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David A. Kessler, MD - Food and Drug Administration

David A. Kessler - Swearing In Ceremony

2/22/91

Mr. Secretary, Dr. Mason, friends and honored guests,

Allow me to start my remarks by saluting the men and women who are engaged in
the Persian Gulf. I know that some of your sons and daughters, friends and
colleagues, are there. They are very much on our minds as we proceed with
this ceremony.

I want to thank all of you for coming. Your presence means a lot to me.
It's great to have my wife, my parents, and my children here today.

This ceremony marks an exceptional event in my life. First of all, I want to
say that in leaving New York I left a hospital that I loved -- and many
wonderful people -- and that was not easy for me.

I am well aware of the challenges I am about to face. I know they are many.
But I am willing, I am eager, to get on with the job. If the issues are
complex, my own motives are not. I simply want to be part of our response to
these challenges.

This afternoon, I want to spell out some of the challenges we face.

If we are to succeed, we must make them shared challenges. Everyone who has
a stake in the nation's health has a role in our work.

What are some of the challenges that we must face together?

Certainly, we must carry out the tasks that have traditionally been FDA's
"bread and butter." We must restore full confidence in the integrity of the
data upon which we base our work. We must increase domestic and import
inspections; reduce review times for product applications and streamline
enforcement procedures by paying more attention to our field activities. We
must recognize that we have become an information agency and we must manage
accordingly.

But that is only part of the story. The environment in which we operate has
produced an entirely new set of challenges. We must think about how to
apply traditional principles to non-traditional problems.

Over the past decade, these new challenges have tested our mettle -- and they
will continue to do so.

o The AIDS epidemic.

Who could have predicted, even 10 short years ago, the effect of this
modern-day scourge? Since 1981, we have lost 100,000 Americans to this
epidemic -- a quarter of them in 1990 alone.

o The changing medical model.

Patients are demanding more choice, more information, and a greater say in
their health care. This is as it should be. But easier access, earlier
access, may change the risk/benefit calculus.

Patients must understand that greater risk may be involved when they choose
to use products earlier in the development and review process. But in no
event should fraudulent products see the light of day.

o The global marketplace.

The United States now imports a variety of foods from all over the world.
The U.S. is also a major exporter of foods, drugs, and medical devices. We
must maintain our role as world leaders even as we come to grips with a host
of international issues. It is a more competitive world.

o Changing patterns of food production and consumption.

There has been a virtual revolution in the way Americans grow, buy and
consume food.

o A new generation of therapies.

The number of Investigational Drug, Biologic, and Device applications is
beginning to increase exponentially, and these newer products tend to be more
complex.

Reviewing their safety and efficacy will require greater expertise in
traditional disciplines and a thorough understanding of new technologies.

To me as a physician, though, there's an exciting and invigorating aspect to
this landslide of applications. Itmeans that a new medical armamentarium --
with its new promise for patients -- is on the horizon.

Each of these challenges will test FDA's own creativity and resolve.

If we -- collectively -- are to succeed, if we are to meet these challenges
-- we must defend and uphold certain principles.

Above all, we must stand for the principles that breathe life into the Food,
Drug and Cosmetic Act. In the broadest sense, I see two such principles.

Our society has judged that it is the purveyor of goods that must be
responsible for ensuring that they are safe, effective, and properly
labeled. Over the years, Congress has shown remarkable consistency in
upholding this principle -- largely, I believe, because its members
recognized that the FDA can never be a ubiquitous policeman.

Bu the FDA is a policeman. Congress has given FDA the authority to deal with
those who would shirk their statutory responsibilities. And I promise you,
the FDA will not be a "paper tiger."

The other fundamental principle that gives life to our statute is the FDA's
positive duty to promote and protect the public health. This principle
requires the agency to act promptly and efficiently in everything we do.

All of us must care deeply about keeping unsafe products off the market. But
the corollary is that we should also care as deeply about making important
new therapies and technologies available, as promptly as we can, to those who
need them. Every decision the agency makes is a decision involving balance.
There can be no perfect decisions. Our decisions are based on current
scientific knowledge. As that knowledge is updated or revised we must remain
open to change as well.

Finally, and most importantly, we must stand for -- and insist upon --
honesty in everything that we do. Nothing is more important. We must be true
to the fundamental principle of science -- a scrupulous commitment to
honesty. The past two or three years have taught all of us painful lessons
about what can happen when integrity takes a back seat to expedience.

These are the things we must stand for: fealty to the Food, Drug and
Cosmetic Act, a willingness to enforce the statute, a commitment to strong
management, and integrity in everything we do.

Only in this way can we respond to the challenges, and the opportunities,
that we -- the community of those who care about health -- now face.

Let me close by speaking directly to FDA employees. I know that you joined
the agency because you wanted to protect the American consumer. And that is
exactly what you are going to do.

Do not let current or past problems outweigh the pride you can rightfully
take, day in and day out, in a job well done. Always remember that you are
working for the most important, the most respected, consumer protection
agency in the world.

There will be problems; there will be setbacks. But they should never get in
the way of the satisfaction you can take in the knowledge that every day you
make a difference.

The times demand a lot, but they demand no more than the FDA is capable of
delivering. Time and again you have proven your dedication, you have
demonstrated your ability to stick to your work until it is done.

This is one of the traits I most admire in you. It is an honor to join your
ranks today. I am proud to call myself a "Food and Drugger."

As the custodians of a proud heritage, we must always be willing to make the
tough decisions that are required of us. Regulators do not win popularity
contests -- and they should never try. But they should take great pains
never to be arrogant or overbearing.

Thirteen years ago Don Kennedy said the FDA was a large, slow-moving object
that bleeds profusely when hit. I suppose that says something about
bureaucratic inertia and about the FDA's vulnerability to attack from the
outside and from within. But large, slow-moving objects have momentum, too,
and when they are well-aimed they get where they are going, no matter what.

The story of the Food and Drug Administration is a series of proud chapters
in American history, written not by Commissioners, but by the men and women
of the FDA.

Their collective imprint on this agency -- and on the public health -- is
their greatest achievement, their enduring legacy. We must never lose sight
of the fact that the agency's record in assuring safety is unparalleled.

I pledge my every effort to drive appropriate change, to bring out this
agency's great resolve, vigor, and intellect. But change does not come from
the Commissioner alone.

True change comes from those who actually do the hands-on, day-to-day work.
And in our quest for change, in our desire to fix things, we must preserve
all that is good in this agency.

The Food and Drug Administration, Mr. Secretary, has the will and the talent
to serve this nation well. It has the most vital resource, the dedication of
its people.

Today we are here to celebrate not one person's new job, but the resurgence
of community, of tradition, of respect, of values that come alive only when
they are shared.

FDA is a great agency, and I am honored to become its Commissioner.