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David A. Kessler, M.D. - Annual Educational Conference

David A. Kessler, M.D.

Commissioner of Food and Drugs

Annual Educational Conference
Food and Drug Law Institute

Washington, D.C.
December 11, 1990

Thank you, Peter.

I am proud to share the podium today with FDA's strongest and most steadfast

It is a great honor to be back in Washington -- like coming home again. I am
comforted to know that very little has changed in this town. Let me give you
two examples of what I mean.

Even before I was sworn in, a Congressman wrote to me. I wasn't even in
town. Addressed to me as "Commissioner-Designate," the letter asked in no
uncertain terms that I make available several documents. At the bottom of
the letter, there was a postscript. It said, "Welcome and good luck."

At the same time, a reporter called my home, inquiring about my academic
background -- not about my record in medical school, not about my record in
law school, not even about how I did in college. What she wanted to know was
my high school grade point average!

This morning, I would like to share with you some of my thinking about the
Food and Drug Administration, about where it stands now, and where I intend
to lead it.

I begin my tenure as Commissioner with a deep appreciation for the rich
history and tradition of the Food and Drug Administration. Few institutions,
few agencies, have such continuity of mission. A special spirit pervades
FDA; it derives from the deep devotion of FDA people to the agency and its

That commitment to FDA's mission is one of the main reasons why I joined the
agency's ranks.

FDA is without a doubt, without reservation, the most important consumer
protection agency in the world. It is an extraordinary collection of
individuals from many different professional fields. Many are trained as
scientists, others are trained in the law, still others are trained on the

Whatever their professional training, all of the employees of the FDA share a
commitment, the commitment to protect and enhance the health of the American

That mission has not changed during this century. It has served the American
public well in assuring that we maintain a remarkable standard of product
safety. Whatever the system's imperfections, FDA stands as a model
scientific regulatory agency.

My goal as Commissioner is to build upon the tradition of excellence and to
reaffirm the fundamental mission of the agency. Such a reaffirmation is
important whenever there is a change in FDA's leadership, but it is
particularly crucial after a difficult period.

When I think about our mission, this is what it means to me:

o Americans should be able to walk into their pharmacies without worrying
about the potency or effectiveness of generic drugs.

o Consumers should be able to eat seafood with confidence.

o And when an FDA investigator presents his or her credentials to inspect a
factory, management should know that the FDA means business.

I assume the leadership of the Food and Drug Administration with no
illusions. The FDA faces a daunting set of tasks under the best of
circumstances, and these are trying times.

The interim report of the Edwards Commission said the FDA is under stress.
And I am enough of a realist to understand that there is no magic potion, no
instant solution that can resolve this stress.

The problems now facing the agency have developed over a number of years, and
it will no doubt take a number of years to resolve them. Some of them are
internal; others are external.

Both types need to be dealt with -- and they will be.

My job is to provide the leadership, to shape the direction of the agency as
we prepare for the challenges ahead. I will defend the agency when it is
right, but I will not be defensive.

In leading the FDA, I will be methodical and measured, but I will always
strive to move the agency forward. I'm being realistic -- not pessimistic --
when I ask you not to hold your breath for any miracles. Don't be dismayed
if events seem to take us off track. Pick any area under the purview of
FDA. There can be a crisis in any of a thousand areas -- and there will be
crises. But we will manage them.

Be assured that I do not intend to allow the crises of the moment to alter
our long-term strategy.

It's one thing to reaffirm a mission, however, and another thing altogether
to accomplish it. Let me set out for you my initial thoughts concerning the
agency's agenda. In discussing these six agenda items, I underline the word

My first priority -- the agency's credibility -- is the most difficult one to
talk about. It is difficult because I know that FDA employees are deeply
committed to their mission. But it must be said: the most important thing
we can do to rebuild the credibility of the agency is to ensure the integrity
of its processes.

Many thoughtful people within the Agency are telling me that there is nothing
seriously wrong with FDA, that it is not broken. But they must realize that
there is a perception in many quarters that the agency is beset by
significant problems. That perception can seriously undermine confidence in
the agency, and then become the reality.

Some may argue that by stressing integrity, I express a lack of trust in the
agency. I mean nothing of the sort. In fact, I think I know how FDA
employees feel: deeply angered that all should be tarnished by the gross
misconduct of a few. My emphasis on restoring FDA's integrity simply
reflects my conviction that the agency cannot be strong until and unless we
have done everything possible to prevent misconduct in the future.

My first priority, therefore, is to restore the Agency's own credibility --
to ensure the integrity of FDA's internal decisions, and to do everything
possible to ensure the integrity of those who deal with the FDA.

We will continue to initiate our own investigations as necessary, and we will
cooperate fully with any other investigations. We will be part of the
discovery process. An agency such as the FDA cannot tolerate any implication
of wrongdoing.

I raise this unpleasant and difficult issue first because it affects
everything we do. The bottom line is this: without the integrity of the
Agency's own programs, and without the integrity of those who deal with FDA,
we can't get on with any business.

My attention will be focused immediately on this task. I will have more to
say about it in a short period of time.

Second on the agenda, the FDA needs to stand -- I need to stand -- for
carrying out the law. I take the statute very seriously. This does not mean
more regulation; it does not mean less. It means that we will enforce the

We have already begun to assess the enforcement tools available to the
field. We are analyzing legislative proposals to bring these tools
up-to-date. We will streamline the enforcement process, making sure the
field has both the authority and the resources to move expeditiously. We
will also strengthen those aspects of compliance programs that need

During its first half century, the FDA protected consumers almost entirely
through law enforcement actions. In the past twenty or thirty years, we have
relied increasingly on pre-market approvals, balanced by post-marketing
surveillance and enforcement.

That gradual shift of emphasis may have short-changed the field. I am
therefore asking everyone in FDA headquarters to pay more attention to our
field operations.

Enforcement does not preclude good communication and cooperation with the
regulated industry. It certainly does not preclude respect for what the
regulated industry does.

Indeed, many segments of industry want steady and strong enforcement. One of
the lessons of the past decade teaches us that it's in the best interest of
industry to have strong enforcement.

But in the end our jobs are different, even though our mission may be similar.

FDA is the regulator, and you should know that I have no problem stating that

The FDA must stand for, it must embody, strong and judicious enforcement.
Fairness will be our guide.

Third on the agenda, it is important to ensure that the Agency has the
management structure and the management systems to enable things to get
done. We need to build, or reinforce, those systems at all levels.

My obligation is to make sure that every part of the agency fits with every
other part. I will make no organizational changes lightly, but you can
expect some changes in the months and years ahead. Such changes must be
designed to accomplish specific goals, such as improving responsiveness in
the areas where FDA moves too slowly.

Fourth, we need to make sure that the Agency will really be state-of-the-art
in dealing with science. This is a longer-term goal, and in the end it is
one of my greatest concerns. It is something we will strive for.

I believe that we must more fully incorporate the basic principles of
scientific peer review in our product decisions. We must learn from the peer
review system, and capitalize on advisory committees to make better use of
outside scientific expertise. We must also step back and undertake a
comprehensive assessment of the FDA's laboratory capabilities.

Underlying this objective will be our quest for a unified FDA campus. You
can expect this topic to remain at the forefront of the agency's priorities.
It's going to take years, as those kinds of projects always do, but we are
building the momentum.

The scientific facilities, the training of our people
-- both must be state-of-the art. The FDA field inspector, walking into a
biotech plant, must be able to evaluate its new products credibly and

Fifth, it's important to recognize that enormous opportunities exist, today,
to improve the public health. Among the many items competing for FDA's
attention, I would list these as especially important: blood safety,
seafood, prescription drug advertising, the regulation of medical devices,
generic drugs, food protection, dietary supplements, a framework for the
regulation of biotechnology, and international harmonization. But two
current issues in particular stand out: AIDS and food labeling.

Concerning AIDS: I come from a hospital that serves a significant number of
AIDS patients. I know first-hand how this disease devastates, not just the
afflicted but the family, the friends, and the community. I have witnessed
the frustration and impatience of people affected by AIDS, and I share it.

AIDS requires special attention. First, because we are only in the initial
decade of research, and our ever-increasing understanding of the HIV virus is
beginning to pay clinical dividends. Second, because the consequences of
AIDS are devastating in the U.S., and they are even more profound globally.
And third, because the disease is transmissible.

The scope of what I can accomplish, and what FDA can accomplish, has limits
-- after all, we are part of a larger biomedical research process -- but we
can push those limits outward, and we will.

FDA can also contribute significantly to a healthier America through its
responsibility for food labeling. The label must present accurate
information in a way that people can understand and use. Ladies and
Gentlemen, I don't understand the food label. When I read the nutrition
label in its current format, I really don't grasp how much sodium and fat are
too much. I don't think in terms of grams.

In addressing the AIDS issue and in developing the regulations for nutrition
labeling -- as well as in dealing with other issues facing the Agency -- I
have made it clear to the senior staff that I expect creative approaches.

That leads me to the sixth and final agenda item. I have asked the FDA
Center Directors to come up with new agendas for their centers over the next
month or so. I have gone a step further and told them that I expect bold and
dynamic approaches. Many of the old ways of doing business at the FDA are
fine, but the times call for a boldness of thought equal to the opportunities
we face.

I have already met with Dr. Carl Peck, who told me that he intends to
increase the prominence of the Division of Over-the-Counter Drugs within his
Center. I will support that initiative.

You should know that I am confident that Dr. Peck and his team will develop
the structure and systems -- and manage -- so that we can continue to reduce
the time required for new drug development and review. And I know what a
challenge that is.

To encourage ingenuity and accountability, we must "empower" a sense of
leadership at all levels. This means a couple of things. First, it means
that -- in our quest to be more efficient, to review more applications or to
collect more import samples -- we must never forget that we are managing
people. Second, and this requires skill and care, it means that in our
dealings with industry we must strive to be thoughtful and appropriately
responsive -- but never arbitrary or disrespectful.
We must empower all managers. For it is only when Center Directors and their
managers feel they have the authority to act that they can fairly be held

My goals for the FDA encompass these six elements: the FDA must be an agency
with restored credibility; an agency with strong enforcement; an agency with
effective management; an agency that strives for state-of-the-art science; an
agency with empowered leadership at all levels; and an agency clearly focused
on areas that will have the greatest public health impact.

Before I conclude, let me offer my thoughts about a couple of additional
issues: Congressional oversight, and resources.

On Congressional oversight, it's important to remember that I know that
world. I welcome the oversight. It's a constitutional responsibility.

I pledge that I will cooperate, and the Agency will cooperate fully -- and we
will learn.

But Congress must understand the "downside" of criticism. I know from my own
experience on the Hill that there can be extensive long-term consequences
from the way oversight is conducted.

These consequences last much longer than today's newspaper headlines.
Criticism often hurts in ways that aren't intended. It can damage the morale
of 8,000 FDA employees, and it can damage the FDA's credibility with the
public. Thus, I ask for constructive criticism, criticism aimed at
bolstering the agency
-- not harsh words that demoralize it.

The final issue is resources. It's no secret that while the FDA's
responsibilities have continued to rise, often rather dramatically, its
resources have not. I'm pleased that Congress has recognized this imbalance
and has begun to address it.

But, for a moment, let's attempt to place the current FDA budget in
perspective. The FDA budget for salaries and expenses during Fiscal Year
1991, 654 million dollars, reflects a generous increase. And yet that number

o less than one-sixth of the annual gross income of just one, major domestic
cosmetics and toiletry products firm;

o approximately one-sixteenth of the 1989 sales of a single U.S. food
manufacturer; and

o only one-thirtieth of the last year's total income of a firm that
manufactures food and household products.

I cite these figures to provide a sense of proportion. I'm trying to express
how relatively meager FDA's resources are, especially when compared to those
of the companies and industries covered by our mandate. It's truly
incomprehensible to me, with its current level of funding, how the FDA
carries out its mission.

Given its rather modest means, FDA must carefully establish its priorities.
I welcome the involvement of the Hill in setting those priorities.

The current attitude, however, seems to be something like this: "Everything
is equally important, and FDA must do it all." This attitude must change. If
it does not, if the FDA is required to be all things to all people, then we
shall almost surely fail.

We must not fail, for the FDA is the primary custodian of new medical
advances in the United States. We shall not fail. Our highest priority must
be to preserve and to strengthen the FDA. Strong leadership is important, and
I intend to be a strong leader.

But what is at stake as we go forward transcends the reputation or tenure of
any one FDA Commissioner.

We cannot recruit the best people from outside FDA -- any more than we can
retain the experience and talent the agency already possesses -- in an
atmosphere of constant criticism and second guessing.

I pledge to you that I will devote my every energy to the tasks at hand. But
I remind you, too, that those tasks will not be completed in the first 100
days, and they may not all be accomplished in the first thousand days.

I am proud of what FDA employees have accomplished, and I will be faithful to
the Agency's honorable, 84-year-old tradition of public service. There will
be changes at the FDA. There will be movement. But I assure you that the
changes will be orderly. And yes, I know how difficult change can be in any
large organization.

We will plan, we will anticipate, we will think creatively, and we will move
steadily toward our goals. We will fix what needs fixing. We won't be able
to fix everything, but we will make a start. I am convinced that achievement
comes only with perseverance.

The FDA's responsibilities are vast. Its resources may be inadequate, but
let me remind all of you neither to underestimate the vigor of this agency
nor the strength of its resolve.