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James S. Benson - DHHS Advisory Committee

"STATE OF THE FOOD AND DRUG ADMINISTRATION"

Presented by
James S. Benson

Acting Commissioner of Food and Drugs
of the
DHHS Advisory Committee
on the
Food and Drug Administration
May 18, 1990

Chairman Edwards, distinguished members of the Committee, ladies and
gentlemen.

Six months ago, Secretary Sullivan appointed me interim head of a Federal
agency with a long and proud heritage. Being named interim Commissioner was
for me the single highest honor in my 25-year career in the Public Health
Service. But with honor comes responsibility.

With this responsibility came the realization of the great challenges FDA
faces as we begin a new decade and head toward a new century. Challenge
also presents opportunity and that to me is the most exciting part of my job
in this moment in time.

We find ourselves in a period of history in which we all must assess the
kind of government our Nation wants and needs. In defining the nature of
the FDA our society wants to have, we must look at our origins and how the
span of eight decades has changed who we are and what we do.

In plotting our future, we must be able to articulate our role and our
mission. We have to examine the ways in which our agency can best respond
to the most serious and demanding public health problems facing today's and
tomorrow's society. We must establish priorities that are grounded in
reality and be able to close the ever-widening gap between public
expectations and the "real world" consideration with which we deal every day.

And that's where you come in. The creation of the Committee is both timely
and welcomed. Each of you brings a unique and special perspective. Some of
you know the FDA well--even intimately. Others have only a general
familiarity with the agency or with certain parts of it.

Whatever your orientation, your orientation, your role on this Committee is
extremely important. In many ways you can and should consider yourselves as
representatives of the 250 million Americans who depend heavily on what we
do to assure the safety and effectiveness of products that affect their
lives every single day.

This morning, I would like in a general way to reflect briefly on the major
progress FDA had made in recent years and give you a picture of the "state
of the FDA" as it exists today. Because Dr. Edwards is planning to devote
more time at later Committee and Subcommittee meetings to review specific
problems and concerns in each of our programs, I want to provide a macro
view of the agency. In doing so, I will concentrate my remarks on two main
themes: expectations and credibility.

AN OVERVIEW OF MAJOR FDA ACCOMPLISHMENTS

Although my principal role today is to define the most critical barriers and
obstacles to an effective FDA, I want to begin my presentation on a more
upbeat note. For all the criticisms and problems with which we are beset,
the "state of the FDA" is good. We remain a positive and respected force in
American society, as borne out by a recent Roper poll showing FDA with a 74
percent favorable public rating-behind only the National Park Service, the
FBI and NASA. The survey also revealed that FDA received the highest public
opinion rating among the nine regulatory agencies included in the survey.

In its long history, FDA has made major contributions to the public health
of our Nation. Let me give your just a few recent examples.

In the mid-1980's, we have developed and implemented a "fast track" system
for expediting the review of AIDS drug and other new therapies. This new
system allowed AZT, for example, to be approved in record time.

In roughly the same period, the Agency developed a new process to encourage
the treatment use of investigational drugs, such as AIDS therapies, to make
them more available to the desperately ill.

We have fortified our blood bank surveillance program to assure that blood
used in transfusions is not contaminated with the AIDS virus, and have
expedited the review of various new blood screening products.

We have improved the timeliness, effectiveness and efficiency of the new
drug review process, which has yielded significant reductions in NDA
backlogs and record numbers of approvals of new chemical entities.

Similarly, in the 1980's we eliminated the large backlog of each of the
major medical device review areas, a major milestone in the 14-year history
of that program. Average review time were also reduced and brought more in
line with time limits prescribed by law.

We demonstrated an ability to mobilize our forces and resources during
national crises such as the 1986 tampering with Tylenol and the inspection
in 1987 of hundreds of samples of domestic and imported cheese for the
presence of listeria monocytogenous, which led to the detention of all
cheese from France.

Over the last five years, we have doubled the resources we allocate to
inspect a rising volume of imported food products, especially produce and
seafood, resulting in a jump in the number of detentions from 15,000
shipments in 1984 to 25,000 in 1988.

In the area of biotechnology, we have approved over a dozen therapeutics and
vaccines in less than half the usual processing time, including: landmark
drugs for lethal leukemia and against rejection of kidney transplants, a new
generation of hepatitis vaccine, and a clot dissolver for treatment of heart
attacks.

Last fall, we contributed to the President's food safety plan to establish
scientifically sound threshold tolerance levels for pesticides in foods,
provide for national uniformity in regulating pesticide tolerances, and
simplify the process by which those pesticides shown to pose a danger to
public health are removed from the market.

Earlier this year, Secretary Sullivan and FDA embarked upon a sweeping
reform in the way foods are labeled in order to assist consumers in
controlling their diets and to better understand health messages used in
labeling and advertising food products.

Of course, our job occasionally requires us to take tough stands to protect
public health. Disapproving product that may threaten people's health or
pocketbooks or offer false hope is also part of our job description. Famous
examples from the past are the quack cancer "cures"--krebiozen and laetrile,
and, of course, the drug thalidomide.

These are but a few examples of how FDA has made a difference in American
life. They are the more visible-the more dramatic. But they should not
overshadow the "nuts and bolts" work that regularly goes on in FDA--for
example, the rigorous scientific reviews of nearly 25,000 premarketing and
research applications received annually; the 6,000 imports offered each day
for review; and the 80 domestic plant inspections that occur every day.

With this backdrop, I'd like now to move to the main focus of today's
discussion-that is, the contemporary problems and expectations to which we
must respond.

FDA'S MISSION: CONSTANT CHANGE TO DEAL WITH RISING EXPECTATIONS

Since its genesis in 1906 with passage of the Pure Food and Drugs Act, the
FDA's mandate--along with its public recognition-has grown enormously. In
the last 20 years alone--as society has demanded more of government and as
social conscience over societal risks has grown-the FDA has been
increasingly called on to use its expertise and authority to safegaurd
peoples health.

In many ways, FDA has been caught up in the groundswell of social activism
and enlightened consumerism. We have evolved from an agency originally
responsible for ensuring the sagety of foods and drugs to an organization
that today regulates products worth 750 billion, or one quarter of our
Nation's consumer expenditures. The per capita cost for FDA's public health
protection is $2.40 a year-a bargain by any measure.

This swirl of change has altered the limits and bounds of FDA's regulatory
jurisdiction and, quite frankly, has brought about differing perceptions of
our exact mission within and outside the agency. Some see FDA as a
regulatory, or law enforcement agency. Some view us as a consumer
protection agency. Still others characterize FDA as a science-based
organization charged to protect and promote the public health.

If you'll permit me to reveal my own bias, I tend to think of our role as
problem-solving. Our job isn't simply to regulate products, but to minimize
the risks and maximize the medical benefits associated with them. This
allows us to analyze each product-related problem in public health terms,
and to build solutions based on regulatory or non-regulatory action, or an
optimum mix of the two.

-- Changing Functions

This broad spectrum of opinion isn't the result strictly of the wide variety
of products we regulate. It also has to do with the broad range of
operational functions in which we are normally engaged. One of these
functions is enforcement. Since enactment of the first food and drug law
shortly after the turn of the century, we have served as the Nation's food
and drug policeman.

A second function is premarket approval. This responsibility has become
increasingly important with the "pharmaceutical revolution" in the 1940's
and 1950's and the passage of the Medical Device Amendments in 1976. In
1970, FDA was responsible for nine different premarket approval procedures.
That number today is 23.

A third major task is post-marketing surveillance. Assuring the safety and
effectiveness of drugs and medical technologies before they are marketed is
only part of our job. Monitoring their performance in the "real world" is,
arguably, a pivotal and perhaps even more important function.

Another function is regulation. During the 1970's in particular, as more
attention was focused on more openness in government, regulation became an
important adjunct to enforcement. In a sense, our regulations, derived from
law, serve as a template for both FDA and industry, codifying what we expect
from ourselves and from manufacturers.

Finally, we have the triad of research, education and prevention, With the
addition of radiological health, biologics, and medical devices, and the
creation of our toxicological assessment program, these activities have
assumed greater prominence in recent years. In the context of
problem-solving, they are crucial tasks that enable us to better quantitate
risks and to develop public health strategies that are targeted with greater
precisions and cost-effectiveness.

Personally, I'm a firm believer in the value of education, not as a
substitute for regulation, but as a complement to regulation, Teaching
people how to minimize risks-whether it's health professionals or
consumer-can have a profound effect on health promotion and disease
prevention. It also enables consumers to take charge of their own health
care-to make informed decisions, and to exert greater control over their
lives.

-- Greater Emphasis on Communication

The consumerist movement that swept the country in the 1970's and 1980's has
resulted in more and more demands on FDA for information-whether it's
nutritional labeling for processed food, information on barrier products to
curb the spread of HIV, or warnings about bogus products that bilk consumer
in search of effective medical treatment.

To a very great extent, the communications age in which we live has resulted
in a more informed public with a craving for information. This is
particularly true in the area of risk information. People are being
bombarded with communications about a multitude of hazards, leading them to
demand that their products, their environment, and their lives be "risk
free."

When the word "cancer" is raised, people still tend to think in
black-and-white terms: something either"causes cancer" or it doesn't--it's
unsafe. Often they don't distinguish between high and low risks--that
lifetime exposure to agent A, for example, may cause cancer in 1 out of a
million. Their reaction is quite understandable. Given all the conflicting
facts and figures they're confronted with, people find it difficult to
differentiate major risks from minor risks, proven from suspected.

To some extent, this inability to separate the important from the
unimportant is in part due to the inadequacy of how we as public health
officials interpret and communicate risk. So part of our job is to improve
the ways we present risks and options for controlling them.

-- FDA's Mission Is A Moving Target

Unceasing demands by a growing number of constituencies and special interest
groups have also contributed to the diffusion of FDA's mission.

Government institution-if they're to succeed-have to be somewhat malleable.
They have to reflect what society wants, or feels that it wants. Over the
years, FDA has found itself in the middle of a classic struggle. At certain
times, there have been calls for FDA to be a tougher cop. In other times,
there's been greater emphasis on voluntary compliance and greater
cooperation with industry.

With the constant clamor for new life-saving and cost-beneficial products,
we are often criticized for moving too slowly. We have felt this most
acutely with the AIDS epidemic, where individuals who have not benefitted
from approved remedies are willing to turn to anything that might offer
help. However, when problems arise, such as unexpected adverse reactions
from approved products, some people want us to slam on the brakes.

This kind of "ebb-and-flow" environment makes it difficult to maintain a
clear identity and sense of purpose. Obviously, we can't entrench ourselves
in one mode of operation. But it is important for and organization like
FDA, which is constantly in the public cross-fire and prone to periodic
shifts in direction, to have a clear mission and philosophy.

Our overall mission becomes even cloudier when you consider how much change
is going on in the industries that we regulate. The emergence of
biotechnology, for example, will inevitably immerse us in bio-ethical issues
that go far beyond our traditional safety and effectiveness questions.

As we move closer to a consolidated European market in 1992, this dilemma
will take on even more significance. And as democratic reforms take hold in
Eastern Europe and international markets expand, American business will
understandable press for a level playing field. We must assure that our
regulatory requirements are harmonized with those of other nations to the
maximum extent possible, so that American industries are not placed at a
competitive disadvantage. We must not unnecessarily impede new product
development, and, at the same time, we must carry out our public health
mission.

So as we venture into the future, having a clear sense of self-image and
direction is critically important. I hope that yesterday's presentations on
each of our major programs gave you an appreciation for the diversity of our
mission, as well as the difficulty we face in coping with broadening
expectations by a growing number of trade, health professional, and consumer
advocacy groups.

- A Surge in Public Expectations...

Before I discuss the nexus between heightened demands and the ability of our
support structure to deal to with them, let me illustrate how expectations
have grown in recent years.

One type of expectation relates to product approval. The sheer number of
applications requiring premarket review has skyrocketed from 4,200 in 1970
to 12,800 in 1989 -- an increase of about 300%, and we've seen a similar
trend in the number of product research applications. And there's no real
end in sight.

In the drugs program, we project a doubling of the number of investigational
new drug approval applications in the next five years. The same is true for
product licensing applications for biologics, with an estimated 340%
increase in applications expected by 1995.

With medical devices, we've seen a similar upsurge in the volume of produict
applications. From fiscal years 1980 to 1989, the growth rate was 185%. We
anticipate a steady slope upward, particularly with greater numbers of
experimental devices reaching maturity and their sponsors coming to FDA for
market approval.

This proliferative trend in product evaluation will continue to stretch the
system even further. And yet, somehow this problem is lost in the minds of
manufacturers seeking fast approvals to gain a competitive edge. Clinicians
and patients continue to expect product review outputs to stay at high
levels, especially in cases involving promising new drugs, biologicals and
devices.

The same situation holds true for our field operations. The universe we
must keep watch over is constantly expanding. The products we regulate are
becoming more complex. As a result, our plant inspections and reviews of
manufacturing methods and quality control procedures have become more
intensive and sophisticated. Our investigators have to be more skilled and
kept current with scientific and technologicaql advances in order to capably
do their job.

The review of imports is another barometer of change. In 1970, there were
half a million entries annually. Today, that number exceeds 1.5 million.

Increased attention to moving innovative products into the marketplace
faster has resulted in greater emphasis on post-market surveillance
programs. This activity is essential in order to pinpoint defective and
unsafe products. In 1970, we were processing and analyzing 12,000 adverse
drug reaction reports; today, the number approximates 70,000. Add to this
some 16,000 medical device reports, which did not exist in the 1970's.
Collecting and analyzing this data has led to greater numbers of
manufacturer inspections and mo9re regulatory case development.

Taking on this added work has been difficult since the field resources have
slumped. In 1971, half of FDA's resource were earmarked for field
activities. This year, only 38% of our total resources "pool" will be used
to support field programs.

Administrative tasks have also risen significantly. Consider the 70,000
consumer inquiries, the 40,000 Freedon of Information requests, 3,000
Congressional letters and 180 citizen petitions we respond annually. All of
this work is essential to open government, but it has a substantial cost.
Over time, it has incremently added to public expectations and required an
increasingly larger investment of resources to manage these activities.

In short, people expect more than we are capable of delivering.
Paradoxically, we live in an age when people want less government, have less
respect for Federal workers, yet, at the same time, demand more and better
protection from the risks of everyday life.

Some expectations are driven by misperceptions. As they do with cancer and
AIDS, people are often unaware of the limits of science and press for
speedier approvals of therapeutically beneficial products. When we can't
fulfill their expectations, intense frustration sets in, resulting in
government being seen as the villain or as incompetent and unresponsive.

THE EFFECT OF INCREASING EXPECTATIONS
ON FDA INFRASTRUCTURE

Obviously, as our job has changed over the years, so too has the complexion
of our organizational structure and physical working environment. At the
heart of this issue is whether we've been able to keep pace with a rising
tide of demands. The simple answer is "no."

I do not want to dwell on the specific issues of resources. But it is
important for this committee to recognize that uncontrolled and unrealistic
expectations place a heavy burden on the timeliness, efficiency, quality and
thoroughness with which we do our job. The plain truth is that over the
last 15 years, FDA has been overwhelmed with new organizational and
statutory responsibilities. Many are an outgrowth of calls for action by a
growing number of constituency groups with diverse agendas. Rather than
indexing resource levels to our program responsibilities and following the
"pay as you go" principle, policy-makers have forced FDA to absorb costly
new programs without commensurate resource increases to implement them.

Since 1976, Congress has assigned FDA vast responsibilities under several
new laws, requiring major initiatives in areas such as medical devices,
generic drugs, drug diversion, orphan drugs, pesticides, AIDS and anabolic
steroids. The cumulative effect has forced FDA to "withdraw" more assets
than it has in its resource bank. In effect, we are "overdrawn" on
virtually all accounts. FDA managers have been forced to cannibalize core
functions and other programs to accommodate these new legislated tasks.

THE STATE OF FACILITIES

Another handicap is our work environments--both in headquarters and the
field--which have been badly neglected. Office and laboratory facilities
are overcrowded and deteriorated due to age and inadequate maintenance
funding. Let me cite a few examples.

-- One example is our downtown office which houses the foods program. A
General Services Administration study concluded that $85 million would be
required to retrofit the building to bring it to currently accepted
conditions for a laboratory.

-- Another example is our Center for Veterinary Medicine research facility
in Beltsville, where senior scientists are quartered in refurbished trailer
homes and many of the adjacent laboratories are housed in buildings
constructed in the 1930's for farm animal research.

-- In our generic drugs program, people are forced to compete for space used
to store mounting stacks of product applications and for document filing and
retrieval.

-- Also, the agency has had to scavenge for scarce office facilities in
order to hire additional scientists to cope with a burgeoning workload in
our AIDS program.

But the problem goes beyond outmoded facilities. In the Washington
metropolitan area above, FDA staff are geographically scattered. At
present, they are located in 23 buildings on 7 different sites. This
fragmentation causes extreme inefficiency in our operations. It severely
hampers communication. It undermines valuable resource sharing and slows
new product evaluation. Coupled with decaying and overcrowded work
environments, this situation often makes employment with FDA very
unattractive. This is especially evident when highly-qualified
professionals look at what we have to offer and compare it to academia or
private industry.

FINDING A LONG-TERM SOLUTION...

What's the answer? One optimal solution with considerable appeal is the
consolidation of all of FDA's headquarters components at one location. Such
a step would have several benefits:

-- first, it would provide close interaction between our researchers,
product reviewers and policy-makers;

-- second, it would allow for greater resource management;

-- third, it would have a synergistic effect on our science base;

-- finally, it would enhance our ability to compete with the private sector
in recruiting and retaining top-flight regulatory and scientific
professionals.

WHILE WE ATTEND TO IMMEDIATE NEEDS

While we are actively pursuing this long-range goal within the
Administration, we welcome this Committee's support and assistance in making
the goal a reality. In the meantime, we are making headway in addressing
the very real and immediate space problems.

To cope with increasing AIDS work, we have successfully worked with the
Congress and others to acquire the funding necessary to construct a new AIDS
building. This new facility will be situated on the NIH campus and thus
provide a valuable link to the AIDS-related laboratory staff in our
biologics center. Once completed in 1994-95, this facility will accommodate
some l50 laboratory and office personnel.

Also, after years of anticipation, we will soon occupy our Mod I animal
research facility in Beltsville. This laboratory was designed to be
state-of-the-art and will solve many of the facility problems that plagued
our animal research in the past.

In addition, we are introducing an innovative approach by joining an
industry, academia, government consortium called the National Center for
Food Safety and Technology. Located in Chicago, this Center provides
versatility for uses ranging from laboratory experimentation to pilot plant
development to test market production. The research complex includes
containment facilities and extensive laboratory and office space. The
Center creates an environment in which scientists from FDA and other sectors
of the food science community can interact on neutral ground, pool their
resources, and work together on projects designed to maintain the safety and
quality of our food supply.

We're making similar headway in upgrading our facilities and laboratories in
the field, many of which are chronically out-of-date and run down. This is
a time-consuming, station-by-station upgrade. In the Seattle and Denver
regions, we've acquired new, modern facilities. Two years ago, we completed
a major renovation of our Philadelphia field office. Plans are in the works
to improve working conditions in several other field locations over the next
three years.

These are important--even crucial steps. However, the bottom line is that
these incremental improvements will not solve the overall problem of a
scattered agency.

EQUIPMENT IS OBSOLETE

Another serious impediment to hiring quality people and staying abreast with
our fast-changing technological world is equipment. Because FDA is a
people-intensive organization, support limitations such as poorly equipped
and maintained laboratories and aging computer systems directly and
significantly impede program performance. In many cases, our scientists
must spend valuable time trouble-shooting and repairing equipment that they
use in research, testing, and methods development work, and analyses of
product samples. They have had to resort to customizing equipment from
available parts to perform specialized tasks. And, on occasions, they have
had to borrow equipment from industry in order to validate proposed test
methods.

Without the requisite analytical "tools," we cannot keep pace with evolving
science and changing public health needs. For example, dioxin in fish and
paper cartons are of significant interest to us, yet detecting levels ins
the l ppt range and below requires highly sophisticated and expensive
instrumentation. But because of the cost, we cannot afford to install this
equipment in more than one of our laboratories. The same problem holds true
for equipment used to perform analysis of milk for sulfa drugs, antibiotics
and other residues.

Replacement of scientific equipment has been deferred to the point that much
of what the agency has exceeds replacement standards and life expectancies.
For example, merely replacing our field scientific instruments that will
wear out over the next four years would cost $26 million. Another $20
million of new equipment is needed to analyze chemical contaminants,
identify pathogens, and test drug samples. This is a critical need that,
left unattended, will set the agency further behind the scientific and
industrial communities.

The purchase and upgrade of data processing equipment has also been put off
for too long. FDA's Field Information System, for example, which is a
central link in field management, is over 10 years old. It needs to be
replaced to improve field management capability, along with the development
of a support and information system to help improve import surveillance.

Data processing systems are needed to provide improved data bases for
regulatory intelligence gathering and processing, like that required by the
Congressional-mandated program for collecting data on pesticides used in
domestic and imported food products.

We have been unable to commit improvement capital for the systems supporting
post-marketing surveillance, trend analysis and evaluation of information
from reports of death, injury, and malfunction of medical devices and
radiological products. The increased emphasis on AIDS product review has
drawn critical operating resources from the needed epidemiological and
biostatistical systems supporting the regulation and monitoring biologics.
As public health crises arise--such as AIDS, product tamperings, and events
like the Alar "scare"--resources may continue to be diverted away from
improvements in our operational and data systems capabilities.

The Impact on Self-Image

Hardware and facilities aside, the fundamental question is how life in FDA
has affected the self-image and morale of our personnel. The success of any
institution hinges on its people. FDA has long prided itself on the
expertise, professionalism and high dedication of the men and women who make
up the agency. They have always responded to challenge with a firm
commitment to the ideals of public service and public health protection.
They persevere, despite limited funds, low salaries, difficult working
conditions, and public misunderstanding and bias against government workers.

Yet, despite their devotion to public service, we see telltale signs of
erosion. For example, the increase in the amount of public criticism and
oversight from within and outside the government has tended to create and
aura of distrust and lower morale.

Certainly, an appropriate amount of oversight is necessary and beneficial.
The generic drugs situation is a case in point. The discovery of procedural
and ethical deficiencies in our own ranks and in the industry has deeply
embarrassed and angered us all. At the same time, the investigations
responsible for exposing the misconduct have resulted in critical
improvements in our generic drug review program that will serve the public
good.

In our view, while the events of the last year were an aberration, they have
contaminated the atmosphere in which we work. Although accountability is a
necessary part of our government system, the potential exists for unduly
disruptive oversight. If this happens, our people are apt to become more
disenfranchised. The time that should be spent on getting the job done will
be used to respond to outside investigations.

All of these factors have a pernicious effect on productivity and employee
attitudes toward government service. They diminish our ability to recruit
and retain top-grade people. In turn, this affects our capability to deal
with increasingly complex public policy and scientific issues.

I should stress that this isn't my view alone. In its report last year, the
National Commission on the Public Service--headed by Paul Volcker--observed:

"...there is evidence on all sides of an erosion of performance and morale
across government in America. Too many of our most talented public
servants--those with the skills and dedication that are the hallmarks of an
effective career service--are ready to leave. Too few of our brightest
young people--those with imagination and energy that are essential for the
future--are willing to join."

"If these trends continue, America will soon be left with a government of
the mediocre, locked into careers of last resort or waiting for a chance to
move on to other jobs."

So unless we attend to these "warning signals" soon, FDA's "track record" in
the 1990's and beyond could be marked by lackluster performance rather than
the record of high achievement that the American people have come to expect
and admire.

Fortunately, the Administration and the Congress have been increasingly
sympathetic and supportive. Our budget has been on a steady upswing since
1987. This positive trend extends to the current fiscal year, and we are
hopeful that it will continue into future years. That's the good news. The
bad news is that we are still behind the curve. We have not yet recovered
from several years of losses, when increasing workloads out paced our
resources.

Other efforts are being made to help us rebound. Some Congressional leaders
have stepped forward with bold legislative initiatives to revitalize the
agency in areas such as facilities, automation, regulatory professional
training, comparability in the salary structure for scientists, and a range
of other management solutions.

KEEPING CREDIBILITY HIGH

The second major theme I want to address is credibility. There is an
obvious dynamic between expectations and credibility. Simply put, as unmet
expectations go up, credibility declines.

Although the after-effects of de-regulation have contributed to some loss in
the public's confidence in Federal regulators, we must shoulder some of the
blame. Historically, we have done an inadequate job in explaining ourselves
and why particular actions are in the public interest.

We have perhaps underestimated the ability of consumers to deal effectively
with risk information. We have shrouded ourselves in process rather than
communicating openly with industry about what we expect of them. We have
allowed ourselves to be assigned more responsibilities than we can
realistically absorb, resulting in less quality across-the-board and more
public disillusionment

To maintain public credibility, we must pay more attention to conveying
clear risk/benefit information, to elucidating our regulatory requirements
and the importance of public health.

Communicating Risk and Benefits Effectively

Dr. Peter Sandman, a Rutgers University professor and expert on risk
communication, has said that: "When people are treated with fairness and
honesty and respect for their own decisions, they are a lot less likely to
overestimate small hazards."

One of the major challenges we face in our modern culture is to clearly
communicate information about product risks. We must help people understand
that nothing is perfectly safe, and that it may be not only acceptable but
inevitable to live with very small statistical risks. We must be able to
help people understand that while government agencies responsible for
protecting millions of people are properly concerned with risks of 1 in
100,000, risks of that magnitude should not necessarily be worrisome for
individuals.

In our case, we are also bound by law to take action. The so-called Delaney
Clauses, enacted into law three decades ago, prohibit any amount of any
additive in food and other products, no matter how small, if that substance
has been shown to cause cancer in laboratory animals. This requirement
still exists, even though state-of-the-art analytical methods enable
chemical residues in food to be detected at minute levels not contemplated
when the legal concept was originally considered.

This adds to the public's confusion. As a public health agency, we face the
dual task of assessing and interpreting relative risks, and doing so in a
balanced and undistorted way. We must help consumers re-orient their
thinking. As I said earlier, many consumers seem to be demanding what
amounts to a risk-free environment in which to live. They want absolute
assurance of the safety, effectiveness, and quality of the products they
consume and use.

We have to provide consumers with the best information possible in order to
avoid unjustified and widespread apprehension, as we saw in the case of Alar
and apples. As a result of a concerted campaign by consumer activists,
apples and applesauce were removed from school lunch programs in several
major cities. But once the scientific facts were made clear, most people
recognized that the risks associated with Alar, especially when compared to
other environmental and societal risks, are very small indeed.

Communication breakdowns in how we do our job also affects our credibility.
Most people, I suspect, assume that FDA inspects every product as it comes
off the assembly line or as it enters U.S. ports. This assumption, of
course, is unfounded. As a practical matter, resource limitations preclude
a product-by-product examination. That fact undoubtedly leads some people
to the conclusion that we aren't doing our job properly and that uninspected
products are potentially unsafe.

We must do a better job of explaining to the public as a whole that periodic
quality control inspections and routine sampling of domestic manufacturers
and foreign importers are the most cost-effective means for assuring product
safety. Failing this, our credibility with American consumers will be lost.

Giving the public a better appreciation for what we do extends to our
product evaluation processes. Surprisingly, the general public does not
have a firm grasp of how, for example, we approve human drugs, or the value
of the present regulatory system.

Here again, we must be more aggressive in enlightening the public on the
importance of our pre-clearance system. We must be able to convince
consumers that current controls over development and marketing of drugs,
which are designed to assure that they are safe, effective and labeled
properly, are in the public interest. The public needs to be made aware
that our drug review process is conceptually similar to systems employed by
virtually every modern nation. We must make clear that the theoretical
alternative of no laws or regulations and sole reliance on tort law to
protect consumers--which existed prior to 1938--would have serious
ramifications. In fact, I believe that our present system optimizes the
introduction of safe and effective drugs to the market in a cost-effective
way.

For example, without today's drug regulatory practice, events such as the
case involving elixir of sulfanilamide--a pediatric sulfa drug prepared in a
highly toxic solvent that killed dozens of children--could recur. Without
the system as we know it, there would be the added danger of giving people
with disease drugs that do not work optimally. And there would be an even
larger loss. Choosing the proper drug, selecting the right dose and
dose-interval, and modifying the dose for special populations, would be
impossible without important data derived from valid, well-controlled
clinical trials.

And finally, the absence of clear standards of safety and effectiveness
would make it impossible to distinguish valid from invalid claims, or to
tell bogus from real medications. In such a world, unscrupulous merchants
can take advantage of the seriously ill and their families, at great
financial and human cost.

Explaining Ourselves to Industry

The same need for improved communications exists with industry. Acting as
"gatekeeper" to the marketplace is a serious responsibility, particularly
when the economic stakes are high. Although the safety and effectiveness of
"new" products are the main concerns in our decision-making process, we are
conscious of the need for equitable treatment of industry.

Whether it is human drugs, medical devices, or food additives, the principle
of fairness must always apply. Guaranteeing fairness demands a common
understanding FDA's "rules of the road" by everyone we regulate. This is
especially important in light of the diversity of the industries we
oversee--ranging from small, single product firms that employ less than 20
persons to major corporations with multiple product lines.

Elucidating our regulatory requirements benefits everyone. A well-informed
industry is better able to plan its R & D and product application
development work. Quality submissions save time, reduce frustrations among
manufacturers and our reviewers, and hasten the introduction of innovative
products with the potential to improve people's lives. Our challenge is to
provide clear, effective and uniform communications about what's expected of
industry.

Exerting More Leadership

Since its inception, the FDA has been recognized as the leader in enforcing
the food and drug laws of our country. And while we still have a high
profile--and I'd like to think a solid reputation--others are asserting
greater control over food and drug safety.

One by-product of de-centralized government has been an increased role by
the states. In attempting to pick up the slack, states have passed laws
that some believe are more appropriately within the purview of the Federal
government. Proposition 65, which calls for toxic chemical warning labels
on FDA-regulated products, is a good example. Another is the effort by a
number of states to regulate health fraud in the food industry in order to
prevent deceptive and misleading health claims.

These actions are certainly well intentioned. They do, however, create
problems of fragmentation, non-uniformity, and in the end, uncertainty in
the marketplace. I've always felt that Federal-state partnerships are a
bedrock of effective government service. But for the system to work, FDA
must maintain its leadership position in the development and implementation
of national food and drug policy.

SUMMARY

In closing, I want first to thank each of you for taking time from your busy
schedules to participate on this Committee. Your work is extraordinarily
important. It comes at a propitious time and can have a profound and
lasting effect on the future of the Food and Drug Administration in carrying
on its important legacy.

I want to extend to you our assistance and support. The charge that
Secretary Sullivan has given this Committee provides a major opportunity to
focus national attention to the problems that have grown and festered.

More importantly, this Committee represents the vehicle by which these
problems can be resolved.

What you have heard thus far has largely been a statement of the problems.
We have not offered specific solutions at this stage. That's not to say
that we don't have ideas or proposals. We look forward to future Committee
meetings and the opportunity to discuss possible solutions to existing
problems.

One activity that FDA has underway and fits into the "problem
identification" scheme is what we refer to as a "comprehensive needs
assessment." This long-range planning initiative is designed to project
what the agency's needs will be five years hence, although many areas of
need are applicable to today's environment. This work should be completed
in late fall and could be a useful resource to the Committee.

In summing up, let me leave you with three key thoughts.

FDA's commitment to public health protection remains high. Our desire to
continue as a leader in the food and drug community is strong, even in the
face of mounting responsibilities, unattainable expectations, and a
deteriorating support structure.

In preparing FDA for the future, it is essential that we--this Committee and
the agency together--build upon the science base, regulatory authority, and
public health experience and expertise that are the cornerstones of FDA.
Renewal rather than re-building should be the watchword.

We must aggressively seek new ways to communicate effectively with
consumers, other Federal and state health officials, industry, and health
professionals. We have to make what I call the "black box" more
transparent. Doing so will make us more "user friendly," will improve our
relationship with industry, and enhance our credibility among the
constituencies we serve.

Dr. Edwards himself may have said it best. In addressing the Consumer
Federation as FDA Commissioner in 1971, he said:

"As we move into the pivotal decade of the '70's, the citizens' interest has
achieved a status higher than ever before. The industries which have
brought so many good things--along with some not-so-good things--to our
lifestyle have new and better opportunities to serve our society and
economy. If we can avoid the mindless destruction of our institutions and,
instead, build upon them in a rational way, the people of this country--the
consumers of the future--will have a better deal than then ever had before."

His words are as meaningful and appropriate today as they were then.