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David A. Kessler, M.D. - Food and Drug Law Institute

The New, Old-Fashioned FDA

by

David A. Kessler, M.D.
Commissioner of Food and
Drugs

Annual Conference - Food and Drug Law Institute
Washington, D.C.
December 10, 1991

Good Morning.

As you can see, the Food and Drug Administration is not what it used to
be. It is most assuredly not the same agency you saw last year.

In meeting the senior leadership team, you are seeing many of the people
who are changing the FDA.

* It is a team that believes strong enforcement provides the best
incentative to ensure compliance with the law.

* It is a team that regards strong management as essential for making
decisions -- and then acting on them.

* It is a team that places a premium on information consumers need to make
informed choices.

Each of the leaders you have just met has come to the FDA to help shape
this agency.

The leadership team is in place, and you have heard their views.

You have heard from Mike Taylor: FDA will base its work on sound policy
-- and our ultimate constituent, the American consumer, will benefit.

You have heard from Carol Scheman: for too long, the FDA has been
incorrectly or incompletely understood. We must get out message out.

You have heard from Elkan Blout: this agency will forge lasting ties
with the scientific infrastructure of the Nation, to strengthen our own
capability science, and to draw on outside expertise.

You have heard from Mary Jo Veverka: "business as usual" is a luxury we
can no longer afford.

You have heard from Ron Chesmore: the "new" spirit of the invigorated
FDA grows out of good, old-fashioned, straightforward enforcement.

Tomorrow you will hear from FDA Chief Counsel Margaret Jane Porter,
someone already quite familiar to all of you. She will reemphasize our
collective commitment to enforce the law.

And you have heard from Jane Henney -- the team member who will be the
Deputy directly responsible for FDA operations. She will serve and
strengthen the individual Center Directors by supporting them -- by working
with them -- by holding them accountable.

And this is only one echelon of the new leadership team. Let me briefly
mention several other members who are bringing their considerable talents
and fresh perspectives to this agency:

* Rush Merkatz, a nurse-clinician who serves as a special assistant to the
Commissioner on women's health issues;

* Amanda Pedersen, who is just completing her first year as the agency's
Chief Mediator and who I believe has already made an important difference in
conflict resolution;

* Sharon Natanblut, an expert in communicating about health, who is
managing several initiatives important to me personally;

* Kay Holcombe, an able administrator and scientist, who as Acting
Associate Commissioner for Legislative Affairs manages our relations with
Congress;

* Jim Phillips, who comes to the FDA after nearly two decades of
investigative experience on the Hill -- and who will serve as a kind of
"early warning system" for the agency;

* and Gary Fendler, the newest member of the team, who has joined FDA as
Associate Commissioner for Public Affairs after running communications at
the Securities and Exchange Commission.

It's a credit to the FDA, to this Department, and ultimately to the
Administration that the agency has been able to recruit such experienced and
talented people.

Why have they come?

They have come, in part, because they care deeply about public
service. I recognize that it has become fashionable to be cynical about
government. I am familiar with the view that today's problems are so
complicated as to defy solution.

The members of this team do not accept such fashionable cynicism.

Just as things are not always what at first they seem, the new
leadership team is only part of the story. The management of this agency
consists of much more than a team of deputies and senior advisors.

They are complemented and strengthened by the FDA Center Directors, who
fill an equally vital leadership role -- and who are critical members of the
team.

They are experienced professionals -- eminent scientists deeply invested
in the mission of this agency. They are as committed to driving change at
this agency as anyone on the podium.

The Center Directors are not new. They represent the best of the FDA.
They have my full and unequivocal support.

Last year I spoke of organizational change, which I promised would not
be undertaken lightly. In that spirit, the agency has attracted new talent
-- valuable for its enthusiasm and fresh ideas -- without giving up its own
best people, valuable for their experience and professionalism.

This is no accident. We have deliberately meshed FDA veterans with
relative newcomers -- the "old" with the "new" -- and this constellation is
part of our overall strategy for repositioning the agency.

Perhaps the best barometer of change at the FDA comes from rank-and-file
FDA employees themselves -- as they describe how the agency has changed in
the past year.

Here is a sampling of comments. Listen carefully to the words these FDA
veterans have chosen to describe some of the changes at the agency.

* One senior compliance official believes that the new emphasis on
enforcement is having an effect.

He says, and I quote, "When we do find problems in the field, firms are
much more willing to fix them -- and to resolve matters more quickly."

* "Our actions are more crisp," according to another senior official.

"The main difference is that we are not allowing ourselves to get into
long, drawn-out disagreements."

* "The agency appears to have much more vitality," observes a public
affairs specialist in a district office.

* "We're willing to talk to the public," says another. "The agency is
more open and honest."

* A headquarters employee observes, "I'm finally proud that we're out
there -- visible and open to the public -- as we should be."

* The director of a New Drug Evaluation Division notes, and I quote, "an
increased interest in rational management of the drug review process" over
the past year.

* Another division director has perceived "an increase in morale and a
better definition of our mission.

* A Regional Food and Drug Director perhaps summed up the changes best
when he concluded that "There is a feeling the agency is doing something
worthwhile.

"We have not had that for a while."

From comments such as these it is clear to me that the FDA is moving in
the right direction. Its mission is very much alive.

We will strive to keep up that momentum.

It is a part of the conventional wisdom around this town that the
Commissioner wields considerable power. To some extent that is true: a
commissioner can do lots of things.

It is my firm belief, however, that any Commissioner can accomplish only
one lasting achievement: and that is to instill in FDA employees a sense of
pride, a true commitment to their mission.

That's what this new leadership team is really about. And I want people
to understand what we're trying to accomplish at the agency.

Leadership is the ability to shape the culture of an organization.

The FDA faces a daunting set of tasks. Enormous forces converge upon
the FDA. They include the industries whose products the agency regulates;
individual consumers and organized consumer groups; members of Congress;
health professionals; other government agencies; and even the international
community.

And that leads me to my first point this morning. I hope we have made
it clear over the past year that these and other forces do not in any way
paralyze the agency.

To compensate for all the forces that converge at the agency, I believe
that we must exert a certain boldness about our mission -- a boldness that
is not traditionally characteristic of large government bureaucracies.

The FDA cannot be held prisoner of external forces. On the contrary.
These forces energize us.

Today's FDA is not at the mercy of external forces. We are setting the
agenda. It will not be set for us.

What I'm saying is that today's FDA is an intensely focused FDA. And
that has ramifications for the way people should do business with us.

First, events of the past year should suggest that the FDA takes its
enforcement responsibilities very seriously. Once we have focused on an
issue, we pursue it until it is resolved.

In that connection, I recognize that the past year may have been
unsetting for some segments of industry. We are changing the way we do
business.

You have my pledge that the FDA understands the need for dialogue, that
with enforcement a priority, we owe the industry clear guidance about our
expectations.

Second, as the competing forces converge on the FDA, as they express
their positions on policy matters, they should recognize one thing:
arguments based on specialized interests alone are unlikely to carry the day.

Industry, consumer groups, and other organizations: these groups need
to be in touch with what is going on outside the Beltway. It is these
broader forces -- and not insider interests -- that will guide FDA's
consumer protection and product review policies.

It is no secret, especially to the food and drug law community, that
people have built careers on fancy footwork to stymie the agency.

I have been simply amazed -- and I continue to be amazed -- by the
attitudes of thos who seek remedies (outside the FDA, instead of bringing
issues to Amanda Pedersen or to other senior FDA managers.

If we are not able to resolve matters, then of course interested parties
may appropriately raise their concerns elsewhere. That's fundamental
premise of our system.

We will be politically accountable, but the political process should not
intrude on scientific or regulatory judgments.

Third, there are some factions who have found in the FDA a convenient --
and all-purpose -- whipping boy. Whether the issue is product review time,
product safety, or openness to change, some have found the FDA a handy
target for real or imagined grievances.

Sometimes, these complaints are on the mark. When they are, the FDA
must listen to them, and be ready to respond.

At other times, critics of the FDA resemble those who -- not
understanding the true source or complexities of the problem -- are in
search of a scapegoat.

FDA will entertain all constructive suggestions, we will listen to harsh
criticism, and we will try to do better.

But today's FDA will no longer stand by in silence when it is unjustly
criticized. We will acknowledge the blame -- but only the blame we deserve.

Consider laments about FDA's product approval process.

How many times have we heard that the FDA is unnecessarily holding up
this or that application? How often are Americans told that they are paying
a high price for the alleged bureaucratic delay -- in economic cost, or
worse yet, needless suffering and death?

Tremendous advances have been made in our drug review process. Those
advances need to be acknowledged. The Agency is committed to streamlining
its processes.

We need to work together to produce high quality applications, review
them promptly, and make important new therapies available as fast as we can.

That brings me to another point: concerns about the drug review process
and what used to be called "drug lag."

On the one hand, there are those who have proposed a quick fix for the
gap they perceive between treatments available in the U.S. and those
approved elsewhere. Their advice: "The FDA should lower its standards."
In my opinion, that is unacceptable.

There is already a remarkable degree of latitude in our current
statutory mandate.

On the other hand are those who argue that, in product review, the
status quo must reign. Innovation is unwelcome, because it may involve
risks.

This "risk-averse" point of view also will not thrive in the FDA of
today. In fact, when it comes to drugs for life-threatening diseases, the
riskiest thing we can do is to be unwilling to take risks.

Let me remind each of you that the current risk-benefit equation -- the
current standard -- permits greater risks when greater benefits are possible.

When it comes to product review, you have my commitment that the agency
will innovate and experiment. It is critical at this point in our history
to push the limits of our creativity and recognize our ability to make a
difference. The American public demands no less of us.

Let me give you an example of what I mean. Ten years ago, women's
health groups were among the strongest advocates of the most stringent
consumer protection. They argued forcefully that the FDA was not being
thorough enough in product reviews.

Now, some of those same groups say just the opposite. Recently, I was
sitting across the table from a representative of a women's group, and she
said to me, "I never thought I'd be asking you to accelerate the review of
certain drugs -- even if all the results are not in -- but that's exactly
what I'm doing."

Another argument we sometimes hear is that the FDA should change its
ways in order to make American products more competitive. I agree that some
of the agency's processes need updating, and we are hard at work on that.

But the FDA must never compromise its integrity and its standards.

In my view, an efficient regulatory process plus high standards will
ensure American competitiveness.

We must always be efficient in our work. Unless we are efficient, we
will have a devastating effect on the competitiveness of this country.

But our standards must also remain high. Weakened standards would, I
believe, have an equally devastating effect on the nation's competitiveness.

Product standards established efficiently and thoughtfully provide
incentives to improve quality, adopt new technologies, and meet the needs of
consumers.

In short, they make an industry more competitive -- not less.

A further point. It is simply not enough for the FDA to focus solely on
the contents of the vial or ampule or package and ensure that the product
inside is safe.

FDA must do everything in its power to facilitate informed consumer
choice about the products it regulates and to see that consumers have
adequate information to use products safely and to their best advantage.

We are strongly committed to dealing with those who engage in false or
misleading practices. But it goes beyond that.

Ensuring accurate and useful information complements and enhances FDA's
more traditional consumer protection and product review work.

You will see an increased emphasis on information across the board.

This "push to inform," as one journalist put it, permeates the sweeping
reform of the Nation's food label.

And we must not focus exclusively on adults. FDA is looking at ways to
make America's children more nutrition-conscious by educating them about the
food label.

The push to inform also underlies my belief that we need to bridge the
information gap by encouraging pharmacists and physicians to provide more --
and better -- information about drug products.

I would encourage you to think about innovative ways to educate
Americans about the products they use -- and to consider how we can help you.

I'm not talking about advertising, or even about education in a
promotional environment.

I'm talking about innovative ways to provide real information so that
consumers can make decisions that affect their lives.

This is a real public health opportunity. Although the potential payoff
is large, the investment is modest. And it is an area that has been
neglected in the past.

Let me shift gears.

It was exactly fifty-two weeks ago today that I stood before you, during
my second week at the FDA.

I am well aware that there is only one chance to make a first
impression. And I wouldn't presume to characterize the impression you
formed just one year ago.

Some people, I am told, hope that things will change in the coming year
now that FDA is back on the map. They contend, the story goes, that the new
Commisioner had to get everyone's attention. That explains his emphasis on
enforcement. He will soon move on to other things.

Let there be no mistake: the past year at the FDA has had very little
to do with getting people's attention.

It has had everything to do with the way we do business.

You can rest assured that, whatever your first impression of the new FDA
management, I have no problem with the perception that today's FDA is
serious about enforcement. It will remain a top priority.

Last month I visited the Baltimore District Office of the FDA. It was a
routine visit, part of a continuing effort to get in touch with the consumer
protection roots of the FDA.

That visit convinced me that the enforcement message is permeating the
agency.

I walked in the main entrance, and in the reception area there hung a
banner with a big sign.

"THE WATCHDOG IS BACK," the caption read, "AND IT HAS TEETH".

Enforcement really matters to me. I care about it. But that banner in
the District Office signifies something else -- something that is stronger
and runs much deeper.

It signifies a renewed pride in the FDA, and a restored commitment to
its mission.

By emphasizing enforcement in the past year, we have clarified one of
the FDA's most important goals. And we have "energized" the agency and its
employees in ways that have implications beyond enforcement.

When individual employees are enthusiastic about what they do, the
agency takes on a wholly different dynamic.

Let me emphasizes that the focus on enforcement does not preclude an
equally intense dedication to other goals. I care very deeply about getting
important new therapies to patients who need them so desperately. This,
too, is a goal that matters a lot to me.

A reporter asked me a question the other day about the new, accelerated
drug approval process.

"How many important new therapies," he asked, "are you willing to move
through the system?"

Carl Peck was standing at my side, and he whispered the answer in my ear.

"As many life-saving drugs as the pharmaceutical industry can develop,"
he said.

I couldn't agree more. Just as the renewed emphasis on enforcement has
energized our field force, the current push to get important new therapies
to patients sooner has captured the imagination of our Center for Drug
Evaluation and Research. The number of pilot projects and creative ideas
flowing out of that center has never been greater.

I have a third goal. I want consumers to have the information they need
to use products wisely and well. The ability of our Center for Food Safety
and Applied Nutrition to reshape the food label demonstrates the commitment
of the agency to a more well-informed public.

I want the goals to be clear. For until our goals become clear, there
will be uncertainly -- we will hesitate as an agency. We will always hold
back a little and never be truly effective.

There are three simple goals: strong enforcement, getting important
products out, and ensuring accurate information.

These are clear and simple goals. Goals that I believe in -- and goals
that FDA employees support.

These goals set the course for the agency.

There's a fourth agenda item -- one that cuts across everything that we
do.

It is fostering an environment conducive to making decisions. I want
the FDA to be a decisive agency.

Those are my goals.

I know that these things won't come easy. Nothing worthwhile ever does
-- especially in this town.

It is difficult to drive change.

I recognize that -- as we continue to strengthen enforcement -- there
are those who will grumble.

I recognize that -- as we devise creative new approahes to move
potentially life-saving drugs to patients more quickly -- there will be
those who will grumble.

And I recognize that -- as we revitalize the management of this agency
-- there will be those who will grumble.

I recognize that you can't do anything useful in life without generating
a few grumbles.

We at the agency are willing to tackle the enormity of the tasks we
face, recognizing deep down that we will never do it all.

What separates us from the cynics, I would suggest, is that we are
willing to try despite the long odds. The FDA is committed to making a
difference.

We have a strong team in place. We have an agency of dedicated public
servants, 8,000 strong.

Moreover, we have a renewed sense of partnership among our agency and
the Department of Agriculture, the Federal Trade Commission, the
Environmental Protection Agency, and the National Institutes of Health.

At the State level, we are working more closely than ever with the
Attorneys General, as well as our food and drug counterparts across the
Nation.

This renewed partnership, this pooling of resources, makes us even
stronger.

And, as I said last year, never underestimate the vigor and the vitality
of this organization and its people.