98-31387. FDA Plan for Statutory Compliance

[Federal Register Volume 63, Number 226 (Tuesday, November 24, 1998)]
[Notices]
[Pages 65000-65040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31387]



[[Page 64999]]

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Part III





Department of Health and Human Services





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Food and Drug Administration



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FDA Plan for Statutory Compliance; Notice

Federal Register / Vol. 63, No. 226 / Tuesday, November 24, 1998 / 
Notices

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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.

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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 
``[e-mail]''. 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 ``[e-mail]''. 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

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[GRAPHIC] [TIFF OMITTED] TN24NO98.004



BILLING CODE 4160-01-C

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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.

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[[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.

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[[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.

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[[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.

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    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 place Codex holds in resolving international trade issues: 
the international standards that are adopted must reflect the standards 
and the high level of safety required in the United States. Support for 
pharmaceutical GMP mutual recognition agreements (MRAs) was predicated 
on the likelihood of there being equivalent standards as well as truly 
effective regulatory programs in MRA countries. The need for expanded 
funding support for Codex activities and for monitoring of imports was 
noted. A few typical comments are as follows:
Assurance that Foreign Product Meets High Standards Expected of 
Domestic Product
     ``Realizing this would require improved resources and 
budgets, it would still seem appropriate to perform periodic [foreign] 
quality assurance inspections and [border] laboratory analyses for 
identity, potency, and purity to ensure the quality of the drugs 
manufactured in foreign countries, do, in fact, equal ours.'' [state, 
local, or federal government]
     ``We do think more emphasis needs to be placed on 
inspections of imports for safety and purity, with the important caveat 
that such inspections should not constitute non-tariff trade 
barriers.'' [trade association]
     ``We have concerns regarding imported foods. In many 
cases, the hygienic requirements for production and processing of a 
food in the United States are more stringent than in countries with 
competing foods that are exported into the United States. More effort 
needs to be focused by CFSCAN in reducing the risk to the consuming 
public from the imported foods.''. [trade association]
Support for Codex Activities
     ``* * * the Codex has grown in significance as more and 
more of our nation's food supply is either imported or exported. Food 
regulatory bodies around the world, including the FDA, have begun to 
recognize that harmonized international standards are not just a good 
idea. They are essential if the country is going to compete in today's 
global marketplace.'' [trade association]
     ``Codex quality and safety standards are being utilized 
increasingly to resolve food safety disputes between nations in the 
World Trade Organization. Therefore, FDA must play an active role in 
Codex to ensure international standards and guidelines are consisent 
with US requirements.'' [trade association]
Support for Mutual Recongition Agreements (MRAs)
     ``CVM needs to determine whether foreign countries' 
requirements and systems for animal drug approvals ae equivalent to 
those in the United States.'' [trade association]
     ``While the MRA is attempting an honorable and desirable 
result, we would like to stress that the foreign countries should not 
only have equivalent standards but effective regulatory programs as 
well.'' [state, local, or federal government]
    * * * but a Cautionary Note
     ``FDA needs to be a spokesperson for public health. The 
whole drive behind international harmonization is trade concerns * * * 
That may be fine from an economic standpoint, but it has nothing to do 
with FDA's public health mission. FDA needs to be there * * * to put 
public health * * * if not first, at least equal to trade concerns.'' 
[consumer advocacy group]
     ``* * * there is no question that we are bound by 
international agreements to harmonize regulatory standards in the area 
of food regulation * * * [T]his presents not only a threat but an 
opportunity because if we are going to go about harmonizing regulatory 
requirements, we can go up or down * * * When our current requirements 
may not be that high, we should raise our requirements and advocate the 
stronger requirements to become the international standard and a model 
for the U.S.''. [consumer advocacy group]
3. Current Innovations/Reinventions
    FDA must ensure that the structure in place at the point of origin 
results in product being shipped to the United States meeting FDA 
requirements for safety, quality and/or therapeutic efficacy. This is a 
prevention-based strategy. A secondary strategy is detection based: 
conduct inspections of establishments shipping product to the United 
States, and screen product at the border for more intensive review.

[[Page 65026]]

Electronic screening allows conforming product to more quickly into 
commerce, while identifying product that may need more review at the 
border.
    To deal with an explosively expanding workload and flat resources, 
FDA has directed its non-Prescription Drug User Fee Act of 1992 (non-
PDUFA) foreign inspection activities toward higher risk products and is 
expanding PDUFA inspections to include more comprehensive inspections 
of facilities. More screening of product at the border is being 
accomplished through electronic means. And finally, analysis of product 
at the border is increasingly targeted toward product that is expected 
to pose high risk, as identified in the electronic screening. This 
risk-based prioritization means that many medium-risk product 
manufacturing facilities are not inspected, and most lower risk product 
facilities are not inspected.
4. Plan for Meeting Statutory Requirements and Public Expectations
    With additional resources, FDA expects to strengthen the safety net 
that extends from the point of production in source countries through 
their entry into the U.S. These strategies encompass: (1) Reducing the 
probability that violative products will be exported to the United 
States; (2) Making rapid and reliable decisions on product entry at the 
border; and (3) Targeting violative products at the border and 
preventing their entry.
    To reduce the probability that violative products will be exported 
to the United States, FDA will continue to participate in international 
negotiations and establishment of mutual recognition agreements with 
other nations. These activities will assure that products from those 
nations are meeting FDA standards, and will also increase the number of 
foreign inspections. As international regulatory agreements are 
negotiated among trading nations, the Agency will explore new and 
innovative institutional arrangements, such as a third-party 
certification of both imports and exports. These arrangements will have 
to be cost-effective, with statutory mandates, and enforce health and 
safety standards. To allow rapid entry of safe products, FDA continues 
to enhance its electronic screening process. To target violative 
products at the border, the Agency will maintain its ability to conduct 
laboratory analysis on a small percentage of products with potential 
problems, by increasing its sample analysis. The Agency will also 
enhance the electronic import entry system to provide for a broad-scope 
collection and analysis of information on product-country intersects 
that will allow development of national profiles. These profiles will 
provide the basis for establishing systematic risk-based priorities in 
examining import entries. Many of these efforts are obviously resource 
intensive, and linked closely with the steadily rising volume of 
imports.
5. Performance Goals for FY 1999
    Consistent with the strategic directions noted above, FDA has 
established performance goals that support moving toward higher 
assurance of imported product safety in a time of increasing imports, 
as noted in the table below. The FD&C Act provides for sampling of 
product at import, and FDAMA modifications require the Agency to engage 
in activity designated to harmonize regulatory requirements with the 
objective of reducing the burden of regulations. Goals to support these 
activities address the short-term screening of imports at the border as 
well as longer term infrastructure development internationally, and 
these are noted in the table below. A more comprehensive table, 
illustrating legislative provisions, follows.
    Associated with the immediate need at the border, the performance 
goals relate broadly to assuring the integrity of the screening system, 
such as by confirmation of the accuracy of entries and continual 
updating of the screening criteria and by improving the overall 
sampling and the targeted sampling rates at the border. Goals relating 
to international infrastructure development reflect ongoing commitment 
and heavy investment in international standard setting forums and 
negotiating equivalence agreements and mutual recognition agreements. 
Success in these realms would allow FDA to rely more on the regulatory 
structures in place at the point of origin of products being shipped to 
the United States. And finally, there are times when direct FDA 
inspections of foreign manufacturing sites are necessary to ensure the 
quality of product being shipped to the United States, and several 
performance goals reflect this need.

FY 1999 Performance Goals

Enhance the safety of imported products through increased 
surveillance of imported food products at the border, increased 
foreign inspections (from a target level of 40 to 75-100), through 
providing education, outreach, and technical assistance to foreign 
countries on the use of GAP/GMP guidance for produce, and through 
the evaluation of food production systems in foreign countries.
Enhance import screening capabilities for public health while 
ensuring that 55 percent of entries are released within 15 minutes.
Assess potentially violative imports through direct examination of 3 
percent of entries.
Accept at least 20 percent of imports into the U.S. market through 
evidence that source country quality systems/standards/ audits meet 
the requirements of the FD&C Act.

BILLING CODE 4160-01-M

[[Page 65027]]

[GRAPHIC] [TIFF OMITTED] TN24NO98.009



[[Page 65028]]

[GRAPHIC] [TIFF OMITTED] TN24NO98.010



[[Page 65029]]

[GRAPHIC] [TIFF OMITTED] TN24NO98.011



BILLING CODE 4160-01-C

[[Page 65030]]

Subobjective C2--Adverse Event Reporting

1. Identification of Needs
    FDA needs to work with its community of stakeholders and develop a 
systematic approach to address the problem of over 2 million injuries 
and deaths a year occurring as a result of consuming/using FDA-
regulated products. The ideal approach should be comprehensive, 
involving the participation of regulatory agencies, health care givers, 
the regulated industry, and the consumers/patients themselves. 
Components of this system include:
     A full understanding of the causes of product-related 
deaths and injuries: FDA needs to ensure that causes attributable to 
product labeling, design, or composition are addressed in the premarket 
review programs, where required. FDA currently receives yearly 
thousands of reports of injuries and deaths associated with the misuse 
or failure of FDA-regulated products. FDA should improve the quality of 
information on adverse events and product failure and develop methods 
to enhance understanding of causes of product-related injuries. 
Currently, for example, the FDA's ability to identify and track the 
causes of food-borne illness is very limited.
     New postmarket information-gathering programs: FDA often 
has little date with which to make fundamental decisions about some 
products. This is especially true for products like foods and cosmetics 
for which no premarket approval is required. New programs must be 
initiated, in collaboration with other agencies, to provide such data. 
The Agency also needs to implement new ways of gathering data. The 
National Sentinel Reporting System, a nationally representative sample 
of medical device user-facilities, is expected to be a less expensive 
way of providing better and quicker data on medical device-related 
problems than the 100 percent mandatory reporting system now used. This 
system cannot be implemented without the necessary funds.
     Rapid dissemination of findings: FDA needs to be an active 
participant in a multi-institutional network that can detect adverse 
effects quickly and can disseminate information to health professionals 
industry, and consumers quickly.
     Outreach and education: A significant component of 
improving the current situation is to improve the feedback to health 
care personnel and consumers. Requested resources will be devoted to 
developing strategies , such as consumer publications and public 
service announcements, to reduce the number of injuries from food and 
cosmetic products.
2. Stakeholder Views
    There is strong stakeholder support for improving the data 
collection, analysis, and dissemination of information from the 
existing Adverse Event Reporting System and for some of the news data 
collection initiatives. A few indications of these views follow:
     ``The process for adverse event/injury reporting is 
perhaps the most urgent task facing FDA today. The process by which 
adverse injury report data is captured and converted to agency and 
consumer use must be addressed.'' [consumer advocacy group]
     ``Perform analysis and trend reporting on error and 
accident reports and make this available to the industry.'' [trade 
association]
     ``Improve the handling of adverse event reports for 
dietary supplements to involve the industry earlier.'' [trade 
association]
     ``Consumer safety is being threatened by funding cuts in 
1996 that eliminated the adverse-reaction report part of the voluntary 
reporting program for cosmetics. [trade association]
     ``Accurate food safety statistics are vital to developing 
an effective strategy for enhancing the safety of our nation's food 
supply.'' [trade association]
3. Current Innovations/Reinventions
    FDA has initiated several programs for gathering information on 
adverse events/injuries associated with the misuse or failure of FDA-
regulated medical products and foods. These include the following:
MedWatch
    MedWatch covers drugs, biologics, medical and radiation-emitting 
devices, and special nutritional products, such as medical foods, 
dietary supplements, and infant formulas. The MedWatch form is used for 
voluntary and mandatory reporting of adverse events and product 
problems by health professionals; the reports are sent on to the 
appropriate FDA component for analysis and follow-up action. Over 140 
health professional and industry organizatios have joined the MedWatch 
effort as MedWatch Partners and actively support the program by 
promoting the importance of reporting serious adverse events or product 
problems to their members.
Adverse Events Reporting System (AERS)
    With its new computer system, the Adverse Events Reporting System 
(AERS) is expected to form the basis for a revitalized 
pharmacovigilance program for the United States. AERS continues to be 
developed and will be relied upon by both CDER and CBER over ensuring 
years to provide accurate, accountable data for the performance goals 
identified for injury reporting.
    FDA is responsible for monitoring the market for adverse effects of 
medical devices. FDA expects to receive over 63,000 postmarket reports 
in FY 1998, including mandated reports from medical device 
manufactures; voluntary reports from medical device professionals 
received through the problem reporting program (MedWatch); and results 
of field inspections. FDA currently is managing the huge numbers of 
reports in three phases. During the first phase, the reports are 
screened for completeness and entered into the data management system. 
During the second phase, the reports are analyzed for similar events, 
judged for severity, and searched for trends. The final phase focuses 
on action, such as issuing safety alerts and notifications to users 
(i.e., health professionals and patients) warning them of concerns and 
advising them how to prevent future occurrences.
    Some manufacturers have been granted approvals to submit summary 
reports quarterly for adverse events involving specific devices. This 
summary erporting system is bieng expanded and will produce usable 
information at a small cost to both FDA and the industry.
FoodNet
    FoodNet is the product of a cooperative venture among USDA, CDC, 
and FDA; it attempts to estimate the incidence of foodborne illness 
that is not revealed in obvious outbreaks. Most foodborne illness 
occurs in ways that appear sporadic and unrelated to each other. 
FoodNet, which has the ability to provide more comprehensive 
information through sources such as case-control studies and surveys of 
laboratories and physicians, can help FDA and its federal colleagues 
link illnesses that have a common cause, no matter where they occur.
National Antimicrobial Resistance Monitoring System (NARMS)
    The National Antimicrobial Resistance Monitoring System (NARMS) was 
established in January 1996 as a collaborative effort among the FDA, 
USDA, and CDC. The system was

[[Page 65031]]

initiated in response to public health issues associated with the 
approval of fluoroquinolone products for use in poultry. The NARMS 
program monitors changes in susceptibilities to 17 antimicrobial drugs 
of zoonotic enteric pathogens from human and animal clinical specimens, 
from healthy farm animals, and from carcasses of food-producing animals 
at slaughter. The objectives of the system include: to provide 
descriptive data on the extent and temporal trends of antimicrobial 
susceptibility in Salmonella and other enteric organisms, to facilitate 
the identification of resistance in humans and animals as it arises, 
and to provide timely information to veterinarians and physicians. The 
ultimate goal of these activities is to prolong the lifespan of 
approved drugs by promoting prudent and judicious use of antimicrobials 
and taking appropriate public health action.
Vaccine Adverse Events Reporting System (VAERS)
    CBER and CDC jointly overseas the Vaccine Adverse Events Reporting 
System (VAERS), which receives mandatory reports as required by the 
National Vaccine Injury Act about adverse effects from vaccines. CBER 
and its colleagues are discussing electronic submission of reports, 
which would provide more rapid access of the VAERs data to 
manufacturers.
4. Plan for Meeting Statutory Requirements and Public Expectations
    Prompt identification of new, previously unrecognized problems with 
FDA-regulated products has the potential to decrease morbidity and 
mortality associated with those products and maximize the safety of 
approved products. Thousands of deaths and injuries could possibly be 
avoided, or their consequences reduced, through a comprehensive 
strategy aimed at finding out why incidents occur and implementing 
strategies to prevent them from occurring again.
    One of the Agency's primary objectives is the development and 
implementation of a system for improving the quality of information on 
adverse events and product defects associated with FDA-regulated 
products. This system needs to address issues of injury reporting by 
focusing on three areas: surveillance and epidemiology; research; and 
education and outreach. FDA believes that such a system would maximize 
the safety of FDA-regulated products through increased reporting of 
potentially dangerous adverse events or product problems to FDA or the 
manufacturer. Increased reporting provides greater assurance that a 
potential problem with a marketed product will be discovered and 
appropriate corrective action will be taken, and it ensures systematic 
feedback to the health care community and the public. None of these 
systemic improvements are possible without adequate funding.
Surveillance and Epidemiology
     With sufficient resources, FDA continues to develop and 
revitalize its system for reporting, monitoring, and evaluating adverse 
events associated with FDA-regulated products. AERS is the basis for 
this revitalized program.
     FDA is also developing active reporting systems for foods 
and for medical devices. These active systems use statistical selection 
of sites to provide better estimates of adverse events from the events 
that are reported.
     FDA will implement a National Sentinel Reporting System to 
provide an alternative to 100 percent mandatory reporting by medical 
device user-facilities. The system will use a nationally representative 
sample of user-facilities to track postmarket adverse events and is 
intended to save the industry millions of dollars in reporting costs. 
The system also will provide FDA clinicians and analysts with more 
timely, and better quality, postmarket data, thus improving FDA's 
ability to detect and to analyze medical device-related problems. In 
addition, this system is intended to provide FDA with ready access to a 
network of clinical facilities that could offer clinical insight into 
problem investigation and participate in specific research and 
educational efforts on product problems. However, this cannot be 
implemented without the necessary funds.
Research
    Methodologic and surveillance research efforts designed to 
understand the causes of, and the factors contributing to, product-
related injuries are critical to reducing the number of FDA-regulated 
product injuries. Research will be initiated in ``human factors 
sciences'' to identify labeling and product interface design features 
that may cause or contribute to use error, a leading cause of avoidable 
deaths and injuries.
Education and Outreach
    Improving feedback to health care professionals and consumers is 
critical to the improvement of adverse event reporting. Rapid 
dissemination of findings on injuries to the relevant stakeholders and 
the education of the medical community require additional resources. 
The Agency has begun to collaborate with other agencies and 
professional groups to produce teleconferences that convey general 
information or product-specific information, nationwide.
    An integrated science-based system for reporting, monitoring, and 
evaluating food and cosmetics-based adverse events is necessary to make 
fundamental regulatory decisions and policies. This system will depend 
on a research program aimed at understanding how health care 
professionals, as well as the public, can better recognize product-
problems, and on a related research program on methods of analyzing the 
data. The clinical evaluation of adverse events and the determination 
of risk assessment requires medical officers and other trained 
personnel to take follow-up actions, make clinically-based decisions, 
and report activities to FDA's existing staff.
5. Performance Goals for FY 1999
    The table provided in this section links FDA's statutory 
requirements with performance goals in the FY 1999 Performance Plan, 
illustrating the Agency's efforts to consolidate several systematic 
approaches into one performance system.
    Highlighted below are key performance goals for FY 1999 in the area 
of adverse event reporting. These performance goals deal with creating 
new, active surveillance systems, or with improving passive reporting 
programs to make them more useful and available. For more complete 
identification of performance goals and statutory requirements see the 
table at the end of this section.

FY 1999 Performance Goals

Implement AERS for the electronic receipt and review of Adverse Drug 
Report (ADR) reports
Evaluate pilot efforts for new postmarket surveillance system
Increase the number of reports on device events that are received 
and processed in summary form by using electronic reporting
Develop baseline surveillance data on foodborne illness under the 
FootNet program
Improve public access to information on adverse events with Special 
Nutritionals
Increase the number of human and animal isolates in National 
Antimicrobial Resistance Monitoring System (NARMS)

[[Page 65032]]



----------------------------------------------------------------------------------------------------------------
                                                                                 FY 1997            FY 1998
      Statutory authority         Relevant statute     Relevant FY 1999        performance        performance
                                 and/or regulation     performance goals         baseline           baseline
----------------------------------------------------------------------------------------------------------------
Applicants must report to FDA    FD&C Act, Section  By the end of FY 1999,  Implementing the   FY 1998: Pilot,
 adverse drug experience          505; Public        implement the AERS      core system is     five firms
 information.                     Health Service     for the electronic      currently under    electronic entry
                                  Act, Section       receipt and review of   way and will be    uncoded only.
                                  2101-2134; 21      voluntary and           completed by FY    Periodic reports
                                  CFR 314.50,        mandatory ADR reports.  1998.              only.
                                  314.80-81,
                                  314.98, 314.540,
                                  and 600.80.
Plan and implement a sentinel    FD&C Act Section   Evaluate pilot efforts  Not applicable...  Recruit 24 pilot
 user reporting system.           519(b)(5).         for new sentinel                           facilities.
                                                     device reporting
                                                     system as alternative
                                                     to universal user
                                                     facility reporting.
    CDRH
Device user-facilities are       FD&C Act Section   Increase the number of  Not applicable...  FY 1998: 20,000
 required to report adverse       519(b)(1).         low-risk postmarket                        reports received
 events.                                             reports received and                       in summary form.
                                                     processed in summary
                                                     form. The total
                                                     number of summary
                                                     reports will be
                                                     increased from 20,000
                                                     in FY 98 to over
                                                     25,000 in FY 99. This
                                                     will be done by using
                                                     innovative
                                                     surveillance methods
                                                     and improving quality
                                                     and analysis needed
                                                     for Safety Alerts and
                                                     other actions..
    CDRH
CFSAN..........................  .................  Work with CDC and       Sentinel Sites     Expand the
                                                     other federal           expanded to        demographic
                                                     agencies to develop     provide better     diversity and
                                                     baseline surveillance   coverage of the    size of the
                                                     data on foodborne       representative     population
                                                     illnesses required to   areas of the       covered by
                                                     evaluate the            United States.     FoodNet by
                                                     effectiveness of, set                      increasing the
                                                     better priorities                          number active
                                                     for, and determine                         surveillance
                                                     appropriate outcomes                       sites from 7 to
                                                     for the Food Safety                        8. Begin
                                                     Initiative.                                implementation
                                                                                                of PulseNet,
                                                                                                which provides
                                                                                                data required to
                                                                                                do more rapid
                                                                                                and accurate
                                                                                                tracebacks to
                                                                                                determine the
                                                                                                causes of
                                                                                                foodborne
                                                                                                outbreaks.
CFSAN..........................  .................  By the end of FY 1999,  Two releases in    The requisite
                                                     improve public access   FY 1997.           hardware and
                                                     to timely information                      software systems
                                                     on adverse events                          need to be
                                                     related to dietary                         purchased for
                                                     supplements, infant                        integration of
                                                     formulas, and medical                      current Center-
                                                     foods by increasing                        based limited
                                                     the frequency of                           capability
                                                     public releases of                         systems.
                                                     information in the
                                                     Special Nutritionals
                                                     Adverse Events
                                                     Monitoring System
                                                     from two per year to
                                                     four per year.
CVM............................  .................  Assure that food        Salmonella         Salmonella
                                                     derived from animals    isolates: 1,287    isolates: 2,000
                                                     and animal products     human, 2,391       human, 3,000
                                                     is safe for human       veterinary.        veterinary.
                                                     consumption by
                                                     increasing the number
                                                     of human and animal
                                                     isolates in the NARMS
                                                     database.
----------------------------------------------------------------------------------------------------------------
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.


[[Page 65033]]

Objected D--Ensuring access to the scientific and technical 
expertise needed by the Secretary--

1. Identification of Needs
    FDA's ability to access the scientific and technical expertise 
necessary to carry out its mission must be enhanced, i.e., improving 
the science infrastructure, by upgrading the status of its facilities 
and equipment; augmenting and targeting its science expertise toward 
important new health enhancing technologies; and linking its science 
information to external sources.
Upgrade Facilities and Equipment
    FDA's current science capability, both internally generated and 
externally coordinated, supports a wide range of risk management 
activities, covering the life cycle of Agency-regulated products. The 
integrity of the science base should be sustained by state-of-art 
equipment and facilities, but at a minimum they must be in good repair. 
The present status of this infrastructure, in many cases, is 
considerably less than adequate. For instance, replacing the FDA's Los 
Angeles laboratory and expanding the Arkansas regional facility will 
provide the physical tools necessary to meet FDA's obligations.
Augment and Target Science Expertise
    Although FDA's science efforts are supporting current efforts in 
premarket review, postmarket safety assurance, and product use 
monitoring, these programs are falling short of meeting the Agency's 
statutory mandates and public expectations. As the programs are 
enhanced to meet expectations, the Agency's access top state-of-the-art 
science must be expanded. This will be accomplished both through 
strategic recruitment of needed expertise and through creative 
collaboration with outside institutions. Because FDA must regulate 
increasingly complex products, the Agency's science capabilities must 
be able to keep pace with new scientific developments. Further, the 
science expertise must be positioned so that appropriate risk 
assessments can be targeted toward emerging technologies that are 
significant in protecting public health and which must reach the market 
place quickly.
Link Science Information to External Sources
    FDA must make strides in linking its science information bases to 
external sources so that synergies can be realized and appropriate 
information can be brought to bear on risk assessment and risk 
management decisions promptly. If FDA does not enhance its ability to 
link its science information with other outside sources, it will lose 
comparability and communicability with these sources. Further, it will 
not be as able to capitalize on cost-effective use of science 
information to support regulatory decisions.
2. Stakeholder Views
    Stakeholders strongly support the need for FDA maintaining a strong 
and well-linked science base to support increasingly complex regulatory 
judgments. A few illustrations of these views are indicated below:
     ``These needs to be a continuing strong commitment within 
the Food and Drug Administration towards maintaining an appropriate 
scientific base. It has been the experience of our member companies, 
with numerous examples relating to both clinical development and 
complex manufacturing issues, that these are speedily resolved because 
of the scientific expertise within [FDA]. [trade association]
     ``Our company's long history in biotechnology has 
repeatedly shown the value of active research scientists at [FDA]. 
[FDA's] personnel that are involved in research related to safety, 
efficacy, basic biology, mechanism of action, and other associated 
areas provide an important component for in-depth understanding of 
issues and bring an understanding and response to issues in a 
scientifically and regulatory responsible and appropriate manner.'' 
[industry representative]
     ``[FDA] Staff need to understand modern science . . . 
there is just not going to be any way that proper regulation can occur 
without people being able to communicate at the same level about this 
science. There needs to be maintenance and renewal of the state-of-the-
art scientific leadership.'' [professional association]
     ``I express the public's strong interest in the Agency's 
ability to retain highly qualified scientists within the FDA. I ask, 
and adverse reporting statistics demand, that products be reviewed on 
the merit of scientic evidence, safety and effectiveness.'' [consumer 
advocacy group]
     Implement programs whereby Agency scientists participate 
in staff exchange programs with academia, other government agencies and 
industry. [health organization]
3. Current Innovations/Reinventions
    FDA is expanding its access to scientific expertise through 
creative collaboration with the broader scientific community. This is 
being accomplished through several approaches:
Industry-Government-Academic Collaboration
    Industry-government-academic collaboration enhances the Agency's 
scientific expertise, thereby using added resources that would 
otherwise be unavailable to the government. Examples of these 
collaborations are below.
     The FDA Science Board, a high-level committee of 
representatives from industry and academia advise the Commissioner and 
Chief Scientist on FDA scientific issues and activities.
     FDA has two significant collaborations with industry, the 
Collaboration for Drug Development Improvement (CDDI) and the Product 
Quality Research Initiative (PQRI), intended to leverage resources and 
to work with industry to improve the drug development process.
     FDA currently has approximately 25 collaborative research 
and development programs (CRADAs), which are designed to foster 
scientific collaboration between the federal government and sectors 
outside the government; a list of these programs can be found on the 
FDA Internet site. FDA is actively soliciting new collaborative 
agreements with industry in addition to advertising opportunities on 
the Internet.
     FDA has joint programs with the University of Maryland and 
the Illinois Institute of Technology to enhance safety of the food 
supply. This is particularly important in light of the government's 
Food Safety Initiative, which is designed to assure the American public 
that they can consuming the safest food possible.
     FDA annually sponsors a Science Forum and workshops to 
bring together scientists of like disciplines from across and outside 
the Agency to address cross-cutting topics. Examples of recent 
workshops include the deoxyribonucleic acid (DNA) microarray workshop, 
alternative toxicology testing methods, and mechanisms of 
carcinogenesis.
Intergency Collaboration
    Encourage interagency cooperation allows the substantial expertise 
of other government scientists to focus their efforts on similar 
problems. For example, working with other agencies allows the FDA to 
prevent illness and epidemics. The Agency collaborates with the NIH to 
speed drug and vaccine development so these products can reach 
consumers more quickly. This interagency cooperation also allows the 
Agency to determine modes of infection and thereby educating 
scientists, which could lead to new testing methods.

[[Page 65034]]

Exchanging Scientific Expertise
    Industry and FDA collaboration provides an atmosphere to encourage 
the exchange of scientific expertise. The FDA sponsors workshops on 
cutting-edge topics such as gene therapy and Simian Virus and DNA 
vaccines. The FDA/National Institute of Dental and Craniofacial 
Research (NIDCR) model MOU allows for use of scientific expertise on 
panels and as consultants to the CDRH's device group. Added to these 
face-to-face contacts, Agency scientists are encouraged to publish in 
professional journals so their non-government peers can learn from 
their work.
Information Technology
    Information technology is a tool that allows FDA scientists to 
learn about new discoveries and to increase their abilities to review 
applications. For the Agency to produce excellent scientific work, FDA 
scientists must be aware of the latest developments and theories 
quickly and in a timely fashion so they can incorporate them into their 
work. Facing these scientists is the daunting task of accessing a 
voluminous amount of new information, which is generated too quickly 
for one person to follow. To assure this knowledge is incorporated into 
Agency decisions, FDA scientists use information technology to access 
databses of latest discoveries located in-house and in external 
scientific databases.
    Information technology (IT) tools go beyond finding articles with 
new theories and approaches. The Agency uses IT tools to validate 
computer models to speed reviews. For instance, FDA scientists can 
review a comprehensive database on carcinogenicity of over 700 drugs. 
IT tools also are used to validate computer models in a timely manner 
so application decisions can meet statutory requirements.
4. Plan for Meeting Statutory Requirements and Public Expectations
    Section 903 of the FD&C Act, as amended by FDAMA, requires FDA to 
carry out research relating to foods, drugs, cosmetics, and devices in 
realizing the intent of the Act. Section 903 also requires FDA to 
consult with experts in science, medicine, and public health and other 
stakeholders in carrying out its mission. In addition, FDAMA law 
(Section 414) mandates policies that foster collaboration between 
federal agencies and other science-based agencies.
    FDA's plan for meeting these statutory requirements will encompass 
a variety of actions intended to enhance its science capabilities. One 
approach is for the Agency to conduct research projects that identify 
the causes of and factors contributing to product-related injuries. For 
instance, Agency scientists are examining labeling and product features 
that can be altered to prevent product-related accidents. To conduct 
these research efforts, the Agency will maintain and strengthen its in-
house scientific expertise by expanding innovative and successful 
programs (e.g. in-house Fellows programs).
    The Agency will continue to enhance its scientific collaborations 
with the larger scientific community by initiatives with the University 
of Maryland, Georgetown University, and other institutions of higher 
learning. Similarly FDA will strengthen the Agency's science base 
linkage to external sources to provide comprehensive science 
underpinning for important national health initiatives, such as working 
closely with CDC and USDA in the establishment of NARMS.
    In addition to these steps, the Agency is developing improved 
methods to detect food pathogens and to assess health risks more 
rapidly so that consumers can implement preventive measures.
5. Performance Goals for FY 1999
    The table below links the performance goals and measures with the 
science-related statutory requirements. FDA's main statute, the FD&C 
Act, provides broad authority to the Secretary to authorize research 
efforts. Performance Goals illustrate two types of efforts. The first 
identifies development of methods or products that can be applied to a 
specific health risk problem. For instance, one goal calls for studies 
on antibiotic resistance of foodborne pathogens.
    The second type of goal identifies a long-range systemtic solution 
to a range of problems. Illustrative of this type is a multi-year 
research plan to improve methods for detection, control, and prevention 
of microbial contamination. A measure for this type of goal is more 
difficult to establish. Because scientific progress often results from 
diverse efforts, measuring this goal is an incremental process of small 
steps. In this goal, establishing relationships with stakeholders is a 
major step.
    Highlighted below are key performance goals for FY 1999 in the area 
of science. Several goals enable the Agency to put science behind 
methods for quickly detecting potentially high-risk products. Other 
goals focus on collaborating with key stakeholders to increase 
science's role in regulatory policy. For more complete identification 
of performance goals and statutory requirements see the table at the 
end of this section.

FY 1999 Performance Goals

Implement a multi-year research plan to develop and improve methods 
for the detection, control, and prevention of microbial 
contamination on fresh produce.
Develop model to assess human exposure to a variety of foodborne 
pathogens.
Work with industry and academia to develop new techniques for 
eliminating pathogens on fresh prodcue.
Support product review by developing faster, more accurate tests on 
mechanisms of toxic actions.
Demonstrate a model toxicity knowledge base to support and expedite 
product review.
Develop better models to predict risk for cancer, reproductive, 
developmental, neurological, genetic, and acute toxicological 
outcomes.

----------------------------------------------------------------------------------------------------------------
                                      Relevant statute and/     Relevant FY 1999         FY 1998 performance
        Statutory authority               or regulation         performance goals              baseline
----------------------------------------------------------------------------------------------------------------
The Secretary is empowered through   FD&C Act, Section       ......................  Develop and begin
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   implementing an
 ``research relating to foods,                                                        interagency research plan
 drugs, cosmetics and devices''.                                                      that more effectively
                                                                                      coordinates the food
                                                                                      safety research activities
                                                                                      in FDA and USDA.
The Secretary is empowered through   FD&C Act, Section       ......................  ...........................
 the Commissioner of FDA to conduct   903(d)(2)(C).
 ``research relating to foods,
 drugs, cosmetics and devices''.

[[Page 65035]]

 
The Secretary is empowered through   FD&C Act, Section       ......................  ...........................
 the Commissioner of FDA to conduct   903(d)(2)(C).
 ``research relating to foods,
 drugs, cosmetics and devices''.
The Secretary is empowered through   FD&C Act, Section       ......................  Formalize PQRI
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   collaboration.
 ``research relating to foods,
 drugs, cosmetics and devices''.
The Secretary is empowered through   FD&C Act, Section       ......................  Identify specific issues
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   and areas of research
 ``research relating to foods,                                                        focus and develop research
 drugs, cosmetics and devices''.                                                      protocols.
The Secretary is empowered through   FD&C Act, Section       ......................  Identify priority material
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   for standard development.
 ``research relating to foods,
 drugs, cosmetics and devices''.
The Secretary is empowered through   FD&C Act, Section       ......................  ...........................
 the Commissioner of FDA to conduct   903(d)(2)(C).
 ``research relating to foods,
 drugs, cosmetics and devices''.
The Secretary is empowered through   FD&C Act, Section       ......................  Use model animal and cell
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   culture transgenic systems
 ``research relating to foods,                                                        to evaluate risk to the
 drugs, cosmetics and devices''.                                                      human genome.
The Secretary is empowered through   FD&C Act, Section       ......................  Conduct case-control
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   molecular epidemiology
 ``research relating to foods,                                                        studies to assess breast
 drugs, cosmetics and devices''.                                                      and prostate cancer in
                                                                                      African-American women/
                                                                                      men.
The Secretary is empowered through   FD&C Act, Section       ......................  Computer-based predictive
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   system is being used as
 ``research relating to foods,                                                        model for rodent and human
 drugs, cosmetics and devices''.                                                      hormone-binding proteins.
The Secretary is empowered through   FD&C Act, Section       ......................  Present at a scientific
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   forum a unifying approach
 ``research relating to foods,                                                        to safety assessment for
 drugs, cosmetics and devices''.                                                      both carcinogenic and non-
                                                                                      carcinogenic effects.
The Secretary is empowered through   FD&C Act, Section       ......................  Screen animal products and
 the Commissioner of FDA to conduct   903(d)(2)(C).                                   environments for a
 ``research relating to foods,                                                        microorganism harboring
 drugs, cosmetics and devices''.                                                      antibiotic resistance.
----------------------------------------------------------------------------------------------------------------
FY 2000 Performance Goals are not identified in this Plan. Specification of these goals is dependent upon final
  determination of the President's FY 2000 Budget submission to Congress.

Objective E--Establishing Mechanisms, by July 1, 1999, for Meeting 
the Time Periods Specified in This Act for the Review of all 
Applications and Submissions Described in Subparagraph A (Objective 
A) and Submitted After the Date of Enactment of the FDAMA

    In the spring of 1999 FDA plans to reevaluate where it stands in 
relation to this objective. The Agency plans to make information on 
this objective easily available to Congress, the public, regulated 
industry, and other stakeholders. FDA is exploring making this 
information available on the Internet.

Objective F--Eliminating Backlogs in the Review of Applications and 
Submissions Described in Subparagraph A (Objective A), by January 
1, 2000

    Objectives E and F are directly related. The strategies followed to 
achieve Objective E will also achieve Objective F. By making 
improvements and changes to the review process to meet the time frames 
for reviewing applications and submissions, any backlogs for them will 
be eliminated. Therefore, this section will address both objectives.
1. Identification of Needs
    While, the Prescription Drug User Fee Act of 1992 (PDUFA) has been 
a great success, there is a gap in performance for applications not 
covered by PDUFA that needs to be filled for FDA to meet its statutory 
review requirements. In addition, public expectations, internal time 
frames, and PDUFA goals provide important benchmarks for FDA 
performance.
    FDA needs to reduce total product development time, meet statutory 
review requirements, expedite and add value to new technologies, 
maintain high-quality interactive reviews, and target laboratory work 
to support and expedite science-based reviews. FDA has successfully 
adopted a number of innovations and re-engineering approaches to 
improve review performance. FDA has now reached the point, however, 
where additional improvements toward meeting statutory requirements 
cannot occur without additional resources.
    FDA ultimately needs to speed safe and effective products to the 
American public by reducing the overall development and review time for 
new products without compromising product quality and safety.
2. Stakeholder Views
    Making new products available to the public more quickly and 
streamlining the product development and review process while ensuring 
safety are important goals.
     Some consumer advocacy groups want the Agency to assign 
the highest

[[Page 65036]]

priority to expediting the development and review of drugs, while 
others expressed fear that meeting review deadlines could result in 
safety risks.
     ``Replace the resource-intensive [Generally Recognized as 
Safe] GRAS petition process with a streamlined notification system. 
Finalize the GRAS notification regulation.'' [trade association]
    Using a risk-based strategy for reassigning resources is a major 
Agency strategy. A number of stakeholder comments seemed to support 
this strategy.
     A major health organization stated that many blood 
products have been in the public arena for a long time, and placing 
such products on the lowest review requirement tier would allow the 
transfer of resources to new products.
     A health professional society said that FDA should 
reassess the risk-benefit of analysis of lifestyle-modifying drugs and 
subject them to a different type of scrutiny than that which is used to 
treat or to prevent disease or other medical conditions. Also, they 
said it is hard to argue that it is worth taking a lot of work with a 
new drug product which in no way adds therapeutic benefit.
    A number of stakeholders said that proper implementation of fast-
track provisions will expedite entry into the marketplace for drugs for 
serious and life-threatening illnesses.
     A biotechnology industry council suggested that the PDUFA 
II goals be applied first to fast-track products. They also said that 
definitions need further clarification and a broad, flexible definition 
is needed for ``serious and life-threatening illnesses.'' The council 
also suggested that quarterly conferences be held to discuss surrogate 
end points and that fast-track designation should be done by directors 
of review divisions.
    There was both support for the Agency's strategy for implementing 
third-party reviews and also concern about the strategy.
     A major trade association said that more medical devices 
should be added to the list for using third-party reviews.
     A regulatory organization said that FDA should continue to 
offer its reviews as an alternative to third-party reviews and that FDA 
should carefully review the third-party evaluations just as it would 
the work of its own staff.
    A major concern of industry stakeholders was that FDA communicate 
what is expected of them in developing and testing new products and in 
providing evidence for approval.
     A major trade association said that FDA should make its 
procedures transparent, particularly in terms of Good Review Practices 
(GRPs). Various documents such as GRPs and reviewer handbooks should be 
provided to industry and other stakeholders to provide a better 
understanding of the workings of FDA and to allow industry to bring its 
procedures into conformity.
    Improving the efficiency of the review process by implementing an 
electronic submission and review process was also an industry priority.
     A biotechnology industry representative suggested that 
information flow and documentation needs to be handled more efficiently 
and suggested that this could be done through the establishment of a 
standard electronic information exchange environment that would set the 
standards for industry.
    Animal drug industry stakeholders placed a high priority on FDA 
implementing the recently enacted Animal Drug Availability Act (ADAA).
     Full implementation of the ADAA was an issue brought up by 
many of the stakeholder groups, including drug manufacturers, livestock 
producers, and feed producers. All of the speaker who mentioned it 
strongly urged FDA to devote whatever resources were necessary to fully 
implement ADAA.
3. Current Innovations/Reinventions
    FDA has been pursuing a number of strategies for many years to 
improve on-time performance in reviewing applications and submissions, 
especially for new products. Many of these strategies were developed in 
conjunction with the Agency's stakeholders. Many strategies focus on 
speeding up the review process and encompass risk-based priorities, re-
engineering FDA processes, information technology, communications with 
industry and other stakeholders, and scientific support for reviews.
    Strategies also focus on the drug development stage (i.e. pre-
Investigations New Drug [pre-IND] and IND), and on assisting industry 
during the testing and pre-application process. A day saved in 
developing a new therapy is just as valuable as a day saved in 
reviewing it. FDA is working with product sponsors to ensure that they 
know what is expected of them so that product testing and preparation 
of the application are more effectively and efficiently done. As PDUFA 
has shown, these pre-application efforts have resulted in higher 
quality applications, faster reviews, and an increasing approval rate. 
Non-PDUFA applications have benefited from PDUFA improvements and 
innovations. However, FDA performance on non-PDUFA applications still 
needs improvement.
    FDAMA start-up and additional workload may reduce review 
performance in the near term, especially for medical devices and other 
non-PDUFA products. The growing complexity of medical devices requires 
that more time be spent interacting with sponsors and keeping 
guidelines up to date. Increased guidance and interactions with 
industry are resource-intensive activities. These factors will 
challenge FDA's ability to meet time frames.
Establish Risk-Based Priorities
    FDA is focusing more on actual and potential risks in establishing 
priorities. FDA will identify and concentrate resources on high-risk, 
high-impact products or work areas, those where its direct intervention 
helps consumers and health care professionals the most. Despite current 
and anticipated budget constraints, resources will be redirected; and 
while some key areas will be increased, some low-risk product areas 
will be decreased. Several examples of these effects include:
     Exempting low-risk medical devices from the premarket 
notification requirement;
     Using a threshold of regulation approach for very low risk 
noncarcinogenic indirect food additives.
     Giving priority to high-risk, food safety-related, food 
additive petitions.
    Conducting risk versus benefit communications research to assess 
the public's ability to understand risks versus benefits in drug 
information and to develop useful and meaningful ways of presenting 
important information about a drug's known risks and benefits.
    FDA's research agenda includes development of more predictive 
animal and non-animal models for safety and efficacy evaluation. FDA 
scientists are developing new approaches for use in predicting risk 
associated with human toxicity; developing computer-based systems to 
aid in the assessment of human toxicity; and conducting research on 
specific agents, concepts, or methods that can be applied to questions 
of human health and safety.
    In addition to the risk-based priorities, FDA has identified high-
impact areas such as pregnancy labeling, antibiotic resistance, 
medication errors, consumer information and direct-to-the consumer 
advertising policies that require the expenditure of further resources. 
In conjunction with stakeholders, FDA already is devising innovative 
strategies and methods to address the public health impact of these 
emerging issues.

[[Page 65037]]

Re-Engineer FDA Processes
    The Agency has been working to change its culture to fulfill its 
dual mission of promoting and protecting public health. As a result, 
FDA has been re-engineering many of its product review processes for 
the last several years. In fact, many e provisions of FDAMA codified 
results of re-engineering efforts initiated by the Agency. The 
following provides highlights of a variety of re-engineering efforts, 
resulting from FDAMA, other laws, stakeholder input, and the Agency's 
own initiative.
    The introduction and expansion of the Project Management System 
(PMS) to expedite review processes for both CDER and CBER established 
team-based project management programs designed to improve the quality 
and efficiency of the drug review process. These programs have 
demonstrated their effectiveness and continue to be refined and 
enhanced. Team-Based Project Management is a powerful technique 
combining the use of multidisciplinary teams led by project managers 
and scientific leaders who use the tools and techniques of project and 
resource tracking. Review disciplines are organized into 
multidisciplinary teams early in the review process to develop a review 
plan and commit to target interim and milestone completion dates. Teams 
meet periodically to exchange information, discuss significant aspects 
of the applications, review progress toward meeting target completion 
dates, and make resource adjustments. Project management is being used 
throughout the Agency.
    FDA is committed to the implementation of the third-party provision 
of FDAMA and is already pursuing that program. A key factor will be to 
apply lessons earned from the earlier third-party pilot program for 
medical devices. The fact that the earlier pilot worked well for the 
limited number of manufacturers who participated in the program, 
combined with the expanded list of eligible devices under FDAMA, should 
go a long way toward attracting additional submissions from industry.
    FDA plans to issue guidance that describes its fast-track policies 
and procedures. To ensure compliance with the legislatively managed 
time frame of 60 days for designation, FDA is using management tools 
similar to those which have contributed to FDA's success in meting 
PDUFA goals. The guidance will include the Agency's definition of ``a 
serious or life-threatening condition.'' In accordance with the 
statutory mandate, FDA currently is working with NIH, sponsors, and its 
advisory committees in the timely evaluation of proposed surrogate end 
points. For many years FDA has been working with sponsors to develop 
surrogate end points that are reasonably likely to predict clinical 
benefit for serious and life-threatening conditions.
    Streamlining efforts will be focused on reducing the overall time 
required for product development. More guidance and meetings will be 
provided during the development process to assist firms in conducting 
appropriate clinical trials and in developing the scientific evidence 
needed to gain approval of new products.
    During FY 1998 CFSAN implemented a proposed notification procedure 
for independent GRAS determinations. The Agency's current plan is to 
codify this process during FY 1999. Once codified, this procedure will 
largely replace the resource-intensive GRAS affirmation petition 
process with a less resource-intensive notification process.
    Other efforts to simplify regulatory approaches and to reduce the 
burden on stakeholders include:
     Implementation of a phased review process as in CVM where 
CVM works with the sponsor throughout the research and development 
process and reviews technical sections of a New Animal Drug Application 
(NADA) as they are completed;
     Implementation of additional premarket notification 
programs in lieu of requiring preapproval before marketing (For 
example, CFSAN has worked to prepare for implementation of a premarket 
notification program for food contact substances established by 
FDAMA.);
     Development of GRPs for Agency reviewers (CBER and CDER 
conducted a series of workshops to develop an action plan that will 
evolve into guidelines that describe and develop GRPs guidance. A 
reviewer's handbook is also being developed.);
     Development of a list of approved drugs for which 
additional pediatric information may produce health benefits;
     Elimination of certain labeling requirements;
     Amendment of regulations to provide additional flexibility 
for health claims on foods and to clarify nutrient content claims; and
     Allowing use of abbreviated study reports in an NDA.
Capitalize on Information Technology
    FDA is aggressively moving towards an electronic regulatory 
submissions environment. The benefits of electronic submissions 
include:
     lower paper handling costs for FDA (e.g. document room 
contract, offsite storage, onsite storage);
     quicker access to information by reviewers (e.g. no 
waiting for a paper copy and no rekeying of data for analysis; and
     time and cost savings during product development (most 
firms have their data in electronic format and won't have to waste time 
creating/delivering a paper submission to FDA).
Work More Closely With External Stakeholders
    A common theme in all of the improvements to the review process has 
been an intensive effort to improve communication with sponsors and 
manufacturers. This dialogue, which occurs by telephone, by 
videoconference, and in person, helps manufacturers understand what FDA 
is looking for in product submissions. Explanations include what 
information will be needed and why. Unresolved questions are resolved 
on the spot. Communication with industry continues to improve, with 
more companies taking advantage of opportunities to consult with FDA.
    These efforts have already contributed to improved review 
performance. For example, CDRH has zero backlogs of 510(k)s, Pre-
Marketing Approvals (PMAs), and PMA supplements. In addition, CDRH has 
begun implementing additional meetings as required by FDAMA, such as 
determination meetings, where a prospective PMA applicant may request a 
meeting to determine the type of scientific evidence necessary for PMA 
approval; agreement meetings, where prior to submitting an 
Investigational Device Exemption (IDE) application, a sponsor may 
request a meeting with FDA to discuss the specific investigational plan 
for a class III or implantable device; and 100-day PMA meetings, where 
within 100 days after the submission of a PMA, the sponsor may request 
a meeting to discuss the application.
    FDA is working to make Agency processes transparent by providing a 
variety of information in a variety of ways including:
     Increased sponsors/applicants meetings;
     Presubmission conferences;
     Presentations to industry about a variety of topics on the 
most common GMP deficiencies that prevent approval;
     Providing potential applicants with assistance during the 
development process;

[[Page 65038]]

     Comprehensive guidance for preparation of submissions to 
FDA; and
     Initiating industry education programs/services regarding 
studies and safety data needed to support petitions and notifications.
    FDA continues to rely on outside advisory committees for advice in 
reviewing product applications. Outside experts add a wide spectrum of 
judgement, outlook, and state-of-the-art experience to FDA's 
decisionmaking process. These expert advisors add to FDA's 
understanding, so that final Agency decisions reflect a balanced 
evaluation. FDA is working to improve the advisory committee process 
and make-up of committees to address stakeholder concerns.
    FDA participates in international harmonization activities that can 
result in reduced regulatory burden for the regulated industry, much of 
which markets products throughout the world. By harmonizing 
requirements to the maximum extent possible, the industry hopes to 
reduce the costs involved in bringing products to market. Activities 
are underway in the Codex Alimentarius forum to develop and adopt a 
standard for food additives. Activities to date have also included work 
toward major parts of common technical documents that could be used for 
premarket filings in the three major industrialized markets. Efforts 
are underway with medical devices to identify areas of divergence in 
the various regulatory requirements, with an eye toward ultimate 
harmonization of requirements. With drugs and biologics, these 
activities should result in both higher quality products regardless of 
production site, and their getting on the market quicker due to reduced 
conflict in regulatory requirements in major markets. By relying both 
on manufacturer self certification of conformity with international 
harmonized standards as part of the accepted premarket application and 
on third-party reviewers for preliminary 501(k) determinations, FDA has 
reduced the demand on staff to review original documentation.
Strengthen the Scientific and Analytical Basis for Regulatory Decisions
    Addressing the adequacy of the research and scientific 
infrastructure is one of FDA's highest priorities, especially as it 
supports the review of pre-market applications. Laboratory work is 
targeted to develop in-house scientific expertise, scientific guidance, 
and science-based standards. In-house scientific expertise is used to 
consult on product reviews, especially in areas of emerging 
technologies. Guidance can benefit both applicants and review staff in 
developing and reviewing applications. FDAMA requires FDA to recognize 
and use appropriate standards in the application review process for 
medical devices. Evidence that a product meets established standards 
will expedite the review process.
    FDA still faces shortages of certain expertise, especially through 
attrition. Some positions are very difficult to recruit. FDA needs to 
use a number of pay incentives (higher initial pay, bonuses, 
comparability allowances, etc.) to attract and retain medical officers, 
especially for certain specialties. Other positions include 
pharmacokinetics specialists, statisticians, and computer specialists. 
As a result, FDA sometimes is lacking critical skills in the review 
area such as having an orthopedic surgeon to review surgical devices.
4. Plan for Meeting Statutory Requirements and Public Expectations
    Because of the success of PDUFA, FDA will continue to use PDUFA 
submission and review mechanisms to improve the review performance of 
non-PDUFA applications and reduce product development time. Ultimately 
matching PDUFA's success without additional resources comparable to 
those provided by user fees is problematic.
    PDUFA is different from some European review systems in that it 
provides the certainty of a result within a definite time. Examples of 
the submission and review mechanisms used to accomplish this are: (1) 
presubmission consultations; (2) refuse-to-file authority and increased 
application quality; (3) project management; and (4) complete first 
actions.
    Several interlocking strategies will be used to meet FDA's review 
goals. To ensure wise use of reviewers' time, FDA will continue to re-
engineer its product review processes in many areas and will continue 
to look for more effective means of shortening processes without 
sacrificing quality and safety concerns. Second, several initiatives 
are underway to reduce the direct review burden on the Agency by 
reducing the requirement for pre-approval in some areas and replacing 
it with an industry notification process. Third, consultation with 
product sponsors early in their research and development process will 
raise the likihood that high-quality commercial applications will 
follow and make their way through the FDA system in the shortest time 
possible. Finally, all of FDA's product review centers will continue to 
automate their application submission and review tracking systems. This 
should result in not only faster review times, but also increases in 
Agency productivity. Without an infusion of resources, however, it is 
unlikely that FDA will be able to meet its statutory obligations in all 
product areas.
Additional Steps
    Make available and reassign more resources by using a risk-based 
priority system and seek additional resources as needed. FDA will 
redirect resources to high-risk and high-impact product areas and 
decrease resources in areas that pose a lower risk or benefit.
    Expand collaboration with product sponsors to expedite product 
development.
    Provide more productive interactions with industry through up-to-
date guidance review, industry education, and reviewer training.
    Increase efforts with other industrialized countries to harmonize 
product protocols.
    Expand electronic submission and review systems.
    Target laboratory support for emerging technologies.
    Expand use of third-party reviews.
5. Performance Goals for FY 1999
    The table provided in this section highlights some key PDUFA and 
non-PDUFA applications and summarizes the time frames, performance 
goals, baseline performance, and the number of applications overdue. A 
more comprehensive table and listing of applications and submissions 
covered by this Plan are in Appendix D.
    The PDUFA time frames and performance goals are the result of in-
depth negotiations between the drug industry and FDA. Industry and FDA 
determined that both the time frames and the percentage goals were 
realistic, achievable with the additional user fee resources, and 
desirable. The PDUFA time frames for drug applications differ in some 
cases from the FD&C Act statutory requirements. Biologics applications 
are covered by the Public Health Service Act, which does not have any 
statutory time frames. Also, the PDUFA goals do not stipulate that 100 
percent of applications be completed on time. In many cases, however, a 
100 percent performance level was achieved. Industry is pleased with 
the certainty of a timely action and response from the review process 
and the net result of a higher percentage of applications being 
approved faster. Patients have benefitted by having more therapies 
available more quickly. Performance goals for PDUFA

[[Page 65039]]

applications are based on the PDUFA time frames.
    Performance goals for non-PDUFA applications are based primarily on 
the statutory time frames with two exceptions. Non-PDUFA biologics 
applications have no time frames. FDA has voluntarily adopted the 
original PDUFA time frames for these applications. Also performance 
goals for food and color additive petitions are based on 360 days, 
twice the statutory time frame of 180 days. This is being done to 
provide realistic targets as the petition review process is being re-
engineered.
    FDA has developed clear performance goals that will enhance and 
further expedite reviews for product applications. Setting these goals 
has provided a valuable management tool for identifying performance 
expectations and assessing achievements. Using the PDUFA model, 
performance is measured based on the percentage of applications acted 
on within the appropriate review time frame. The on-time performance 
measure is important because it represents definitive decisions both to 
approve and not to approve. An accurate portrayal of the timeliness of 
the Agency's decision making should focus on the length of time to all 
decisions, both positive and negative.
    Overdue applications are those whose review period exceeded the 
time frames and were under active review at the end of the fiscal year.
    Highlighted below are key performance goals for FY 1999 in the area 
of application review. These goals represent applications for new and 
priority products and for new medical uses of approved products. For 
more complete information see the table at the end of this section and 
Appendix D.

FY 1999 Performance Goals

Review 90 percent of priority NDAs/PLAs/BLAs within 6 months.
Review 90 percent of priority efficacy supplements within 6 months.
Review 70 percent of blood PLAs/BLAs within 12 months.
Review 50 percent of PMAs within 180 days.
Review 30 percent of food and color additive petitions within 360 
days.

----------------------------------------------------------------------------------------------------------------
                                                             Percentage of first actions
                                                              within review time period
                                                          --------------------------------
            Time frame                Relevant  statute        FY 1999         FY 1997            Overdue*
                                                             performance      baseline
                                                              plan goal      (estimate)
                                                              (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
PDUFA:
    Review Priority NDAs within 6   FD&C Act Sec. 505(b)               90             100  0
     months (CDER) (PDUFA II         requirement is 6
     commitment letter).             months.
    Review Standard NDAs within 12  FD&C Act Sec. 505(b)               90              99  0
     months (CDER) (PDUFA II         requirement is 6
     commitment letter).             months.
    Review Priority NDAs/PLAs/BLAs  FD&C Act Sec. 505(b)               90             100  0
     within 6 months (CBER) (PDUFA   requirement is 6
     II commitment letter).          months. None for
                                     PLAs/BLAs.
    Review Standard NDAs/PLAs/BLAs  FD&C Act Sec. 505(b)               90             100  0
     within 12 months (CBER)         requirement is 6
     (PDUFA II commitment letter).   months. None for
                                     PLAs/BLAs.
    Review priority efficacy        FD&C Act Sec. 505                  90             100  0 (CBER)
     supplements within 6 months     requirement is 6
     (CDER & CBER) (PDUFA II         months for NDAs.
     commitment letter).             None for PLAs/BLAs.
Non-PDUFA:
    Review ANDAs within 180 days    FD&C Act Sec. 505(j).              60              54  .....................
     (CDER).
    Review and act on blood and     No statutory                       70              83  4
     source plasma PLAs/BLAs and     requirement.
     PLA/BLA major supplements
     within 12 months (internal
     time frame) (CBER).
    Review PMAs within 180 days     FD&C Act Sec.                      50              65  0
     (CDRH).                         515(d)(1)(A).
    Review 510(k)s within 90 days   FD&C Act Sec. 510(k)               90              98  0
     of receipt.                     and (n).
    Review food and color additive  FD&C Act Sec. 409 and              30            **24  .....................
     petitions within 360 days.      Sec. 721 requirement
     (CFSAN) Goals are based on      is 6 months.
     360 days. FY 1997 baseline
     based on 180 days**.
    Review NADAs and ANADAs within  FD&C Act Sec.          ..............              75  .....................
     180 days (CVM).                 512(c)(1).
----------------------------------------------------------------------------------------------------------------
*The number of applications overdue at the end of FY 1998.
**(Within 180 days) For petitions received in FY 1996, using the previous petition review procedure, 24 percent
  of petitions received ``first action'' within 180 days. CFSAN re-engineered the petition review process in FY
  1998 and redefined ``first action.'' FY 1997 figures and FY 1999 are not directly comparable.
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.

FDAMA Plan Appendices

Introduction

    These appendices and corresponding Internet resources provide 
direct access to information being used within FDA to implement the 
FDA Modernization Act. The actual text of the law passed by 
Congress, verbatim comments from stakeholders related to improving 
the way FDA conducts business and the current implementation plan 
are available for review and comment.
    Considerable space is devoted to stakeholder participation. Even 
so, only a fraction of the information is attached--the balance of 
information has been organized on FDA's website (http://
www.fda.gov). By clicking on ``FDA Modernization Act'' anyone can 
navigate through the wealth of FDAMA-related materials currently 
available.
    The text of the FDA Plan for Statutory Compliance is located on 
the Internet at http://www.fda.gov/oc/fdama/fdamapln/default.htm>. 
Additional questions or comments or requests for printed copies of 
these Appendices may be directed to the Planning and Management 
Communications Staff by telephone at 301-827-5207, by e-mail to 
[e-mail], and by FAX to 301-827-5225.

Appendix A: Statutory Authority

http://www.fda.gov/oc/fdama/fdamapln/appenda
    (1) Section 903 of Federal Food, Drug, and Cosmetic Act

[[Page 65040]]

    (2) Section 406 of FDA Modernization Act of 1997

    Note: Section 406 of the FDA Modernization Act amends, and has 
been incorporated into, Section 903 of the Federal Food, Drug, and 
Cosmetic Act. Copies of both sections have been included here. They 
include FDA's current mission and annual reporting requirements.

Appendix B: Stakeholder Involvement in 1998

http://www.fda.gov/oc/fdama/fdamapln/appendb
    (1) A message to FDA Stakeholders (includes 7 key questions)
    (2) Supplemental questions asked of stakeholders
    (3) Written summaries of each stakeholder meeting
    (4) Stakeholder comments organized by FDAMA objectives

    Note: Involving stakeholders in modernizing the way FDA meets 
its statutory and public health responsibilities is perhaps the most 
significant advancement addressed in FDAMA. In 1998 FDA made 
dramatic progress in gathering ideas for improving the Agency's 
effectiveness. Stakeholders include experts in science, medicine, 
and public health, as well as consumers, product manufacturers, 
importers, and retailers. Most of the information contained in this 
section is also available on FDA's website.

Appendix C: FDAMA Implementation Chart

http://www.fda.gov/oc/fdama/fdamapln/appendc

    Note: This chart shows FDA's current status on implementing 
FDAMA. It provides a section-by-section overview including a brief 
description of each task, statutory deadlines, and key contacts 
within the Agency. This is the actual implementation framework used 
by the Agency.

Appendix D: Application and Submission Review

http://www.fda.gov/oc/fdama/fdamapln/appendd

    Note: This report includes a summary of 32 of FDA's most 
important functions as they relate to applications from 
manufacturers. Examples of these requirements are, ``Review priority 
New Drug Applications within 6 months,'' and ``Review infant formula 
notifications within 90 days.'' Also included are statistics that 
show current performance levels, future targets, and overdue 
applications. Other applications and submissions are also 
identified.

Other Information Resources Available via Internet

    FDA's web site at http://www.fda.gov/oc/fdama/comm includes a 
special section on the FDA Modernization Act of 1997. Various 
reports, meeting summaries, stakeholder comments, and implementation 
updates are available continuously for persons with Internet access. 
Visitors can learn more about FDA as well as view first-hand the 
Agency's progress in achieving its mission.

Full text of FDAMA, Public Law 105-115:
    http://thomas.loc.gov/bass/d105/d105laws.htm1
Transcripts of public meetings:
    http://www.fda.gov/ohrms/dockets/dockets/98N0339/calendar.htm
Federal Register Notice of 9/14/98 public meeting
    http://www.fda.gov/ohrms/dockets/98fr/082098b.pdf
FY 1999 Performance Plan
    http://www.fda.gov/ope/FY99pplan/pplan.htm
Department of Health and Human Services (DHHS) main web site:
    http://www.dhhs.gov.

    Dated: November 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-31387 Filed 11-20-98; 8:45 am]
BILLING CODE 4160-01-M