additives, blood products, animal drugs, and generic drugs; and adverse event reporting and followup. Analysis of the Gap Between What is Expected of FDA and Its Actual Performance FDA faces a critical issue today. Because of a convergence of challenges outlined in previous sections, the Agency has been unable to fully meet its explicit statutory obligations; nor has it been able to completely guarantee the more implicit health and safety responsibilities the statute requires and the public demands. Figure 2 illustrates that a sizable gap still exists between statutory requirements of ``on-time review'' for several product areas, and what FDA currently is able to deliver. Figure 3 shows a similar gap between mandated and actual inspectional coverage for FDA-regulated industries. BILLING CODE 4160-01-M [[Page 65008]] [GRAPHIC] [TIFF OMITTED] TN24NO98.005 BILLING CODE 4160-01-C [[Page 65009]] The agency has listened carefully to its stakeholders over the past several months and has combined their views with its own emerging strategies to develop a plan for narrowing the gap. The following section provides a summary of stakeholder views. Stakeholder Consultation FDA's assessment of the challenges it faces in fulfilling its mission and the identification of the disparity between expectations and what is achievable given the current climate set the stage for consultations with its external stakeholders. This consultation is necessary to determine the most effective ways of narrowing the gap. FDA depends on the views of its stakeholders for two crucial reasons: (1) stakeholders are affected by the outcomes of FDA's strategies and should therefore play a role in formulating them; and (2) stakeholders are also the collaborators that are necessary for successful implementation of the Plan. In the sections that follow, the process of stakeholder consultation is discussed, and a summary of their views is provided. The Process Section 406(b) of FDAMA prescribes that the plan for statutory compliance be developed: after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and advocacy groups, and the regulated industry. The experts and representatives referenced in Section 406(b) comprise the constituency of the FDA. The Agency informally consults with these constituents on a regular basis. Section 406(b) codifies this process and provides a mechanism for formal input from and feedback to its constituency. In response to this requirement, the Agency designed a process that provided multiple avenues for input, including the following: Public meetings were held and tailored to address concerns associated with each of FDA's product centers: foods, human drugs, animal drugs, biologics, and medical devices. In addition, there was a meeting focusing on health professionals and an Agency-wide meeting addressing cross-cutting issues. Dockets were provided for stakeholders to make additional comments subsequent to the public meetings. These dockets will remain open indefinitely. Electronic communication vehicles were established that allow stakeholders to communicate with FDA via Internet responses to the Agency's home page as well as through e-mail. District Consumer Forums were held to solicit comments from stakeholders. On going communication vehicles were used to actively solicit stakeholder views on current and future directions for the Agency. These vehicles include speeches made by the Agency's senior leadership, ongoing exchanges in smaller forums such as workshops, and one-on-one conversations. FDA adopted a uniform approach in framing the stakeholder discussions and comments. Agency officials first outlined the stakeholder consultation process. The leadership then provided a framework outlining the emerging technological and public health challenges faced by FDA. Finally, to focus stakeholder comments and discussion, questions (Appendix B) were developed that related to each of the six objectives addressed by the 406(b) plan and were available to stakeholders prior to the meetings. The process of engaging the Agency's stakeholders and receiving useful feedback is an ongoing one. This initial round of stakeholder views will continue to be analyzed and interpreted during Fall 1998. Results of the analysis will be shared with FDA's external as well as internal audiences. The next round of formal stakeholder meetings is being scheduled for Spring 1999, and regular contacts will continue to be maintained. Although longer term assessment is forthcoming, a preliminary evaluation of stakeholder views has been conducted. An overview of these views is provided in the next section. Stakeholder comments are assessed in greater detail in Part Two of the Plan and are related to Agency strategies. Summary of Stakeholder Viewpoints FDA's stakeholders commented on many aspects of the Agency's operations. The recommendations made by stakeholders regarding the Agency's priorities and the strategies FDA should use in carrying out its responsibilities reflect a wide range of concerns and perspectives. The full context of stakeholder views expressed at public meetings and in written comments are captured in transcripts and dockets that are available on FDA's Internet Web page http://www.fda.gov/oc/fdama/comm. Appendix B-4 also provides a compendium of stakeholder recommendations, classified both by 406(b) objectives and by the strategic directions that are identified in the next section of the Plan. Major themes that emerged from the stakeholder comments are summarized below. Areas of Consensus Most stakeholders agree on several broad issues. Many agreed that FDA priorities should be risk-based, scientifically rational, and focused on protecting public health. In addition, the Agency should view meeting its statutory obligations as a high priority. A number of organizations cautioned that the Agency should limit its participation in new activities, especially those that go beyond the scope of its core statutory requirements. Although stakeholders varied in their interpretations of core responsibilities, some stakeholders highlighted the importance of preserving FDA's regulatory role and encouraged the Agency to develop more creative strategies to exercise its regulatory responsibilities. Many stakeholders acknowledged the difficulties inherent in making trade-offs among program activities when resources are constrained. Making new safe and effective treatments available to patients in a timely manner is also a high priority for FDA. To optimize the performance of the premarket review and approval system, stakeholders recommended that FDA continue to re-engineer its systems and strive for internal efficiencies; communicate earlier in the premarket review process, more frequently, and more openly with industry and other stakeholders; and make FDA policies and procedures more consistent and more transparent to industry and the public. Several groups would like FDA to adopt a more uniform and consistent approach to addressing risks of public health significance. Consistency of FDA policies and procedures seemed to be a greater concern than their transparency. Requests for improved communication emphasized two-way communication--not only from the FDA to its stakeholders but also from stakeholders to FDA beyond adverse event reporting. Stakeholders value FDA developing a strong scientific and analytic base for its regulatory decisions. They believe that FDA should use the expertise of other organizations to help meet its goals. For example, delegating or collaborating on certain functions (such as research, standard-setting, and some aspects of product review) to third parties were offered as a means of leveraging limited resources. Several stakeholder groups want to be more involved in FDA advisory committees. These views are consistent with FDA's transition to a more open and collaborative relationship with its [[Page 65010]] regulatory counterparts and industry. Continued FDA leadership and participation in the international arena was encouraged to ensure that international standards and guidelines are consistent with U.S. requirements. Even through it was recognized that FDA had limited resources to meet all of its statutory obligations and to meet public expectations, industry representatives opposed the collection of user fees for medical devices and the blood banking industry, as well as for veterinary products, as a means of funding premarket review activities. Similarly the concept of an ``FDA seal'', viewed as a form of user fees, was not supported. Areas of divergence Although the first order of concern of all stakeholders is consumer health protection and availability of medical products, there is no consensus on the role FDA should play nor what approach should be taken in this daunting task. Key differences among stakeholders include the following: FDA's Role in Education Stakeholders differed sharply in their opinions on the legitimacy and primacy of FDA's role in consumer education. While some stakeholder groups believe that industry and health professionals should be responsible for consumer education, others assert that FDA should play an essential role in providing objective information about regulated products to consumers and in facilitating patient participation in ongoing clinical trials of promising new therapies. One consumer advocacy group, the National Council on Patient Information and Education, requested FDA's support in developing a collaborative, national consumer FDA's Enforcement Activities Some stakeholders called for expanded FDA authority and additional resource appropriations to allow the Agency to carry out its responsibilities, for example, in the areas of drug safety monitoring and monitoring the sale of unapproved veterinary products. Other stakeholders acknowledged that FDA would need to share enforcement responsibilities with others. For example, one group supported a division of tasks in the inspection arena, with FDA covering the imports, and states being responsible for domestic inspections. Use of Third Parties There were mixed views in this area as well. Many consumers preferred that FDA regulate the industry more directly, while several industry representatives advocated for greater use of third parties, as long as the arrangement was carefully monitored by the Agency. Advisory Committees Views regarding the composition of FDA advisory committees diverged greatly. Some pressed for broader presentation of interested persons while others advocated that FDA place greater emphasis on the depth of knowledge of advisory committee members. The Agency was urged to recruit renowned experts to serve on advisory committees. Some advisory committees were criticized for favoring nonscientific issues over sciences when they make recommendations. Unresolved Issues Perhaps the issue that remains most problematic is the overall question of balance among FDA's functions. The appropriate mix of premarket review, post-market inspection, and surveillance activity is an ongoing topic of debate among the Agency's stakeholders. One stakeholder summed up the issue: ``How should FDA balance the need for strong and timely premarket review programs with the need for effective postmarket inspection, surveillance, and enforcement programs? That is like asking the American people to find a balance between building safe aircraft and providing adequate maintenance over the course of a plane's life.'' (Patient Group) Although stakeholders expressed their views regarding the emphasis FDA should place on various issues, these comments frequently focused on a single FDA Center or two Competing issues. FDA does not have sufficient information at this time about the priority Agency stakeholders wish to assign to a particular issue relative to other issues competing for resources within an FDA Center or within the Agency as a whole. In some instances the proposed strategies appear to be contradictory. For example, how should the Agency balance setting risk-based priorities or meeting public expectations when doing so directly competes with meeting its statutory obligations? Identification of Agency-Wide Objectives and Strategic Directions The six objectives specified in FDAMA Section 406(b) and outlined on page 1 of this Plan, provide FDA with a broad framework for meeting its statutory requirements and public expectations. The Agency's senior leadership believes the following strategic directions are necessary to focus its efforts in achieving the objectives set forth by Congress. These directions represent an amalgam of approaches that have been emerging for several years, and which have been modified both by new FDA challenges and by the productive suggestions made by external stakeholders. Figure 4 identifies the link between key stakeholder themes and the strategic directions outlined in this section of the plan. BILLING CODE 4160-01-M [[Page 65011]] [GRAPHIC] [TIFF OMITTED] TN24NO98.006 BILLING CODE 4160-01-C [[Page 65012]] The strategic directions are broad in scope and cross-cut components of the organization. As such, they provide a context to guide all of the Agency's more specific goals and programs. They also serve as a way to galvanize diverse activities into a set of unified directions for the long-term. (1) Establish risk-Based Priorities Although the importance of setting risk-based priorities was a concept repeatedly endorsed by many stakeholder groups, there was not consensus regarding what constituted the highest risk areas. FDA must listen to its stakeholder community, but then it must decide, based on continuing consultation with its stakeholders, which health and safety risks most directly threaten the well-being of U.S. consumers, and allocate its resources accordingly. In the harsh light of limited resources, FDA simply cannot meet everyone's demands and cannot address all risks with the same degree of urgency or intensity. For example, the Agency is unable to respond to its highest priority health risks and at the same time fully meet its biennial statutory inspection requirements for drugs, biologics, and medical devices. it may be appropriate to reassess the practicality of mandates that emphasize industry coverage, regardless of risk, when those mandates may divert limited resources away from addressing serious health and safety concerns. The Agency has and will continue to increase the efficiency of ``fast track'' processes to address the most urgent needs for therapies so that these therapies can enter the marketplace rapidly. Resources will continue to be redirected toward the review of these products. Surveillance and compliance efforts also will continue to be directed toward identifying and taking action to correct the most serious health and safety problems associated with products that are in the marketplace or about to enter the market. The Presidential Food Safety Initiative will continue to focus attention and devote resources to those areas of the food supply that pose the greatest risk of illness and/or death to consumers. (2) Strengthen the Scientific and Analytical Basis for Regulatory Decisions A strong science base continues to underpin each of the Agency's regulatory decisions. Such decisions must be made throughout the lifespan of FDA-regulated products from initial research, development and testing, through production, marketing and consumption. A strong science base consists of the expertise, the risk assessment protocols, the test methods, product guidance and performance standards, and the facilities and equipment necessary for conducting excellent science. The emerging emphasis in this strategic area is to seek means for achieving synergies in science capability through access to and collaborative efforts with sources of scientific expertise beyond FDA. A recent example that the Agency hopes will achieve research synergies through collaboration is the pharmaceutical quality and drug development science initiative that the Agency has begun to pursue under a cooperative research agreement among FDA, professional societies, and industry. The initiative will provide a venue to conduct research on pressing questions about pharmaceutical manufacturing that can inform regulatory decisions regarding needs in such areas as supplement submission requirements or bioequivalence studies after there are manufacturing changes. Such collaborative efforts are reinforced in the objectives identified in FDAMA Section 406(b). The key lies in ``ensuring access to the expertise,'' wherever it is most cost-effective. (3) Work More Closely With External Stakeholders FDA will need to multiply the Agency's capability to address complex public health problems by working with stakeholders in planning, implementing, and evaluating solutions to these problems. The solutions don't lie solely in expanding the mass of the Agency. Consumers, the regulated industry, health professionals, and FDA's regulatory counterparts in the U.S. and abroad each represent components of a total network that can potentially improve health outcomes. To help ``activate'' that network, FDA is engaged in several strategies some just emerging and others in a more mature phase. These `'activation strategies'' include: collaboration with stakeholders to create synergies in protecting the public health; ensuring that stakeholders are well informed about the Agency's regulatory processes [the processes should be as transparent as possible] and the products that are affected by these processes; involving stakeholders early in the Agency's processes; and ensuring that all affected stakeholder groups' interests are well represented in product testing and approval decisions. FDA is striving to create synergies through collaboration with appropriate outside colleagues in product research and testing, development, production, marketing, and consumption/use to ensure safety, quality, and efficacy.The Agency's Joint Institute for Food Safety and Applied Nutrition [JIFSAN] (with the University of Maryland) and the Moffett Center in Illinois are illustrative of such synergies working at the level of applied research and development to ensure safe foods. Industry representatives and health professionals made it clear to FDA during the stakeholder consultation process that they can be more effective colleagues in improving health outcomes in their role as product developers and users if they are (1) well informed about the Agency's regulatory review, surveillance, and compliance processes; and (2) consulted prior to regulatory decisions on both the pre- and post- market side of product commercialization. FDA will continue implementing strategies to engage in preventive problem solving, as well as initiatives that will make the Agency's processes as clear and understandable as possible to participants. Consumers and patients expressed a need to have prompt, complete, understandable, and unbiased information about products that FDA regulates, particularly new therapies. Well-informed consumers are more effective contributors to the management of their own health risks. FDA has launched several initiatives that are intended to keep the consumer well-informed through such vehicles as publishing the availability of important new drugs on the Internet. FDA is also attempting to ensure that the interests of all affected patients are well represented in such areas as clinical trial designs for new therapies. In addition, FDA will ensure that the interests of the consumer are represented in such deliberative bodies as advisory committees when recommendations on new products are being considered. (4) Re-Engineer FDA Processes FDA has used both an internal and an external focus in redesigning many of its regulatory review processes. From the external perspective, FDA is implementing several protocols that will result in simplified regulatory approaches and, as a result, a reduced burden for the regulated industry. Many of these regulatory reinventions are embodied in provisions in FDAMA. For example, the Agency may start review of a ``fast-track'' drug application before the application is complete if preliminary clinical data demonstrate that the product may be effective. Fast-track status also is being established for humanitarian medical devices, and new product development protocols will allow medical device sponsors to use [[Page 65013]] recognized study results that have been generated by other sources as part of their own application submission. Other regulatory simplification strategies have been instituted independent of FDAMA. For example, a phased review process for animal drugs has been designed that enables the Agency to provide periodic feedback to product sponsors throughout the drug review process to foster ``continuous improvement'' in the application. FDA is also focusing internally to achieve greater efficiencies and effectiveness in its review and tracking processes. For example, implementation of project management techniques allows an opportunity for convergent thinking and action to occur so that multiple disciplines can coordinate their efforts in providing thorough but timely reviews of product sponsors' applications. (5) Adopt a Systems Rather Than a Piecemeal Approach to Agency Regulation Several stakeholders during the public meetings noted that they could be more efficient and effective participants in promoting and protecting public health if they could understand the total context of what the Agency was trying to do and what its future directions were. The establishment of a systems approach within FDA is closely related to the establishment of risk-based priorities. Use of a systems orientation is an effective way to identify what is truly high-priority risk and then to address that risk in a systemic manner. Systems solutions, such as the Food Safety Initiative, the integrated adverse event reporting initiative, and the important monitoring system, are examples of FDA acting in concert with other collaborators to address the highest priority, most pervasive risks facing consumers. The Agency also has adopted a systems orientation in many of its individual programs. To illustrate, medical device inspectors have embarked on a new approach to determine industry compliance with Good Manufacturing Practices (GMPs). They are pilot-testing a systems- oriented inspectional strategy whereby medical device plants are given guidance on the establishment of a total Device Quality System, so that the control of product safety and quality is owned by the firm, rather than their having to respond to a series of external compliance requirements that must be responded to one at a time. The seafood Hazard Analysis and Critical Control Points (HACCP) initiative provides another example where FDA worked with the seafood industry to implement a systems approach to ensure the safety of seafood consumed by the American public. (6) Capitalize on Information Technology FDA has been on a long course of improvement in taking advantage of the opportunities offered by a rapidly evolving information technology environment. Information technology has been used for quite some time by the Agency in order to improve internal efficiencies. For example, a key element in accelerating the review of new drug therapies has been automating major portions of the drug review process. When both product sponsor and Agency reviewer can use electronic communication to establish a common ground of understanding, then all parties benefit. It is a critical element that has become pervasive in all mission- oriented as well as support activities. More recently, the Agency has turned its attention to using information technology as a way of improving communication with external stakeholders. One of the most powerful examples of how stakeholders are assisted is in the rapid provision of information on new drug therapies via the Internet to consumers and patients. FDA's home page provides an opportunity for all of FDA stakeholders to be aware of recent Agency regulatory decisions, and, just as important, to receive input in the form of suggestions and other opinions from Agency officials. The Agency will expand use of information technology to bring relevant information to bear in the area of produce surveillance and adverse event reporting. Well-designed and integrated information systems will dramatically reduce the gap between adverse effects associated with consumption and problem correction. Making the Transition From Strategic Context to Targeted Planning The strategic directions outlined above provide the context for understanding Part Two of the 406(b) Plan. In Part Two, specific performance targets and associated strategies re outlined for FY 1999. Part Two is organized into sections that correspond to the six objectives outlined in Section 406(b) of FDAMA (Section 903(f) of the FD&C Act as amended). Thus, specific performance targets can be directly related to achieving the objectives of the Act. Within each objective, strategies for FY 1999 relfect the Agency- wide strategic directions identified in Part One. Thus, the Agency's targeted planning for FY 1999 is strategically aligned with its intended directions over the next several years. Part Two--FDAMA Plan For FY 1999 This Plan outlines key performance goals and strategies designed to achieve these goals during FY 1999. The Plan serves several purposes: (1) It provides a blueprint for narrowing the gap between what FDA is expected to do by law and by the stakeholder community and what FDA currently can accomplish given its existing Agency resources. (2) It responds to Section 406(b) of FDAMA, which requires the Agency to develop such a plan: ``The Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act.'' (3) It moves FDA closer to fulfilling its strategic goals, and thus, its mission of consumer health protection and promotion. (4) Finally, the Plan provides a specific set of performance commitments that will serve as a basis for managing towards results and for reporting progress. The Plan is organized according to the six objectives outlined in Section 406(b) of FDAMA. These objectives address critical components of FDA's responsibilities. The Agency, working in collaboration with key players in both the public and private sector, will pursue each objective as part of a total consumer health protection and enhancement system. The process begins with the research and development of new products with great health- and life-sustaining potential, and ends with the safe and effective consumption of these products. Figure 5 illustrates how FDAMA objectives are crucial elements of FDAs total contribution to beneficial public health outcomes. BILLING CODE 4160-01-M [[Page 65014]] Part Two--FDAMA Plan For FY 1999 This plan outlines key performance goals and strategies designed to achieve these goals during FY 1999. The Plan serves several purposes: (1) It provides a blueprint for narrowing the gap between what FDA is expected to do by law and by the stakeholder community and what FDA currently can accomplish given its existing Agency resources. (2) It responds to Section 406(b) of FDAMA, which requires the Agency to develop such a plan: ``The Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan brining the Secretary into compliance with each of the obligations of the Secretary under this Act.'' (3) It moves FDA closer to fulfilling its strategic goals and thus, its mission of consumer health protection and promotion. (4) Finally, the Plan provides a specific set of performance commitments that will serve as a basis for managing towards results and for reporting progress. The Plan is organized according to the six objectives outlined in Section 406(b) of FDAMA. These objectives address critical components of FDAs responsibilities. The Agency, working in collaboration with key players in both the public and private sector, will pursue each objective as part of a total consumer health protection and enhancement system. The process begins with the research and development of new products with great health- andlife-sustaining potential, and ends with the safe and effective consumption of these products. Figure 5 illustrates how FDAMA objectives re crucial elements of FDA's total contribution to beneficial public health outcomes. BILLING CODE 4160-01-M [[Page 65015]] [GRAPHIC] [TIFF OMITTED] TN24NO98.007 Billing Code 4160-01-C [[Page 65016]] The six 406(b) objectives are addressed in five sections below. The five sections examine the FDAMA objectives in order by objective (A, B, C, D, and E&F). Each section provides: Identification of Needs--Outlines the unmet demands stated by law and expressed by the Agency's stakeholders, which FDA must address to achieve the FDAMA objective and to fulfill its mission. Stakeholder Views--Selected Stakeholder opinions on the importance of the need being addressed. Current Innovations and Reinventions--Creative improvements FDA has underway that will help achieve objectives. Plan for Meeting Statutory Requirements and Public Expectations--Key strategies that are planned for the future that will narrow the gap between expectations and current capabilities. Performance Goals for FY 1999--FY 1999 goals are based on final Congressional appropriations and may be subject to adjustment pending Agency resource allocation decisions. Objective A--Maximizing the Availability and Clarity of Information About the Process for Review of Applications and Submissions (Including Petitions, Notifications, and any Other Similar Forms of Requests) Made Under This Act 1. Identification of Needs FDA's ability to provide clear, adequate, and timely information on its application review processes must be improved by making FDA processes transparent to stakeholders and involving stakeholders early in the review process. Make FDA Processes Transparent While the Agency has developed written information (i.e., regulations, guidance documents, or internal procedures) on its review processes and requirements, more needs to be done to ensure that stakeholders understand FDA requirements. This lack of understanding is reflected in the quality of regulatory submissions received by FDA. Transparent processes also include openness on how FDA develops its requirements and how those requirements are applied within the agency during the review process. Collaborate with Stakeholders Early in the Regulatory Decisionmaking Processes In passing FDAMA, the Congress expected major improvements on how products are reviewed and approved by FDA. To meet this expectation, FDA must change how it responds to the product applicants during the review process--from being reactive to proactive through early applicant consultations. By consultation with product sponsors, the Agency will be able to help define the critical issues that must be addressed in a product application, to define the types of clinical trials that appear necessary, and to avoid unnecessary effort. This shifting of resources is not, however, without cost, and additional resources will be needed to meet the increasing number of product submissions generated by the doubling of biomedical research funding at the National Institutes of Health and by the regulated industry. 2. Stakeholder Views Stakeholders endorsed the concept of a more open and collaborative relationship between FDA and its regulatory colleagues and industry. Many stakeholders commended FDA for the efforts the Agency has already made to address this objective. Requests for improved communication about application review processes emphasized not only communication from FDA to industry, but also greater stakeholder participation in regulatory decisionmaking. The examples below illustrate some of the further improvements stakeholders requested: Make FDA policies and procedures more transparent, particularly those related to Good Review Practices [trade association]. Provide requested clear, concise, and up-to-date guidance to product sponsors. Where the existing guidance is deemed inadequate or scientifically outdated, FDA should issue guidance about the specific product applications [trade association]. Work closely with product sponsors to ensure submissions are properly formatted [trade association]. Provide a sample submission guide to applicants and make available more templates, prototypes, and examples of submissions to clarify FDA's expectations of the regulated industry and to expedite the review process [trade association]. Provide as much feedback to industry as possible in the earliest time frame because many of the questions that are generated will result in long-term experiments or clinical trials [industry representative]. Industry input in developing guidance documents, such as the one on inclusion of women in clinical trials, and regulations is key in maintaining the integrity of the clinical trials process and of the application review process [consumer advocacy group]. Collaborate and interact more with the regulated industries to avoid issuing guidance documents that do not adequately take into account useful perspectives that can be provided by industry to the FDA [trade association]. Use the formal binding presubmission consultations to reduce backlogs and to speed the approval process. [trade association]. ``Expedite the approval of appropriate nutrient content claim and health claim petitions and citizen petitions related to food labeling.'' [trade association]. 3. Current Innovations/Reinventions FDA is improving its review processes and specific product applications through collaborative agreements, process re-engineering, and information technology. Agreements Among FDA, Industry, and Others Enhance Review Processes FDA, academia, and industry are working to establish a program to provide research to inform and assist FDA in developing regulations and guidance regarding the types of product quality information that should be submitted in a product application (e.g., Collaboration for Drug Development Improvement and Product Quality Research Initiative). FDA collaborates with regulatory authorities of Europe and Japan on drug development requirements (e.g., International Harmonization). FDA Continues to Improve Review Processes Through Process Re- engineering FDA's medical device program improved by providing manufacturers with regulatory options to reduce regulatory burden for lower risk products and by improving communication with manufacturers. As part of the Reinventing Government Initiative (REGO), FDA has simplified the filing process by consolidating review application forms for biotechnology-based drugs, blood, vaccines, and other drugs into just one form. This enables companies to provide higher quality submissions to the FDA and reduces their application preparation time. During FY 1997 and early FY 1998, the Foods Program conducted under contract a review of deficiencies in over 600 industry-submitted food and color additive petitions. CFSAN currently is reviewing the contractor's report and expects to use the information to improve guidance to petitions and to [[Page 65017]] implement a stronger refusal to file policy. FDA Uses Information Technology To Improve Access of Review Processes The FDA website (www.fda.gov) provides specific information to particular stakeholder groups: consumer, industry, state and local officials, patients, health professionals, women, and children. FDA has published information on its review processes to assist applicants. For example, the FDA Center for Drug Evaluation and Research (CDER) Handbook is available on the Internet. The Foods Program is completing testing on a document management and workflow system that will replace the current tracking system for petition reviews and will make petition data available on demand in electronic format on reviewer's and administrator's desktops. The new workflow tracking system will permit realtime access to detailed information on petition status and tasks. 4. Plan for Meeting Statutory Requirements and Public Expectations Section 903 of the FD&C Act, as amended by FDAMA, authorizes the Commissioner to conduct educational and public information programs relating to the responsibilities of FDA. Under FDAMA (Section 406), FDA's mission is expanded to include the prompt review of clinical research and regulatory submissions, harmonization of regulatory requirements with other countries, and consultation of various experts in fulfilling the mission. FDA's plan for meeting these statutory requirements will encompass a variety of actions intended to make Agency processes transparent and to improve collaboration between product sponsors and the agency. These include: Continuation of developing appropriate regulations, guidance documents, and internal operating policies and procedures. Expansion of the use of communication media and information technology (e.g., the FDA website) to provide written materials and information on FDA regulatory review processes. Improvement of the efficiency and effectiveness of Agency review processes through process re-engineering, project management, performance management, and electronic technology. Development of innovative approaches to facilitate sponsor and Agency consultations. 5. Performance Goals for FY 1999 The table provided in this section links the performance goals and measures with statutory requirements addressing information about the review processes. Under the FD&C Act, the Commissioner is authorized to conduct educational and public information programs relating to FDA's responsibilities. These performance goals illustrate two types of efforts. The first type identifies the development of a method that can be applied to a review process. An example would be to recognize a standard used for a medical device review. The second type identifies an improvement to enhance the Agency's ability to provide updated information or to achieve greater capability and capacity for accepting electronic regulatory submissions. Highlighted below are key performance goals for FY 1999 in the area of electronic regulatory submissions. These goals are critical to the Agency's ability to provide timely review of clinical research and regulatory submissions, which is the intent of FDAMA. For more complete identification of performance goals and statutory requirements see the table at the end of this section. FY 1999 Performance Goals Complete the development of industry guidance required for electronic submission by the end of FY 2002. Achieve electronic submission capability for certificates to foreign governments. Achieve capability and capacity for electronic submission and archiving of information required to submit New Drug Applications (NDAs) without paper copy by the end of FY 2002. Achieve capability and capacity for electronic submission and archiving of Abbreviated New Drug Applications (ANDAs) by the end of FY 2002. ---------------------------------------------------------------------------------------------------------------- Relevant statute and/or Relevant FY 1999 FY 1997 performance Statutory authority regulation performance goals baseline ---------------------------------------------------------------------------------------------------------------- Applicants are invited to meet with FD&C Act, Section 505 By the end of FY 2002, In FY 1997, electronic FDA before submitting an application and 21 Code of Federal CDER will complete signature guidance was to discuss the presentation and Regulations (CFR) development of published. format of supporting information. If 314.50(f)(4). industry guidance the applicant and FDA agree, the required for applicant may submit tabulations of electronic submission. patient data and case report forms in a form other than hard copy, for example, on microfiche or computer tapes. Before 30 days after the date of FD&C Act, Section By the end of FY 1999, In FY 1998, develop and submission of an application to 801(e) and 802, 21 CFR CDER will achieve pilot Export export a drug, the FDA must review 210, Drug Export electronic submission Certificate Program. the application to determine if it Amendments Act of 1986 capability for meets all applicable requirements. (PL. 99-660), FDA certificates to Export Reform & foreign governments. Enhancement Act of 1996. For records submitted to the Agency, FD&C Act, Sections 201- By the end of FY 2002, By FY 1997, establish persons may use electronic records 903; PHS Act Section CDER will achieve the structure of the in lieu of paper records or 3512, 21 CFR 11. capability and Electronic Document electronic signatures in lieu of capacity for Room (EDR). traditional signatures, in whole or electronic submission in part, provided that certain and archiving of requirements are met. information required to submit NDAs without paper copy. By the end of FY 2002, By FY 1997, establish CDER will achieve the structure of EDR. capability and capacity for electronic submission and archiving of ANDAs. [[Page 65018]] Any record of the FDA that is FD&C Act, Sections 201- By the end of FY 2002, By FY 1998, the disclosed in an authorized manner to 903, 5 United States CDER will make Electronic Document any member of the public is Code 552, 21 CFR 20. publicly releasable Room, as required by available for disclosure to all information available the Electronic Freedom members of the public, except that via Internet. of Information Act, data and information subject to the will be initiated. exemptions established in 21 CFR 20.61 for trade secrets and confidential commercial or financial information, and in Section 20.63 for person privacy, shall be disclosed only to the persons for the protection of whom these exemptions exist. Publish regulations for adequate and Animal Drug FDA Center for ADAA enacted by 10/9/96 well-controlled clinical trials by 4/ Availability Act Veterinary Medicine 9/98 and substantial evidence by 10/ (ADAA), (P.L. 104-250) (CVM) will revise 9/98. Section 2(e). Investigational New Animal Drug Application procedural regulations and implement provisions of the ADAA and CVM's REGO initiatives. Recognize and approve list of FD&C Act, Sections 514 FDA Center for Devices 0 recognized standards suitable for use in (b) and (c). and Radiologic Health application review. (CDRH) will recognize over 415 standards for use in application review and update the list of recognized standards. ---------------------------------------------------------------------------------------------------------------- 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. Objective B--Maximize the Availability and Clarity of Information for Consumers and Patients Concerning New Products 1. Identification of Needs FDA is reviewing applications for new drugs, biologics, medical devices and food additives more quickly. Dissemination of information that will enhance consumption decisions about these new products must keep pace with the products' earlier availability. The Agency would like to provide timely information to consumers and patients, however, in some instances products are reaching the market faster than FDA can inform its stakeholders. The Agency's ability to disseminate information must be enhanced by upgrading its technology, its computers, and the training of its employees to keep abreast with the latest developments in technology. FDA is under pressure from Congress, the medical community, patients, and industry to provide timely unbiased information to its stakeholder. Dissemination of information to consumers and patients concerning new products must keep pace with the earlier availability of products. The Agency is aware of the growing diversity of consumer health needs and interests. To respond to this diversity, FDA is attempting to target product information that it is tailored, as much as possible, to appropriate patient and professional audiences. The growth in health benefits made possible by scientific advances and new product technology is a tremendous benefit to U.S. consumers. The speed of technology development, combined with increasing product complexity, requires creative approaches in keeping everyone rapidly and accurately informed. FDA recognizes that consumers and patients want and deserve active input and participation in the Agency's policy and product decisions. The Agency is receiving rapid input from consumers. FDA considers collaborations with others in the public and private sector critical to achieving synergies in information technology. FDA has accepted the challenge of dissemination of accurate and timely information, although at times it can be daunting, particularly because of the widespread audiences the Agency serves. Use of the Internet has become increasingly central in FDA communication with its stakeholders. FDA must upgrade its capabilities in this area. 2. Stakeholder Views Stakeholders strongly agree that maximizing the availability and clarity of information to consumers and patients about new FDA- regulated products is a priority. A selection of stakeholder comments is provided below: ``We have consistently argued that efforts to reform the Agency must build on, not dismantle, the ability of the FDA to safeguard drug products . . . As the FDA's authority has been relaxed, we feel that safety has been relaxed as well.'' [consumer advocacy group] ``We see the FDA . . . as a data warehouse, as an information source.'' [professional association] ``. . . FDA should aggressively educate patients' advocacy groups, disease-specific organizations, disease experts, and new biotech companies about FDA's function, process, and scope.'' [consumer advocacy group] Ensure the validity and integrity of drug information provided on the Internet. [State, local, or federal government] Re-evaluate [FDA's] policy on direct-to-consumer advertising. [professional association and consumer advocacy group] ``Do not depend upon scientists to review the direct-to- consumer advertising.'' [State, local, or federal government] ``Although Congress imposed this requirement, or at least asked FDA to come up with ways to maximize information about new products, our feeling on this was that this is really not [[Page 65019]] a function for FDA to promote new products. Rather, FDA's obligation would be to refer inquiries about new products, new drugs, etc. to the appropriate parties, and that might be professional societies, physicians, medical device companies, and drug companies. [trade association] Use plain language on product labels. [consumer] Make risk and safety data and statistics available to the public via the toll-free Consumer Information Line. [consumer advocacy group] Inform the public when companies have been asked to revise or pull ads, and explain why. [consumer advocacy group] 3. Current Innovations/Reinventions FDA is currently expanding its information for consumers and patients. The following are illustrations of the information exchange: Collaboration The Agency is collaborating with industry to inform patients and consumers of the availability of new drugs (prescription and over-the- counter [OTC] drugs). FDA engages in cooperative research with industry for new food items as well as collaborates with industry to bring better food labels and information to its stakeholders. The Agency is collaborating with industry to provide technical, non-financial assistance to manufacturers to enable them to bring their products that meet FDA standards to the market more quickly. Outreach FDA has an outreach program to keep physicians informed of new drugs available to their patients. The Agency is working cooperatively with the drug industry, consumers, and patients to inform them of new drugs and emerging new drugs. Patients are able to receive information on new therapies approved by foreign countries before they are approved by the Agency. Additionally, the Agency's Public Affairs Specialists in the field offices furnish information to interested consumers and patients concerning new drugs, devices, etc. FDA delivers educational and technical assistance in the area of food safety messages and uses. The FDA Consumer/Fact Sheets and National Food Safety Hotlines are part of the Agency's outreach. The Internet is used to bring new information to consumers and patients. Each Center has its own web page. Many of these pages are interactive and allow the user to communicate with the Agency directly. Printed materials are provided to those that are without Internet capabilities, and many of the materials are in several languages. These materials help to inform consumers and patients about new drugs. The Veterinary Newsletter, exhibits, and Public Affairs Specialists programs keep the veterinary community abreast of the newest drugs and technology being developed. During the 20th century, the nation has witnessed a more dramatic extension of longevity than humankind has ever seen. The Agency is making a concerted effort to ensure that older persons, their families, and their communities are aware of FDA's responsibilities and how the Agency can be a resource for them in improving the quality of their lives. FDA's consumer protection and public health mission plays a particularly important role in building a sound health foundation for ensuring quality of a long life for older persons. The needs of the U.S. aging population are stimulating innovative research and technological advancements for both preventing and treating disease. The Agency makes a meaningful contribution to this research by facilitating the timely availability of safe and effective products, keeping unsafe or ineffective products off the market, and providing easily understandable and meaningful information about the availability of new products, as well as how to use products safely and effectively. In October 1998, the United Nations launched the International Year of the Older Person 1999 to bring global attention to the phenomenon of an aging world and the need to begin to establish the policies, programs, and services needed to meet the needs of an aging world. The Agency is an active participant in this initiative. 4. Plan for Meeting Statutory Requirements and Public Expectations Section 406(b) requires the Agency to maximize the availability and clarity of information for consumers and patients concerning new products. FDA is engaged in a variety of activities to fulfill this requirement that revolve around four themes. First are Agency efforts to ensure that product information is tailored to meet the special needs of diverse populations. One example is the implementation of public awareness campaigns for consumers, i.e., Take Time to Care, Office of Women's Health; Mammography Awareness Seminars; Food Safety Programs (Fight BAC!TM); Over the Counter Labeling Changes (OTC) Campaign; and the Partnership for Food Safety Education. As the population becomes more culturally diverse, FDA must reach out to consumers in ways they will understand. For instance, Public Affairs Specialists give seminars on new drug therapies, health fraud, labeling, etc. in different languages to fulfill the needs of diverse populations. The Agency is entering into an increasing number of stakeholder ``collaborations'' to achieve a multiplier effect (e.g., with print media, radio, television, industry, other federal agencies, consumers, health professionals, and associations). Another example is implementation of the Pharmacist Education Outreach Program to assist pharmacists in explaining the drug approval process to consumers. Another approach is focusing FDA resources so that patients are an integral part of the health care decisionmaking process. FDA has established programs to make promising investigational drugs, therapies, and devices available to patients with serious and life- threatening conditions. For example, FDA has also included patient representatives on advisory committees considering products for HIV/ AIDS, cancer, and other serious diseases. The technological revolution provides the Agency the tools to offer quick access to a wide range of information to consumers through various methods. The Internet is being used as a means for two-way communication--both to disseminate information about new products and to quickly answer questions about new and existing products. Additionally, the Agency will participate with NIH in the establishment of (under Section 402 of the Public Health Service Act) a registry of publicly and privately funded clinical trials for experimental drugs and biologics being tested for serious or life-threatening medical conditions. This registry will simplify the process of obtaining information. [[Page 65020]] 5. Performance Goals for FY 1999 The table provided in this section links the performance goals and the measures with statutory requirements to regulate information provided to consumers and to ensure that consumers understand OTC drug information. The FY 1999 performance goals focus on both OTC and prescription drugs. FDA wants consumers and patients to receive and to be able to refer to the highest quality information when taking either OTC or prescription medications. Highlighted below are key performance goals for FY 1999. These goals seek to provide drug information, in easily understood language, to consumers and patients faster through various outreach efforts. For more complete identification of performance goals and statutory requirements see the table at the end of this section. FY 1999 Performance Goals Evaluate drug information provided to 75 percent of individuals receiving new prescriptions. Improve OTC information and consumers' ability to understand it by 2001. BILLING CODE 4160-01-M [[Page 65021]] [GRAPHIC] [TIFF OMITTED] TN24NO98.008 BILLING CODE 4160-01-C [[Page 65022]] Objective C--Implementing Inspection and Postmarket Monitoring Provisions of this Act A central part of FDA's responsibilities to protect the public health includes: (1) ensuring that manufacturing establishments and the products being produced by these establishments--both domestic and imported--are meeting safety and quality standards that are acceptable to the U.S. and (2) monitoring these products to identify and correct any problems associated with their consumption and use. Through inspection and monitoring activities, potential hazards are identified and corrected in time to prevent or minimize public exposure. The discussion that follows is divided into these two areas of postmarket responsibility. Subobjective C1.--Assuring Product Safety A. Domestic Inspections 1. Identification of Needs FDA is responsible for ensuring the safety of products produced and distributed by more than 100,000 domestic establishments. The Agency uses its inspection authority, as directed by the statute, to provide this assurance. Approximately 45,000 of these establishments manufacture or process regulated product. FDA inspected 30 percent of these facilities in FY 1997. A sizable number of the remaining establishments (23,000) are distribution facilities, of which FDA inspected 10 percent in FY 1997. The remainder includes 10,000 mammography facilities, which FDA inspects at a nearly annual rate, and a varied assortment of other establishment types, e.g. control laboratories, importer/brokers, clinical investigators, and conveyances, of which FDA inspected about 14 percent in FY 1997. Overall, approximately 40 percent of FDA's current inspectional coverage is provided through contracts with states. As these varying inspectional coverage statistics indicate, FDA exercises considerable discretion regarding the frequency and comprehensiveness of inspections. For approximately 25 percent of this inventory, however, the law requires FDA to conduct inspections at specified maximum time intervals. Certain manufacturing facilities must be inspected at least once every 2 years, and mammography facilities must be inspected at least once each year. In recent years, inspection coverage has fallen short of meeting these statutory requirements. The table below summarizes the Agency's recent coverage of the domestic inventory including the segment subject to statutory minimum inspection coverage as well as the segment over which the Agency has discretion regarding inspection frequency. To meet the statutory requirements, 100 percent of the mammography facilities and at least 50 percent of the other statutory establishments should have been inspected in FY 1997. As the data show, with the exception of mammography facilities, neither goal was reached. ---------------------------------------------------------------------------------------------------------------- Statutory coverage Non-statutory coverage ----------------------------------------------------------------- Program area Inventory Coverage in FY Coverage in FY Establishments 1997 (percent) Establishments 1997 (percent) -------------------------------------------------------*--------------------------------*----------------------- Biologics..................... 5,685 2,787 46 2,898 13 Human Drugs................... 19,749 6,408 23 13,341 12 Devices (excluding mammography)................. 27,638 4,870 28 22,768 9 Mammography............... 10,000 10,000 96 ............... .............. Foods......................... 49,000 NA NA 49,000 23 Animal Drugs and Feeds........ 6,414 1,688 27 4,726 13 ---------------------------------------------------------------------------------------------------------------- * Status as of May 1998. 2. Stakeholder Views Agency stakeholders expressed strong support for more regulatory enforcement in general, and the continued focus on risk-based inspections in particular. ``Stratify the inspections based upon past history of compliance of companies, the degree of risk of the product, and various other elements.'' [trade association]. FDA should increase its efforts to monitor the marketplace to remove unapproved products and also those that provide unfair competition. [trade association] Inspections should take a comprehensive approach and ``focus on the health impact of the regulations, not just the `black- and-white' of the regulations. [state, local or Federal government] There should be more enforcement efforts to prevent distribution of illegally marketed and compounded drugs, unapproved drugs not manufactured in accordance with current GMPs, illegal extralabel use practices, illegal distribution of veterinary prescription drugs, marketing of unapproved feed ingredients, and extraordinary claims on animal feed labels. [trade and professional associations] Stakeholders endorsed HACCP systems for seafood and retail settings and the possible expansion of HACCP into other food-related areas, but only when supported by science and a high consumer safety priority. [trade association] ``Move towards a voluntary HACCP-based system for dairy products and away from checklist inspections and prescriptive plant processing regulations.'' [trade association] HACCP would be applicable in general for ``foods with a demonstrated high risk (e.g., unpasteurized juice).'' In contrast, stakeholders urged the Agency not to ``promote the HACCP process for device conformance,'' but to consider ISO certifications [standard setting organization]. Stakeholders encouraged FDA to work closely with the states and to ``be a leader (i.e., leadership in science, setting standards, evaluating state programs, certifying inspectors).'' [state, local or federal government]. The Agency should provide more guidance and training to state investigators to minimize inconsistency between investigations in different states and districts, thereby contributing to a level playing field for regulated firms. The Agency should involve states in the development of enforcement strategies related to animal drugs and feeds. [state, local or federal government] [[Page 65023]] Stakeholders tended to support the idea of third-party inspections, especially noncritical inspections. The Agency should identify more functions that could be performed by third parties. [trade association] In some cases, particularly the manufacture of animal feeds, voluntary self-inspection with third-party oversight might be appropriate. [state, local or federal government] At the same time, however, the Agency needs to be careful to avoid duplication of effort and to ensure consistency between FDA inspectors and third parties. [trade association] 3. Current Innovations/Reinventions The Agency's domestic inspection program is an integral part of the strategy for monitoring the compliance status of the regulated industry. The goals of an inspection may be many and varied, i.e., to verify data submitted to the FDA in a new drug or biologic application, and to ensure continued compliance with application commitments. Inspections monitor the regulatory control over manufacturing operations including compliance with current GMP regulations. The results of inspections form the basis for many of the Agency's administrative and regulatory decisions, including new drug, device, or biologic approvals, as well as detecting industry problems or objectionable conditions and practices. Establish Risk-Based Priorities Given the large inventory of establishments it must inspect with limited resources, FDA targets the highest risk products and those facilities whose violations of standards would most likely expose the public to unnecessary risk. The cornerstone of the Agency's drug (human and animal), medicated feed, biological, and medical device inspection strategy is the biennial inspection requirement, which mandates the inspection of critical establishments in the Agency's inventory, primarily manufacturers, at least once every 2 years. While FDA has no such legal mandate for food inspections, it is moving toward establishing a vertically integrated food safety system that is risk- based and which would allow it to inspect high-risk establishments every 1 to 2 years and moderate-to-low risk establishments every 4 years. Adopt a System Rather Than a Piecemeal Approach to Agency Regulation Manufacturing processes are becoming more complex due to the rapid advancement of science and technology. This trend continues to accelerate. This increasing complexity is mirrored in FDA's approach to ensuring comprehensive, consistent, and fair inspections.Where, in the past, the Agency often perceived its role as providing quality control for the industries it regulated, today, it recognizes the essential role that establishments themselves must play to ensure product quality assurance.The Agency is focusing more on ensuring that the systems the industry has in place to monitor the quality of its products are adequate. This approach stresses the importance of HACCP-type inspections and frequently requires that the Agency take a multidisciplined, team approach to inspections. the FDA Center for Biologics Evaluation and Research (CBER), which used to conduct many inspections on its own, joined with the FDA Office of Regulatory Affairs (ORA) to form `Team Biologics' whereby teams of CBER product specialists and specially trained investigators from ORA's field force work together to conduct surveillance inspections. Follow-up compliance actions are handled under a streamlined system that provides concurrent review by CBER and ORA. CDER, to ensure inspection consistency, is developing standards for investigator training and certification for performance of pharmaceutical inspections. CFSAN has developed and implemented HACCP controls for seafood and has proposed HACCP controls for the juice industry. All seafood processors had been inspected by the end of FY 1998 to verify proper use of HACCP, and 6,681 industry officials and federal and state inspectors have been trained in seafood HACCP through the Seafood Alliance. CDRH, whose quality systems regulations ask manufacturers to take more responsibility for assuring the quality of devices, is moving toward systems-oriented inspections and developing HACCP-type programs for firms with a good compliance history. Work More Closely With External Stakeholders The Agency increasingly has emphasized communication and education as alternatives that are at times preferable to and more effective in achieving and maintaining compliance than the more traditional enforcement approaches used in isolation. It accomplishes this by providing training and workshops for industry groups, seeking the views of stakeholders, and sharing information with stakeholders and colleagues. Some examples of the Agency working closely with external stakeholders include: CBER produced a satellite broadcast on blood establishment inspections to educate the industry and held a workshop for manufacturers of licensed in vitro diagnostics. CDRH undertook education efforts on quality systems requirements. CFSAN issued guidance on GMPs and Good Agricultural Practices (GAPs), worked with the U.S. Department of Agriculture (USDA) to achieve adoption of the Food code by an increasing number of states, collaborated with JIFSAN/World Health Organization (WHO) for risk assessment, and cooperated with USDA and the Centers for Disease Control and Prevention (CDC) to implement a national education program on retail food preparation practices. CDER, ORA, and a major industry scientific trade organization in conjunction with a university developed a new approach for training field investigators in pharmaceutical manufacturing operations and the application of GMP and other FDA regulations to new drug development. CVM, in cooperation with stakeholder groups, sponsored satellite teleconferences concerning compliance with the BSE feed regulation and the Animal Medicinal Drug Use Clarification Act, which concerns extralabel drug use. District offices conduct ``grass roots'' meetings and industry exchange meetings on a variety of regulatory matters as a means of facilitating an ongoing dialogue with various constituencies. 4. Plan for Meeting Statutory Requirements and Public Expectations Under provisions of the Food, Drug and Cosmetic Act and the Public Health Service Act, FDA is required to conduct biennial inspections of approximately 16,000 registered drug, biologic and device production facilities. Although there is no statutory requirement that mandates a particular frequency for the inspection of any food establishment, or those drug, biologic and device facilities excluded from the biennial requirement, the statute obliges the Agency to ensure the safety of regulated products within these establishments. Accordingly, goals have been set within these establishment categories to achieve an average inspection cycle of once every 4 years, with appropriate risk-based variations in this cycle where warranted. FDA fell short of meeting its statutory biennial and annual inspection obligations by approximately 4,000 [[Page 65024]] inspections in FY 1997. In an effort to improve its performance in these critical areas, FDA plans to rely increasingly on states and other third parties, both for direct help with some statutory inspections and for other important inspectional obligations, thus freeing some of FDA's own resources to cover additional statutory obligations. Because all public and private sector organizations in the future will be subject to the same resource-constrained environment, FDA may have to consider that even a highly collaborative inspectional network may not be adequate to completely meet existing statutory inspectional requirements. A strategic reassessment may be in order to determine the kinds of statutory flexibility that would be desirable to preserve the comprehensive consumer protection intent of the FD&C Act, and at the same time, allow FDA to address the most critical health and safety priorities. Some examples of Agency initiatives either planned or already underway include the following: Developing contracts with states and public health agencies to inspect unlicensed blood banks. Reinstating state contracts for medical gas inspections, oxygen bars, and emergency medical services. FDA is considering a pilot First Party Audit Program (FPAP). Concentrating its own resources on the highest risk devices such as cardiac implantables and relying on third parties for inspection of lower risk products. Continuing to develop contracts and collaborations with states for both statutory and non-statutory animal drug and feed inspections. Conducting joint surveillance work with CDC and USDA and working with the Association of American Feed Control Officials (AAFCO) to develop a model program for medicated feed manufacturers that includes self inspection. Special Emphasis on Food Safety: The Agency recognizes its obligation to ensure the safety of the food supply, and the public expects food to be safe. To met this expectation, FDA needs to inspect high-risk establishments every 1 to 2 year and moderate-to-low risk establishments every 4 years. This level of inspection coverage will require an additional 4,000 to 6,000 annual inspections. FDA's own food safety assurance efforts is being integrated with a national risk-based food safety system. This will require close collaboration with USDA, CDC, the states, food manufacturers and food retailers. Key elements of the initiative are: Surveillance activities that enhance electronic communication with states and other agencies to permit rapid identification of and response to foodborne hazard outbreaks; A cooperative inspection and monitoring effort with states that focuses on high-risk firms, and emphasizes enforcement of initiatives such as FDA's BSE Feed regulation. Education emphasizing safe handling practices for consumers and retailers through FDA's Model Food Code; and Research to develop improved methods of detecting and identifying pathogens and formulating preventive interventions. 5. Performance Goals for FY 1999 This section contains two tables. The first table summarizes the Agency's domestic inspection performance goals for FY 1999. The second table links these performance goals to the statutory requirements. FY 1999 Performance Goals Inspect 46 percent of registered biologic firms Inspect 23 percent of registered drug manufacturers, propagators, compounders, or processors Inspect 28 percent of registered class II and III medical device manufacturers, propagators, compounders, or processors Conduct 8,898 inspections of mammography facilities Ensure that 50 percent of seafood industry operating under HACCP Develop HACCP final rule for fruit and vegetable juices Inspect 50 percent of registered animal drug and feed establishments ---------------------------------------------------------------------------------------------------------------- Relevant statute and/or Relevant FY 1999 FY 1997 performance Statutory authority regulation performance goals baseline ---------------------------------------------------------------------------------------------------------------- Biennial GMP inspections of biologic FD&C Act--Sec. 510(h).. Coverage: 46 percent... Coverage: 46 percent. firms (50 percent annually). Biennial inspections of registered FD&C Act--Sec. 510(h).. Coverage: 23 percent... Coverage: 23 percent. drug manufacturers, propagators, compounders, or processors (50 percent annually). Biennial inspections of registered FD&C Act--Sec. 510(h).. Coverage: 28 percent... Coverage: 28 percent. class II and III medical device manufacturers, propagators, compounders, or processors (50 percent annually). Annual inspections of mammography PHS Act--Sec. 354...... Conduct 8,898 Conduct 8,280 facilities. inspections. inspections. General authority to inspect food, FD&C Act--Sec. 704..... Ensure that 50 percent ....................... drugs, devices, or cosmetic of seafood industry establishments. operating under HACCP. Develop the HACCP final rule for fruit and vegetable juices. Biennial inspections of registered FD&C Act--Sec. 510(h).. Coverage: 20 percent... Coverage: 27 percent. animal drug and feed establishments (50 percent annually). ---------------------------------------------------------------------------------------------------------------- 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. Subobjective C1--Assuring Product Safety (Continued) B. Imports 1. Identification of Needs Imported products pose multiple challenges to FDA. These include the sheer volume and diversity of products, the difficulty of ascertaining exactly which establishments are shipping products to the United States, and the difficulty of verifying conformity with GMPs quality systems. Each of these challenges, is described in the following paragraphs. The Volume and Diversity of Products FDA is responsible for ensuring the safety of nearly 4 million line entries that cross our borders annually, or over 12,000 entries per day. Imports of all products that FDA regulates have been increasing; pharmaceuticals, both finished and bulk, are increasing very [[Page 65025]] rapidly. Approximately $57 billion of FDA-regulated product was imported in 1997. The sources are diversifying and including more products from countries that are typically categorized as emerging economies, with emerging regulatory infrastructures. The products include, among others, food products that have been implicated in serious disease outbreaks in the United States, food products that could pose health threats if not processed and handled properly, over- the-counter drugs that do not require a new drug application with the Agency, as well as approved drugs, biologics, and medical devices. Difficulty in Ascertaining Establishments Shipping to the United States Section 417 of FDAMA [510(i) of the Act] now requires all foreign manufacturing establishments whose drug and device products are imported into the United States to register. There is, however, no universal registration requirement for producers of imported food products. Manufacturers/packers of low-acid canned food, acidified foods, and infant formula (all of which products are considered at high risk) register or list with the FDA; other food producers and processors are not required to register or list with FDA, making identification of sources of product difficult. Difficulty of Verifying Conformity with GMPs/Quality Systems There are two ways that typically are used to confirm that product has been produced properly--end point product testing (which for imports could be analysis of border samples) and on-site inspections. There are difficulties with both of these approaches. To date, no effective, scientifically based method has been established for general screening of foreign drug product for adherence to GMPs. Analysis of product samples is reasonably effective in assuring conformity, but the volume of trade and resource limitations preclude high rates of analysis. On-site inspections, the way of affirming conformity with good manufacturing practices/quality systems, are expensive and pose a host of logistical and practical difficulties. All foreign firms are aware that an FDA inspection is planned well in advance of the inspection, unlike the inspection of domestic establishments. Regardless of these challenges, there is consistent expectation from the Congress that FDA assure foreign product safety, and there is recurring congressional focus on FDA inspections of foreign manufacturing facilities. 2. Stakeholder Views Stakeholders want assurances that foreign products meet the high standards expected of domestic products, and encourage FDA to conduct foreign inspections and periodic testing of product to confirm quality. Stakeholders strongly support FDA's activities in Codex and international harmonization, reflecting a desire to minimize regulatory burden while assuring that foreign produced food products are safe and therapeutic products are safe and effective. Stakeholders especially stress the importance of effective participation in Codex, because of the special pla [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-31387. Public record. Not legal advice.