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A Message to FDA Stakeholders
July 22, 1998

Last November, Congress passed, and President Clinton signed into law, the FDA Modernization Act (FDAMA) of 1997, a far-reaching piece of legislation that touches virtually every aspect of FDA's activities. In enacting FDAMA, Congress affirmed FDA's role as a protector and promoter of the public health of American citizens, endorsed many actions that FDA had already taken to streamline its operations, and added substantial new obligations. Implementing FDAMA is one of the most demanding challenges faced by the agency in its 92 year history, and we are committed to meeting this challenge.

Congress also recognized that FDA's responsibilities are vast and that the Agency's stakeholders can play an important role in helping the agency determine how best to meet them. Therefore, in Section 406(b) of FDAMA, Congress charged FDA with consulting with "appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry." Following these consultations, FDA is to develop and publish a plan for complying with each of its obligations under the Federal Food, Drug and Cosmetic Act. The agency is required to review the plan biannually and to revise it, as necessary in consultation with the same stakeholders.

The plan, which must be published in the Federal Register by November 21, 1998, will address six specific objectives. The first two objectives focus on maximizing the availability and clarity of two types of information that are important for producers and consumers: information about FDA's processes for reviewing applications and other submissions to the agency, and information about new products. The third objective is to meet the agency's inspection and postmarketing obligations, and the fourth is to ensure that FDA has access to the scientific and technical expertise it needs to meet its obligations.

As you know, the FDAMA mandates specific time frames for FDA to review or otherwise act upon certain applications and submissions to the agency. The fifth objective in Section 406(b) of FDAMA is to establish mechanisms, by July 1999, for meeting all of these time frames for submissions received after FDAMA's enactment date. And finally, the sixth objective is to eliminate any backlogs in the review of applications and submissions by January 1, 2000.

Congress has required FDA to report on its progress in meeting the plan's objectives, to publish such a report annually, and to solicit public comment on it. The agency is to compare its performance to the plan and to other statutory obligations, and notably, to identify and suggest revision of any regulatory policy that has a significant negative effect on the Agency's ability to comply with the plan's objectives.

FDA welcomes FDAMA's affirmation of its public health mission. Since the start of this decade, FDA has pursued many of the objectives of FDAMA by streamlining regulatory procedures, setting new priorities, entering into novel collaborative arrangements, and carrying out far-reaching managerial reforms. Our own broad-based modernization program has succeeded in improving the agency's efficiency while maintaining our traditionally high standards for product quality and consumer protection. Agency productivity has been increasing by about 17 percent a year; FDA initiatives have won more than 40 awards from the Vice President's National Partnership for Reinventing Government; and last year, we were honored to receive the prestigious prize for Innovations in American Government from the Ford Foundation.

Innovations and efficiencies alone, however, may not be sufficient to deal with the enormous growth in FDA's obligations that has been fueled by rapid technological developments, increased complexity of regulated products, and mushrooming global trade. As a result of these developments, FDA finds itself severely challenged to meet all of its statutory obligations.

In accordance with the Congressional directive, and in the agency's long tradition of close dialogue with its constituents, in the weeks and months ahead we will meet with our stakeholders to seek their views on how to accomplish the 406(b) objectives. These consultations, which will occur in different formats and venues, will be completely open, and the agency is receptive to all constructive input and proposals. The resulting plan will be shaped with careful attention to the views of all stakeholders. We fully anticipate that this consultation process will continue in the years ahead -- not only because of FDAMA, but because dialogue with our stakeholders is a very important part of the way in which we do business. We have high expectations that stakeholder input will provide us with creative practical solutions and will tell us how they can help to identify ways for us to work cooperatively.

Developing a realistic plan for meeting our public health obligations is a formidable task. We are concerned about the growing gap between where we are and where we want to be in some critical areas. In the previous few years, we have focused agency priorities on application review and as a result believe other agency activities now need increased focus and attention. As we look at the six specific objectives of the plan, we can easily see areas where, we will have great difficulty in fulfilling what is expected of us in just the next year. We think the following represent several of the most critical issues facing the FDA and while the projections for some of these areas, as outlined below, are tentative, and by no means address the entire spectrum of the agency's statutory obligations or public health goals, they are indicative of the growing concerns within the Agency about the workload we are facing. We welcome your feedback and suggestions.

• ADVERSE EVENT/INJURY REPORTING: A recent article in the Journal of American Medical Association (JAMA), estimated that in 1994, 106,000 people died and another 1.3 million Americans were injured as a result of adverse reactions to properly prescribed medications. Whether that number is accurate can be debated but there is no doubt that the number of injuries and deaths is substantial. Additional injuries and multibillion-dollar hospitalization costs and economic losses also result from medication errors, misuse or improper use of medical devices, and errors and accidents in the manufacture of biological products. FDA presently receives data on some of these adverse events and acts accordingly. Nonetheless, a much more extensive active surveillance system is needed to detect and analyze the many types of injuries caused by FDA regulated products. We believe a more comprehensive and cooperative program with health professionals and patients would have significant impact on reducing these injuries. In addition, an integrated, science-based system for reporting, monitoring, evaluating and providing feedback to health professionals and consumers on adverse events related to all FDA-regulated products would make a significant contribution to public health and public confidence. The development of an integrated system would maximize the availability and clarity of information about new products, and meet the FDAMA objective for postmarketing monitoring.
• PRODUCT SAFETY ASSURANCE: The FDA's statutory responsibilities underpinning product safety assurance and enforcement require an integrated, proactive approach to achieve an acceptable and expected level of consumer protection. The challenge to monitor the quality and safety of all regulated products from domestic and foreign sources, however, is growing. The agency, even in conjunction with its state regulatory partners, is able to annually inspect less than a third of the domestic firms within its purview. The number of FDA inspections for foods, drugs and devices [excluding mammography], including inspections by state agencies under contract to FDA has decreased between 1991 and 1998. In the area of imports, the total volume of FDA-regulated imports exceeds $50 billion per year, with some categories of imports growing at an exceedingly rapid rate. Imports continue to grow in volume, complexity, and diversity of sources. The magnitude of this increase is best illustrated by comparing the $51 billion value of import shipments in fiscal year 1997 with the $65 billion import value projected for the year 2000. This growth in the value of import shipments can be viewed as an increase in import value of $5 billion per year or, most astounding, $10 million per day. Our ability to meet the postmarket monitoring objective in the plan, is inherently related to our ability to meet our enforcement obligations. Enforcement is an integral adjunct to outreach in such areas as injury reporting and product safety assurance, and an important stimulant for voluntary compliance and partnership programs. Unfortunately, in recent years, FDA's traditional enforcement actions have declined despite new challenges to public health protection. Moreover, new technologies such as the emerging use of cord blood stem cells, tissues and reproductive tissue banking, and the use of materials of animal origin for transplantation will require new regulations aimed at ensuring quality and safety, for which FDA now lacks sufficient enforcement capability.
• PRODUCT APPLICATION REVIEWS: New product submissions are increasing 12 percent a year, and at this rate would double the agency's application workload in six years. This increase in workload trend, increasingly complex technology, and unchanged staffing levels, have led to delayed FDA action on products not covered by user fees -- new blood products, animal drugs, generic drugs, medical devices and food additives. Delay in approval of safe and effective products can cost billions of dollars in health care costs. Our plan must address ways to meet these obligations.
• FOOD SAFETY: Even though the United States has the safest food supply in the world and the FDA has begun implementing the Administration's food safety program, more needs to be done to protect the public against food-borne illnesses that annually claim 9,000 lives and cause multimillion dollar economic losses. The most important measures currently beyond the agency's capacity include improvement of FDA's outbreak response network for quick identification of the source of contaminated food; a strengthened monitoring program to identify and contain antimicrobial resistance to both human and veterinary drugs; increased research and risk assessment to improve food production systems and knowledge about mechanisms of microbial contamination; the development of additional industry guidance on food production preventive control systems; technical assistance to domestic and foreign producers; and contractual agreements with state inspectors to inspect food production facilities as part of an integrated national food inspection system. A strong food safety program helps meet the 406(b) objectives on maximizing the availability of information on new products and on postmarket monitoring.
• OUTREACH: FDA's ability to communicate our requirements and procedures to the regulated industry is critical to the industry's voluntary compliance with product standards, regulations and guidelines. Similarly the agency's consumer-focused educational efforts are critical to public understanding of the importance of proper nutrition, correct use of drugs, and avoidance of unsafe products. There is an urgent need to stimulate voluntary adverse event reporting by health professionals in order to counter the high incidence of device and medication associated injuries. Information exchanges and outreach are the foundation of a continuing collaboration with professional organizations, consumer groups, and foreign governments and regulatory counterparts which contributes importantly to FDA's many mission-oriented activities. Widespread availability of understandable information is a powerful tool in accomplishing FDA's public health objectives.
• SCIENTIFIC INFRASTRUCTURE and RESEARCH: One of FDA's traditional strengths has been the quality of the science underlying its decisions. FDA's clinical and laboratory research program is a cornerstone of the agency's science-based decision-making process, and strong regulatory and research components are essential to the successful accomplishment of any plan for meeting the agency's statutory obligations. A strong scientific infrastructure, including research contributes to the quality of product assessments, helps to reduce development time, expedites and adds value to new technologies, and supports the development of science-based guidance documents and risk assessments. Scientific efforts such as research improve our ability to predict the potential for an adverse effect from exposure to a product and is critical for promoting human health and predicting product safety. A high-quality intramural research program allows the agency to maintain the expertise to quickly address complicated questions as they arise in the product review process, and to anticipate future problems in the increasingly complex arenas of novel drug and biologic products, medical devices, and foods. Postmarket drug quality research is important for detection of unanticipated adverse effects of medications. A strong science base and increased scientific research are essential to meeting all six of the plan's objectives, but are particularly central to the last three--ensuring access to the scientific and technical expertise needed for meeting the Agency's obligations under the law, establishing mechanisms for meeting statutory review deadlines by July 1999, and eliminating review backlogs by January 2000.
• TOBACCO: FDA has identified an additional major public health goal not expressly addressed by FDAMA, which is the need to reduce tobacco use by minors. In the first half of this fiscal year, 10 state authorities under contract to FDA attempted or completed 10,636 checks of retailer compliance with the ban on sale of tobacco products to minors. In order to reach the goal of a 50 percent reduction in underage smoking by the year 2004, this surveillance needs to cover all or most of the tobacco retail outlets, estimated to number almost one million. The agency also needs to expand its program for providing retailers with information about the FDA tobacco rule.

Although we have shared areas where we have real concerns about our ability to meet our statutory obligations, our stakeholders can be assured that we are embarking on this consultation process with no preconceived conclusions. It is our hope that the above information will serve to enhance the flow of ideas we hope will emerge from our exchanges, and from the continued outreach and consultation process.

FDA remains committed to meeting its many responsibilities through a continuous search for new efficiencies and collaborative or work-sharing arrangements with its constituents and other members of the regulatory community, both in the U.S. and abroad. We welcome comments and suggestions, and we are dedicated to carrying out these consultations in a spirit of candor and cooperation.

To help focus comments, the following questions have been developed in the context of the objectives described in section 406(b) of FDAMA.

1. What can FDA do to improve its explanation of the Agency's submission review processes, and make explanations more available to product sponsors and other interested parties?
2. How can the Agency maximize the availability and clarity of information concerning new products?
3. How can FDA work with its partners to ensure that products--domestic and foreign--produced and marketed by the regulated industry are of high quality and provide necessary consumer protection; and how can FDA best establish and sustain an effective, timely, and science-based postmarketing surveillance system for reporting, monitoring, evaluating, and correcting problems associated with use/consumption of FDA-regulated products?
4. What approach should FDA use to ensure an appropriate scientific infrastructure with continued access to scientific and technical expertise needed to meet its statutory obligations and strengthen its science-based decision-making process?
5. What do you believe FDA should do to adequately meet the demands that are beginning to burden the application review process, especially for non-user fee products, so that it can meet its statutory obligations to achieve timely product reviews?
6. What suggestions do you have for the Agency to eliminate backlogs in the review process?
7. What other objectives related to the Agency's statutory obligations or public expectations -- beyond the six objectives -- should be included in the FDA plan?

We have established a docket to receive any input that you may have on the six objectives outlined in section 406(b) of FDAMA. The more specific and concrete you can be in your suggestions, the more helpful they will be in developing the 406(b) plan. The docket number is 98N-0339. Comments may be sent via hard copy to the following address:

Comments can also be sent via email to: FDADOCKETS@OC.FDA.GOV.

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