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 median 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 Centers 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 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 of 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.